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BioLineRx Provides Update on Phase 2 Open-Label Study for BL-8040 as Novel Stem Cell Mobilization Treatment – PR Newswire (press release)

The study consists of donor and patient pairs for allogeneic hematopoietic cell transplantation. The first part of the study, which is nearing completion, is intended to enroll an initial cohort of 10 donor and recipient pairs, consisting of patients with advanced hematological malignancies and their HLA-matched sibling donors. Interim results show that a single injection of BL-8040 mobilized sufficient amounts of cells required for transplantation at a level of efficacy similar to that achieved by using 4-6 injections of G-CSF, the current standard of care. Furthermore, all recipients transplanted so far have experienced a successful neutrophil engraftment. The recipients will be followed for one year to assess acute and chronic GVHD events. As for the donors, BL-8040 treatment was safe and well tolerated.

Philip Serlin, Chief Executive Officer of BioLineRx, stated, "We are very encouraged by these initial results of the Phase 2 clinical trial for assessing BL-8040, our lead oncology and hematology platform, as a single agent for hematopoietic stem cell mobilization for allogeneic transplantation. Hematopoietic stem cells are increasingly used as part of the treatment regimen for certain types of hematological cancers, as well as for severe anemia and immune deficiency disorders. These results, supporting BL-8040 as a one-day dosing and up-to-two-day collection regimen, for rapid mobilization of substantial amounts of stem cells, represent a significant improvement over the current standard of care, which requires four-to-six daily injections of G-CSF and one-to-four apheresis sessions.If there are no safety concerns regarding graft failure or rejection after the interim safety review of donor-recipient pairs participating in Part 1 of the study, we will continue with Part 2 of the study, which will permit enrollment of recipients with either matched sibling or haploidentical donors, up to a total enrollment in the study of 24 donor-recipient pairs. We are looking forward to the topline results expected by the end of 2017."

"We continue our efforts to maximize the potential of our unique BL-8040 oncology platform, with multiple clinical studies for additional indications up and running or expected to start in 2017, including several combination studies with immune checkpoint inhibitors and a registration study in stem-cell mobilization for autologous transplantation," added Mr. Serlin.

The Phase 2 open-label study is conducted in collaboration with the Washington University School of Medicine, Division of Oncology, and will enroll up to 24 donor/recipient pairs, aged 18-70. The trial is designed to evaluate the ability of BL-8040, as a single agent, to promote stem cell mobilization for allogeneic hematopoietic cell transplantation. On the donor side, the primary endpoint of the study is the ability of a single injection of BL-8040 to mobilize sufficient amounts of cells for transplantation following up to two apheresis procedures. On the recipient side, the study aims to evaluate the time to engraftment rate following transplantation of the BL-8040 collected graft.

The study will also evaluate the safety and tolerability of BL-8040 in healthy donors, as well as graft durability, the incidence of grade 2-4 acute and chronic GVHD, and other recipient related parameters in patients who have undergone transplantation of hematopoietic cells mobilized with BL-8040.

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and certain hematological indications. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About Stem Cell Mobilization

High-dose chemotherapy followed by hematopoietic cell transplantation has become an established treatment modality for a variety of hematologic malignancies, including multiple myeloma, as well as various forms of lymphoma and leukemia. Modern peripheral stem-cell harvesting often replaces the use of traditional surgical bone marrow stem-cell harvesting. In the modern method, stem cells are mobilized from the bone marrow using granulocyte colony-stimulating factor (G-CSF), often with the addition of a mobilizing agent such as Plerixafor (Mozobil), harvested from the donor's peripheral blood by apheresis, and infused to the patient after chemotherapy ablation treatment.

An allogeneic hematopoietic cell transplant involves matching a patient's tissue type, specifically their human leukocyte antigen (HLA) tissue type, with that of a related or unrelated donor. HLA proteins are found on all cells of our body and are the main way the immune system tells the difference between our own cells and foreign cells. The closer the HLA match between a donor and recipient, the greater the chance a transplant will be successful. If the HLA match is not close enough, the donor's immune system, which accompanies the donated stem cells, recognizes the HLA mismatch, and will attack the recipient's tissues. This process is known as graft versus host disease (GVHD).

Approximately 70% of people with a hematological malignancy or bone marrow failure syndrome who need an allogeneic transplant have an HLA-identical sibling or unrelated donor available. For patients who need a stem cell transplant but do not have an HLA-matched related or unrelated donor, recent medical advances have made possible the use of a partially matched or haploidentical related donor. A haploidentical related donor is usually a 50% match to the recipient and may be the recipient's parent, sibling or child.

The advantage of having a haploidentical transplant is thatit increases the chance offinding a donoras almost everyone has at least one haploidentical relative. Relatives can usually be asked to donate stem cells much more quickly than unrelated volunteer donors, particularly when the volunteer donors live in other countries, thereby allowing transplants to be done in a more timely manner.

With improvements in medical treatment, complications of a haploidentical transplant, such as GVHD, rejection of the graft and slow recovery of the immune system appear not to be increased compared to transplants using HLA-matched related or unrelated donors. Since this is a relatively new approach to stem cell transplantation, a haploidentical transplant is a treatment option that is not offered at all treatment centers, but is becoming more common.

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology. The Company in-licenses novel compounds, primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML and is in the midst of a Phase 2b study as an AML consolidation treatment and a Phase 2 study in stem cell mobilization for allogeneic transplantation; and BL-7010 for celiac disease and gluten sensitivity, which has successfully completed a Phase 1/2 study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada), on the basis of which the Company has initiated a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck's KEYTRUDA; and a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech's Atezolizumab in several Phase 1b studies for multiple solid tumor indications and AML.

For additional information on BioLineRx, please visit the Company's website athttp://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated onFacebook,Twitter, andLinkedIn.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2016. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts: PCG Advisory Vivian Cervantes Investor Relations +1-212-554-5482 vivian@pcgadvisory.com

or

Tsipi Haitovsky Public Relations +972-52-989892 tsipihai5@gmail.com

SOURCE BioLineRx Ltd.

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Borrowing from nature: UW-Madison scientists use plants to grow … – Madison.com

To grow clusters of human stem cells that mimic organs in the lab and might be used someday in tissue implants, Bill Murphy, a UW-Madison professor of biomedical engineering, creates tiny scaffolds made of plastic or rubber.

The three-dimensional scaffolds must support the cells and feed them, help them organize and allow them to communicate.

One spring day in 2014, Murphy looked out his office window near UW Hospital, onto the universitys Lakeshore Nature Preserve, and saw a structure that does those very things naturally: plants specifically, cellulose, the main component of the cell walls of green plants.

Now, Murphy and Gianluca Fontana, a UW-Madison post-doctoral fellow with help from Olbrich Botanical Gardens have grown skin, brain, bone marrow and blood vessel cells on cellulose from plants such as parsley, spinach, vanilla and bamboo.

Plants could be an alternative to artificial scaffolds for growing stem cells, the researchers reported Monday in the journal Advanced Healthcare Materials.

Rather than having to manufacture these devices using high-tech approaches, we could literally pick them off of a tree, said Murphy, co-director of the UW-Madison Stem Cell and Regenerative Medicine Center.

The strength, porosity and large surface area of plants could prove superior to making scaffolds using current methods, such as 3-D printing and injection molding, Murphy said.

Plants have a huge capacity to grow cell populations, he said. They can deliver fluids very efficiently to their leaves ... At the microscale, theyre very well organized.

In addition, there are many plants to chose from. After Murphys inspirational gaze out the window, he and Fontana tested plants as scaffolds for stem cells using varieties they could easily obtain: parsley, spinach, jewelweed, water horsetail, summer lilac and, from the UW Arboretum, softstem bulrush.

Then Fontana asked John Wirth, Olbrichs conservatory curator, about other species that might work. Wirth invited Fontana to walk through the tropical greenhouse and take samples back to his lab.

I had never had a request like this before; it made me look at plant material in a different way, Wirth said. I think its a fantastic way of using these pieces of living tissue, to grow human tissue.

Olbrich plants that proved useful include vanilla, bamboo, wasabi, elephant ear, zebra plant and various orchids.

To use plants as scaffolds, the scientists strip away all of the cells, leaving husks of cellulose. Since human cells have no affinity for plants, they add peptides as biological fasteners.

Theyre like grappling hooks for the cells to attach to the plant, Murphy said.

To determine if plant scaffolds could really replace those made of plastic or rubber, the researchers hope to test the cellulose models in animal studies this year.

A major goal of tissue engineering is to develop implants that could regenerate tissue in people to repair bone or muscle damage after traumatic injuries, for example.

It is likely the human body wouldnt reject tissue implants formed on plant scaffolds because the plant cells would be removed, Murphy said.

Were crossing kingdoms, he said. But were optimistic that these materials would be well-tolerated.

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Borrowing from nature: UW-Madison scientists use plants to grow ... - Madison.com

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Science in Focus: Creating Neurons from Skin Cells to Understand … – UCSF News Services

Studying brain disorders is complicated for many reasons, not the least being the ethics of obtaining living neurons. To overcome that obstacle, UC San Francisco postdoc Aditi Deshpande, PhD, is starting with skin cells.

Thanks to developments in stem cell technology, new information about the human brain is now being gleaned from a simple cheek swab or skin sample. This technology is key to the kind of progress Despande and researchers like her are making. It allows them to work with cells otherwise unobtainable living brain cells that have the same genetics as the patients.

