Hyris developed a rapid T-cell test to track patients' immunity levels to SARS-CoV-2 for global clinical use after having inked an exclusive licensing agreement with Duke-NUS Medical School. This new solution leverages the Hyris SystemTM, a proprietary platform that enables genetic testing in any setting, at any time, with results available in real-time through its AI-powered platform.

Hyris supports research over COVID-19 Immunity

LONDON, Oct. 14, 2021 (GLOBE NEWSWIRE) -- After almost two years of fight against COVID-19, governments, NGOs, and corporations are now focusing on strategies and solutions to boost population immunity and move onto the next phase - possibly out of the pandemic.

Hyris, a global, innovation-based biotechnology company renowned for its inclusive approach to genetic analysis, offers a wide range of solutions to support medical professionals and decision-makers in the fight against COVID-19. The proprietary genetic testing Hyris SystemTM has been successfully used to detect the presence of the Coronavirus on surfaces and environments (the SARS-CoV-2 Environmental test) and the infection COVID-19 into individuals (SARS-CoV-2 Human test). The tests have been able to reliably detect the presence of all the main Variants of Concern since July 2020, helping to keep people safe around the world effectively.

"Alongside with limiting the spread of SARS-CoV-2 new variants and potential hotspots, getting high immunity rates among populations is the number one priority for policymakers and health institutions," says Stefano Lo Priore, Founder and CEO at Hyris. "Hyris integrated its solutions with a simple yet effective test, to measure a patient T-cell immune response to the SARS-CoV-2 virus, which causes COVID-19."

The T-cell clinical test kit was developed through an exclusive licensing agreement between Hyris and Duke-NUS Medical School. "This new kit enables quick evaluation of T-cell immune responses in COVID-19 convalescent patients as well as vaccinated people," adds Isabella Della Noce, Chief Biologist at Hyris. "This is a new dimension for vaccine strategies as we face the threat of new virus variants."

Story continues

Led by Professor Antonio Bertoletti from the Programme in Emerging Infectious Diseases at Duke-NUS, the research team discovered a simple and rapid method to measure the T-cell immune response to the SARS-CoV-2 virus. The study, titled "Rapid measurement of SARS-CoV-2 spike T cells in whole blood from vaccinated and naturally infected individuals", was published in the Journal of Clinical Investigation.

According to Duke-NUS' press release, this discovery allows a rapid and large-scale expansion of studies to track T-cell activity across the world while not requiring specialised or expensive equipment, helping to define the correlates of protection from T-cells and antibodies for the development of COVID-19 vaccines.

Many progressive organisations and medical centres worldwide have already chosen the Hyris System as the ideal 'Point of Care' solution in the fight against COVID-19. Such a test is a prime example of how scientific innovation is key to the fight against the SARS-CoV-2 virus. "Today, more than ever before, we need wider access to diagnostic systems and tests, but also to support and validate vaccination campaigns around the world," concludes Lo Priore.

Contact a Hyris expert to discover how to perform beyond your current diagnostic capability info@hyris.net.

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Recommendation and review posted by Bethany Smith

The Direct-to-consumer Genetic Testing market report provides a granular assessment pertaining to the key development trends and dynamics impacting this industry landscape over the analysis timeframe. It offers significant inputs with respect to the regulatory outlook as well as geographical landscape of this business space. The study also elaborates on the factors that are positively influencing the overall market growth and encloses a detailed SWOT analysis. Additionally, the document comprises of limitations & challenges impacting the future remuneration and y-o-y growth rate of this market.

The report offers an in-depth analysis of the competitive landscape alongside raw materials and downstream buyers of Direct-to-consumer Genetic Testing market. Moreover, the study assesses the effect of COVID-19 pandemic on the growth opportunities of this industry vertical.

Elaborating on the competitive landscape of Direct-to-consumer Genetic Testing market:

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Development policies and plans arediscussed as well as growth rate, manufacturing processes, economic growth are analyzed. This research report also states import or export data, industry supply, and consumption figures as well as cost structure, price, industry revenue (Million USD), and gross margin by regions like North America, Europe, Japan, China, and other countries.

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Direct-to-consumer Genetic Testing Market 2021 Global Outlook, Research, Trends and Forecast to 2026 - Northwest Diamond Notes

Recommendation and review posted by Bethany Smith

The company is leveraging success with its COVID-19 tests to position itself better for a post-pandemic world. Key Points

Fulgent Genetics' (NASDAQ:FLGT) sales soared thanks to its COVID-19 tests. Its stock more than quadrupled in 2020 and is up over 50% so far this year. In this Motley Fool Live video recorded on Sept. 29, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss what's going on now with Fulgent.

Keith Speights: Your thoughts on Fulgent Genetics, ticker is FLGT?

Brian Orelli: The company is still developing genetic tests, which was what they were doing before the pandemic. They're still doing COVID-19 testing, which is what they pivoted or added during the pandemic. Then they are using all that cash that they're getting from the COVID-19 to expand fairly quickly.

They bought a company that does more other types of tests for cancers, looking at imaging the tumors and that thing and looking at the chromosomes. I think that they are using that to expand their offerings, so now that they will be able to do genetic testing on the tumors, but also offer other services. That should make them a one-stop-shop for tumors.

They also did a deal with another company that has a predictive test, I believe, for cancer. They're partnering with that company. The other one was an acquisition where they just bought the whole testing facility to expand their offerings in cancer.

This article represents the opinion of the writer, who may disagree with the official recommendation position of a Motley Fool premium advisory service. Were motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

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People who are at a greater risk for developing, or have previously received a diagnosis of, a hereditary cancer have an acceptable method available to them to identify what the chances of passing those and other genetic mutations on to their future children are.

The procedure, known as preimplantation genetic testing, helps identify what, if any, genetic abnormalities are present in embryos that were created during the process of in vitro fertilization (IVF).

This procedure may effectively aid people with a previous diagnosis, or risk, of hereditary cancer from passing those genetic mutations on to future offspring.

During the recent 12th Annual Joining FORCES Against Hereditary Cancer Conference, Dr. Terri L. Woodard, an associate professor in the Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center in Houston, discussed the topic of fertility preservation and parenting issues that cancer survivors and previous often face. Moreover, Woodard highlighted what people should know about certain genetic testing procedures.

Increase in Genetic Mutations

Woodard noted that previous research has shown that adolescents and young adults diagnosed with cancers that are frequently associated with old age often have a higher percentage of inherited cancer mutations.

However, she explained, those rates are higher than were once thought.

In fact, Woodard cited a study of more than 1,000 adolescents aged between 18 years and 39 years and noted that the results demonstrated that approximately 21% of the participants diagnosed with early-onset cancer had a germline mutation. Only 13% of the remaining patients had a germline mutation.

This just highlights the fact that many of these young individuals have genetic mutations that can be passed down along to their offspring, she said. Because these patients are younger, there are often fertility and family building issues that arise.

Fertility and Future Family Planning Concerns

There are several genetic conditions associated with a greater cancer risk, according to Woodard. If people have any of those conditions, they are likely to want to pursue genetic testing. For instance, she highlighted hereditary breast and ovarian cancer syndrome. Woodard noted that many of these patients may experience some form of infertility at a younger age than other people. These patients also may need to undergo risk-reducing surgeries to prevent ovarian cancer.

Another condition, known as Li-Fraumeni syndrome, is associated with a greater risk for developing sarcomas, central nervous system tumors, breast cancer and gonadal germ cell tumors all of which, according to Woodard, negatively affect a persons fertility.

Thats why, she said, many of these individuals need to be partaking in fertility preservation conversations with their care team.

Additionally, some of these cancers may require treatment that negates a persons ability to have children.

Fertility Preservation Methods

Woodard shared insight on some of the fertility preservation methods that people have access to. She noted that eggs, embryos and sperm can all be frozen for use later. Ovarian and testicular tissue freezing are also possibilities, according to Woodard.

Another option available to patients who require radiation to the areas surrounding their reproductive organs is gonadal shielding. In this instance, radiology technicians use protective shields to minimize radiation exposure to certain areas.

People can also go through an experimental approach known as ovarian suppression. Woodard explained that a gonadotropin-releasing hormone agonist is used in women to suppress the ovary during chemotherapy.

The thought is that a quiet ovary is more resistant to the effects of chemotherapy than one that is actively cycling, she said during her presentation.

She cautioned, however, that the data that are available on this approach are quite variable.

Family Building Options

There are a great range of opportunities available to patients when deciding to have a family, Woodard explained. Depending on their comfort levels, she said, options available to patients range from natural conception to IVF and plenty more.

For people who may have premature ovarian failure because of their cancer treatment, there is an option to use donor eggs, sperm or embryos. There are also gestational carriers for women who may no longer have a uterus or are deemed too high risk to carry a pregnancy to full-term.

And lastly, Woodard noted that people can pursue adoption. However, she explained, it can sometimes be difficult for people with a history of cancer to adopt.

Sometimes adoption can be challenging for survivors of cancer because some agencies see it as too risky and do not allow those patients to have kind of the initial screening, she said. Asking an adoption agency, whether a cancer diagnosis will disqualify them early on, is a very important question for patients to ask.

Genetic Testing for Future Children

Woodard concluded her discussion by reviewing genetic testing methods that are available for patients to use for assessing the possibility of passing inherited mutations down to future children.

Patients who are already pregnant may use prenatal genetic testing, she said. Prenatal screening lets the parents know what the chances are that the child would have abnormal genetics. Diagnostic prenatal tests are slightly different in that they can show if a fetus is affected with a certain disorder.

The problem with prenatal genetic testing is that the patient is already pregnant, she said. If we find an abnormality, it really has some implications and has patients (making) some hard decisions on whether they would want to continue the pregnancy or not.

For those patients who are not yet pregnant and may be considering IVF, preimplantation genetic testing is a viable option.

Woodard explained that an embryo is tested after the initial IVF prior to transplanting the embryo back into the patients uterus. There are several types of preimplantation genetic testing, but one specifically tests the embryo for a specific gene.

If a woman is a carrier of a BRCA mutation, and she wants to test her embryo for that mutation, this is the type of testing we would use, she explained.

Although some consider preimplantation genetic testing to be unethical or controversial because some people use it for sex selection of their baby Woodard noted its a viable option for many trying to start a family without passing genetic mutations down to their offspring.

(Preimplantation genetic testing) is an acceptable method to prevent transmission of mutations to offspring, but requires in-depth genetic counseling and support, she concluded.

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Novel Procedure Considered an 'Acceptable Method' to Preventing Transmission of Hereditary Cancer Mutations to Children - Curetoday.com

Recommendation and review posted by Bethany Smith

Expanded in-house testing capabilities enable faster and more accurate diagnosis, prognosis and treatment planning for a wide variety of cancers.

Florida Cancer Specialists & Research Institute (FCS) recently expanded its molecular testing capabilities at its state-of-the-art Pathology Laboratory in Fort Myers and is providing patients with clinical next-generation sequencing (NGS) that are offered at FCS clinics throughout Florida. NGS testing is available for testing of solid tumors and hematologic malignancies and lymph nodes.

Through its NGS tests, FCS pathologists can detect oncogenic mutations in hundreds of different genes, tumor mutational burden and microsatellite instability simultaneously. This form of genetic testing allows clinicians to make faster diagnoses of a wide range of cancers while providing recommendations for clinical trials options and personalized therapies based on each patients results.

This latest innovation has been a collaboration and strategic vision of FCS executive and physician leadership along with the medical and clinical teams at the FCS Pathology Lab. Having NGS capabilities and resources housed and managed within the organization further complements FCS genetics counseling capabilities by enabling the development of more comprehensive risk assessments.

FCS Chief Executive Officer Nathan H. Walcker said, We see tremendous clinical and strategic value to performing this very important testing in-house. With genomic testing, we are providing our physicians with enhanced tools to optimize treatment options for our patients, including improved clinical trial matching opportunities.

Adding Next Generation Sequencing capabilities is very exciting and will certainly open up more clinical trial opportunities for our patients and practice, said Manish Patel, MD, FCS Director of Drug Development. We have many clinical trials that involve molecularly targeted therapies, and these will now be more efficiently matched to our patients mutational profiles.

This level of advanced laboratory services is rarely available from a community oncology practice, Walcker continued. Our continuous investments in the highest quality and most advanced technologies and the partnerships we have established with globally recognized industry leaders further enhances our ability to deliver truly personalized medicine to our patients, leading to more positive outcomes.

According to FCS President & Managing Physician Lucio Gordan, Centralized NGS capabilities can help drive the ultimate patient-centered goal of more personalized therapy and increased cure and response rates through faster molecular diagnosis and treatment planning. NGS testing can provide us with a clearer and more distinct understanding of each patients individual diagnosis, he concludes.

FCS established critical partnerships with global technology and software leaders in NGS testing and has built the fundamental infrastructure for the success of the lab that includes a dedicated laboratory geneticist, molecular pathologist and supporting clinical experts.

Following FCS clinical research and development, together with its independent test validations of Illumina 500+ solid tumor panel; Invitae VariantPlex Myeloid panel and the Invitae FusionPlex PanHeme panel on the Illumina NextSeq 550Dx sequencing platform, FCS is now able to offer these tests to current patients.

The genetic test results are analyzed and interpreted by FCS variant scientists using the PierianDx CGW software. Powered by a comprehensive knowledgebase and secure, scalable data analysis platform, PierianDx CGW will enable FCS to perform quick and accurate classification and interpretation of the results to help identify FDA-approved therapies or match patients within the practices large network of participating clinical trials.

The launch of the NGS lab and testing capabilities has been positively received among physicians and clinicians throughout FCS. Providing NGS capabilities and expertise inhouse greatly enhances access and integration of molecular testing into precision treatment planning, said FCS Assistant Managing Physician Michael Diaz, MD.

Having Florida Cancer Specialists and Research Institute as a customer represents another important step in our journey to bring genomic solutions to the fight against cancer, said Phil Febbo, MD, Chief Medical Officer at Illumina. By unlocking the power of the genome, we will help researchers and clinicians process, analyze and make genomic data more accessible to advance future cancer care and improve outcomes.

As pioneers in genetics, Invitae is focused on making genetic information available to as many people as possible who can benefit from it. We are delighted and proud to begin this strategic collaboration with FCS and applaud the practice for embracing and investing in this groundbreaking approach. It will not only expand access to genetic testing but will truly transform oncology care in the years to come, said Robert Daber, Chief Scientific Officer, Oncology, of Invitae.

We are thrilled to provide our best-in-class bioinformatics and knowledge platform to support personalized, community-based cancer care, states Mark McDonough, CEO of PierianDx. Partnering with leading-edge institutions like Florida Cancer Specialists aligns with our mission to democratize clinical genomics and to vastly advance the precision and accuracy of cancer care.

Recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. In the past four years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with Florida Cancer Specialists participation. * Trained in prestigious medical schools and research institutes, our physicians are consistently ranked nationally as Top Doctors by U.S. News & World Report.

Founded in 1984, Florida Cancer Specialists has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies, genomic-based treatment, and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff.

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Florida Cancer Specialists & Research Institute Expands Next Generation Genomic Testing Capabilities to Advance Cancer Care - OncLive

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PEOPLE who have at least two grandparents from the Scottish Traveller community are urged to take part in the first genetic study of the group.

Edinburgh University researchers are seeking to understand how Scottish Travellers relate to Irish Travellers, English Gypsies and Welsh Kale, as well as those in settled communities.

Those who take part will be asked to provide a saliva sample for genetic testing, as well as complete a survey about their health and lifestyles.

Previous research helped to define the Irish Traveller community as a distinct ethnic group, the university said.

Lead researcher, Professor Jim Wilson, said: Scottish Traveller groups have never been involved in studies using the power of modern genetics. I was delighted to be asked by representatives of this community to carry out a study that will reveal how the Traveller communities fit into the genetic landscape of Scotland and the British Isles.

Samantha Donaldson, a Scottish Traveller from Dunfermline and a member of the studys public involvement panel, said: For us Travellers, also known as Nacken, this study could be very useful.

Many myths surround our origins, so the study could potentially prove or disprove some of these stories. Travellers have some of the greatest health inequalities in Scotland.