Deshpande begins with skin cells obtained from the Simons Foundation from volunteers whose DNA contains a specific deletion or duplication of one chromosome. She cultures these cells and then turns them into induced pluripotent stem cells cells that have been coaxed back to their embryonic state and are able to become any other type of cell. From there, she reprograms them to become a specific type of neuron thats involved in attention and information processing.

The deletion or duplication Deshpande is looking for stems from a 2008 finding by Lauren Weiss, PhD, an associate professor of neurology in the UCSF Department of Psychiatry and the UCSF Institute for Human Genetics.

Weiss discovered a 29-gene region of DNA on chromosome 16 that is associated with autism, seizures and other brain disorders. Normally, a person has two copies of the region one on each copy of chromosome 16. In some of Deshpandes samples, the region is deleted from one chromosome, leaving one copy. In others, the region is duplicated, resulting in three copies. Subjects with only one copy of the region were more likely to have macrocephaly an enlarged brain than a typical subject, and those with three copies were more likely to have microcephaly a smaller brain.

Whats really interesting, said Deshpande, is that although these subjects seem to have opposite features in terms of brain size, we see a related effect, based on whether they have fewer or more copies of the region.

Some known models of autism show a connection between a neurons growth or appearance and macrocephaly, she explained. We wanted to know if the same thing is happening here.

To compare the effect of the mutation, Deshpande first stains the obtained skin cells so that she can visualize the neurons under a microscope. After staining, Deshpande used cell-counting software to assess several thousands of neurons from deletion and duplication samples and measure them against normal neurons. She found that the neurons missing the DNA region exhibited some differences compared to typical neurons.

Her next step in her research is to discern which of the regions 29 genes are involved in these differences.

The work is meticulous, but Deshpande doesnt mind. I simply love looking at neurons, she said. It really makes you appreciate the complexity of the brain.

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Science in Focus: Creating Neurons from Skin Cells to Understand ... - UCSF News Services

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Stem Cell-based Modelling can be Difficult for Rare Genetic Variants – Technology Networks

Some heritable but unstable genetic mutations that are passed from parent to affected offspring may not be easy to investigate using current human-induced pluripotent stem cell (hiPSC) modeling techniques, according to research conducted at The Icahn School of Medicine at Mount Sinai. The study serves to caution stem cell biologists that certain rare mutations, like the ones described in the study, are difficult to recreate in laboratory-produced stem cells.

Stem cell-based disease modeling involves taking cells from patients, such as skin cells, and introducing genes that reprogram the cells into human-induced pluripotent stem cells (hiPSCs). These master cells are unspecialized, meaning they can be pushed to become any type of mature cell needed for research, such as skin, liver or brain. The hiPSCs are capable of renewing themselves over a long period of time, and this emerging stem cell modeling technique is helping elucidate the genetic and cellular mechanisms of many different disorders.

Our study describes how a complex chromosomal rearrangement genetically passed by a patient with psychosis to her affected son was not well recreated in laboratory-produced stem cells, says Kristen Brennand, PhD, Associate Professor of Genetics and Genomic Sciences, Neuroscience, and Psychiatry at the Icahn School of Medicine, and the studys senior investigator. As stem cell biologists dive into studying brain disorders, we all need to know that this type of rare mutation is very hard to model with induced stem cells.

To investigate the genetic underpinnings of psychosis, the research team used hiPSCs from a mother diagnosed with bipolar disease with psychosis, and her son, diagnosed with schizoaffective disorder. In addition to the normal 46 chromosomes (23 pairs), the cells in mother and son had a very small extra chromosome, less than 1/10th normal size. This microduplication of genes is increasingly being linked to schizophrenia and bipolar disorders, and the extra chromosomal bit, known as a marker (mar) element, falls into the category of abnormally duplicated genes.

For the first time, the Mount Sinai research team tried to make stem cells from adult cells with this type of mar defect. Through the process, they discovered that the mar element was frequently lost during the reprogramming process.

While mar elements in the general population are rare (less than .05 percent in newborn infants), more than 30 percent of individuals with these defects are clinically abnormal, and mar elements are also significantly more likely to be found in patients with developmental delays.

The study found that the mothers cells were mosaic, meaning some cells were normal while others were not, and the hiPSCs the team created accurately replicated that condition: some were normal and some had the extra mar chromosome. But the technique did not work well with the sons cells. While all of his cells should have had the mar element, as with his mother, some of the reprogrammed stem cells did not contain the extra bit of chromosome.

We realized we kept losing the mutation in the stem cells we made, and the inability to recreate cells with mar elements may hamper some neuropsychiatric research, says Dr. Brennand. The bottom line is that it is essential that stem cell biologists look for existing mar elements in the cells they study, in order to check that they are retained in the new stem cells.

Reference:

Tcw, J., Carvalho, C. M., Yuan, B., Gu, S., Altheimer, A. N., Mccarthy, S., . . . Brennand, K. J. (2017). Divergent Levels of Marker Chromosomes in an hiPSC-Based Model of Psychosis. Stem Cell Reports. doi:10.1016/j.stemcr.2017.01.010

This article has been republished frommaterialsprovided by Mount Sinai Hospital. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Stem Cell-based Modelling can be Difficult for Rare Genetic Variants - Technology Networks

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Abnormal development of the brain in an intractable disease, thanatophoric dysplasia – Science Daily

Abnormal development of the brain in an intractable disease, thanatophoric dysplasia
Science Daily
It is only possible, by using appropriate animal model that reproduces relevant pathophysiology, to uncover the process of pathogenesis and to develop therapy. Since the research on abnormalities of bones in TD is progressing with iPS cells at Kyoto ...

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Abnormal development of the brain in an intractable disease, thanatophoric dysplasia - Science Daily

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A Cure for Clara: Gene therapy developed at Auburn University set for human trials – Alabama’s News Leader

Clara suffers from rare, fatal genetic disorder

The race to find a cure for a rare genetic disease has become a Hoover family's mission as they try to save their little girl. "A Cure for Clara," may come from of all places Auburn University's College of Veterinary Medicine.

Everything appeared normal when Baby Clara came into the world. By 14 months though, she was lagging behind in development. "Our first red flag, she wasn't walking," explains her mom Jenny Bragg. Then the heartbreaking diagnosis came last August. Clara had GM1 gangliosidosis which is an inherited disorder. It destroys nerve cells.

"She was terminal; they said there was nothing they could do for her and we should go home and enjoy our time with her," recalls Bragg with tears in her eyes. She and her husband scoured the internet looking for something, any hope.

That lead them to Auburn University and groundbreaking research at the College of Veterinary Medicine. GM1 had been cured in cats and the researchers were preparing for human clinical trials. The gene therapy involves a single IV injection.

A research cat named Cinnamon who was treated is now seven years old. Others have also been cured. "They could live a normal life span. Showing this treatment works in animals is the first step to see if it's applicable to humans," explains Auburn Researcher and Professor Doug Martin, Ph.D.

The remarkable results hold promise for curing other fatal diseases. "If we can find the gene that causes Huntington's disease, Lou Gehrig's disease, the same basic technique and approach can be used," says Martin.

Human trials are set for six children including Clara if she stays healthy in November at the National Institutes of Health in Bethesda, Maryland. "I do have apprehension . on the other hand it's our only shot saving her life," says Jenny Bragg.

To make sure those human trials happen another $400,000 needs to be raised. A special fundraiser is set for Saturday, April 8th at the Redmont Hotel: Clara's Birthday Bash.

For more information go to:

ACureforClara.com

All the proceeds go to the Cure GM1 Foundation.

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A Cure for Clara: Gene therapy developed at Auburn University set for human trials - Alabama's News Leader

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Cesca Therapeutics (KOOL) Announces CLI Feasibility Study Published in Stem Cells International – StreetInsider.com

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Cesca Therapeutics Inc. (NASDAQ: KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced the publication in a peer reviewed journal of data from its Critical Limb Ischemia (CLI) feasibility study utilizing the Companys innovative point-of-care technology. The report was published in the Stem Cells International and is available online at https://www.hindawi.com/journals/sci/2017/4137626/ref/.

Results from the seventeen patient clinical study titled, Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System, (the Study) were obtained using Cescas automated point-of-care technology. The single treatment procedure was performed at the patients bedside and took less than 60 minutes. The Study results showed significant improvement in wound healing, rest pain and six-minute walking distance, along with significant reduction in intermittent claudication pain following the treatment.

Dr. Venkatesh Ponemone, Study Director and Executive Director of TotipotentRX, a Cesca subsidiary and the corresponding author of the article commented, We are targeting difficult to treat or life threatening conditions such as CLI with our autologous, cell-based therapies. We believe our innovative point-of-care cell processing systems, such as those used in the Study, can play an important role in optimizing the quality and quantity of target cells used to improve patient outcomes.

Dr. Xiaochun "Chris" Xu, Cesca's Interim CEO added, We are pleased that the Study was recognized and published in a peer reviewed journal. The encouraging data highlights Cescas capability to develop effective automated cellular processing systems. We welcome strategic partners to help us further refine their use in larger clinical settings.