If we are genetically predisposed to certain conditions more than other groups, or if we have illnesses that are more likely to affect us,

then health professionals may be able to use data to address some of these inequalities.

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People urged to take part in genetic study of Scottish Traveller community - The National

Recommendation and review posted by Bethany Smith

FACTS AT A GLANCEEdition:9;Released:April 2021Executive Pool:383Companies:42 - Players covered include Alta Genetics, Inc.; Animal Genetics Inc.; Crv Holding B.V.; Envigo, Inc.; Ew Group GmbH; Genus PLC; Hendrix Genetics BV; Neogen Corporation; Vetgen; Zoetis, Inc. and Others.Coverage:All major geographies and key segmentsSegments:Product & Service (Live Animals, Genetic Materials, Animal Genetic Testing Services)Geographies:World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

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ABSTRACT-

Global Animal Genetics Market to Reach $7 Billion by 2026Amid the COVID-19 crisis, the global market for Animal Genetics estimated at US$4.6 Billion in the year 2020, is projected to reach a revised size of US$7 Billion by 2026, growing at a CAGR of 7% over the analysis period. Live Animals, one of the segments analyzed in the report, is projected to record a 7.6% CAGR and reach US$5.1 Billion by the end of the analysis period. After a thorough analysis of the business implications of the pandemic and its induced economic crisis, growth in the Genetic Materials segment is readjusted to a revised 6.8% CAGR for the next 7-year period.

The U.S. Market is Estimated at $1.5 Billion in 2021, While China is Forecast to Reach $1.2 Billion by 2026The Animal Genetics market in the U.S. is estimated at US$1.5 Billion in the year 2021. China, the world`s second largest economy, is forecast to reach a projected market size of US$1.2 Billion by the year 2026 trailing a CAGR of 6.5% over the analysis period. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 6.6% and 5.6% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 5.7% CAGR.

Animal Genetic Testing Services Segment to Reach US$836.6 Million by the year 2026In the global Animal Genetic Testing Services segment, USA, Canada, Japan, China and Europe will drive the 4.4% CAGR estimated for this segment. These regional markets accounting for a combined market size of US$514.3 Million in the year 2020 will reach a projected size of US$696.9 Million by the close of the analysis period. China will remain among the fastest growing in this cluster of regional markets. More

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New Analysis from Global Industry Analysts Reveals Steady Growth for Animal Genetics, with the Market to Reach $7 Billion Worldwide by 2026 -...

Recommendation and review posted by Bethany Smith

BOSTON, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today announced that it has submitted its Type II variation application to the European Medicines Agency (EMA) for IMCIVREE (setmelanotide) for the treatment of obesity and control of hunger in adult and pediatric patients six years of age and older with Bardet-Biedl syndrome (BBS) or Alstrm syndrome.

This marks an important milestone toward our goal of delivering IMCIVREE globally to patients with BBS and, ultimately, many other rare genetic diseases of obesity, said David Meeker, M.D., Chairman, President and Chief Executive Officer of Rhythm. IMCIVREE achieved clinically meaningful and statistically significant results in our Phase 3 trial in BBS and provided evidence of marked and sustained weight loss in patients with Alstrm syndrome treated in our Phase 2 and 3 trials. Based on these data, we believe IMCIVREE will be the first medicine to effectively address the severe, early-onset obesity and hyperphagia that characterize these diseases. We look forward to working closely with regulatory authorities in the European Union to deliver IMCIVREE to these additional populations.

The BBS community in the EU is particularly well established, with approximately 1,500 patients diagnosed and being cared for at academic centers, said Yann Mazabraud, Executive Vice President, Head of International of Rhythm. Importantly, many of these patients present with the severe obesity and hyperphagia that treatment with IMCIVREE is designed to address. We are eager to continue our targeted efforts to increase understanding of BBS and the potential benefits of IMCIVREE and, if authorised, look forward to bringing this treatment to market quickly as a key step toward transforming the care of people living with rare genetic diseases of obesity.

The EMA submission is based on data from Rhythms pivotal Phase 3 clinical trial of setmelanotide in patients with BBS or Alstrm syndrome. The EMA submission is based on data from Rhythms pivotal Phase 3 clinical trial of setmelanotide in patients with BBS or Alstrm syndrome. As previously reported, the study met its primary endpoint and all key secondary endpoints, with statistically significant and clinically meaningful reductions in weight and hunger at 52 weeks on therapy. All patients who met the primary endpoint defined as more than 10 percent weight loss had BBS and none had Alstrm syndrome. However, data from this Phase 3 trial is supported by results from the Phase 2 trial, which suggest that treatment with setmelanotide may result in decreased weight and hunger in people living Alstrm syndrome. In addition, data from a predefined exploratory endpoint showed that, in BBS and Alstrm syndrome patients younger than 18 years old, setmelanotide treatment was associated with clinically meaningful reductions in BMI-Z scores. The BMI-Z score, or BMI standard deviation score, represents the number of standard deviations from median BMI by child age and sex.

About Bardet-Biedl and Alstrm Syndromes BBS and Alstrm syndrome are ultra-rare genetic diseases that affect multiple organ systems. Clinical features of BBS may include cognitive impairment, polydactyly, renal dysfunction, hypogonadism, and visual impairment. Clinical features of Alstrm syndrome may include progressive visual and auditory impairment, insulin resistance and Type 2 diabetes, hyperlipidemia, progressive kidney dysfunction, cardiomyopathy, and short stature in adulthood. Insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life is common in people living with either BBS or Alstrm syndrome. Rhythm estimates that BBS affects approximately 1,500 to 2,500 people and that Alstrm syndrome affects approximately 500 people in the United States, with a similar prevalence estimate in Europe. Currently, there are no approved therapies targeting the MC4R pathway for reducing body weight and hunger in BBS or Alstrm syndrome.

AboutRhythm Pharmaceuticals Rhythm is a commercial-stage biopharmaceutical company committed to transforming the treatment paradigm for people living with rare genetic diseases of obesity. Rhythms precision medicine, IMCIVREE (setmelanotide), was approved inNovember 2020by theU.S. Food and Drug Administration(FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing and in July andSeptember 2021, respectively, by theEuropean Commission(EC) and Great BritainsMedicines & Healthcare Products Regulatory Agency(MHRA) for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. IMCIVREE is the first-ever FDA-approved and EC- and MHRA-authorized therapy for patients with these rare genetic diseases of obesity. Rhythm is advancing a broad clinical development program for setmelanotide in other rare genetic diseases of obesity, and is leveraging the Rhythm Engine and the largest known obesity DNA database -- now with approximately 37,500 sequencing samples -- to improve the understanding, diagnosis and care of people living with severe obesity due to certain genetic deficiencies. Rhythms headquarters is inBoston, MA.

IMCIVREE (setmelanotide) Indication In the EU andGreat Britain, IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. IMCIVREE should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Inthe United States, IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. The condition must be confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

Limitations of Use IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign;Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity.

Important Safety Information

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal:Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males and sexual adverse reactions in females occurred in clinical studies with IMCIVREE. Instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation:Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation. Monitor patients for new onset or worsening of depression. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors.

Skin Pigmentation and Darkening of Pre-Existing Nevi:IMCIVREE may cause generalized increased skin pigmentation and darkening of pre-existing nevi due to its pharmacologic effect. This effect is reversible upon discontinuation of the drug. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmentary lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants:IMCIVREE is not approved for use in neonates or infants.

ADVERSE REACTIONS

The most common adverse reactions (incidence 23%) were injection site reactions, skin hyperpigmentation, nausea, headache, diarrhea, abdominal pain, back pain, fatigue, vomiting, depression, upper respiratory tract infection, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Treatment with IMCIVREE is not recommended for use while breastfeeding.

To report SUSPECTED ADVERSE REACTIONS, contactRhythm Pharmaceuticalsat +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

See Full Prescribing Information and EU SmPC for IMCIVREE.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, our expectations surrounding potential regulatory submissions, approvals and timing thereof, our business strategy and plans, including regarding commercialization of setmelanotide, and our participation in upcoming events and presentations. Statements using word such as expect, anticipate, believe, may, will and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our liquidity and expenses, the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies, clinical trials and commercialization prospects, and general economic conditions, and the other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the quarterly period endedJune 30, 2021and our other filings with theSecurities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Corporate Contact: David Connolly Head of Investor Relations and Corporate Communications Rhythm Pharmaceuticals, Inc. 857-264-4280 dconnolly@rhythmtx.com

Investor Contact: Hannah Deresiewicz Stern Investor Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com

Media Contact: Adam Daley Berry & Company Public Relations 212-253-8881 adaley@berrypr.com

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Rhythm Pharmaceuticals Completes Submission of Type II Variation Application to the European ... - Tyler Morning Telegraph

Recommendation and review posted by Bethany Smith

SAN DIEGO, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (BNGO), developer of the Saphyrsystem that uses optical genome mapping (OGM) for the detection and analysis of structural variants (SVs), today announced the publication of a study in which OGM and next-generation sequencing (NGS) with linked-reads were used together to resolve genetic diseases that were previously unclassified after evaluation by whole-exome sequencing (WES) alone. This study, from the University of California, San Francisco (UCSF) and Childrens Hospital Oakland (now UCSF Benioff Childrens Hospital Oakland) and appearing in the September 23, 2021 peer-reviewed issue of Nature Publishing Journal of Genomic Medicine, shows the benefit of combining OGM with short-read sequencing for improved detection of clinically relevant variants in genetic disease research.

The studys authors, Shieh, et al., describe their Full-Genome Analysis (FGA) approach with automated analysis using NGS linked-read sequencing and OGM to evaluate a full spectrum of genetic variants found in inherited genetic diseases.FGA identified structural variants and small variants with an increase in detection capability of 40%(20 of 50 cases). The number of resolved cases attributable to SVs was notable in the study, as 50% of exome-negative cases (four of eight cases) were solved by identifying an SV or rearrangement. The authors also identified candidate variants in another 60% (18 of 30 cases) for future follow-up.

In one specific case, the authors found a rare 32kb heterozygous de novo intronic duplication within theNHEJ1gene that was not detected by standard microarray analysis because it was small and intronic. It had also escaped detection in copy number variants called from short-read, whole genome sequencing (WGS) data but was easily identified with their FGA method using OGM.

The findings reinforce that the combination of OGM and NGS used in the FGA method detects and localizes SVs such as duplications missed by WGS, and can quickly identify translocations and phase variants across long distances. For individuals with undiagnosed conditions, these two technologies encompass what is currently provided by the combination of chromosome analysis karyotyping, microarray testing and short-read WGS. FGA provides information beyond current assays and results in higher resolution genome maps that can be used for future studies.

As observed in the study, Bionanos Saphyr system, which can detect all classes of SVs, such as insertions, deletions, inversions, duplications, translocations and copy number variations, complemented NGS. Accordingly, when used together, they can provide the clinical research community with the ability to see the entire genome and identify a more comprehensive set of genetic variants to diagnose rare diseases accurately.

Erik Holmlin, PhD, CEO of Bionano Genomics, commented, This studys results go beyond just reinforcing the power of OGM it shows us how we can significantly impact peoples lives by combining NGS and OGM in genome analysis to find answers. Fifty percent of the participants in this study had clinically relevant variants hidden in their genomes that WES alone had not uncovered. OGM, together with a linked-read assay using NGS, revealed key answers for these participants. We believe there is tremendous potential in using OGM together with NGS to understand disease from the very beginning of any study. Congratulations to Dr. Shieh and his team on this tremendous progress.

This publication is available athttps://www.nature.com/articles/s41525-021-00241-5

About Bionano Genomics

Bionano is a genome analysis company providing tools and services based on its Saphyrsystem to scientists and clinicians conducting genetic research and patient testing; it also provides diagnostic testing for those with autism spectrum disorder (ASD) and other neurodevelopmental disabilities through its Lineagen business. Bionanos Saphyr system is a research use only platform for ultra-sensitive and ultra-specific structural variation detection that enables scientists and clinicians to accelerate the search for new diagnostics and therapeutic targets and to streamline the study of changes in chromosomes, which is known as cytogenetics. The Saphyr system is comprised of an instrument, chip consumables, reagents and a suite of data analysis tools. Bionano offers genome analysis services to provide access to data generated by the Saphyr system for researchers who prefer not to adopt the Saphyr system in their labs. Lineagen has been providing genetic testing services to families and their healthcare providers for more than nine years and has performed more than 65,000 tests for those with neurodevelopmental concerns. For more information, visitbionanogenomics.comor lineagen.com.

Forward-Looking Statements of Bionano Genomics

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, expect, plan, anticipate, estimate, intend and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the utility of the combination of OGM and NGS, including with respect to enabling the accurate diagnosis of rare diseases, and its potential benefits to the research community. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive products; observations from studies may not be replicated or have the anticipated benefits once implemented by the clinical research community; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; the loss of key members of management and our commercial team; and the risks and uncertainties associated withour business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2020 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on managements assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionanogenomics.com

Investor Relations:Amy ConradJuniper Point+1 (858) 366-3243amy@juniper-point.com

Media Relations:Michael SullivanSeismic+1 (503) 799-7520michael@teamseismic.com

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Study Shows the Combination of OGM and NGS with Linked-Reads Detects Significantly More Clinically Relevant Variants Resulting in Higher Success Rates...

Recommendation and review posted by Bethany Smith

video:A new GeneSight Mental Health Monitor national survey finds many Americans are experiencing anxiety symptoms, but some wont seek treatment. view more

Credit: GeneSight Mental Health Monitor

Many Americans are experiencing anxiety symptoms as a result of the pandemic. Yet, one in five say they wont seek treatment for mental health conditions and others say they wont get help until these symptoms take a toll in their lives.

Nearly half (46%) of all respondents rated their anxiety symptoms as moderate to severe over the past six months, according to the GeneSight Mental Health Monitor from Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine.

Of those surveyed who are diagnosed with anxiety, the numbers are even worse 86% rated their anxiety symptoms as moderate to severe over the past six months. While the pandemic is only 18 months old, more than half of those diagnosed with anxiety say they lived with symptoms for years or decades before seeking treatment.

For those who havent sought treatment but are concerned they may be suffering from anxiety, only 36% are planning to seek treatment. When asked what it would take to get help for their anxiety, 47% said a debilitating panic attack. Additional reasons included not being able to leave their homes (34%), sleep issues (31%), an unshakeable feeling of dread (30%) and a negative impact to relationships (30%).

Imagine waiting until you lose your hearing to treat an ear infection. Patients who are experiencing anxiety symptoms shouldnt wait to seek treatment, said Robin Miller, Internist, MD, MHS, owner of Triune Integrative Medicine in Medford, Oregon. If you are afraid to go out, experiencing panic attacks, cant sleep, or your relationships are suffering, you dont have to live like this. You don't have to wait. You don't have to suffer for years. Help is out there and treatment can help.

The impact of COVID on anxiety

Many American adults expressed concern regarding how the pandemic has impacted their mental health:

Mental health conversation is shifting

Of those diagnosed with anxiety, nearly half said they would feel more comfortable talking about their mental health today than they would a year ago.

The pandemic appears to have made people willing to share their mental health struggles, said Mark Pollack, MD, chief medical officer for Mental Health at Myriad Genetics. Talking about mental health challenges is the first step towards getting treatment.

Mental health disorders should be treated

While more people appear to be willing to talk about their mental health, one out of five respondents still say they wont seek treatment. The top reasons for those who would NOT seek treatment for a mental challenge are:

Untreated anxiety can be associated with distressing and disabling panic attacks, intense worry, and disruption to your life, work and relationships, said Dr. Pollack. Like other medical conditions, individuals should seek evaluation and treatment as early as possible, to minimize the distress and dysfunction associated with these conditions.

Anna, a 32-year-old mother who was first diagnosed with anxiety in her early 20s, said that seeking treatment wasnt easy. She went through an extensive trial-and-error period with different medications and dosages.

Medication seems to work fast in my body, so after taking a medication that was supposed to help me, my anxiety would instead get worse I would have suicidal thoughts and be paralyzed with worry, said Anna. My doctor would increase the dosage or change medications, which would lead to horrible side effects.

Anna then took the GeneSight test, which analyzes how a patients genes may affect their outcomes with medications commonly prescribed to treat anxiety, depression, ADHD, and other psychiatric conditions.

After reviewing the results of my test, my psychiatrist reduced the dose by half, and it helped me. I honestly dont know if I would have taken another medication if it hadnt been for genetic testing, said Anna. Im glad I pursued treatment until I found a medication and dosage that worked for me. Now that Im not riddled with crippling anxiety, everything has gotten better. Im a better mom. Im more motivated, more outgoing and friendly.

For more information on how genetic testing can help inform clinicians on treatment of depression, anxiety, ADHD, and other psychiatric conditions, please visit GeneSight.com. To download graphics, a multimedia video and other information regarding the survey, please visit https://bit.ly/2Y4qGri.

About the GeneSight Mental Health Monitor

The GeneSight Mental Health Monitor is a nationwide survey of U.S. adults conducted by ACUPOLL Precision Research, Inc. in Aug.-Sept. 2021 among a statistically representative sample of adults age 21+, including a representative sample diagnosed with anxiety. The margin of error in survey results for the total base population at a 95% confidence interval is +/- 3%.

About the GeneSight Test

The GeneSight Psychotropic test from Myriad Genetics is the category-leading pharmacogenomic test for 61 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. The GeneSight test can help inform clinicians about how a patients genes may impact how they metabolize and/or respond to certain psychiatric medications. It has been given to more than 1.5 million patients by tens of thousands of clinicians to provide genetic information that is unique to each patient. The GeneSight test supplements other information considered by a clinician as part of a comprehensive medical assessment. Learn more at GeneSight.com.

About Myriad Genetics

Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and wellbeing for all, empowering individuals with vital genetic insights and enabling healthcare providers to better detect, treat and prevent disease. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit the company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, EndoPredict, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries.

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Americans' anxiety impacted by the ongoing pandemic, yet 1 in 5 say they won't seek - EurekAlert

Recommendation and review posted by Bethany Smith

Genes are the basic units of inheritance in all living organisms. They provide cells with the necessary information for normal functioning, but they can be altered by the same environmental factors that cause cancer to develop.

Genetic testing helps identify specific genes that have mutated or been altered in a way that causes normal cells to become cancerous. These results are used by healthcare providers to predict responses to various types of treatment and monitor the progress of the disease. Genetic testing can refer to both germline testing (mutations in cells without cancer ) and also somatic testing of a patients tumor (mutations in cells with cancer).

What genetic testing means is understanding in a comprehensive way all the genetic abnormalities that may be present in one patients cancer that may not be present in others.

When examining genetic changes within tumor cells, researchers look for two main things:

These genetic abnormalities are what researchers are beginning to use as biomarkers for predicting patient responses to different forms of treatment.

In some families, bladder cancer occurs at higher rates than in the general population. In these cases, careful examination of the genealogy may reveal specific mutations passed from parent to child that may lead a medical provider to suspect one of the hereditary forms of bladder cancer. Some germline mutations linked to bladder cancer include:

While its possible, inherited gene mutations arent as commonly associated with bladder cancer as they are with other types of cancer, such as breast and ovarian. Sometimes, bladder cancer may occur in families because of toxic chemical or environmental exposures.

There are certain factors that increase an individuals risk for developing bladder cancer even if no family history exists. These include smoking and exposure to specific chemicals over long periods of time.

There are also inherited genetic syndromes that may place an individual at greater risk for developing bladder cancer. These include:

If genetic testing reveals you lack certain genes mutated in bladder cancer, you may be less likely to respond to certain treatments. These include targeted therapies, immunotherapies and chemotherapy drugs.

Genetic testing is not the only factor that determines your response to certain treatments. Even if your bladder cancer has all the genetic mutations that predict response to certain treatments, it still may not respond to them, because genetics is only one factor in determining a treatments effectiveness.

To increase the likelihood of response, bladder cancer treatments need to be combined with interventions designed to help your immune system target and kill cancer cells.

Genetic testing may also inform some decisions you and your medical team make as part of your ongoing care. If you are planning additional treatment after surgery or radiation, genetic testing may help determine the most appropriate treatment to use.

Genetic testing may be beneficial for many people with cancer. However, no guidelines exist to determine who should get genetic testing and the type of testing that should be done.

When I counsel a patient whos now undergoing their first treatment for advanced bladder cancer, Ill often encourage them to undergo genetic testing, mainly because we may find a genetic marker that is present in their cancer that might help me direct them toward a specific clinical trial that involves a drug that is specific for their genetic mutation, explains Dr. Balar.

Dr. Balar also recommends genetic testing for any patient with stage II or greater cancer. I advocate for early testing to have that information available early on so that if its needed, that information is readily available to make treatment decisions.

If youve been diagnosed with bladder cancer, talk to your healthcare team about the benefits and limitations of genetic testing.

Learn more about SurvivorNet's rigorous medical review process.

Lindsay Modglin is a freelance writer. Read More

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What Can Genetics Tell Us About the Molecular Features of a Bladder Cancer Tumor? - SurvivorNet

Recommendation and review posted by Bethany Smith

J Cardiovasc Nurs. Author manuscript; available in PMC 2014 Jul 21.

Published in final edited form as:

PMCID: PMC4104807

NIHMSID: NIHMS100185

1Department of Bioengineering, University of Illinois at Chicago

2Department of Physiology and Biophysics and Department of Bioengineering, University of Illinois at Chicago

1Department of Bioengineering, University of Illinois at Chicago

2Department of Physiology and Biophysics and Department of Bioengineering, University of Illinois at Chicago

Stem cells have the ability to differentiate into specific cell types. The two defining characteristics of a stem cell are perpetual self-renewal and the ability to differentiate into a specialized adult cell type. There are two major classes of stem cells: pluripotent that can become any cell in the adult body, and multipotent that are restricted to becoming a more limited population of cells. Cell sources, characteristics, differentiation and therapeutic applications are discussed. Stem cells have great potential in tissue regeneration and repair but much still needs to be learned about their biology, manipulation and safety before their full therapeutic potential can be achieved.

Stem cells have the ability to build every tissue in the human body, hence have great potential for future therapeutic uses in tissue regeneration and repair. In order for cells to fall under the definition of stem cells, they must display two essential characteristics. First, stem cells must have the ability of unlimited self-renewal to produce progeny exactly the same as the originating cell. This trait is also true of cancer cells that divide in an uncontrolled manner whereas stem cell division is highly regulated. Therefore, it is important to note the additional requirement for stem cells; they must be able to give rise to a specialized cell type that becomes part of the healthy animal.1

The general designation, stem cell encompasses many distinct cell types. Commonly, the modifiers, embryonic, and adult are used to distinguish stem cells by the developmental stage of the animal from which they come, but these terms are becoming insufficient as new research has discovered how to turn fully differentiated adult cells back into embryonic stem cells and, conversely, adult stem cells, more correctly termed somatic stem cells meaning from the body, are found in the fetus, placenta, umbilical cord blood and infants.2 Therefore, this review will sort stem cells into two categories based on their biologic properties - pluripotent stem cells and multipotent stem cells. Their sources, characteristics, differentiation and therapeutic applications are discussed.

Pluripotent stem cells are so named because they have the ability to differentiate into all cell types in the body. In natural development, pluripotent stem cells are only present for a very short period of time in the embryo before differentiating into the more specialized multipotent stem cells that eventually give rise to the specialized tissues of the body (). These more limited multipotent stem cells come in several subtypes: some can become only cells of a particular germ line (endoderm, mesoderm, ectoderm) and others, only cells of a particular tissue. In other words, pluripotent cells can eventually become any cell of the body by differentiating into multipotent stem cells that themselves go through a series of divisions into even more restricted specialized cells.

During natural embryo development, cells undergo proliferation and specialization from the fertilized egg, to the blastocyst, to the gastrula during natural embryo development (left side of panel). Pluripotent, embryonic stem cells are derived from the inner cell mass of the blastoctyst (lightly shaded). Multipotent stem cells (diamond pattern, diagonal lines, and darker shade) are found in the developing gastrula or derived from pluripotent stem cells and are restricted to give rise to only cells of their respective germ layer.

Based on the two defining characteristics of stem cells (unlimited self-renewal and ability to differentiate), they can be described as having four outcomes or fates3 (). A common fate for multipotent stem cells is to remain quiescent without dividing or differentiating, thus maintaining its place in the stem cell pool. An example of this is stem cells in the bone marrow that await activating signals from the body. A second fate of stem cells is symmetric self-renewal in which two daughter stem cells, exactly like the parent cell, arise from cell division. This does not result in differentiated progeny but does increase the pool of stem cells from which specialized cells can develop in subsequent divisions. The third fate, asymmetric self-renewal, occurs when a stem cell divides into two daughter cells, one a copy of the parent, the other a more specialized cell, named a somatic or progenitor cell. Asymmetric self-renewal results in the generation of differentiated progeny needed for natural tissue development/regeneration while also maintaining the stem cell pool for the future. The fourth fate is that in which a stem cell divides to produce two daughters both different from the parent cell. This results in greater proliferation of differentiated progeny with a net loss in the stem cell pool.

Four potential outcomes of stem cells. A) Quiescence in which a stem cell does not divide but maintains the stem cell pool. B) Symmetric self-renewal where a stem cell divides into two daughter stem cells increasing the stem cell pool. C) Asymmetric self-renewal in which a stem cell divides into one differentiated daughter cell and one stem cell, maintaining the stem cell pool. D) Symmetric division without self-renewal where there is a loss in the stem cell pool but results in two differentiated daughter cells. (SC- Stem cell, DP-Differentiated progeny)

The factors that determine the fate of stem cells is the focus of intense research. Knowledge of the details could be clinically useful. For example, clinicians and scientists might direct a stem cell population to expand several fold through symmetrical self-renewal before differentiation into multipotent or more specialized progenitor cells. This would ensure a large, homogeneous population of cells at a useful differentiation stage that could be delivered to patients for successful tissue regeneration.

Pluripotent stem cells being used in research today mainly come from embryos, hence the name, embryonic stem cells. Pre-implantation embryos a few days old contain only 10-15% pluripotent cells in the inner cell mass (). Those pluripotent cells can be isolated, then cultured on a layer of feeder cells which provide unknown cues for many rounds of proliferation while sustaining their pluripotency.

Recently, two different groups of scientists induced adult cells back into the pluripotent state by molecular manipulation to yield induced pluripotent stem cells (iPS) that share some of the same characteristics as embryonic stem cells such as proliferation, morphology and gene expression (in the form of distinct surface markers and proteins being expressed).4-8 Both groups used retroviruses to carry genes for transcription factors into the adult cells. These genes are transcribed and translated into proteins that regulate the expression of other genes designed to reprogram the adult nucleus back into its embryonic state. Both introduced the embryonic transcription factors known as Sox2 and Oct4. One group also added Klf4 and c-Myc4, and the other group added Lin28 and Nanog.6 Other combinations of factors would probably also work, but, unfortunately, neither the retroviral carrier method nor the use of the oncogenic transcription factor c-Myc are likely to be approved for human therapy. Consequently, a purely chemical approach to deliver genes into the cells, and safer transcription factors are being tried. Results of these experiments look promising.9

Multipotent stem cells may be a viable option for clinical use. These cells have the plasticity to become all the progenitor cells for a particular germ layer or can be restricted to become only one or two specialized cell types of a particular tissue. The multipotent stem cells with the highest differentiating potential are found in the developing embryo during gastrulation (day 14-15 in humans, day 6.5-7 in mice). These cells give rise to all cells of their particular germ layer, thus, they still have flexibility in their differentiation capacity. They are not pluripotent stem cells because they have lost the ability to become cells of all three germ layers (). On the low end of the plasticity spectrum are the unipotent cells that can become only one specialized cell type such as skin stem cells or muscle stem cells. These stem cells are typically found within their organ and although their differentiation capacity is restricted, these limited progenitor cells play a vital role in maintaining tissue integrity by replenishing aging or injured cells. There are many other sub-types of multipotent stem cells occupying a range of differentiation capacities. For example, multipotent cells derived from the mesoderm of the gastrula undergo a differentiation step limiting them to muscle and connective tissue; however, further differentiation results in increased specialization towards only connective tissue and so on until the cells can give rise to only cartilage or only bone.

Multipotent stem cells found in bone marrow are best known, because these have been used therapeutically since the 1960s10 (their potential will be discussed in greater detail in a later section). Recent research has found new sources for multipotent stem cells of greater plasticity such as the placenta and umbilical cord blood.11 Further, the heart, until recently considered void of stem cells, is now known to contain stem cells with the potential to become cardiac myocytes.12 Similarly, neuro-progenitor cells have been found within the brain.13

The cardiac stem cells are present in such small numbers, that they are difficult to study and their function has not been fully determined. The second review in this series will discuss their potential in greater detail.

Since Federal funding for human embryonic stem cells is restricted in the United States, many scientists use the mouse model instead. Besides their ability to self-renew indefinitely and differentiate into cell types of all three germ layers, murine and human pluripotent stem cells have much in common. It should not be surprising that so many pluripotency traits are conserved between species given the shared genomic sequences and intra-cellular structure in mammals. Both mouse and human cells proliferate indefinitely in culture, have a high nucleus to cytoplasm ratio, need the support of growth factors derived from other live cells, and display similar surface antigens, transcription factors and enzymatic activity (i.e. high alkaline phosphatase activity).14 However, differences between mouse and human pluripotent cells, while subtle, are very important. Although the transcription factors mentioned above to induce pluripotency from adult cells (Oct3/4 and Sox2) are shared, the extracellular signals needed to regulate them differ. Mouse embryonic stem cells need the leukemia inhibitory factor and bone morphogenic proteins while human require the signaling proteins Noggin and Wnt for sustained pluripotency.15 Surface markers used to identify pluripotent cells also differ slightly between the two species as seen in the variants of the adhesion molecule SSEA (SSEA-1 in mouse, SSEA-3 & 4 in humans).16 Thus, while pluripotency research in mouse cells is valuable, a direct correlation to the human therapy is not likely.

Last, but certainly not least, a big difference between mouse and human stem cells are the moral and ethical dilemmas that accompany the research. Some people consider working with human embryonic stem cells to be ethically problematic while very few people have reservations on working with the mouse models. However, given the biological differences between human and mouse cells, most scientists believe that data relevant for human therapy will be missed by working only on rodents.

Cell surface markers are typically also used to identify multipotent stem cells. For example, mesenchymal stem cells can be purified from the whole bone marrow aspirate by eliminating cells that express markers of committed cell types, a step referred to as lineage negative enrichment, and then further separating the cells that express the sca-1 and c-Kit surface markers signifying mesenchymal stem cells. Both the lineage negative enrichment step and the sca-1/c-Kit isolation can be achieved by using flow cytometry and is discussed in further detail in the following review. The c-Kit surface marker also is used to distinguish the recently discovered cardiac stem cells from the rest of the myocardium. A great deal of recent work in cardiovascular research has centered on trying to find which markers indicate early multipotent cells that will give rise to pre-cardiac myocytes. Cells with the specific mesodermal marker, Kdr, give rise to the progenitor cells of the cardiovascular system including contracting cardiac myocytes, endothelial cells and vascular smooth muscle cells and are therefore considered to be the earliest cells with specification towards the cardiovascular lineage.17 Cells at this early stage still proliferate readily and yet are destined to become cells of the cardiovascular system and so may be of great value therapeutically.

Scientists are still struggling to reliably direct differentiation of stem cells into specific cell types. They have used a virtual alphabet soup of incubation factors toward that end (including trying a variety of growth factors, chemicals and complex substrates on which the cells are grown), with, so far, only moderate success. As an example of this complexity, one such approach to achieve differentiation towards cardiac myocytes is to use the chemical activin A and the growth factor BMP-4. When these two factors are administered to pluripotent stem cells in a strictly controlled manner, both in concentration and temporally, increased efficiency is seen in differentiation towards cardiac myocytes, but still, only 30% of cells can be expected to become cardiac.18

Multipotent cells have also been used as the starting point for cell therapy, again with cocktails of growth factors and/or chemicals to induce differentiation toward a specific, desired lineage. Some recipes are simple, such as the use of retinoic acid to induce mesenchymal stem cells into neuronal cells,19 or transforming growth factor- to make bone marrow-derived stem cells express cardiac myocyte markers.20 Others are complicated or ill-defined such as addition of the unknown factors secreted by cells in culture. Physical as well as chemical cues cause differentiation of stem cells. Simply altering the stiffness of the substrate on which cells are cultured can direct stem cells to neuronal, myogenic or osteogenic lineages.21 Cells evolve in physical and chemical environments so a combination of both will probably be necessary for optimal differentiation of stem cells. The importance of physical cues in the cells environment will be discussed in greater detail in the final review of this series. Ideally, for stem cells to be used therapeutically, efficient, uniform protocols must be established so that cells are a well-controlled and well-defined entity.