About Cesca Therapeutics Inc.Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. These include:

Forward-Looking StatementThe statements contained herein may include statements of future expectations and other forward-looking statements that are based on managements current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

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Cesca Therapeutics (KOOL) Announces CLI Feasibility Study Published in Stem Cells International - StreetInsider.com

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Retired Richland sergeant battling rare blood disease, awaiting marrow transplant – Tri-City Herald


Tri-City Herald
Retired Richland sergeant battling rare blood disease, awaiting marrow transplant
Tri-City Herald
People who are healthy, between 18 and 44, and want to register as a bone marrow/stem cell donor can do it at join.bethematch.org/hope4sarge or join.bethematch.org/hopeforsarge. A swab kit will be mailed to their home with instructions and a confirmation.

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Retired Richland sergeant battling rare blood disease, awaiting marrow transplant - Tri-City Herald

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Cellaria Adds Next-Generation RNA Reprogramming and Stem Cell Services – GlobeNewswire (press release)

March 20, 2017 08:43 ET | Source: Cellaria Bio

CAMBRIDGE, Mass., March 20, 2017 (GLOBE NEWSWIRE) -- Cellaria, LLC, a scientific innovator that develops revolutionary new cancer models for challenging tumors, today announced the expansion of its offerings to include a suite of stem cell services. The initiative advances Cellarias mission to provide more accurate patient and disease-specific cell models to help researchers focus and accelerate their research and discovery efforts.

Cellarias new stem cell division will provide RNA reprogramming and differentiation services in a comprehensive, yet modular workflow. The companys initial reprogramming focus will be on custom solutions for primary cell establishment, induced pluripotent stem cell (iPSC) generation, banking and characterization. Cellaria will also offer customizable differentiation services for various cell types such as neurons, hepatocytes and skeletal muscle.

By incorporating the most advanced RNA technology, Cellarias reprogramming platform will enable access to a broad set of patient cells, including cells derived from human skin and blood, for the development of the next generation of disease models. With the addition of an extremely flexible and tailored differentiation system, Cellaria provides a single source solution to stem cell services.

Human induced pluripotent stem cells (iPSCs) are generated from adult cells and have the ability to self-renew and differentiate into various different cells of the body. Human iPSCs have significantly impacted the scope of regenerative medicine and tools used to interrogate disease pathology. Cellarias comprehensive stem cell offerings, combined with over 20 years of in-house experience in RNA-iPS cell biology, will provide models that are easily translatable and impactful to disease research.

RNA Reprogramming is a valuable and necessary tool for creating disease-specific cell lines for modeling, said David Deems, chief executive officer at Cellaria. It is also increasingly being identified as a mechanism of tumor plasticity. We are genuinely excited to add a comprehensive suite of stem cell services and begin exploring the intersection between stem cell and cancer models.

More information on Cellarias stem cell services is available at cellariabio.com/stemcell.

About Cellaria Cellaria creates high quality, next generation in vitro disease models that reflect the unique nature of a patients biology. All models begin with tissue from a patient, capturing clinically relevant details that inform model characterization. For cancer, Cellarias cell models exhibit molecular and phenotypic characteristics that are highly concordant to the patient. For RNA-mediated iPS cell line derivation and stem cell services, Cellarias cell models enable interrogation of patient and disease-specific mechanisms of action. Cellarias innovative products and services help lead the research community to more personalized therapeutics, revolutionizing and accelerating the search for a cure. For more information, visitwww.cellariabio.com.

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New trial for blindness rewrites the genetic code – Medical Xpress

March 20, 2017 New trial for blindness rewrites the genetic code. Credit: Shutterstock

Researchers have started a new gene therapy clinical trial to treat X-linked retinitis pigmentosa (XLRP), the most common cause of blindness in young people.

Retinitis pigmentosa is currently untreatable and leads to a slow and irreversible loss of vision.

The trial is being run by Nightstarx Ltd (Nightstar), a biopharmaceutical spinout company of Oxford developing gene therapies for inherited retinal diseases, and researchers from the University of Oxford. On 16 March 2017, a 29 year old British man became the first patient with X-linked retinitis pigmentosa to undergo gene therapy. The operation took place at the Oxford Eye Hospital, part of the Oxford University Hospitals NHS Foundation Trust.

Gene therapy uses a virus to insert the correct copy of a defective gene into cells, and has shown promise for treating genetic causes of blindness. Unfortunately, the gene involved with retinitis pigmentosa, RPGR, is highly unstable, making gene therapy particularly challenging. The RPGR gene's unusual genetic code has made it very difficult to work with in the laboratory.

However, a research team led by Professor Robert MacLaren from the University of Oxford has reprogrammed the genetic code of RPGR to make it more stable, but in a way that does not affect its function. This has allowed the gene to be delivered reliably by a viral vector into retinal cells.

The current trial is the first in the world to test a treatment for retinitis pigmentosa caused by RPGR.

Robert MacLaren, Professor of Ophthalmology at the University of Oxford, who is leading the trial said: "The effect of RPGR-related disease on families with retinitis pigmentosa is devastating and we have spent many years working out how to develop this gene therapy. Changing the genetic code is always undertaken with great caution, but the new sequence we are using has proven to be highly effective in our laboratory studies.

"The genetic code for all life on Earth is made up of four letters G, T, A and C. In RPGR, however, half of the gene comprises only two letters A and G. This makes the gene very unstable and prone to mutations, making it a lead cause of blindness in patients with retinitis pigmentosa. RPGR is vital for the light sensitive cells at the back of the eye."

The trial has started at the Oxford University Hospitals NHS Foundation Trust and is sponsored by Nightstar, a University of Oxford spin-out company. It is supported by the NIHR Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust. Up to 30 patients will be enrolled.

David Fellows, Chief Executive Officer of Nightstar remarked: "We are delighted to report the advancement of this exciting gene therapy program into patients. If successful, this gene therapy has the potential to transform the lives of many patients (and their families) around the world."

Dr Aniz Girach, Chief Medical Officer of Nightstar commented: "The current trial is an open-label dose-escalation study designed to enrol at least 24 patients who will receive a single subretinal injection of the RPGR gene therapy. The primary goal of the study is to assess safety and tolerability of this gene therapy over a 12 month period."

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New trial for blindness rewrites the genetic code - Medical Xpress

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Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies. – UroToday

Efficacy and safety of testosterone gel 2% (TG) were evaluated in two phase 3, open-labelled, single-arm, multicentre studies (000023 and extension study 000077). Hypogonadal men having serum testosterone levels <300ng/dl at two consecutive measurements were included. Study duration was 9months (000023: 3months; 000077: 6months). Starting dose of TG (46mg) was applied on upper arm/shoulder. The primary endpoint (000023) was responder rate (subjects with average 24-hour serum testosterone concentration 300-1050ng/dl on Day 90). Study 000077 evaluated the safety of TG in patients rolling over from study 000023 over a period of 6months. Of 180 subjects in 000023, 172 completed and 145 rolled over to 000077, with 127 completers. The responder rate was 85.5%. Fewer subjects in 000077 (12.7%) versus 000023 (31.8%) had maximum testosterone concentration (Cmax ) >1500ng/dl, with no significant safety concerns. Significant improvements in sexual function and quality of life were noted in both studies. Subjects experienced few skin reactions without notable increases in prostate-specific antigen and haematocrit levels. TG was efficacious with an acceptable safety profile. Cmax >1500ng/dl did not exhibit distinct impact on safety parameters. However, further optimisation of titration schema to reduce Cmax is warranted while maintaining the average steady state total testosterone concentration.

Andrologia. 2017 Mar 10 [Epub ahead of print]

L Belkoff, G Brock, D Carrara, A Neijber, M Ando, J Mitchel

Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA, USA., Division of Urology, Department of Surgery, Western University, London, ON, Canada., Ferring Galenisches Labor AG, Gewerbestrasse, Allschwil, Switzerland., International Pharma Science Center, Ferring Pharmaceuticals, Copenhagen, Denmark., Ferring International PharmaScience Center US Inc., Parsippany, NJ, USA., Target Health Inc, New York, NY, USA.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28295450

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Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies. - UroToday

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Testosterone therapy has positive effects on anthropometric measures, metabolic syndrome components (obesity, lipid … – UroToday

To alleviate late-onset hypogonadism, testosterone treatment is offered to suitable patients. Although testosterone treatment is commonly given to late-onset hypogonadism patients, there remains uncertainty about the metabolic effects during follow-ups. We assessed the associations between testosterone treatment and wide range of characteristics that included hormonal, anthropometric, biochemical features. Patients received intramuscular 1,000mg testosterone undecanoate for 1year. Patient anthropometric measurements were undertaken at baseline and at each visit, and blood samples were drawn at each visit, prior to the next testosterone undecanoate. Eighty-eight patients (51.113.0years) completed the follow-up period. Testosterone treatment was associated with significant increase in serum testosterone levels and significant stepladder decrease in body mass index, total cholesterol, triglycerides and glycated haemoglobin from baseline values among all patients. There was no significant increase in liver enzymes. There was an increase in haemoglobin and haematocrit, as well as in prostate-specific antigen and prostate volume, but no prostate biopsy intervention was needed for study patients during 1-year testosterone treatment follow-up. Testosterone treatment with long-acting testosterone undecanoate improved the constituents of metabolic syndrome and improved glycated haemoglobin in a stepladder fashion, with no adverse effects.