Pluripotent stem cells have not yet been used therapeutically in humans because many of the early animal studies resulted in the undesirable formation of unusual solid tumors, called teratomas. Teratomas are made of a mix of cell types from all the early germ layers. Later successful animal studies used pluripotent cells modified to a more mature phenotype which limits this proliferative capacity. Cells derived from pluripotent cells have been used to successfully treat animals. For example, animals with diabetes have been treated by the creation of insulin-producing cells responsive to glucose levels. Also, animals with acute spinal cord injury or visual impairment have been treated by creation of new myelinated neurons or retinal epithelial cells, respectively. Commercial companies are currently in negotiations with the FDA regarding the possibility of advancing to human trials. Other animal studies have been conducted to treat several maladies such as Parkinsons disease, muscular dystrophy and heart failure.18,22,23

Scientists hope that stem cell therapy can improve cardiac function by integration of newly formed beating cardiac myocytes into the myocardium to produce greater force. Patches of cardiac myocytes derived from human embryonic stem cells can form viable human myocardium after transplantation into animals,24 with some showing evidence of electrical integration.25,26 Damaged rodent hearts showed slightly improved cardiac function after injection of cardiac myocytes derived from human embryonic stem cells.21 The mechanisms for the gain in function are not fully understood but it may be only partially due to direct integration of new beating heart cells. It is more likely due to paracrine effects that benefit other existing heart cells (see next review).

Multipotent stem cells harvested from bone marrow have been used since the 1960s to treat leukemia, myeloma and lymphoma. Since cells there give rise to lymphocytes, megakaryocytes and erythrocytes, the value of these cells is easily understood in treating blood cancers. Recently, some progress has been reported in the use of cells derived from bone marrow to treat other diseases. For example, the ability to form whole joints in mouse models27 has been achieved starting with mesenchymal stem cells that give rise to bone and cartilage. In the near future multipotent stem cells are likely to benefit many other diseases and clinical conditions. Bone marrow-derived stem cells are in clinical trials to remedy heart ailments. This is discussed in detail in the next review of this series.

Pluripotent and multipotent stem cells have their respective advantages and disadvantages. The capacity of pluripotent cells to become any cell type is an obvious therapeutic advantage over their multipotent kin. Theoretically, they could be used to treat diseased or aging tissues in which multipotent stem cells are insufficient. Also, pluripotent stem cells proliferate more rapidly so can yield higher numbers of useful cells. However, use of donor pluripotent stem cells would require immune suppressive drugs for the duration of the graft28 while use of autologous multipotent stem cells (stem cells from ones self) would not. This ability to use ones own cells is a great advantage of multipotent stem cells. The immune system recognizes specific surface proteins on cells/objects that tell them whether the cell is from the host and is healthy. Autologous, multipotent stem cells have the patients specific surface proteins that allow it to be accepted by the hosts immune system and avoid an immunological reaction. Pluripotent stem cells, on the other hand, are not from the host and therefore, lack the proper signals required to stave off rejection from the immune system. Research is ongoing trying to limit the immune response caused by pluripotent cells and is one possible advantage that iPS cells may have.

The promises of cures for human ailments by stem cells have been much touted but many obstacles must still be overcome. First, more human pluripotent and multipotent cell research is needed since stem cell biology differs in mice and men. Second, the common feature of unlimited cell division shared by cancer cells and pluripotent stem cells must be better understood in order to avoid cancer formation. Third, the ability to acquire large numbers of the right cells at the right stage of differentiation must be mastered. Fourth, specific protocols must be developed to enhance production, survival and integration of transplanted cells. Finally, clinical trials must be completed to assure safety and efficacy of the stem cell therapy. When it comes to stem cells, knowing they exist is a long way from using them therapeutically.

Supported by NIH (HL 62426 and T32 HL 007692)

Link:
Introduction to Stem Cell Therapy - PubMed Central (PMC)

Recommendation and review posted by Bethany Smith

Researchers have been looking for something that can help the body heal itself. Although studies are ongoing, stem cell research brings this notion of regenerative medicine a step closer. However, many of its ideas and concepts remain controversial. So, what are stem cells, and why are they so important?

Stem cells are cells that can develop into other types of cells. For example, they can become muscle or brain cells. They can also renew themselves by dividing, even after they have been inactive for a long time.

Stem cell research is helping scientists understand how an organism develops from a single cell and how healthy cells could be useful in replacing cells that are not working correctly in people and animals.

Researchers are now studying stem cells to see if they could help treat a variety of conditions that impact different body systems and parts.

This article looks at types of stem cells, their potential uses, and some ethical concerns about their use.

The human body requires many different types of cells to function, but it does not produce every cell type fully formed and ready to use.

Scientists call a stem cell an undifferentiated cell because it can become any cell. In contrast, a blood cell, for example, is a differentiated cell because it has already formed into a specific kind of cell.

The sections below look at some types of stem cells in more detail.

Scientists extract embryonic stem cells from unused embryos left over from in vitro fertilization procedures. They do this by taking the cells from the embryos at the blastocyst stage, which is the phase in development before the embryo implants in the uterus.

These cells are undifferentiated cells that divide and replicate. However, they are also able to differentiate into specific types of cells.

There are two main types of adult stem cells: those in developed bodily tissues and induced pluripotent stem (iPS) cells.

Developed bodily tissues such as organs, muscles, skin, and bone include some stem cells. These cells can typically become differentiated cells based on where they exist. For example, a brain stem cell can only become a brain cell.

On the other hand, scientists manipulate iPS cells to make them behave more like embryonic stem cells for use in regenerative medicine. After collecting the stem cells, scientists usually store them in liquid nitrogen for future use. However, researchers have not yet been able to turn these cells into any kind of bodily cell.

Scientists are researching how to use stem cells to regenerate or treat the human body.

The list of conditions that stem cell therapy could help treat may be endless. Among other things, it could include conditions such as Alzheimers disease, heart disease, diabetes, and rheumatoid arthritis. Doctors may also be able to use stem cells to treat injuries in the spinal cord or other parts of the body.

They may do this in several ways, including the following.

In some tissues, stem cells play an essential role in regeneration, as they can divide easily to replace dead cells. Scientists believe that knowing how stem cells work can help treat damaged tissue.

For instance, if someones heart contains damaged tissue, doctors might be able to stimulate healthy tissue to grow by transplanting laboratory-grown stem cells into the persons heart. This could cause the heart tissue to renew itself.

One study suggested that people with heart failure showed some improvement 2 years after a single-dose administration of stem cell therapy. However, the effect of stem cell therapy on the heart is still not fully clear, and research is still ongoing.

Another investigation suggested that stem cell therapies could be the basis of personalized diabetes treatment. In mice and laboratory-grown cultures, researchers successfully produced insulin-secreting cells from stem cells derived from the skin of people with type 1 diabetes.

Study author Jeffrey R. Millman an assistant professor of medicine and biomedical engineering at the Washington University School of Medicine in St. Louis, MO said, What were envisioning is an outpatient procedure in which some sort of device filled with the cells would be placed just beneath the skin.

Millman hopes that these stem cell-derived beta cells could be ready for research in humans within 35 years.

Stem cells could also have vast potential in developing other new therapies.

Another way that scientists could use stem cells is in developing and testing new drugs.

The type of stem cell that scientists commonly use for this purpose is the iPS cell. These are cells that have already undergone differentiation but which scientists have genetically reprogrammed using genetic manipulation, sometimes using viruses.

In theory, this allows iPS cells to divide and become any cell. In this way, they could act like undifferentiated stem cells.

For example, scientists want to grow differentiated cells from iPS cells to resemble cancer cells and use them to test anticancer drugs. This could be possible because conditions such as cancer, as well as some congenital disabilities, happen because cells divide abnormally.

However, more research is taking place to determine whether or not scientists really can turn iPS cells into any kind of differentiated cell and how they can use this process to help treat these conditions.

In recent years, clinics have opened that offer different types of stem cell treatments. One 2016 study counted 570 of these clinics in the United States alone. They appear to offer stem cell-based therapies for conditions ranging from sports injuries to cancer.

However, most stem cell therapies are still theoretical rather than evidence-based. For example, researchers are studying how to use stem cells from amniotic fluid which experts can save after an amniocentesis test to treat various conditions.

The Food and Drug Administration (FDA) does allow clinics to inject people with their own stem cells as long as the cells are intended to perform only their normal function.

Aside from that, however, the FDA has only approved the use of blood-forming stem cells known as hematopoietic progenitor cells. Doctors derive these from umbilical cord blood and use them to treat conditions that affect the production of blood. Currently, for example, a doctor can preserve blood from an umbilical cord after a babys birth to save for this purpose in the future.

The FDA lists specific approved stem cell products, such as cord blood, and the medical facilities that use them on its website. It also warns people to be wary of undergoing any unproven treatments because very few stem cell treatments have actually reached the earliest phase of a clinical trial.

Historically, the use of stem cells in medical research has been controversial. This is because when the therapeutic use of stem cells first came to the publics attention in the late 1990s, scientists were only deriving human stem cells from embryos.

Many people disagree with using human embryonic cells for medical research because extracting them means destroying the embryo. This creates complex issues, as people have different beliefs about what constitutes the start of human life.

For some people, life starts when a baby is born, while for others, it starts when an embryo develops into a fetus. Meanwhile, other people believe that human life begins at conception, so an embryo has the same moral status and rights as a human child.

Former U.S. president George W. Bush had strong antiabortion views. He believed that an embryo should be considered a life and not be used for scientific experiments. Bush banned government funding for human stem cell research in 2001, but former U.S. president Barack Obama then revoked this order. Former U.S. president Donald Trump and current U.S. president Joe Biden have also gone back and forth with legislation on this.

However, by 2006, researchers had already started using iPS cells. Scientists do not derive these stem cells from embryonic stem cells. As a result, this technique does not have the same ethical concerns. With this and other recent advances in stem cell technology, attitudes toward stem cell research are slowly beginning to change.

However, other concerns related to using iPS cells still exist. This includes ensuring that donors of biological material give proper consent to have iPS cells extracted and carefully designing any clinical studies.

Researchers also have some concerns that manipulating these cells as part of stem cell therapy could lead to the growth of cancerous tumors.

Although scientists need to do much more research before stem cell therapies can become part of regular medical practice, the science around stem cells is developing all the time.

Scientists still conduct embryonic stem cell research, but research into iPS cells could help reduce some of the ethical concerns around regenerative medicine. This could lead to much more personalized treatment for many conditions and the ability to regenerate parts of the human body.

Learn more about stem cells, where they come from, and their possible uses here.

Read this article:
Stem cells: Therapy, controversy, and research

Recommendation and review posted by Bethany Smith

One of the most common questions Ive gotten over the last decade is, how much does stem cell therapy cost? They actually seem most often to want to know more specifically how much itshould cost.

To try to authoritatively answer this now in 2021 we need data from the present and past along with expert perspectives.

These kinds of questions on what are common and reasonable prices have continued in 2021. However, the types of queries have also evolved as things have gotten more complicated. There are many layers to the question of cost, which I cover here in todays article. In the big picture, the most worrisome potential cost is to your health if you proceed with unproven stem cell injections.

Stem cell cost questions | Stem cells cost $2,500 to $20,000| Why do stem cells cost so much? | How have stem cell prices changed? | Stem cell supplement cost | FTC actions and patients as consumers | Does insurance or Medicare cover stem cell therapy? | Patient fundraising | Looking ahead will stem cell costs go down?| References

This post is the most comprehensive look at stem cell treatment cost and costs of related therapies that Ive seen on the web, especially factoring in our inclusion of historical polling data from past years here on The Niche. The above bullet point list is what is covered in todays post and you can jump to sections that interest you most by clicking on those table of contents bullet points.

You can also watch the video I made summarizing the key points of this post below.

Furthermore, it encompasses other important issues related to insurance, fundraising, and approaches to being a smart consumer. Keep in mind that almost all stem cell therapies outside the bone marrow/hematopoietic sphere are not FDA-approved. They mostly lack rigorous data to back them up too. So this post is definitely not recommending you get them. I advise against it, but many people still want info on cost.

Lets get started.

After more than a decade of blogging about stem cells from just about every angle, its interesting to consider trends in the types of questions I get asked. Beyond cost, I also often get asked How much of a stem cell treatment price does insurance cover?

Of course, insurance (or lack thereof) directly bears on cost too. Ill get more into insurance later in the post.

In a way its not so surprising that cost is so much on peoples minds now for a few reasons.

First, as compared to many years back, people now view stem cell injections as a more everyday thing. Stem cell therapy is often available just down the street at a local strip mall.

Back in 2010 and in the 5 or so years after that, people instead more often viewed stem cells as some amazing thing out of reach to them at that time. Now people view stem cell offerings through the lens of consumers.

Sadly, another major part of the reason for the change in perceptions of stem cell treatments is the tidal wave of stem cell clinics from coast to coast in the US selling unproven and sometimes dangerous offerings.

At the same time, some universities and large medical centers also sell stem cell or similar offerings that arent proven. Im worried that that number may be increasing too and patients who may be paying there for unproven stem cells way at the very high end of the cost spectrum, sometimes above $100K.

Other stem cell suppliers and clinics market stem cell-related stuff that isnt real stem cells such as platelet rich plasma or PRP (see my comprehensive guide to PRP including a helpful infographic here) or injections of often dead perinatal stem cell products.

For all these reasons about once every year or two, I do polling asking the readers of The Niche here about their experiences.

Ive done the polling again now in 2020 in a more comprehensive form.

To have a sense of cost, we need to ask patients certain questions. How much did you pay per injection? How many injections did you get? Where did you get them?

Keep in mind that the total cost of stem cell therapy is the product of the cost per injection times the # of injections. For instance, if a stem cell injection costs $8,000 and you get 10 injections, your total cost is $80,000.

Unfortunately, the unproven stem cell clinics generally do not volunteer data on how much they charge. They also often encourage patients to get many injections.

Our 2020 polling data (you can still participate and I will update this) for stem cell treatments are in the graphic above. Here are some highlights.

The self-reported responses on cost for stem cell treatments, as indicated by respondents to our 2020 polling, suggest the price has gone up.

While the most common answer in 2019 was $2,501-$5,000, in 2020 the most common response was $10,001-$20,000, while $2,501-$5,000 was close behind.

The percentage of people paying the most, more than $100,000, was only slightly (probably non-significantly) higher in 2020, but both in 2019 and 2020 the percentage of people paying over $100K was much higher than in 2018 polling.

Keep in mind this is the cost per injection so how many injections do patients typically get? While the number of injections reported most commonly was 1 in both 2019 and 2020, in 2020, the second most common answer was 6-10 injections, a big boost from 2019. Again, more injections end up multiplying things up to boost the total cost. Only a few people in the polling had many injections, but in my view it is still striking to see anyone say theyve received more than 20 stem cell injections.

For comparison, the 2019 polling can be found here, but some of the key results are captured in a combo screenshot Ive included here. I got a lot more responses to the polling in 2019 so that makes me more confident in the data than in the 2020 polling so far, but I hope well get more responses moving forward in 2020 and if we do, again Ill update the info in this post.

What you can see from 2019 is that a plurality of respondents reported getting one stem cell injection, but 60% of people nonetheless got more than one stem cell injection.

Remarkably about 1 in 20-25 people received more than 20 stem cell injections.

About another 1 in 20 people got 6-20 injections. I find this amount of repeat injections to be surprising and concerning as it amplifies health and financial risks.

In terms of cost per injection, the results are pretty similar to 2018 (see at right below) on the whole.

This kind of polling isnt super scientific, but can gauge trends. Unfortunately, I havent really seen much other published data on stem cell clinic costs in actual journals.

I dont know if its noise or not, but the percentage of people paying over $100K is about 2-fold higher in 2019 versus 2018.

There are more people may be paying $10K-$20K as well now in 2020 vs. 2019 or 2018.

There is growing interest from the public in stem cell supplements. I did a post on this earlier in 2020 so take a look here, which was essentially a review of stem cell supplements like Regenokine. In terms of cost, while supplements are far less expensive than getting stem cell, PRP, or exosome injections, supplements are still pricey for what you get. Its not unusual to pay $100 for a small bottle of stem cell supplements, the other factor to consider is that these supplements generally have no solid, published data behind them so you might as well be paying $100 for water. Its unclear what risks taking these supplements might bring as well.

On the economic side, you might think that the feds like the FTC would be actively pursuing false or even fraudulent marketing of stem cells via the web and other kinds of advertising, but in total so far the FTC to my knowledge has only taken relatively few actions such as this one. and then some letters for COVID-related marketing of stem cells and other biologics earlier this year in 2020.

Oddly, there were just that a couple blips of FTC activity, especially considering the sea of questionable stem cell clinic-related ads out there. This ranges from major newspapers to inflight magazines to mobile ads on a stem-cell-mobile to television. Then of course there are the infomercial seminars.

Patients should also view themselves as consumers. Savvy customers considering paying money to stem cell clinics should do their homework. I often tell patients to use at a minimum the kinds of tough standards they bring to the car-buying process. Over the last few years Consumer Reports has been interested in the stem cell treatment world and done some reporting that is worth reading.

A common question I hear is the following: is stem cell therapy covered by insurance? Unfortunately for patients desperate to try stem cells, insurance generally does not provide any coverage, which often leads them to take extreme financial measures. These steps can include fundraising (more below).

In my view, the Regenexx brand has made a big deal out of how some employers contribute towards costs of their clinics offerings. Im not so clear on where that stands today in 2020.

Does Medicare cover stem cell therapies? Medicare will generally cover the cost of established bone marrow transplantation type therapies. However it does not cover unproven stem cell therapies.

Patients are often reaching out to me so I know that many of them have gone to extraordinary measures to raise the money to pay to unproven stem cell clinics. Its painful to think about what little they get in return. Since we are by definition talking about unproven medical procedures here, in my view this money is largely down the drain.

If you have other data on stem cell economic issues such as what patients pay please let me know. Then theres the issue of what it actually costs the clinics per injection and in turn: whats their profit margin?

What ends up happening is that patients take out second mortgages on their houses, try to collect funds from friends and relatives, or turn to online fundraising. The internet fundraising efforts most often end up on GoFundMe. This is a trend Ive been noticing for years. Some colleagues even published a paper on this trend, a very interesting and an important read. The paper is Crowdfunding for Unproven Stem CellBased Interventions in JAMA by Jeremy Snyder,Leigh Turner , and Valorie A. Crooks. Heres a key passage:

As of December 3, 2017, our search identified 408 campaigns (GoFundMe=358; YouCaring=50) seeking donations for stem cell interventions advertised by 50 individual businesses. These campaigns requested $7439308 and received pledges for $1450011 from 13050 donors. The campaigns were shared 111044 times on social media. Two campaigns were duplicated across platforms but shared separately on social media. Of the 408 campaigns, 178 (43.6%) made statements that were definitive or certain about the interventions efficacy, 124 (30.4%) made statements optimistic or hopeful about efficacy, 63 (15.4%) made statements of both kinds, and 43 (10.5%) did not make efficacy claims. All mentions of risks (n=36) claimed the intervention had low/no risks compared with alternative treatments.

Supposedly GoFundMe has taken some steps to lower the often ethically thorny stem cell fundraising on its site, but Im not sure how much it has changed.

There is pressure on stem cell clinics now in 2021 in large part due to two factors. These could drive costs down or up depending on how things play out. First, the FDA is much more active against unproven stem cell clinics. This may mean more money from the clinics going toward paying attorneys or FDA compliance experts. Youd think this might drive costs up. However, the still large number of clinics may keep pressure to stay with keeping price tags lower.

The second factor is the COVID-19 pandemic, which has forced many clinics to stop injections temporarily. While a surprising number of clinicsI did by phone were still open in a small informal survey, others were in a holding pattern. This may lower supply which could raise prices. But I think demand is likely way down as many patients stay home to avoid COVID risks. This could be temporary though. As things start re-opening, as they are now, the clinics may be able to capitalize on pent-up demand.

To sum up, the answer to the question, How do stem cells cost? is largely driven by clinic firms aiming to profit. Overall, clinics will charge what they think patients will pay them, which will always be a moving target. I urge patients to be cautious both medically, talking to their doctors, and financially.

Originally posted here:
How much does stem cell therapy cost in 2021? - The Niche

Recommendation and review posted by Bethany Smith

There are a number of genes that can cause a person to develop breast cancer. Some of these genes are inheritable, meaning they pass from parent to child. However, having the gene for breast cancer does not always mean a person develops it.

This article will go into detail about the role of genetics in breast cancer, whether breast cancer can skip a generation, and the next steps for a person who has a breast cancer gene.

The American Cancer Society (ACS) notes that inherited genetic factors do not cause the majority of breast cancers. However, there are certain inherited genes that increase a persons chances of developing breast cancer.

A gene is a sequence of DNA that determines certain traits, such as eye or hair color. Genes are transmitted in pairs from biological parents to their child. A child inherits one copy from each parent. Sometimes, a child can inherit a gene with mutations, which means that the gene does not function correctly.

Approximately 510% of breast cancer cases in people are hereditary.

Learn more about breast cancer genes here.

Other forms of breast cancer can occur due to gradual changes in a persons DNA.

These forms of breast cancer, known as somatic mutations, are not due to inherited factors. Somatic mutations occur for a variety of reasons, such as aging or exposure to certain chemicals.

Inherited breast cancer genes cannot skip a generation.

If a person has inherited a gene that causes breast cancer, they have a 50% chance of passing it on to their children. If a persons child does not inherit the mutated gene, the child cannot then pass it on to their future children.

However, while genes cannot skip a generation, the cancer can. Having a mutated gene is not a guarantee that a person will have breast cancer.

A mutated gene is still inheritable, even if the person does not develop breast cancer. This means that a persons child may inherit the mutated gene from them and could develop breast cancer.

There are various inherited gene mutations that can cause a person to develop breast cancer. The most common causes of inherited breast cancer are mutations in the genes BRCA1 and BRCA2.

The BRCA genes are responsible for repairing damage to cells in a persons body. These genes also help certain cells, such as breast or ovarian cells, to grow as expected.

When mutations occur in these genes, it can lead to atypical cell growth. Atypical cell growth can lead to the development of cancer.

If a female inherits a harmful BRCA gene, their risk of developing breast cancer by age 7080 is between 4569%.

Additionally, the ACS notes that males with the BRCA2 gene have a lifetime risk of 6 in 100 for developing breast cancer. Those with the BRCA1 gene have a lifetime risk of 1 in 100.

However, while there has been extensive research on the risk of breast cancer in females with the BRCA1 and BRCA2 genes, there has been less research on the cancer risk in males. As a result, these statistics might not be a true reflection.

Learn more about the BRCA gene here.

The ACS notes that most females who have breast cancer have no family history of the condition. However, having a family history of breast cancer can increase a persons chances of developing it.

A females chances of developing breast cancer double if they have a first degree relative with the condition. A first degree relative is an immediate family member, such as a sister, mother, or daughter.

Breastcancer.org states that a female has a higher risk of inheriting a genetic mutation linked to breast cancer if they have:

The risk of a person developing breast cancer increases with each additional family member who has it. Additionally, having a male relative who has breast cancer also increases a females chances of having it.

More research is necessary to determine the effects of family history on a males chances of developing breast cancer.

If a person is concerned that they may have inherited a breast cancer gene, they should speak with a doctor. A doctor may suggest for a person to undergo genetic counseling.

Genetic counseling involves a person speaking with a genetic counselor about their chances of developing breast cancer. Genetic counselors can also provide a person with resources and support.

This type of counseling can also help a person decide if they would like to take part in genetic testing or not. Genetic testing involves checking a persons genetic profile for breast cancer-causing genes.

Genetic testing for cancer usually involves a person submitting a blood sample. However, other forms of genetic testing can use cell samples from a persons:

If a person knows they have a BRCA gene, there are various medical options available to them.

These options include the following:

Breastcancer.org suggests that a person with a high risk of developing breast cancer may benefit from having more frequent screenings.

A person can speak with a doctor about how often they should get screened for breast cancer.

This can involve:

There are certain medications that can help reduce a persons chances of developing hormone receptor-positive breast cancer.

Hormone receptor-positive breast cancers contain hormone receptors that are activated by certain hormones. When these hormones bind to the hormone receptors, they can stimulate growth in the cancer.

Hormonal therapy medications reduce the amount of these hormones in a persons body.

These medications include:

A person may choose to have risk-reduction surgery if they have a high risk of developing breast cancer.

According to the National Cancer Institute, risk-reduction surgery for breast cancer can involve removing one or both breasts, ovaries, or both pairs. There are two types of risk-reducing surgeries: bilateral prophylactic mastectomy and salpingo-oophorectomy.

Bilateral prophylactic mastectomies involve removing both breasts, including a persons nipples, which is known as a total mastectomy. The other option is a subcutaneous mastectomy, which involves removing as much breast tissue as possible while leaving a persons nipples intact.

A total mastectomy reduces a persons risk of developing breast cancer better than a subcutaneous mastectomy.

A salpingo-oophorectomy involves the removal of a persons ovaries and fallopian tubes. Removing the ovaries reduces the amount of estrogen in someones body, which can slow the growth of some breast cancers. Estrogen can promote the growth of some types of breast cancer.

For people with a mutation in the BRCA1 and BRCA2 genes, a bilateral prophylactic mastectomy can reduce the risk of breast cancer by at least 95%.

It can also reduce the risk of breast cancer in people with a strong family history of this condition by up to 90%.

A salpingo-oophorectomy can reduce the chances of breast cancer in people with a high risk by 50%.

For people with mutated BRCA genes, premenopausal removal of their ovaries and fallopian tubes can reduce breast cancer risk by 50% and ovarian cancer risk by 8595%.

Ovary removal may also increase a persons chances of survival if they do develop breast cancer due to mutated BRCA genes.

Inherited genetic factors may cause a person to develop breast cancer. However, a person who inherits a breast cancer gene may not always develop cancer.

This means that a breast cancer gene can appear to skip a generation, even though it does not.

If a person has a family history of breast cancer, they are at a higher risk of developing it. A person can speak with a doctor about their risk of breast cancer to see if they may qualify for or benefit from genetic counseling.

A person can then decide if they would like to have genetic testing.

If a person has a mutated BRCA gene, there are various medical options available to them. A person should speak with a doctor about which option is right for them.

See more here:
Breast cancer and genetics: Can it skip a generation? - Medical News Today

Recommendation and review posted by Bethany Smith

Biologist Gordon Stenhouse has observed grizzlies respect for humans. He wishes wed return the favour.

I wanted to be a veterinarian, but I didnt get into vet school. So I went into wildlife biology. In the early 80s, I got a job studying polar bears and, over many years in the Arctic, I was fortunate to also work on many other speciesDall sheep, peregrine falcons, Arctic-nesting geese, barren-ground caribou. Of all the species I worked on, I enjoyed polar bears the most.

I worked for the Northwest Territories government out in Manitobas Cape Churchill, where congregations of polar bears gather every fall waiting for the sea ice to form. My job was to figure out how to keep polar bears and people apartwhat we call bear deterrence. I lived with an assistant in a fire tower, basically an eight-by-eight-foot box on a tower, just watching the bears and taking notes. I couldnt really go down on the ground much, because there were bears all around us. I thought I had the best job in the world.

Later, I moved to Alberta and worked for a forestry company, which was a very good jobI had a pension and benefits, all that. But I left it for a one-year position to work with grizzly bears, getting paid by the hour. Just imagine, coming home and telling your wife that when you have two small kids.

MORE:Arctic narwhals have a new enemy: the noise of passing ships

Scientists had just figured out how to do DNA population inventories. You get hair samples from bears and run DNA profiles on themjust like the CSI stuff you see on TV, but it takes more time. We learned there were fewer bears than expected. After a few years of inventory work, the Alberta government put a stop to the spring bear hunt [in 2006]. We began to think, how do we recover bear populations? We learned about how road densities affect the survival of bears and that we needed to manage roadswhich is really managing people.

(Courtesy of Gordon Stenhouse)

We used radio collars to understand bear movements. In the early days, we would have to fly around in a helicopter and find the bear, then send a signal to the collar to get the data. One day were flying and I see people walking on this trail up the hillside. And going down toward these people is our collared bear, a big male. I thought, oh no, this is going to be a wreck. We were going to stop our work and go chase the bear away, but before we could descend, the bear walked off the trail and sat down about 20 m away, the way a dog would sit, on his haunches. He watched these people walk by, and then he went back to the trail and kept walking. Generally bears want to stay away from people, but theyll share their world with us. And its our responsibility to show them the same respect.

Every time I capture and handle a bear, I think this better be worth it. This bear is minding his own business, and you come in with a helicopter and dart him, put a collar on him and when he wakes up, hes missing a tooth. When someone shoots a collared bear that youve followed for many years, you think, how can humans be like this? Here are bears, sharing their world with us, tolerating us, walking by us on the trail. And this is how we treat them?

I think its possible to balance the needs of humans and bears, but its not easy. We have to make decisions that certain areas are more important for wildlife than for humans. It doesnt mean we cant use those areas, but it has to be controlled usemaybe hiking only, maybe no trucks or quads. Or we cant disturb the landscape for natural resource extraction, we just leave it as it is.

READ:Tseketi, the 100-year-old B.C.sturgeon thats here to save her species

We just finished two inventory projects over the last few years, and the populations in two areas have doubled. Weve also learned that some of the changes made for forestry, like taking big patches of old forest and making them into younger patches, can be good for bears. We have produced, in my view, the most comprehensive database of grizzly bears in North America, and this amazing genetic database. Its a gold mine of data. In my office, I had boxes and boxes stacked to the ceiling. While watching the 2014 Sochi Olympics, I realized that they werent using blood samples to test athletes prior to the Gamesthey were taking hair samples, because hair contains long-term signatures of chemicals. So I thought, we must be able to do something more with this hair. We started looking at hair cortisol, to look at stress and reproductive hormones. Id never imagined that we would be able to do that with hair samples when we collected them.

Sometimes in science, you just happen upon a finding. In grad school, we were taught that grizzlies are a solitary species that only come together when they mate, and then the mom is on her own with the cubs. But one year, in 2012, we had three adult female bears collared. And, from the genetics, we knew they were relateda female, her sister and her daughter. All three of these females had cubs, and they met up on a mountain, and over the course of the next few weeks, those bears were together all the time, with their six little cubs running around. They travelled together, bedded down together. It made me think of a family reunion, when people meet at the summer cottage. And I always say to myself, I wonder if they took the right cubs with them when they left?

Despite all the research, we will likely never know everything about the lives of bears. I find it pleasing that we still have much to learn. Canadians are fortunate to have many wildlife species that other parts of the world dont have. We have an environment that represents wilderness, and bears to me are a symbol of wilderness. I like to think that if we can manage their habitat and give them what they need, they will be around for future generations. I hope that we can conserve them for many, many years to come.

As told to Michelle Cyca

This article appears in print in the November 2021 issue of Macleans magazine with the headline, Here be bears. Subscribe to the monthly print magazine here.

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Gordon Stenhouse, Grizzly whisperer, on humans sharing the world with bears - Maclean's

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Men and women are equally likely to inherit or pass on a cancer-predisposing BRCA variantfamily history of cancers needs to encompass both sides of the family

Men with cancer-predisposing BRCA variants have an increased risk of developing breast cancer and are advised to be breast aware

Men with cancer-predisposing BRCA2 variants have an increased risk of developing aggressive prostate cancer (men with cancer-predisposing BRCA1 variants may also have an increased risk); it is not yet known whether prostate specific antigen screening reduces mortality in men with cancer-predisposing BRCA variants

The European Association of Urology recommends that PSA screening is offered to men with cancer-predisposing BRCA2 variants from 40 years of age after discussion of the risks and benefits

Around one in 260 men (~0.4%) inherits a cancer-predisposing BRCA variant that increases their risk of developing prostate, pancreatic, and breast cancer and may affect the health of their family.12 Most of these men are currently unaware that they have a cancer-predisposing BRCA variant, but as genetic testing becomes more common, more men will need medical advice about what having such a variant means for them and their families.