Andrologia. 2017 Mar 10 [Epub ahead of print]

O Canguven, R A Talib, W El Ansari, D-J Yassin, M Salman, A Al-Ansari

Department of Urology & Andrology, Hamad General Hospital, Doha, Qatar., Department of Surgery, Hamad General Hospital, Doha, Qatar., Institute of Urology & Andrology, Norderstedt-Hamburg, Germany.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28295504

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Testosterone therapy has positive effects on anthropometric measures, metabolic syndrome components (obesity, lipid ... - UroToday

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SRK launches BMT, Birthing Centre at Nanavati hospital – Free Press Journal

By FPJ Bureau|Mar 19, 2017 12:05 am

Mumbai : A Bone Marrow Transplant (BMT) and Birthing Centre was launched by actor Shah Rukh Khan on Friday at Nanavati Super Speciality Hospital (NSSH) at Vile Parle. On the occasion, Khan told the people present to take their medicines on timeand do regular check ups and get rid of ailments.

BMT is a procedure to replace damaged or destroyed bone marrow with healthy bone marrow stem cells. Bone marrow is the soft, fatty tissue inside our bones which produces blood cells. Stem cells are immature cells in the bone marrow that give rise to different blood cells.

Dr Nimish Kulkarni, Associate Consultant of BMT, said, BMT are considered the last-mile treatment solutions for patients with blood and cancer disorders. We specialise in providing transplant services for benign hematological disorders like Thalassemia, Sickle cell disease, Aplastic anemia, bleeding disorders and coagulation disorders. Shah Rukh said, I have been associated with Nanavati Hospital before 25 years ago as a patient. Every year more than 10,000 people are dying of cancer in India, even my parents succumbed to cancer. I am glad now we have a world class treatment.

Dr. Ali has looked after me and my various injuries. He has looked after my sister and wife too. Few people know that when my third son, Abram, was born, he was in a very critical condition. He was rushed to the Paediatric centre here and looked after even before we could meet him. Its a strange cycle that my child was saved in the same hospital which has a ward named after my mother. I am thankful to them, Khan added. Kulkarni added, The specialisation also extends to providing advanced transplant treatments for malignant hematological disorders like acute and chronic leukemia, Hodgkins and Non-Hodgkins Lymphoma, Multiple Myeloma, Myelodysplasia,

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Study Yields Neural Crest Cells from Adult Skin Cells Without Genetic Modification – Scicasts (press release) (blog)

Buffalo, NY (Scicasts) A discovery, several years in the making, by a University at Buffalo research team has proven that adult skin cells can be converted into neural crest cells (a type of stem cell) without any genetic modification, and that these stem cells can yield other cells that are present in the spinal cord and the brain.

The practical implications could be very significant, from studying genetic diseases in a dish to generating possible regenerative cures from the patient's own cells.

"It's actually quite remarkable that it happens," says Dr. Stelios T. Andreadis, professor and chair of UB's Department of Chemical and Biological Engineering, who recently published a paper on the results in the journal Stem Cells.

The identity of the cells was further confirmed by lineage tracing experiments, where the reprogrammed cells were implanted in chicken embryos and acted just as neural crest cells do.

Stem cells have been derived from adult cells before, but not without adding genes to alter the cells. The new process yields neural crest cells without addition of foreign genetic material. The reprogrammed neural crest cells can become smooth muscle cells, melanocytes, Schwann cells or neurons.

"In medical applications this has tremendous potential because you can always get a skin biopsy," Andreadis says. "We can grow the cells to large numbers and reprogram them, without genetic modification. So, autologous cells derived from the patient can be used to treat devastating neurogenic diseases that are currently hampered by the lack of easily accessible cell sources."

The process can also be used to model disease. Skin cells from a person with a genetic disease of the nervous system can be reprogrammed into neural crest cells. These cells will have the disease-causing mutation in their chromosomes, but the genes that cause the mutation are not expressed in the skin. The genes are likely to be expressed when cells differentiate into neural crest lineages, such as neurons or Schwann cells, thereby enabling researchers to study the disease in a dish. This is similar to induced pluripotent stem cells, but without genetic modification or reprogramming to the pluripotent state.

The discovery was a gradual process, Andreadis says, as successive experiments kept leading to something new. "It was one step at a time. It was a very challenging task that took almost five years and involved a wide range of expertise and collaborators to bring it to fruition," Andreadis says. Collaborators include Dr. Gabriella Popescu, professor in the Department of Biochemistry in the Jacobs School of Medicine and Biomedical Sciences at UB; Dr. Song Liu, vice chair of biostatistics and bioinformatics at Roswell Park Cancer Institute and a research associate professor in biostatistics UB's School of Public Health and Health Professions; and Dr. Marianne Bronner, professor of biology and biological engineering, California Institute of Technology.

Andreadis credits the persistence of his then-PhD student, Vivek K. Bajpai, for sticking with it.

"He is an excellent and persistent student," Andreadis says. "Most students would have given up." Andreadis also credits a seed grant from UB's office of the Vice President for Research and Economic Development's IMPACT program that enabled part of the work.

The work recently received a $1.7 million National Institutes of Health grant to delve into the mechanisms that occur as the cells reprogram, and to employ the cells for treating the Parkinson's-like symptoms in a mouse model of hypomyelinating disease.

"This work has the potential to provide a novel source of abundant, easily accessible and autologous cells for treatment of devastating neurodegenerative diseases. We are excited about this discovery and its potential impact and are grateful to NIH for the opportunity to pursue it further," Andreadis said.

Article adapted from a University at Buffalo news release.

Publication: Reprogramming Postnatal Human Epidermal Keratinocytes Toward Functional Neural Crest Fates. Stelios T. Andreadis et al. Stem Cells (2017): Click here to view.

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Vision saved by first induced pluripotent stem cell treatment … – Concord Register

iPS cells may help halt failing vision

Getty

By Andy Coghlan

A woman in her 80s has become the first person to be successfully treated with induced pluripotent stem (iPS) cells. A slither of laboratory-made retinal cells has protected her eyesight, fighting her age-related macular degeneration a common form of progressive blindness.

Such stem cells can be coaxed to form many other types of cell. Unlike other types of stem cell, such as those found in an embryo, can be made from adult non-stem cells a discovery that in 2012.

Now, more than a decade after they were created, these stem cells have helped someone. at the RIKEN Laboratory for Retinal Regeneration in Kobe, Japan, and her team took skin cells from the woman and turned them into iPS cells. They then encouraged these to form retinal pigment epithelial cells, which are important for supporting and nourishing the retina cells that capture light for vision.

The researchers made a slither of cells measuring just 1 by 3 millimetres. Before in 2014, they first removed diseased tissue on her retina that was gradually destroying her sight. They then inserted the small patch of cells they had created, hoping they would become a part of her eye and stop her eyesight from degenerating.

Now the results are in. Published today, they show that the treatment hasnt made the womans vision any sharper, but it does seem to have prevented further deterioration with her vision now stable for more than two years. Since the graft, the woman says her vision is brighter.

Takahashi and her team have done incredible work, and deserve all the praise they get for this project, says , director of the Center for iPS Cell Research and Application at Kyoto University, who won the Nobel prize for and collaborated on this work. This is a landmark study and opens the door to similar treatments for many diseases, he says.

This first iPSC-derived retinal graft is an important landmark in the field of retinal regeneration, says at University College London, and head of a trial at Moorfields Eye Hospital in London of similar grafts made instead from human embryonic stem cells.

One worry about this approach is that turning the stem cells into new tissues could lead to cancer-causing genetic mutations though the team found no evidence of this in the treated woman. However, a trial of the technique in another person was cancelled in 2015, after tests revealed that the cells intended to be given to the man had developed genetic abnormalities.

But although it has taken many years to bring , many private centres around the world have been advertising unregulated treatments purporting to use stem cells for some time.

A second study published today shows just how badly some unregulated treatments described as stem cell therapies can go wrong. Three case reports of women given such treatments for age-related macular degeneration detail how one woman went blind and the vision of the other two became much worse.

All three ended up seeking emergency treatment in 2015, after each paid $5000 to a private clinic to receive injections of their own fatty tissue into their eyes.

Patients and physicians in the US should be made aware that not all stem cell clinics are safe, and that stem therapy as provided in private clinics in the US is unproven and potentially harmful, says at the University of Miamis Bascom Palmer Eye Institute, Florida, who subsequently treated two of the women.

Albini advises people to be suspicious of any procedure involving payment. Most legitimate research in the US does not require patients to pay for the experimental procedures, he says, adding that people should check whether a trial has been registered with the US Food and Drug Administration. Be aware that if it sounds too good to be true, it may indeed not be true.

Journal reference: New England Journal of Medicine, DOI: ;

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Team Deciphers How the Body Controls Stem Cells – Scicasts (press release) (blog)

Luxembourg (Scicasts) Stem cells are unspecialized cells that can develop into any type of cell in the human body. So far, however, scientists only partially understand how the body controls the fate of these all-rounders, and what factors decide whether a stem cell will differentiate, for example, into a blood, liver or nerve cell. Researchers from the Luxembourg Centre for Systems Biomedicine (LCSB) of the University of Luxembourg and an international team have now identified an ingenious mechanism by which the body orchestrates the regeneration of red and white blood cells from progenitor cells. "This finding can help us to improve stem cell therapy in future," says Dr. Alexander Skupin, head of the "Integrative Cell Signalling" group of LCSB. The LCSB team has published its results in the scientific journal PLOS Biology.

Although all cells in an organism carry the same genetic blueprints -- the same DNA -- some of them act as blood or bone cells, for example, while others function as nerve or skin cells. Researchers already understand quite well how individual cells work. But how an organism is able to create such a diversity of cells from the same genetic template and how it manages to relocate them to wherever they are needed in the body is still largely unknown.

In order to learn more about this process, Alexander Skupin and his team treated blood stem cells from mice with growth hormones and then watched closely how these progenitor cells behaved during their differentiation into white or red blood cells. The researchers observed that the cells' transformation does not occur in linear, targeted fashion, but rather more opportunistically. Each progenitor cell adapts to the needs of its environment and integrates itself into the body where new cells are needed. "So, it is not as though the cell takes a ticket at the beginning of its differentiation and then travels straight to its destination. Rather, it gets off frequently to look around and see which line is best to take," Alexander Skupin explains. By this clever mechanism, a multicellular organism can adapt the regrowth of new cells to its current needs. "Before progenitor cells differentiate once and for all, they first lose their stem cell character and then check, as it were, which cell line is currently in demand. Only then do they develop into the cell type that best suits their characteristics and which prevails in their environment," Alexander Skupin says.

The researcher likens this step to a game of roulette, where the different types of cells can be thought of as the differently numbered slots in the roulette wheel that catch the ball. "When the cells lose their stem cell character, they are quasi thrown into the roulette wheel, where they first bounce around aimlessly. Only when they have found the right environment do the cells then drop into that niche - like the roulette ball falling into a numbered slot - and differentiate definitively." This way, the body can orchestrate its cell regeneration and at the same time prevent stem cells from being misdirected too early. "Even if a cell takes a wrong turn, it is ultimately sorted out again if its characteristics are unsuitable for the niche, or slot, it has landed in," says Skupin.

With their study, Alexander Skupin and his team have shown for the first time that a progenitor cell's fate is not clearly predetermined and does not follow a straight line. "This observation contradicts the current doctrine that stem cells are programmed to follow a certain lineage from the beginning," Alexander Skupin says. The researcher is furthermore convinced that the processes are similar for other progenitor cells. "In the lab, we have observed the same differentiation pattern in so-called iPS cells, or induced pluripotent stem cells, which can transform into many different types of cells."

This knowledge can help the researchers to improve the effectiveness of therapies in future. Stem cell therapy involves administering a patient his or her own body's stem cells in order to replace other cells that have died as a result of an affliction such as Parkinson's disease. While this promising treatment method has been intensively researched over many years, there has so far been only limited practical success in endogenous stem cell therapy. It is also highly controversial, since it is frequently accompanied by severe side effects and it cannot be ruled out that some cells might degenerate and lead to cancer. "Because we now have a better understanding of how the body influences the direction in which stem cells differentiate, we can hopefully control this process better in future," Alexander Skupin concludes.

Article adapted from a University of Luxembourg news release.

Publication: Cell Fate Decision as High-Dimensional Critical State Transition. Mitra Mojtahedi et al. PLoS Biol. (2016): Click here to view.

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MDA and CMTA Fund Grant to Study Gene Therapy in Charcot … – Marketwired (press release)

CHICAGO, IL--(Marketwired - March 17, 2017) - The Muscular Dystrophy Association (MDA) and the Charcot-Marie-Tooth Association (CMTA) today announced a research grant totaling $119,999 to Kleopas Kleopa, M.D., for a study on the effectiveness of a gene therapy approach in the second most common form of Charcot-Marie-Tooth disease (CMT). The grant is one of 29 new MDA grants totaling more than $7 million.

MDA and the CMTA are co-funding the grant under a partnership formed in 2016 that aims to advance CMT research, therapy development and clinical care, and increase understanding about the disease by improving education for kids and adults affected by CMT, medical professionals and the public.

"MDA is pleased to collaborate with the CMTA to fund this exciting research," MDA Scientific Program Officer Amanda Haidet-Phillips said. "Working together allows us to have a greater impact as we pursue our common goals to help individuals and families with CMT."

Kleopa is a professor and senior consulting neurologist at the Cyprus Institute of Neurology and Genetics, Cyprus School of Molecular Medicine, in Nicosia, Cyprus. The two-year grant, which became effective Feb. 1, 2017, will fund research on whether gene therapy treatment after disease onset leads to functional improvements in CMT1X.

With previous MDA support, Kleopa and his colleagues pioneered a gene therapy approach to treat CMT1X, showing that a single injection of the gene that is mutated in the disease was associated with production of normal protein in nerves and improvement of peripheral nerve health and motor performance.

Kleopa's new work will advance and expand on this approach as his team examines whether repeated injections lead to increased protein levels, and whether treatment at later stages of the disease leads to improvements similar to those seen for treatment in the early stages.

CMTA CEO Gilles Bouchard said, "Partnerships are at the core of the CMTA's STAR (Strategy to Accelerate Research) approach to finding treatments for various types of CMT, so we are very pleased to announce today the first research project jointly funded with MDA."

CMT is one of the neuromuscular diseases MDA fights as an umbrella organization with a big-picture perspective on finding treatments and cures for kids and adults whose weakening physical strength and loss of mobility make the most basic daily activities extraordinarily challenging.

CMT is one of the most common inherited neurological disorders, affecting approximately one in 2,500 people in the United States. It comprises a group of disorders caused by mutations in genes that affect the normal function of peripheral nerves -- the long nerves that extend to the feet and hands. Degeneration of motor nerves results in muscle weakness and atrophy in the arms, legs, hands or feet, and the degeneration of sensory nerves results in a reduced ability to feel heat, cold and pain. Onset of symptoms most often occurs in adolescence or early adulthood, though the disease can also present in later years. There are many forms of CMT, and the severity of symptoms varies widely among individuals. There is no cure for CMT, but physical therapy, occupational therapy, braces and other orthopedic devices and orthopedic surgery can help people cope with the disabling symptoms of the disease.

MDA has funded more than $36 million in CMT research since 1950. Including this most recent award, it is currently funding 16 CMT grants totaling more than $4.3 million. The CMTA funds and promotes targeted activities in its STAR research network with the aim of advancing therapies via alliance partnerships, with 40 current research projects and a funding total of just over $5 million over the last three years.

The MDA and CMTA Boards of Directors approved the grant after careful analysis and deliberation by MDA's Research Advisory Committee and the CMTA's STAR Advisory Board, peer review processes overseen by leading clinicians and scientists in volunteer roles. This year, MDA is funding more than 150 research projects worldwide.

About MDA

MDA is leading the fight to free individuals -- and the families who love them -- from the harm of muscular dystrophy, ALS and related muscle-debilitating diseases that take away physical strength, independence and life. We use our collective strength to help kids and adults live longer and grow stronger by finding research breakthroughs across diseases, caring for individuals from day one and empowering families with services and support in hometowns across America. Learn how you can fund cures, find care and champion the cause at mda.org.

About CMTA

The Charcot-Marie-Tooth Association (CMTA) is a registered 501c3 dedicated to serving an international patient community that suffers from rare and disabling neuropathies of genetic origin (www.cmtausa.org). The CMTA directly engages its STAR scientific and clinical research network in the identification, validation and clinical development of therapies for the different Charcot-Marie-Tooth disorders. The CMTA has focused solely on promoting the education, management and treatment of patients with CMT disorders since 1983.

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MDA and CMTA Fund Grant to Study Gene Therapy in Charcot ... - Marketwired (press release)

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Who wants to live forever? Transhumanism’s promise of eternal life – Irish Times

Mark OConnell has spent the past few years meeting people who want to upload their minds to robots and never die. He has visited warehouses filled with frozen heads, met people who implant technology in their own bodies, and toured the United States in a coffin-shaped camper van with a man who was campaigning to be president.

The general subject of OConnells beautifully written book, To Be a Machine, is transhumanism. And far from being a fringe movement of online nuts, this is, in fact, at the centre of futurist thinking in Silicon Valley Ray Kurzweil of Google is among its foremost theorists. The central tenet of transhumanism is the notion of the singularity, a moment at which we will have both self-aware computers and the technology to allow us to merge our consciousness with machines. (Kurzweil has suggested the year could be 2045.)

OConnell first came across transhumanism 10 years ago, when writing for the now defunct Mongrel magazine. He is, he stresses, a layman, not an expert, and he is even apologetic about describing himself as a journalist, despite writing for the New York Times magazine and the New Yorkers Page Turner blog. (Im emasculated by your professionalism, he says when he sees my uncharacteristically printed-out notes.)

I guess I do have this weird obsession with the machine of the body, OConnell says as we upload sandwiches in a Dublin cafe.

While there is this quite extreme movement with a cluster of interesting ideas to think about in and of themselves, its also a kind of an extreme manifestation of our own f***ed-up relationship with technology and my own f***ed up relationship with being a fallible, dying human being.

So its a way of writing about death? To Be a Machine, he says, is a book about death. I didnt really realise it until Margaret Atwood put it on a list of her favourite books about death . . . I have this thing where anytime I go through a major life change it translates to instant obsession with death. When I got married I thought, The first part of my life is the part before I got married and I didnt die, and the second part is the part where I have been married and I die. He laughs. I am morbidly preoccupied with death.