Men are just as likely as women to have a cancer-predisposing BRCA variant, but many people perceive these variants as only being relevant to women. Paradoxically, this could lead to women at very high risk of breast and ovarian cancer missing out on screening and risk-lowering treatment despite a concerning paternal family history. Clinicians might also be less attuned to paternal family history of cancer in assessing womens breast cancer risk.3 This practice pointer covers what cancer-predisposing BRCA variants are, who might be tested; and what health issues men and their clinicians need to know about. We refer to men, but the article also applies to transwomen and some non-binary

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Care of men with cancer-predisposing BRCA variants - The BMJ

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Carnivore keepers at the Smithsonian Conservation Biology Institutein Front Royal, Virginia, welcomed a litter of fivecheetah cubs today. Five-year-old female Rosalie birthed the cubs at 5:20 a.m., 8:24 a.m., 9:42 a.m., 10:33 a.m and 11:17 a.m. ET. The family can be viewed via the Cheetah Cub Cam. Ten-year-old Nick, who was the first cheetah born at SCBI, sired this litter. Animal care staff will leave Rosalie to bond with and care for her cubs without interference, so it may be some time before they can determine the cubs'sexes. The cubs appear to be strong, active, vocal and eating well. Keepers will perform a health check on the cubs when Rosalie is comfortable leaving them for an extended period of time.

Staff are closely monitoring Rosalie and her cubs behaviors via webcam.Virtual visitors can observe Rosalie and her cubs on this temporary platform until the cubs leave the den. Keepers provided Rosalie with access to multiple dens, so it is possible she may move the cubs to an off-camera location.

"Seeing Rosalie successfully care for this litterher firstwith confidence is very rewarding,"said Adrienne Crosier, cheetah reproductive biologist at SCBI and head of the Association of Zoos and Aquariums'Cheetah Species Survival Plan. "Being able to witness the first moments of a cheetahs life is incredibly special. As webcam viewers watch our cheetah family grow, play and explore their surroundings, we hope the experience brings them joy and helps them feel a deeper connection to this vulnerable species."

SCBI is part of the Cheetah Breeding Center Coalitiona group of 10 cheetah breeding centers across the United States that aim to create and maintain a sustainable North American cheetah population under human care. These cubs are a significant addition to the Cheetah SSP, as each individual contributes to this program.

The SSP scientists determine which animals to breed by considering their genetic makeup, health and temperament, among other factors. Rosalie and Nick were paired and bred July 9 and 10. Keepers trained Rosalie to voluntarily participate in ultrasounds, and SCBI veterinarians confirmed her pregnancy Aug. 16. Since 2007, 16 litters of cheetah cubs have been born at SCBI.

Cheetahs live in small, isolated populations mostly in sub-Saharan Africa. Many of their strongholds are in eastern and southern African parks. Due to human conflict, poaching and habitat and prey-base loss, there are only an estimated 7,000 to 7,500 cheetahs left in the wild. The International Union for Conservation of Nature considers cheetahs vulnerable to extinction.

The Zoos legacy of conservation work extends beyond the public Zoo in Washington, D.C., to SCBI in Front Royal, Virginia. Scientists at SCBI study and breed more than 20 species, including some that were once extinct in the wild, such as black-footed ferrets and scimitar-horned oryx. Animals thrive in specialized barns and building complexes spread over more than 3,200 acres. The sprawling environment allows for unique studies that contribute to the survival of threatened, difficult-to-breed species with distinct needs, especially those requiring large areas, natural group sizes and minimal public disturbance.

SCBI spearheads research programs at its headquarters in Virginia, the Zoo in Washington, D.C., and at field research stations and training sites worldwide. SCBI scientists tackle some of todays most complex conservation challenges by applying and sharing what they learn about animal behavior and reproduction, ecology, genetics, migration and conservation sustainability.

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Cheetah Cubs Are Born at the Smithsonian Conservation Biology Institute - Smithsonian's National Zoo and Conservation Biology Institute

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In the basement of a lab at Baltimores Inner Harbor, The Chosen One was born.

At least, thats what the researchers at the University of Marylands Center for Environmental Science called her. She was the blue crab who would be the foundation of a breakthrough scientific discovery the first map of the species DNA.

Through a process known as genome sequencing, the scientists created a virtual blue crab encyclopedia, which appears on a computer screen as a color-coded network of thousands of nucleotides the genetic building blocks that make a blue crab a blue crab.

The genomes contents, researchers say, hold a range of potential clues to help them better understand and protect the states beloved crustacean. It could help pinpoint what mutations drive disease, for example, or track how climate change affects the species in the wild. It could even provide a blueprint on how to breed the meatiest crabs in a lab for Maryland picnic tables in summers to come.

Scientists had published genome assemblies for 67 different crustaceans, from the Chinese mitten crab to the shrimp. But until this year, the genetic road map of the blue crab remained largely a mystery.

The project took four researchers about four years a timeline that included raising The Chosen One in the lab. Its an arduous process, but one thats become more achievable thanks to technological advancements. By comparison, a first draft of the human genome was unveiled in 2000, but completing it took until this summer.

The work began on the waters of the Chesapeake Bay one day in October 2018. UMCES professor J. Sook Chung boarded a crabbers boat off Pasadena and harvested dozens of young female crabs to bring back to her lab at the Institute of Marine and Environmental Technology in downtown Baltimore.

After years of raising crabs in her lab, one question plagued her: Why is it that one mother crab can produce millions of eggs, but only a lucky few survive to adulthood?

Genomic sequencing could provide the answer.

To get there, the scientists had to raise the chosen crab, which then gave birth in the lab to dozens of healthy babies, proving her genetic viability. Then, they extracted as much blood and soft tissue from that crab and sent those samples to a lab in Rockville for DNA extraction.

Then, Baltimore scientists received a trove of information from the Rockville lab that they had to piece together, bit by bit. It was terabytes upon terabytes of data, which had to be processed by a computer for five to six months at a time. Thats because the results were full of extra, repetitive genetic information, which they had to comb through to craft each individual chromosome.Its a little bit like ads when youre watching Hulu and you get the same ads again and again, said Tsvetan Bachvaroff, another professor at the University of Maryland center.

When the intricate jigsaw puzzle was complete, the group determined that blue crabs have 40 to 50 chromosomes. Thats nearly double the number in humans, but each one is considerably shorter than ours. There are still some small gaps in the blue crab genome, but future research could fill in the holes.

The scientists article was published last month in the peer-reviewed journal G3: Genes, Genomes, Genetics. The entire sequence will soon be available for public viewing.

The Maryland scientists are now able to compare the DNA of other blue crabs to the model theyve created to understand what drives any differences between them. For instance, what genes decide the crabs size and color? What genetic differences separate a Maryland crab from one native to the waters of, say, Venezuela?

In Baltimore, theyve already determined which part of the sequence encodes the hormone that controls molting, when crabs shed their shells so they can grow. Manipulating this gene could pave the way for improvements in large-scale blue crab farming, Chung said. Thats important because when blue crabs grow in a tank, they molt at different times. Crabs with soft bodies are vulnerable to their bloodthirsty brethren.Blue crabs are sort of notorious for cannibalistic behaviors. They dont care if theyre siblings. If you culture them in a communal tank thousands of them eventually, theres just one big crab. They will eat each other, Chung said. If you synchronize all of the animals sharing the water shedding the shell at the same time, you can remove those cannibalistic behaviors.

Molting is also a vulnerable time for crabs in the wild, and the environment theyre in during that time has a profound impact on their future health and size, said Genine McClair, blue crab program manager for the Maryland Department of Natural Resources. Understanding more about what drives the process could help fisheries managers adjust harvest practices in pursuit of the best crabs, she said.

Now, we have this starting point to ask all these questions, and researchers from all over the country can ask these questions, but they have to reference back to Maryland as where it all began, she said.

All told, the sequencing project cost less than $250,000, much of which came from Maryland-based donors like Mike and Trish Davis of Severna Park. The couple, who ran a software company for decades before their retirement 12 years ago, was looking to support projects that might have trouble getting off the ground without an initial burst of donor funds.Its just a tough project because we dont know exactly what the benefits will be, and people dont like to fund that sort of thing, Mike Davis said.

Slowly, Davis and his wife assembled a group of donors, who collectively gave about $140,000 to the genome project, Davis said.

There was a competitive spirit that helped the scientists in Baltimore make their case, Davis said. The scientists joked about a general rivalry with counterparts in Virginia who also study blue crabs.

They told us: Well, its going to get mapped, its just a matter of who, Davis said. We dont want Virginia to do this, of course, as proud Marylanders.

On a recent afternoon, Chung fed the labs latest crop of blue crabs from the bay, each stored in an orange Home Depot bucket, with oxygen tubes piping bubbles into their watery homes. Its a seven-day-a-week job, she said, to keep the crabs healthy and note their progress.

Sporting a red T-shirt with an image of blue crab sewn on the back, Chung weaved between vast blue tanks to a dark corner of the lab, where minuscule baby crabs grow. Each with their own underwater cubicle, illuminated only by gentle red light, the dime-sized crabs are delicate creatures.

In a way, its fitting Chung was part of the genome sequencing work. Her first name, Sook, is another word for a mature female blue crab, as shes quick to point out. And her earlier work had unveiled some of the creatures more carefully guarded secrets. In 2014, for example, she was part of a team that discovered a new sex hormone in the eyestalks of female blue crabs.

But this recent project feels the most significant, she said the equivalent of passing a baton to the relay runners of tomorrow.

This is a digitized legacy to those who are coming for the next generation of scientists, she said. Thats the way I see it. I left something behind.

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Maryland scientists mapped the DNA of a blue crab for the first time. It could unlock new clues to understanding the species. - Frederick News Post

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Have your luscious locks lost their luster lately? While hair loss can be a normal part of getting older, rapid hair loss could be a sign that somethings up. If youve also been losing weight, its important to understand whether your weight loss and hair loss could be related.

Sudden or rapid weight loss is associated with a condition called telogen effluvium (TE). Its the most common cause of widespread hair loss.

Why does it happen? Stress or trauma may temporarily mess with your hairs growth cycle and cause too much hair to shed at once.

Nutrient deficiencies also seem to be connected to this condition, but that doesnt mean its always a good idea to hit the supplement aisle. In some cases, getting too much of certain vitamins can actually make hair loss worse or put you at risk of toxicity.

A healthcare professional can help you decide whether supplements are right for you.

Keep in mind that TE usually lasts only about 6 months and tends to clear up on its own.

If youre following a very restrictive diet to lose weight, you may be cutting out entire food groups. This can lead to deficiencies in nutrients like zinc, protein, iron, and fatty acids. And those deficiencies can be bad news for your hair health.

A 2015 study of 180 women with hair loss found that iron deficiency and psychological stress were common causes of hair loss.

Research suggests that very low calorie crash diets are another culprit for these nutrient deficiencies. Dieting can also cause psychological stress, which is a major hair loss trigger.

Its important to talk with a healthcare professional before starting a new diet. In general, aim for a balanced diet that includes a variety of fresh fruits, vegetables, grains, and proteins.

Amino acids help your body produce the main structural protein of hair, called keratin. Deficiencies in specific amino acids (like leucine, histidine, valine, and cysteine) are common in folks with hair loss.

A 2017 study in 100 people with hair loss found that a large portion of the participants had leucine and histidine deficiencies. Cysteine and valine deficiencies were also common.

To up your amino acid intake, you can add more protein to your diet. Meat is a solid source of protein, but there are vegetarian and vegan protein options too. Some popular choices are:

Weight loss surgery (such as sleeve gastrectomy) has been linked to low levels of protein, vitamins, and minerals and those deficiencies can lead to hair loss.

A 2018 study of 50 folks who underwent a sleeve gastrectomy found that 56 percent of participants experienced hair loss. Researchers also noted that the peeps who had hair loss also had low levels of vitamin B12 and zinc before and after surgery.

Its tough to say exactly how long hair loss will last after weight loss surgery. In a 2021 study of 112 women who had sleeve gastrectomy surgery, 72 percent of participants experienced hair loss after surgery. In 79 percent of those people, the hair loss started 3 to 4 months after surgery and resolved in about 5.5 months.

Hair loss during weight loss tends to be triggered by rapid weight loss or a diet-related nutrient deficiencies. Try to stick to a sustainable weight loss program instead of an overly restrictive diet. And aim to maintain a balanced diet that includes all the vital vitamins and nutrients your body needs.

Always talk with a healthcare pro before making any major changes to your lifestyle. They can customize a diet or supplement regimen to help get your hair growth back on track.

Hair loss itself isnt a risk to your health, but it can be a sign of an underlying medical condition. Its important to contact a doc ASAP if you experience:

Hair loss is a common side effect of rapid weight loss or nutrient deficiencies. While the hair loss itself isnt dangerous, the underlying cause might be more serious.

Talk with a healthcare pro if you start to notice that your hair is shedding or thinning rapidly, if you notice bald patches, or if clumps of your hair start to fall out. They can help you figure out the cause and the best treatment plan for you.

Continued here:
Weight Loss and Hair Loss: Connection, Prevention, and More - Greatist

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The worlds wildlife populations have plummeted by more than two-thirds since 1970 and there are no signs that this downward trend is slowing. The first phase of Cop15 talks in Kunming this week will lay the groundwork for governments to draw up a global agreement next year to halt the loss of nature. If they are to succeed, they will need to tackle what the IPBES (Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services) has identified as the five key drivers of biodiversity loss: changes in land and sea use; direct exploitation of natural resources; climate change; pollution; and invasion of alien species.

1

Changes in land and sea use

Its hidden destruction. Were still losing grasslands in the US at a rate of half a million acres a year or more.

Tyler Lark, from the University of Wisconsin-Madison, knows what he is talking about. Lark and a team of researchers used satellite data to map the expansion and abandonment of land across the US and discovered that 4m hectares (10m acres) had been destroyed between 2008 and 2016.

Large swathes of the United States great prairies continue to be converted into cropland, according to the research, to make way for soya bean, corn and wheat farming.

Changes in land and sea use has been identified as the main driver of unprecedented biodiversity and ecosystem change over the past 50 years. Three-quarters of the land-based environment and about 66% of the marine environment have been significantly altered by human actions.

North Americas grasslands often referred to as prairies are a case in point. In the US, about half have been converted since European settlement, and the most fertile land is already being used for agriculture. Areas converted more recently are sub-prime agricultural land with yields 70% lower than the national average, which means a lot of biodiversity is being lost for diminishing returns.

Our findings demonstrate a pervasive pattern of encroachment into areas that are increasingly marginal for production but highly significant for wildlife, Lark and his team wrote in the paper, published in Nature Communications.

Boggier areas of land, or those with uneven terrain, were traditionally left as grassland, but in the past few decades, this marginal land has also been converted. In the US, 88% of cropland expansion takes place on grassland, and much of this is happening in the Great Plains known as Americas breadbasket which used to be the most extensive grassland in the world.

According to the UNs Convention on Biological Diversity there arefive main threatsto biodiversity. In descending order these are: changes in land and sea use; direct exploitation of natural resources; climate change; pollution and invasive species.

1.For terrestrial and freshwater ecosystems, land-use change has had the largest relative negative impact on nature since 1970.More than a third of the worlds land surface and nearly 75% of freshwater resources are now devoted to crop or livestock production.Alongside a doubling of urban area since 1992, things such as wetlands, scrubland and woodlands which wildlife relies on are ironed out from the landscape.

2. The direct exploitation of organisms and non-living materials,including logging, huntingand fishing and the extraction of soils and water are allnegatively affecting ecosystems.In marine environments, overfishing is considered to be the most serious driver of biodiversity loss.One quarter of the worlds commercial fisheries are overexploited, according to a 2005Millennium Ecosystem Assessment.