There was no better place for him to be, then, than Phoenix, Arizona, where Max More, chief executive of Alcor Life Extension Foundation, showed him a warehouse full of frozen heads.

They call them cephalons, OConnell says. They get a lot of mileage out of that euphemism. But its this really banal, mundane scenario. Its an office where no one seems to be doing that much work. Theres a real air of lassitude about the place, and its literally in a business park beside a place called Big D Floor Covering Supplies.

Is being frozen expensive?

Those who sign up for this postdeath procedure do so in the hope that by the time they are unfrozen there will be a cure for death. I think the preferred scenario is that you upload the brain into a new body, and the old fleshy body is disposed of. Its a religious idea, basically. They hate that interpretation of it.

In his book OConnell cant help but reach for religious allegories. Still, he is reluctant to describe transhumanism as a religion (although he visits a quasi-religious offshoot, Terasem Faith). His narration has a winningly anxious air, and he indulges in long, entertaining tangents where he talks about philosophy, his young son and his own sanity.

Mad as he found some transhumanist ideas, he cant entirely discount them. I was often really aware of being the stupidest person in the room. I had this sensation of being around people who were way more rational than me and way more informed about the technologies. I used this phrase magical rationalism. There was a logic to everything, but it went to this space of craziness.

A case in point: OConnell spent time with a bunch of biohacking body-modification aficionados in a house on the edge of Pittsburgh. They want to be cyborgs, he says. They refer to themselves as practical transhumanists, and theyre in an uneasy relationship with the people talking about mind uploading in the future. They want it now. Theyre like the DIY punk wing of the movement.

Practical transhumanists have unlicensed surgery to have technology implanted in their bodies. So Im a cyborg, but what does it mean? It means I can open my car without taking my keys out of my pocket. The cure is worse than the disease, basically. You have to get unlicensed surgery so you can open the door of your car without taking your key out. They saw it as a gesture towards the future.

Again, theres a hugely religious dimension to it, but if you say that to them they get really impatient, because theyre all hard-core atheists into Sam Harris and Daniel Dennett.

Tim Cannon, the groups de facto leader, recently had an implant removed that left a horrible scar on his arm.

Hed had this thing about the size of a mobile phone in his arm, OConnell says.

in this case a body modification artist named Steve Haworth to put it into you . . . It uploaded information about body temperature to his laptop, which was connected to his heating system. If he got too cold the heat went on.

OConnell laughs. Kind of interesting, but also, would you not just get up and turn on the heating?

Not everyone is drinking the Kool-Aid. Transhumanists ultimately believe that the mind is a vast collection of data that is replicable outside the body. But one sceptical neuroscientist told OConnell that the brain is less like a collection of data and more akin to a shoal of fish. The notion that we might be able to upload to machines anytime soon is unrealistic.

Its a recurring category error that we humans make, OConnell says: to assume that our minds are like the latest technology. I think transhumanist ideas come from spending too much time with a computer and overidentifying with it as an extension of the self. It reminds me of The Third Policeman the confusion between the man and the bicycle . . . I wonder if Flann OBrien was around now, would he be writing about computers?

In another chapter OConnell travels with Zoltan Istvan, a transhumanist theorist and life-size Ken doll, in a camper van designed to look like a coffin, as Istvan campaigns for the US presidency on an anti-death ticket.

I like him against my better judgment, OConnell says. The feeling must be mutual, because Istvan gave To Be a Machine a positive review on Amazon. He wrote, Im unaware of any other prominent writer having done so much research on the movement itself that was not a transhumanist.

How did all this contemplation of death and deathlessness affect OConnell? Hmm, he says and chews his sandwich. This is 80 per cent chewing, 20 per cent thinking, he says after a while. He thinks again. The American political philosopher Francis Fukuyama described transhumanism as the most dangerous idea in the world. OConnell wouldnt go that far himself, but he says he understands the anxiety that comes from long-standing beliefs about what it means to be human. He writes movingly about his animalistic love for his wife and son:

Would he like to be uploaded to a computer to live forever? I would rather be dead. I cant quite intellectually justify it, but it just feels viscerally nightmarish. Maybe I just dont love life that much.

His new friends in the world of transhumanism would call this a deathist philosophy. It is an outlook he couldnt even shake when faced with a minor cancer scare. I think my view of death is still the view of a guy in his mid-30s. Whereas I talk to my dad about it, hes 73 and he has a completely different view. Hes a pharmacist, and says maybe it wouldnt be such a terrible thing. You get to my age and an extra few years would be nice. I suppose its difficult to imagine being at a point where youre like, times up.

Transhumanists, on the other hand, dont talk in terms of an extra couple of years. Many fantasise about travelling the universe eternally as near god-like machines. Meanwhile, scientific types such as Elon Musk and Stephen Hawking warn of the dangers posed by malevolent artificial intelligences.

Theres a sense that these people are off the reservation, says OConnell, but at the same time these are the people creating the future. Fifty years ago, if you had people talking about how we were all going to spend all our time in this semi-imaginary, semi-real realm the internet wed think thats mad, and it doesnt sound all that great.

OConnells current concerns are more prosaic. He worries about who owns the servers on to which our data and personalities might be uploaded (few transhumanists fret about such things) and, in the shorter term, about his sons employment prospects.

The one thing I came out of writing this book completely shitting myself about was the employment implications of this technology. The destruction of jobs, he says, will happen soon.

In the same way that the book is about death and America, its about capitalism as well. I feel like the logic of capitalism is inexorably heading towards owning the means of production and the labour force, and integrating that into one machine and getting rid of as many people as possible.

Ultimately, To Be a Machine is both an insight into transhumanist thought and OConnells very relatable fears and anxieties about mortality and the future. I assume he will follow through on these in his next book, which is about prepping for the fall of civilisation: Its always the apocalypse one way or another.

His son recently asked what happens when people die. Without a religious afterlife to fall back on, his mother told him that his father was writing about people who believed that death would end, so he might never have to worry about it.

OConnell laughs. Also, it was perfect for the book.

Patrick Freyne is interviewing Mark OConnell as part of the Mountains to Sea DLR Book Festival, at the LexIcon in Dn Laoghaire, on Saturday, March 25th, at 7pm; mountainstosea.ie. To Be a Machine: Adventures Among Cyborgs, Utopians, Hackers, and the Futurists Solving the Modest Problem of Death is published by Granta Books

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Who wants to live forever? Transhumanism's promise of eternal life - Irish Times

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Ask The Doctors – Daily Journal Online

DEAR DOCTOR: I've been taking thyroid medication for several years, and my doctor says my blood tests are where they should be, but my face feels like sandpaper, my nails are brittle, and I'm losing so much hair that I can see my scalp. Could there be some underlying problem my physician is missing?

DEAR READER: Hair loss can be a distressing symptom, made all the more so when its cause is a mystery.

Your thyroid hormone levels are an obvious place to start, because both low and high thyroid levels can lead to hair and nail changes. Symptoms of high thyroid levels include hair loss, skin that is unusually smooth and warm, and nails that soften and loosen from the nail bed. The remaining hair becomes thinner, softer and does not hold a wave. Symptoms of low thyroid levels also include hair loss, including in the armpits and genital area, but the hair in this scenario is dull, coarse and fragile. As for the nails, they tend to be delicate, thin and have multiple grooves. That said, if your physician has done a complete panel of thyroid tests and the results have been normal, then most likely the function of your thyroid gland is not the cause of the brittle nails nor the hair loss.

That doesn't mean the thyroid isn't a factor. Autoimmune thyroid disease can lead to hair loss, both patchy and more diffuse, as well as inflammatory conditions of the skin. Such disease isn't always reflected in thyroid hormone levels. Checking anti-thyroid antibodies in the blood can identify autoimmune thyroid disease, and point you and your doctor in a clearer direction.

Hair loss also can be caused by androgenic alopecia, linked to an excess of androgens, a type of male hormone. These hormones are present in both men and women, but they're higher than normal in some women, such as those with congenital adrenal hyperplasia or polycystic ovarian disease, which is relatively common. Simply checking levels of testosterone and dehydroepiandrosterone (DHEA) can either rule out androgenic alopecia or suggest that it be explored further.

Another potential cause is medication. Some medications can lead to hair loss, so if your symptoms seem coincidental to starting a new medication, there might be an association.

Biotin deficiency, which is rare, can also cause hair loss and inflammation of the facial skin. But if you have a normal diet and eat eggs, you have a low likelihood of this condition. Nonetheless, it's something to rule out.

Iron deficiency also can lead to both brittle nails and hair loss. This doesn't explain the skin manifestations that you have, but if you are looking at other possibilities, checking the iron level of the blood should be part of the workup.

Any major illness can lead to hair loss and nail changes, and psychological stress can lead to hair loss. So, if there have been major stressors in your life, either physical or psychological, consider that a potential culprit.

In summary, if your thyroid levels are normal, it would be wise to check your thyroid antibodies, androgens and iron levels -- and your level of stress.

Robert Ashley, M.D., is an internist and assistant professor of medicine at the University of California, Los Angeles.

Send your questions to askthedoctors@mednet.ucla.edu, or write: Ask the Doctors, c/o Media Relations, UCLA Health, 924 Westwood Blvd., Suite 350, Los Angeles, CA, 90095. Owing to the volume of mail, personal replies cannot be provided.

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Dear Dr. Roach: Dietitian is important resource in treating celiac disease – Herald & Review

Dear Dr. Roach: I am a 78-year-old woman who was just diagnosed with celiac disease. I had an endoscopy in 2007 because I was anemic, and the doctor told me I had an ulcer that healed itself. This year I had an endoscopy because I again was anemic, but this time he did a biopsy, which came back as celiac. I have no dysentery or stomach pains, which are red lights for celiac; I have had inflamed joints for years, accompanied by dry skin. Is it possible that I have had this disease for years and was never diagnosed? My doctor told me not to eat wheat but never went any further than that. I have been educating myself about the disease. Who else would I see about this? Also, what would happen if I ate wheat by mistake? I also have been short of breath for years, but heart and pulmonary tests all come back normal. Could celiac be causing this shortness of breath?

A: Celiac disease, also called "gluten-sensitive enteropathy" or "nontropical sprue," is an uncommon but increasingly recognized condition caused by a reaction to gliadin, a protein found in gluten-containing grains, especially wheat, rye and barley. The spectrum of symptoms caused by celiac disease and its associated conditions is too broad for this column to cover comprehensively.

Not everyone with celiac disease has gastrointestinal symptoms, such as diarrhea and weight loss. Some people get mild abdominal pain and mood changes, and never put these together with their diet. At age 78, it's very likely that you have had celiac disease for many years. The anemia 10 years ago possibly was celiac-related, through iron deficiency. People with celiac disease are more likely to develop arthritis as well, and one skin condition, dermatitis herpetiformis, is so characteristic of celiac that a biopsy is not needed.

Shortness of breath is uncommon with celiac disease, but a severe anemia can cause it, as can one rare lung disease, pulmonary hemosiderosis, which often goes away on a gluten-free diet. Disease of the heart muscle itself is rare but more common in people with celiac disease.

Unfortunately, the dietary information you got was woefully inadequate, so I would strongly recommend a visit with a registered dietician nutritionist, who can give you much more information. Don't eat wheat: Proper care of this disease depends on meticulous avoidance of gluten, and even small amounts count.

Dear Dr. Roach: My doctor just tested me for high calcium, and my vitamin D was low. He put me on 12 weeks of 50,000 IU once a week. You said something in a recent article about high vitamin D. Why the difference?

A: Unfortunately, I am confused by your vitamin D treatment: I suspect the vitamin D has nothing to do with the calcium. A high calcium level can be caused by many things, including faulty technique in obtaining blood (if the tourniquet is on too long, the blood can become more acidic, which makes the calcium level appear higher), but I mentioned excess vitamin D (a rare cause) and elevated parathyroid hormone levels in my recent column. A repeated high calcium level should get your doctor to check a PTH hormone level. A high PTH level almost always means a benign tumor of the parathyroid gland, which is often but not always treated surgically.

Dr. Roach writes: I solicited opinions about televisions in physician waiting rooms, and have the results of what readers wrote me. Ninety-three percent of respondents did not like them. Some suggestions included artwork or an aquarium instead; music (especially classical) to provide white noise and privacy; and 1950s television shows or informational shows with closed captioning.

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Dear Dr. Roach: Dietitian is important resource in treating celiac disease - Herald & Review

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Yup, Working Out During Your Period Can Help Dull Cramps and PMS – SELF


SELF
Yup, Working Out During Your Period Can Help Dull Cramps and PMS
SELF
Medical professionals like Spencer Nadolsky, D.O., a licensed practicing board certified family and bariatric medicine physician in Olney, Maryland, agree that exercise is often an effective antidote for period-related woes. Exercise can be a stress ...

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Yup, Working Out During Your Period Can Help Dull Cramps and PMS - SELF

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PHYSICIAN SPEAKS AT UNITED NATIONS ABOUT MEDITATION – The Indian Panorama

UNITED NATIONS (TIP): When you can go to the United Nations to hear a talk about meditation, you know something has changed in the world.

On Friday, March 10, 2017, Dr. Kunwarjit Singh Duggal, guest of the United Nations Salus Well-Being Network, spoke to a packed audience in the Secretariat Conf. Room 8 on Cultivating Inner Peace for Outer Peace. He began: My main message here is to talk about peace. How do we achieve peace? . . . In order to take peace to the next level, we have to find peace within ourselves first before we can go on helping the rest of society.

By his own admission, Dr. Duggal is quite passionate about meditation as an intervention for many of lifes challenges, whether worldly or personal a universal paradigm.

His topic on Friday, particularly timely today,detailed the latest scientific research on theproven benefits of meditation. Noting the many different types of meditation, he talked about several significant studies, most focused on peace, stress and anxiety.

He quoted one randomized controlled study in which people were asked to meditate each morning for 21 days straight for a short duration of time. The researchers measured cortisol (the stress hormone) levels before and after 21 days and found a significant decrease in every participant. Notable studies also found that for patients undergoing orthopedic rehabilitation those who meditated benefitted twice as much as those who were treated only with therapeutic exercise.

One telling example was an experiment done in a troubled San Francisco school district in whichtwo 15-minute periods of quiet time wereinstitutedfor students. The results were improved test scores, attendance, psychological state and enhanced concentration. These students also reported increased calmness and decreased anger. By increasing the calmness in these students, their corresponding troubled geographical regions noted decreased crime rates and improved safety.

Dr. Duggal then presented the meditation technique practiced in Science of Spirituality, Jyoti meditation, after which everyone had a chance to meditate for a short period.

The afternoon concluded with a lively question and answer session.

Dr. Duggal was at the United Nations representing the Science of Spirituality,(NGO), a worldwide, spiritual organization dedicated to transforming lives through meditation. His father, Sant Rajinder Singh Ji Maharaj, head of Science of Spirituality, spoke at the UN last May on Meditation as Medication for the Soul.

Dr. Duggal is a Board-Certified Physical Medicine and Rehabilitation Specialist and Assistant Professor at Rush University Meditation Center in Chicago. He lectures extensively on meditation as an effective intervention for physical and emotional medical disorders.

For more information about Science of Spirituality: http://www.sos.org.

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PHYSICIAN SPEAKS AT UNITED NATIONS ABOUT MEDITATION - The Indian Panorama

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For LGBT Undocumented Immigrants, Detention Means More Fear and Humiliation – Broadly

Often fleeing persecution or violence in their countries of origin, LGBT undocumented immigrants face heightened trauma if they're taken into custody by United States Immigration and Customs Enforcement, which has no mandatory standard of treatment for vulnerable detainees.

Irvin Gonzlez was one of the nearly 700 immigrants detained as part of a series of nationwide Immigration and Customs Enforcement raids in early February, and one of the few whose story garnered national attention. Gonzlez, a transgender woman who was detained in a Texas courthouse shortly after obtaining a protective order against her abusive ex, was immediately held up as an example of the inhumanity of President Donald Trump's immigration policiesbut the media blitz surrounding her case largely ignored one of the most important parts of her story: her gender.

Trump's targeting of immigrantsundocumented and otherwiseand of trans people are typically considered distinct issues that can be boiled down into separate soundbites: deportations for the former, revocation of bathroom access for the latter. Gonzlez's case, however, shines a light on the intersections of xenophobia and transphobia, as well as the horrific conditions LGBT immigrantsespecially those who are transgenderface in detention.

Read more: The Shocking, Painful Trauma of Being a Trans Prisoner in Solitary Confinement

Gonzlez was repeatedly misgendered in the criminal complaint detailing her February 9th arrest. At the El Paso County Jail, where she has been held since her arrest, she was denied hormone treatment for more than two weeks, which caused her to feel nauseated, lose sleep, and grow facial hair, Gonzlez told the New Yorker through her immigration attorney.

These are clear examples of "humiliation and day-to-day microaggressions that trans women face" in detention, Isa Noyola, the director of programs at the Transgender Law Center, told me. "Being denied their identities and their pronouns, all of these things come together," Noyola said.

Transgender immigrants in ICE custody are often denied hormone treatment, according to a 2013 Center for American Progress report on the conditions LGBT immigrants face in detention. Although ICE's Performance-Based National Detention Standards say transgender detainees already receiving hormone therapy before being taken into custody should have continued access to their medication, these standards are not mandatory and are often flouted.

Even in cases when transgender immigrants are granted continued access to hormone therapy, ICE has to request their medical records from their country of origin, which often take upwards of a month to arrive and delay inmates' access to hormone therapy. This was allegedly what happened in Gonzlez's case: US Marshals said they needed to wait for her medical records to arrive from Mexico before she could receive hormones, the El Paso Times reported.

Gonzlez had been deported six times since 2010, ICE spokesperson Leticia Zamarripa said in a statement, adding that Gonzlez was recently convicted for possession of stolen mail in addition to "at least eight [prior] convictions on charges including false imprisonment, assault, larceny, domestic violence and illegal re-entry." But the context of transphobic violence in Mexico casts Gonzlez's re-entry into the United States in a different light, and her criminal and immigration history don't tell the whole story, advocates claim. In Mexico, transgender women often lack access to gender-confirming health care, including hormone therapy, according to a 2016 report by the Transgender Law Center and Cornell Law School's LGBT Clinic. Additionally, Mexico City is the only city in the country that allows transgender people to legally change their name and gender to correspond to their gender identity, but lengthy delays and high costs mean legal name changes are unavailable to many transgender women. Outside Mexico City, anti-discrimination laws don't prohibit discrimination on the basis of gender identity. Throughout the country, trans women face a disproportionate amount of violence; Mexico has one of the highest documented rates of transphobic murders in the world, and Mexico City has the highest rate of transphobic murders in the country. The report also found that increased visibility of LGBT issues in the country has led to an increase in violence and misconceptions, with transgender women "bearing the brunt of this escalation."