3. The climate crisis is dismantling ecosystems at every level. Extreme weather events such as tropical storms and flooding are destroyinghabitats.Warmer temperatures are also changing the timing of natural events such as theavailability of insects and when birds hatch their eggs in spring. The distribution of species and their range is also changing.

4. Many types of pollution are increasing. In marine environments, pollution from agricultural runoff (mainlynitrogen and phosphorus)do huge damage to ecosystems. Agricultural runoff causes toxic algal blooms and even"dead zones"in the worst affectedareas.Marine plastic pollution has increased tenfold since 1980,affecting at least 267 species.

5. Since the 17th century, invasive species havecontributed to 40%of all known animal extinctions. Nearly one fifth of the Earths surface is at risk of plant and animal invasions. Invasive species change the composition of ecosystems by outcompeting native species.

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Hotspots for this expansion have included wildlife-rich grasslands in the prairie pothole region which stretches between Iowa, Dakota, Montana and southern Canada and is home to more than 50% of North American migratory waterfowl, as well as 96 species of songbird. This cropland expansion has wiped out about 138,000 nesting habitats for waterfowl, researchers estimate.

These grasslands are also a rich habitat for the monarch butterfly a flagship species for pollinator conservation and a key indicator of overall insect biodiversity. More than 200m milkweed plants, the caterpillars only food source, were probably destroyed by cropland expansion, making it one of the leading causes for the monarchs national decline.

The extent of conversion of grassland in the US makes it a larger emission source than the destruction of the Brazilian Cerrado, according to research from 2019. About 90% of emissions from grassland conversion comes from carbon lost in the soil, which is released when the grassland is ploughed up.

The rate of clearing that were seeing on these grasslands is on par with things like tropical deforestation, but it often receives far less attention, says Lark.

Food crop production globally has increased by about 300% since 1970, despite the negative environmental impacts.

Reducing food waste and eating less meat would help cut the amount of land needed for farming, while researchers say improved management of existing croplands and utilising what is already farmed as best as possible would reduce further expansion.

Lark concludes: I think theres a huge opportunity to re-envision our landscapes so that theyre not only providing incredible food production but also mitigating climate change and helping reduce the impacts of the biodiversity crisis by increasing habitats on agricultural land.PW

2

Direct exploitation of natural resources

From hunting, fishing and logging to the extraction of oil, gas, coal and water, humanitys insatiable appetite for the planets resources has devastated large parts of the natural world.

While the impacts of many of these actions can often be seen, unsustainable groundwater extraction could be driving a hidden crisis below our feet, experts have warned, wiping out freshwater biodiversity, threatening global food security and causing rivers to run dry.

Farmers and mining companies are pumping vast underground water stores at an unsustainable rate, according to ecologists and hydrologists. About half the worlds population relies on groundwater for drinking water and it helps sustain 40% of irrigation systems for crops.

The consequences for freshwater ecosystems among the most degraded on the planet are under-researched as studies have focused on the depletion of groundwater for agriculture.

But a growing body of research indicates that pumping the worlds most extracted resource water is causing significant damage to the planets ecosystems. A 2017 study of the Ogallala aquifer an enormous water source underneath eight states in the US Great Plains found that more than half a century of pumping has caused streams to run dry and a collapse in large fish populations. In 2019, another study estimated that by 2050 between 42% and 79% of watersheds that pump groundwater globally could pass ecological tipping points, without better management.

The difficulty with groundwater is that people dont see it and they dont understand the fragility of it, says James Dalton, director of the global water programme at the International Union for Conservation of Nature (IUCN). Groundwater can be the largest and sometimes the sole source in certain types of terrestrial habitats.

Uganda is luxuriantly green, even during the dry season, but thats because a lot of it is irrigated with shallow groundwater for agriculture and the ecosystems are reliant on tapping into it.

According to UPGro (Unlocking the Potential of Groundwater for the Poor), a research programme looking into the management of groundwater in sub-Saharan Africa, 73 of the 98 operational water supply systems in Uganda are dependent on water from below ground. The country shares two transboundary aquifers: the Nile and Lake Victoria basins. At least 592 aquifers are shared across borders around the world.

Some of the groundwater reserves are huge, so there is time to fix this, says Dalton. Its just theres no attention to it.

Inge de Graaf, a hydrologist at Wageningen University, who led the 2019 study into watershed levels, found between 15% to 21% had already passed ecological tipping points, adding that once the effects had become clear for rivers, it was often too late.

Groundwater is slow because it has to flow through rocks. If you extract water today, it will impact the stream flow maybe in the next five years, in the next 10 years, or in the next decades, she says. I think the results of this research and related studies are pretty scary.

In April, the largest ever assessment of global groundwater wells by researchers from University of California, Santa Barbara, found that up to one in five were at risk of running dry. Scott Jasechko, a hydrologist and lead author on the paper, says that the study focuses on the consequences for humans and more research is needed on biodiversity.

Millions of wells around the world could run dry with even modest declines in groundwater levels. And that, of course, has cascading implications for livelihoods and access to reliable and convenient water for individuals and ecosystems, he says.PG

In 2019, the European heatwave brought 43C heat to Montpellier in France. Great tit chicks in 30 nest boxes starved to death, probably because it was too hot for their parents to catch the food they needed, according to one researcher. Two years later, and 2021s heatwave appears to have set a European record, pushing temperatures to 48.8C in Sicily in August. Meanwhile, wildfires and heatwaves are stripping the planet of life.

Until now, the destruction of habitats and extraction of resources has had a more significant impact on biodiversity than the climate crisis. This is likely to change over the coming decades as the climate crisis dismantles ecosystems in unpredictable and dramatic ways, according to a review paper published by the Royal Society.

There are many aspects of ecosystem science where we will not know enough in sufficient time, the paper says. Ecosystems are changing so rapidly in response to global change drivers that our research and modelling frameworks are overtaken by empirical, system-altering changes.

The calls for biodiversity and the climate crisis to be tackled in tandem are growing. It is clear that we cannot solve [the global biodiversity and climate crises] in isolation we either solve both or we solve neither, says Sveinung Rotevatn, Norways climate and environment minister, with the launch in June of a report produced by the worlds leading biodiversity and climate experts. Zoological Society of London senior research fellow Dr Nathalie Pettorelli, who led a study on the subject published in the Journal of Applied Ecology in September, says: The level of interconnectedness between the climate change and biodiversity crises is high and should not be underestimated. This is not just about climate change impacting biodiversity; it is also about the loss of biodiversity deepening the climate crisis.

Writer Zadie Smith describes every countrys changes as a local sadness. Insects no longer fly into the house when the lights are on in the evening, the snowdrops are coming out earlier and some migratory species, such as swallows, are starting to try to stay in the UK for winter. All these individual elements are entwined in a much bigger story of decline.

Our biosphere the thin film of life on the surface of our planet is being destabilised by temperature change. On land, rains are altering, extreme weather events are more common, and ecosystems more flammable. Associated changes, including flooding, sea level rise, droughts and storms, are having hugely damaging impacts on biodiversity and its ability to support us.

In the ocean, heatwaves and acidification are stressing organisms and ecosystems already under pressure due to other human activities, such as overfishing and habitat fragmentation.

The latest Intergovernmental Panel on Climate Change (IPCC) landmark report showed that extreme heatwaves that would usually happen every 50 years are already happening every decade. If warming is kept to 1.5C these will happen approximately every five years.

The distributions of almost half (47%) of land-based flightless mammals and almost a quarter of threatened birds, may already have been negatively affected by the climate crisis, the IPBES warns. Five per cent of species are at risk of extinction from 2C warming, climbing to 16% with a 4.3C rise.

Connected, diverse and extensive ecosystems can help stabilise the climate and will have a better chance of thriving in a world permanently altered by rising emissions, say experts. And, as the Royal Society paper says: Rather than being framed as a victim of climate change, biodiversity can be seen as a key ally in dealing with climate change. PW

On the west coast of Scotland, fragments of an ancient rainforest that once stretched along the Atlantic coast of Britain cling on. Its rare mosses, lichens and fungi are perfectly suited to the mild temperatures and steady supply of rainfall, covering the crags, gorges and bark of native woodland. But nitrogen pollution, an invisible menace, threatens the survival of the remaining 30,000 hectares (74,000 acres) of Scottish rainforest, along with invasive rhododendron, conifer plantations and deer.

While marine plastic pollution in particular has increased tenfold since 1980 affecting 44% of seabirds air, water and soil pollution are all on the rise in some areas. This has led to pollution being singled out as the fourth biggest driver of biodiversity loss.

In Scotland, nitrogen compounds from intensive farming and fossil fuel combustion are dumped on the Scottish rainforest from the sky, killing off the lichen and bryophytes that absorb water from the air and are highly sensitive to atmospheric conditions.

The temperate rainforest is far from the sources of pollution, yet because its so rainy, were getting a kind of acid rain effect, says Jenny Hawley, policy manager at Plantlife, which has called nitrogen pollution in the air the elephant in the room of nature conservation. The nitrogen-rich rain thats coming down and depositing nitrogen into those habitats is making it impossible for the lichen, fungi, mosses and wildflowers to survive.

Environmental destruction caused by nitrogen pollution is not limited to the Scottish rainforest. Algal blooms around the world are often caused by runoff from farming, resulting in vast dead zones in oceans and lakes that kill scores of fish and devastate ecosystems. Nitrogen-rich rainwater degrades the ability of peatlands to sequester carbon, the protection of which is a stated climate goal of several governments. Wildflowers adapted to low-nitrogen soils are squeezed out by aggressive nettles and cow parsley, making them less diverse.

About 80% of nitrogen used by humans through food production, transport, energy and industrial and wastewater processes is wasted and enters the environment as pollution.

Nitrogen pollution might not result in huge floods and apocalyptic droughts but we are slowly eating away at biodiversity as we put more and more nitrogen in ecosystems, says Carly Stevens, a plant ecologist at Lancaster University. Across the UK, we have shown that habitats that have lots of nitrogen have fewer species in them. We have shown it across Europe. We have shown it across the US. Now were showing it in China. Were creating more and more damage all the time.

To decrease the amount of nitrogen pollution causing biodiversity loss, governments will commit to halving nutrient runoff by 2030 as part of an agreement for nature currently being negotiated in Kunming. Halting the waste of vast amounts of nitrogen fertiliser in agriculture is a key part of meeting the target, says Kevin Hicks, a senior research fellow at the Stockholm Environment Institute centre at York.

One of the biggest problems is the flow of nitrogen from farming into watercourses, Hicks says. In terms of a nitrogen footprint, the most intensive thing that you can eat is meat. The more meat you eat, the more nitrogen youre putting into the environment.

Mark Sutton, a professor at the UK Centre for Ecology & Hydrology, says reducing nitrogen pollution also makes economic sense.

Nitrogen in the atmosphere is 78% of every breath we take. It does nothing, its very stable and makes the sky blue. Then there are all these other nitrogen compounds: ammonia, nitrates, nitrous oxide. They create air and water pollution, he says. He argues that if you price every kilo of nitrogen at $1 (an estimated fertiliser price), and multiply it by the amount of nitrogen pollution lost in the world 200bn tonnes it amounts to $200bn (147bn) every year.

The goal to cut nitrogen waste in half would save you $100bn, he says. I think $100bn a year is a worthwhile saving.PG

On Gough Island in the southern Atlantic Ocean, scores of seabird chicks are eaten by mice every year. The rodents were accidentally introduced by sailors in the 19th century and their population has surged, putting the Tristan albatross one of the largest of its species at risk of extinction along with dozens of rare seabirds. Although Tristan albatross chicks are 300 times the size of mice, two-thirds did not fledge in 2020 largely because of the injuries they sustained from the rodents, according to the RSPB.

The situation on the remote island, 2,600km from South Africa, is a grisly warning of the consequences of the human-driven impacts of invasive species on biodiversity. An RSPB-led operation to eradicate mice from the British overseas territory has been completed, using poison to help save the critically endangered albatross and other bird species from injuries they sustain from the rodents. It will be two years before researchers can confirm whether or not the plan has worked. But some conservationists want to explore another controversial option whose application is most advanced in the eradication of malaria: gene drives.

Instead of large-scale trapping or poisoning operations, which have limited effectiveness and can harm other species, gene drives involve introducing genetic code into an invasive population that would make them infertile or all one gender over successive generations. The method has so far been used only in a laboratory setting but at Septembers IUCN congress in Marseille, members backed a motion to develop a policy on researching its application and other uses of synthetic biology for conservation.

If a gene drive were proven to be effective and there were safety mechanisms to limit its deployment, you would introduce multiple individuals on an island whose genes would be inherited by other individuals in the population, says David Will, an innovation programme manager with Island Conservation, a non-profit dedicated to preventing extinctions by removing invasive species from islands. Eventually, you would have either an entirely all male or entirely all female population and they would no longer be able to reproduce.

Nearly one-fifth of the Earths surface is at risk of plant and animal invasions and although the problem is worldwide, such as feral pigs wreaking havoc in the southern United States and lionfish in the Mediterranean, islands are often worst affected. The global scale of the issue will be revealed in a UN scientific assessment in 2023.

We have to be very careful, says Austin Burt, a professor of evolutionary genetics at Imperial College London, who researches how gene drives can be used to eradicate malaria in mosquito populations. If youre going after mice, for example, and youre targeting mice on an island, youd need to make sure that none of those modified mice got off the island to cause harm to the mainland population.

In July, scientists announced they had successfully wiped out a population of malaria-transmitting mosquitoes using a gene drive in a laboratory setting, raising the prospect of self-destructing mosquitoes being released into the wild in the next decade.

Kent Redford, chair of the IUCN Task Force on Synthetic Biology who led an assessment of the use of synthetic biology in conservation, said there are clear risks and opportunities in the field but further research is necessary.

None of these genetic tools are ever going to be a panacea. Ever. Nor do I think they will ever replace the existing tools, Redford says, adding: There is a hope and I stress hope that engineered gene drives have the potential to effectively decrease the population sizes of alien invasive species with very limited knock-on effects on other species.PG

Find more age of extinction coverage here, and follow biodiversity reporters Phoebe Weston and Patrick Greenfield on Twitter for all the latest news and features

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When most folks talk about aging deer theyre referring to venison, and the process of hanging a deer for an extended period to improve flavor and tenderness. However, with the rise in popularity of trail cameras, increasingly more hunters are sharing photos on social media and asking, How old is this deer?

When it comes to the answers you have to consider the source. A lot of well-meaning keyboard biologists offer their opinions, often of questionable accuracy. Fortunately, there are some fairly reliable though not foolproof methods for properly aging deer on the hoof, or from a photo. Lets start with does as they can only be reliably divided into two or three age classes. Early in the season its easy to distinguish does from fawns but as the youngsters grow it becomes more difficult, especially if you dont have multiple deer present for comparison.

First, look at the head and face. A fawns forehead and nose will appear much shorter (think: 8-ounce soda bottle) in comparison to the adult does longer nose (16-ounce soda bottle) and larger head. Next, look at the body. Fawns also have short, square bodies, short necks and less muscle development. An adult does body will be larger and more rectangular-shaped. Necks appear longer and older does may have swayed backs or sagging bellies.

Yearling does look somewhere in between and are best judged in the presence of older and/or younger deer. Its not uncommon for female deer to travel in family groups consisting of several generations, often a mature doe, her fawns and her yearling female offspring from the previous year. The same guidelines apply to buck fawns, though they may show a more square head than a doe, and sometimes you can distinguish tiny nubs or buttons that will eventually become antlers.

Now for the antlered bucks. Yearling bucks appear dainty, with thin necks, somewhat resembling a doe with antlers. Their legs appear long and slender compared to their body. Antler development can be highly variable depending mostly on nutrition and genetics. Many will sport spikes or forked antlers but some may carry a rack of six or even eight points. Regardless, main beams and points are usually thin and short.

Two-year-old bucks generally look somewhat gangly and awkward, though a healthy Maine buck could fool a lot of folks into thinking its older. Legs also appear long for their body, and theyll have a thin waist and shoulders and limited neck swelling. During the rut, tarsal glands may be dark, but very small and round. Rack size also varies but six-, eight- or even 10-point racks that score in the 120s and even 130s are not unusual, and a 2-year-old might dress out somewhere between 140 and 180 pounds, possibly more further north. Antler beams will still be relatively narrow at the base but thicker than a yearling and possibly have more rounded points.

Three-year-old bucks will have a fuller, thickly-muscled neck. The chest appears deeper than the hindquarters, giving a race horse appearance. Horizontal lines of the back and stomach are still straight and taut. Another good characteristic is that you can usually distinguish where the neck meets the shoulders. Tarsal glands during the rut will be dark but small, and staining does not extend down the leg to the hoof. Antler beams become thicker and could be 3 1/2 inches in diameter at the base.

At age 4, bucks reach maturity. Skeletal structure stops growing so they can direct more nutrition to body weight and antler mass. Their fully muscled neck now blends seamlessly into a deep chest. Their rump appears full and rounded and legs may appear slightly short for the body. The stomach and back do not sag, yet. Jaw skin is tight and tarsal glands will be noticeably large and dark. Rack size still varies but most of these deer will fall into what most hunters would consider the trophy category. The base of the beams will be thick, about the same diameter as a deers eye, and may show more dark staining.

Not many deer make it that long in heavily hunted areas but a few do, more so in the big woods where hunting pressure is less. Their neck and brisket will appear to be one continuous muscle and their neck will show heavy swelling. Now the legs really appear too short for the big, blocky body. Their waistline will be even (parallel) with the chest and they may start to show a pot belly and sagging back. Tarsals appear noticeably large and very dark with staining down the inside of the leg to the hoof during the rut. Again, rack size varies but even if they dont carry a crown of thorns, beams will be thick and heavy, especially at the bases.

There are objective criteria for what distinguishes a trophy buck, but for most hunters its a personal and very subjective judgement. A yearling might be a trophy for an inexperienced or unlucky hunter. Many 2- and 3-year-old bucks eventually make their way to the taxidermist. And a gnarly old north woods buck that wont score well in the record book but will pull the scales down well past the 200-pound mark might make the grade for big woods hunters. Still, if you plan to be selective, its nice to know what to look for.

Bob Humphrey is a freelance writer and Registered Maine Guide who lives in Pownal. He can be reached at:[emailprotected]

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It's true: Being short on sleep can really affect your weight. While you weren't sleeping, your body cooked up a perfect recipe for weight gain.

When youre short on sleep, its easy to lean on a large latte to get moving. You might be tempted to skip exercise (too tired), get takeout for dinner, and then turn in late because youre uncomfortably full.

If this cascade of events happens a few times each year, no problem. Trouble is, more than a third of Americans aren't getting enough sleep on a regular basis. Yet experts agree that getting enough shut-eye is as important to health, well-being, and your weight as are diet and exercise.

Skimping on sleep sets your brain up to make bad decisions. It dulls activity in the brains frontal lobe, the locus of decision-making and impulse control.

So its a little like being drunk. You dont have the mental clarity to make good decisions.

Plus, when youre overtired, your brain's reward centers rev up, looking for something that feels good. So while you might be able to squash comfort food cravings when youre well-rested, your sleep-deprived brain may have trouble saying no to a second slice of cake.

Research tells the story. A study in the American Journal of Clinical Nutritionfound that when people were starved of sleep, late-night snacking increased, and they were more likely to choose high-carb snacks. In another study done at the University of Chicago, sleep-deprived participants chose snacks with twice as much fat as those who slept at least 8 hours.

A second study found that sleeping too little prompts people to eat bigger portions of all foods, increasing weight gain. And in a review of 18 studies, researchers found that a lack of sleep led to increased cravings for energy-dense, high-carbohydrate foods.

Add it all together, and a sleepy brain appears to crave junk food while also lacking the impulse control to say no.

Sleep is like nutrition for the brain. Most people need between 7 and 9 hours each night. Get less than that, and your body will react in ways that lead even the most determined dieter straight to Ben & Jerrys.

Too little sleep triggers a cortisol spike.This stress hormone signals your body to conserve energy to fuel your waking hours.

Translation: Youre more apt to hang on to fat.

Researchers found that when dieters cut back on sleep over a 14-day period, the amount of weight they lost from fat dropped by 55%, even though their calories stayed equal. They felt hungrier and less satisfied after meals, and their energy was zapped.

Sleep deprivation makes you metabolically groggy," University of Chicago researchers say. Within just 4 days of insufficient ZZZs, your bodys ability to process insulin -- a hormone needed to change sugar, starches, and other food into energy -- goes awry. Insulin sensitivity, the researchers found, dropped by more than 30%.

Heres why thats bad: When your body doesn't respond properly to insulin, your body has trouble processing fats from your bloodstream, so it ends up storing them as fat.

So its not so much that if you sleep, youll lose weight, but that too little sleep hampers your metabolism and contributes to weight gain.

In todays world, snoozing can be difficult, particularly when all your screens (computers, TVs, cell phones, tablets) lure you into staying up just a little longer.

The basics are pretty simple:

SOURCES:

Alfredo Astua, MD, director of sleep medicine, Beth Israel Mount Sinai, New York.

National Sleep Foundation.

CDC.

Hanlon, E. Sleep, February 2016.

Nedeltcheva, A. American Journal of Clinical Nutrition, January 2009.

Hogenkamp, P. Psychoneuroendocrinology, September 2013.

Shlisky, J. Journal of the Academy of Nutrition and Dietetics, November 2012.

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Question: You are known for your expertise in hormone replacement therapy. What otherareas of medicine do you specialize in?

Answer: I am board certified in primary care, metabolic cardiology, and chiropractic medicine.I am also board certified in physician weightmanagement, anti-aging medicine, aesthetic medicine and physiotherapy. I specialize in anti-aging and regenerative medicine, and I also treat patients who are in need of hormone replacement, cardiac management, mens and womens sexual health, and primary andurgent care. I offer my clients a holistic and personalized approach to healthcare.

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Answer: No. Its a misconception as far as pricing. We are able to utilize an individualsinsurance for diagnostic testing and certain medications. The patient pays us directlyfor our services, therefore our time is notlimited with each patient. This allows us to create a dialog and grow a relationship.My goal is to provide health care to everyone regardless of insurance, and our pricesare affordable for everyone.

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The present investigation showed a significant elevation of bone turnover markers in surgically menopausal women who did not receive estrogen treatment. Despite a short period, an asymptomatic but significantly high bone resorption process occurred within 3 months after surgery.

Bone remodeling consists of two opposing activities: resorption of old bone by osteoclasts and formation of new bone by osteoblasts. The functions of bone remodeling are replacing old bone, regulating calcium homeostasis, acidbase balance, and releasing growth factors embedded in bone. The bone remodeling process is tightly coupled in time and area at the bone basic multicellular unit (BMU) level [25]. Bone turnover markers release into the bloodstream during the bone remodeling process and provide dynamic information regarding skeletal status.

During bone resorption, collagen is degraded by osteoclasts. CTX, a non-helical fragment of type I collagen-containing cross-linking regions, is released by cathepsin K, an osteoclast-specific protease. The native form of CTX undergoes spontaneous isomerization, which is attributed to protein aging [26]. They circulate in the blood and are partly excreted in the urine. Bone resorption displays circadian variation. CTX shows the highest diurnal amplitude among the BTMs with a peak at 05.00h and a nadir at 14.00h. Consumption of breakfast reduces serum CTX by 40% [25]. The secretion of the glucagon-like peptide probably mediates this effect of feeding [27]. Therefore, blood for its measurement must be collected in the fasting status in the morning (between 7 and 10 am). It is inadvisable for some patients (such as those with diabetes) in clinical practice and restricts clinic attendance to morning appointments.

Surgical removal of both ovaries in women before menopause leads to an abrupt declination of circulating estrogen levels [6]. From a previous study, serum CTX was elevated as soon as a month after surgery. Serum CTX levels were continuously elevated until 6 months after surgery. Furthermore, they found a significant negative correlation between bone turnover markers levels and lumbar spine bone mineral density (BMD) at preoperative and 6 months after surgery [14]. In another study, bone resorption and formation markers were raised 3 months after the surgical menopause procedure. However, bone markers levels declined to the baseline levels after menopausal hormone prescription for 3 months [23].

In terms of bone formation marker, we selected serum P1NP as the outcome measurement according to the IOF recommendation. Osteoid, composed of type I collagen, is formed in the early phase of bone formation. Procollagen is a trimer of two 1 and one 2 chain. The PINP is cleaved from procollagen molecule before an assembly of type I collagen molecules into fibers [28]. Although type I collagen is not specific to the bone, most circulating PINP originates from it. P1NP is released into circulation and offers several clinical advantages, including low circadian variation and stability at room temperature. Moreover, P1NP levels are not significantly influenced by dietary intake, and, consequently, patients do not need to be fasting [27]. In a previous study, serum P1NP levels were inversely associated with BMD for the lumbar spine, total hip, and femoral neck even after controlling for age, BMI, and years since menopause. P1NP level was significantly higher in postmenopausal women with osteoporosis compared to those with average bone mass. However, in clinical practice, its low specificity does not warrant utility in osteoporosis diagnosis [29].

Estrogen is essential for the maintenance of sufficient bone mass in reproductive age. Bone resorption and formation were modulated and balanced by circulating estrogen levels. Estrogen activates the synthesis of osteoprotegerin (OPG), the decoy antibodies which neutralize the receptor activator of NF-B ligand (RANKL) and inhibits RANK expression (receptor of RANKL). Responses to estrogen result in inhibition of differentiation and activation of the osteoclasts. Furthermore, estrogen modulates proinflammatory cytokines such as IL-1, IL-6, TNF-, and PGE2, reducing the pool of osteoclast precursors. The minor estrogenic mechanism on bone is regulated TGF- expression results in apoptosis of osteoclasts [30]. According to all mechanisms mentioned above, estrogen deprivation is a major detrimental factor on bone physiology. Besides, many studies demonstrated the positive effects of menopausal hormone treatment on bone turnover markers, BMD, and fracture prevention in postmenopausal women [31,32,33,34].

As the primary outcome in the present study, there were no notable changes in serum CTX and P1NP levels at 12weeks in the hormone treatment group compared to baseline. In contrast, serum CTX and P1NP levels were significantly elevated among women who did not receive hormone treatment. In other words, early administration with moderate-dose estrogen could inhibit abnormal bone resorption from acute estrogen deprivation. In secondary outcomes, serum CTX and P1NP levels at 12weeks after surgical menopause procedure were statistically different between the two groups. The 55% lower median serum CTX level than in the no-treatment group is statistically and clinically significant. The timing of hormone initiation might be an essential issue. In our study, hormone therapy was initiated proximately 2 weeks after surgery. In contrast, Peris et al. study [23] started hormone therapy 3 months post-surgery. The differences between our outcomes and Peris et al.'s finding are partly due to the timing of menopausal hormone initiation.

It should be noted that sixteen out of the total 48 women in our study had moderate to severe hot flushes as early as 2 weeks after oophorectomy. Hence, MHT could be considered as soon as possible in women who has MHT indication. The benefit of MHT in this condition is for improving the quality of life and protecting against accelerated bone loss. However, some clinicians may concern about the risk of venous thrombosis with MHT in the early postoperative period, especially in cases of obesity, metabolic syndrome, and advanced age patients. Transdermal estrogen administration with optimum dose is preferred to minimize the thrombosis risk in these patients.

In terms of treatment effects, we showed that early administration of 2mg of oral estradiol valerate significantly suppressed the bone remodeling process. However, a conclusion cannot be made for all oral MHT products in the market. Many available products around the world are 1mg of estradiol plus a variety of progestins. The lower dose of other estradiol products and estrogenic counter-action of various progestins may dramatically affect bone outcomes.

Each participant was evaluated and allocated to the hormone treatment group by FDA-approved MHT indication in the present study. Estradiol valerate 2mg/day was prescribed for 16 women who had moderate to severe hot flushes and five women diagnosed with early menopause at the time of surgery (age<45years). Although early menopause was associated with bone loss in general perception, there was no significant difference in bone turnover markers concentration across quartiles of patient age [29]. To the best of our knowledge, no study confirms a direct association between hot flush symptoms and bone turnover marker concentration. We attenuate selection bias risk by strictly allocating each participant to the hormone treatment group, depending on MHT indication. All participants and a physician assigned treatment did not know baseline bone turnover marker levels at the day of allocation.

Although elevation of bone turnover markers was associated with low BMD and increased risk of fractures, there are many limitations in interpreting bone turnover markers in clinical practices. The biologically interobserver variation, intra-individual variability, analytic reliability, and poorly defined abnormal cut point levels are issues of concern in clinical utility. Vitamin D levels, sunlight exposure, history of fractures over the preceding 12months, vigorous physical activity, and year should be considered and carefully considered for the interpretation of results. Moreover, the changes in the bone turnover markers are the only representative of bone metabolism; they cannot be used for diagnosing osteoporosis. Dual-energy X-ray absorptiometry for bone density measurement is the standard method used in clinical practice and osteoporosis research. Nowadays, bone turnover markers are primarily used for patients with poor responders, nonadherence to therapy patient identification [35], and can be used as indicators to restart treatment after the bisphosphonate drug holiday period [36].

There are incongruences in data interpretation and recommendations of estrogen therapy and bone, especially for postmenopausal osteoporosis. In the age group 5060years or within 10 years after menopause (the window of opportunity concept), the benefits of MHT are most likely to outweigh any risk. Based on the International Menopause Society (IMS) recommendations on women's midlife health and menopause hormone therapy, MHT can be considered first-line therapy in postmenopausal osteoporosis [37]. On the contrary, the North American papers, the American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines (AACE/ ACE) for Diagnosis and Treatment of Postmenopausal Osteoporosis 2020 stated that estrogen was never approved explicitly for postmenopausal osteoporosis. Estrogen is only approved by the US FDA to prevent postmenopausal osteoporosis and should only be used for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered appropriate [38].

Traditionally routine salpingo-oophorectomy at the time of hysterectomy should be revisited, especially in pre and perimenopausal women, because the lifetime risk of developing ovarian cancer in the general population is only 1 in 70 or 1.4% [39], physicians should make sure that their counseling about risks and benefits is based on current evidence. The reduction of ovarian cancer risk, avoid possible morbidities and future surgery of ovarian disease are the significant potential benefits of salpingo-oophorectomy at the time of hysterectomy. However, these potential benefits must be balanced with the consequences of premature loss of circulating estrogen including, bone loss, hot flushes, cognitive impairment, sexual desire loss, and long-term survival rate [39]. This research emphasized this concept. Forty-nine percent (20/41) of women in our cohort did not receive MHT for bothersome vasomotor symptoms and early menopause indication. These women lost their bone significantly as early as 3 months after surgery. Careful clinical evaluation, lifestyle modification for bone health, and long-term follow-up for bone density and/or quality measurement should be considered. In the present study, we gave patients as much information as possible about the risks and benefits of salpingo-oophorectomy at the time of hysterectomy. Based primarily on patient autonomy, the decisions to do salpingo-oophorectomy were made by participants with adequate information from physicians. In our experiences as a medical school center in Thailand, we found that 3040% of advanced age premenopausal and perimenopausal women accepted and decided to remove their ovaries at the time of hysterectomy for benign gynecological conditions. However, bone measurement was offered only in a minority of these patients.

Finally, due to the possible effects of participant age on baseline bone turnover marker levels, we made an additional analysis of the correlation between age and bone turnover markers. However, there was no significant correlation between the serum CTX and age at surgical menopause in both hormone treatment and no treatment group, r=0.28 p-value=0.22, and r=0.14 and p-value=0.56, respectively. In the same way, there were no significant correlations between serum P1NP and age at surgical menopause in both hormone treatment and no treatment group, r=0.01 p-value=0.97 and r=0.08 p-value=0.72, respectively.

There were limitations of this study. As a nonrandomized design, we could not match the baseline prognostic factors between the two groups. This study type cannot eliminate selection bias. The randomized controlled trial to prove this hypothesis should be considered in further study. Because bone turnover markers can be involved by various factors, such as vitamin D status, sunlight exposure, vigorous physical activity, patient's medical data, and history of recent fractures should be recorded and carefully considered.

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