"They're looking at [Gonzlez's] criminal history in a very linear, basic way," Noyola said of ICE and of the conservative news outlets who latched onto reports of Gonzlez's criminal record. "They're not acknowledging the circumstances that can drive an individual to feel that they have to make these choices in order to survive. To not acknowledge the violence that trans women face, trans immigrant women in particular, is a failure of how this whole situation arose."

Gonzlez may be one of the most recent and high-profile examples of ICE's poor track record with LGBT detainees, but she is far from the only one. The Center for American Progress obtained nearly 200 reports of abuse of LGBT detainees in ICE facilities between 2008 and 2013but the group maintains that since LGBT detainees "often fear retaliation if they submit a complaint," this number "likely illustrate[s] a fraction" of the total abuse LGBT immigrants in detention face across the country.

The report found that LGBT immigrants were at an increased risk for sexual assault and verbal and physical abuse by both guards and other detainees and that there were several incidences of LGBT immigrants being humiliated by guards in front of other inmates. Many facilities place LGBT detainees in solitary confinement as an attempt to protect them from the general population, which often has adverse effects on their mental health. According to a 2015 report by the Vera Institute of Justice, suicide rates and incidents of self-harm are much higher for people in solitary confinement than among the general prison population.

For asylum seekers and refugees fleeing violence in their home countries, detention can be a particularly traumatic experience. Andrea Senz, supervising attorney at Brooklyn Defender Services' Immigration Practice, recalled the devastating effects that being detained had on one of her clients, a gay asylum seeker from Mali.

"He had been severely persecuted in his own community and came here seeking safety. He was very, very traumatized by being detained," Senz said. "He had never been in a carceral setting before, and had a lot of mental health challenges and even became suicidal. In detention, there isn't really access to mental health services. In terms of someone who has been through trauma and persecution and needs counseling, there isn't really much of that."

Tasha Hill, LGBTQ rights staff attorney at the ACLU of Southern California, said ICE has repeatedly shown they can't humanely detain LGBT immigrants, particularly transgender women. "It's a particularly cruel way to treat someone who's fleeing persecution in their country of origin," Hill told me.

"ICE has proven they can't keep this population safe, especially because to date, they have insisted upon housing trans women in men's facilities and housing trans men in women's facilities," she added. "This leads to increased feelings of gender dysphoria and to an incredibly high rate of abuse, especially for trans women who are fleeing other countries."

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There are only two ICE detention facilities that house transgender detainees in separate, specialized units: the Santa Ana City Jail in California and the Prairieland Detention Center in Texas, which is operated by Emerald Correctional Management, a private contractor that operates seven facilities and detention centers across the country.

Late last year, Santa Ana city officials announced they would end their contract with ICE in 2020. In February, ICE notified the city that it would terminate its detention contract with the facility in 90 days, leaving many transgender detainees in limbo. The Santa Ana facility, Hill said, housed "sometimes up to half of the trans folks" in ICE custody nationwide, some of whom have already been transferred to men's facilities, Hill said. Others will be sent to the new Prairieland facility. Although immigration advocates initially viewed Santa Ana's severed ties with ICE as a net positive, some are now worried that detaineesespecially those who are transgenderwill be adversely affected.

"There are less resources available to immigrants in Texas, including access to attorneys," Hill said. "If you have an attorney, you're more likely to be granted asylum."

The fact that many transgender detainees will be sent to a for-profit facility is also worrying for advocates. "At least in Santa Ana, there's an activist community that is making an effort to hold the city accountable," she added. "With these private detention facilities, it's just a board of directors trying to make money off locking people up. The safety expectations and the standards are very low."

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For LGBT Undocumented Immigrants, Detention Means More Fear and Humiliation - Broadly

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The Incredible Plan To Restore A Woman’s Fertility And Defy The Limits Of Nature – Gizmodo Australia

Over the course of seven years, Sezenia Tzeni endured seven rounds of in vitro fertilisation. Typically, women undergo only three or four IVF treatments before either getting pregnant or giving up. But for Tzeni and her husband, conceiving a child was more important than almost anything else.

"My mother and friends told me to do an adoption," 36-year-old Tzeni told Gizmodo. "But I wanted to feel it, to feel the feeling of pregnancy and the moving in my belly."

Each time, though, the cycle of hope and disappointment became more devastating. After the seventh round, finally, she stopped trying.

Then, in 2015, a friend told Tzeni, who lives on a small island in Greece, about a clinic in Athens called Genesis. There, a gynecologist named Konstantinos Sfakianoudis claimed to have found a way to rejuvenate ageing ovaries with a blood treatment typically used for healing wounds. So far, Sfakianoudis says, the technique has helped nine women nearing menopause who were having difficulty conceiving to get pregnant via IVF. In pre-clinical trial data provided by Sfakianoudis, 11 of 27 menopausal women saw menopause reversed, with hormone levels returning to those associated with fertility, and menstruation beginning again. Two of those women were able to generate healthy eggs, and one of them got pregnant, though she has not yet given birth.

In another case study, a menopausal German woman treated by Genesis got pregnant and gave birth, according to information Sfakianoudis provided to Gizmodo.

Now, the group is planning to bring its treatment to the US. Genesis is currently in the process of enrolling 50 patients in a clinical trial in collaboration with scientists from UC Berkeley and a La Jolla IVF practice. But the clinic's work has engendered plenty of scepticism. Its bold claim suggests it has managed to reverse a milestone event in a woman's life in a sense, to undo the process of ageing itself. But other than a brief presentation at a conference last winter, Genesis has yet to publish its findings. And even if its technique works, some wonder: Is reinstating fertility in women well into their 50s and 60s something we should even really be doing?

"We were sceptical, too, when it started to work," Sfakianoudis told Gizmodo, via phone from Greece. "Now I could not be more optimistic."

This seemingly miraculous treatment contradicts what has been considered fact since the 1950s: That women are born with all the eggs they will ever have. Estimates suggest that from the time she is born, a woman loses about 1000 egg cells, called oocytes, a month. At puberty, oocytes begin to mature, and during each cycle of ovulation, usually just one ripens to maturity. Eventually, at some point, conventional wisdom holds that a woman's supply of oocytes runs out. Her ovaries stop producing the hormones needed to maintain fertility, and she enters menopause.

Over the past decade or so, though, a small trickle of research has challenged this picture. In 2004, a reproductive biologist then at Massachusetts General Hospital named Jonathan Tilly published a paper suggesting that in mice, oocytes were regularly replenished by stem cells. If he was right (and if the finding held true in humans) it meant that stem cells could be harnessed to produce new eggs, perhaps even reverse menopause. His work was and still is controversial. But since then, new research by Tilly and others gave the idea more credibility. A year after his initial study, Tilly announced that he had identified bone marrow as the source of those egg-producing stem cells. In 2009, a team in China reported that they had similarly isolated "female germline stem cells" in the ovarian tissue of mice, which they then transplanted into infertile mice. Eventually, the mice were able to give birth.

The Greek group's work is rooted in this idea, that a woman's ovaries might just need a boost from stem cells, or something else to kickstart egg production again. Instead of stem cells, though, Genesis turned to a blood treatment known as platelet-rich plasma (PRP). It's an old practice typically used to help muscle and tendon injuries heal faster, though just how effective it is for healing remains unclear. The idea is to spin down a sample of a person's blood in a centrifuge to isolate molecules that help trigger tissue and blood vessel growth, then inject this enriched blood back into the body, hopefully stimulating tissue regeneration to help a wound heal faster. Bone marrow transplants and (the far less invasive) PRP transfusions contain similar growth factors, so Genesis put two-and-two together and began offering their clients transfusions of PRP.

Genesis' idea isn't totally without precedent. At least one fertility clinic in New York offers PRP as a "ovarian rejuvenation treatment" for a cool $US3500 ($4550), citing, accompanied by many asterisks, a single case study presented at a conference of a postmenopausal woman who gave birth after being treated with PRP. A 2015 Chinese study of five infertile women with thin uterine linings all became pregnant after PRP infusions stimulated that lining to grow thicker. A similar trial is currently underway at UCSF. Meanwhile, OvaScience, a biotech startup founded by Tilly, is working to rejuvenate egg cells from older women by adding new cytoplasm and mitochondria.

In 2015, the Greek clinic began treating patients past and nearing menopause with PRP, as well as younger women who had other conditions like uterine scarring that made it difficult to conceive. They found that in all three scenarios, PRP seemed to stimulate egg production. Additionally, and notably less scientifically, they concluded that "the overall state of feminine mental and physical health appeared to improve significantly with the restoration of youthful hormone levels".

Last July, Sfakianoudis's team presented early results at the European Society of Human Reproduction and Embryology annual meeting in Finland. More recently, the clinic partnered with a biotech firm with transhumanist leanings, Ascendance Biomedical, to spin the treatment off into a company, Inovium.

The US trials are an effort by the company to gather more data to back up their findings and lend it legitimacy. The trial will be held at the Center for Advanced Genetics in Carlsbad, CA and supervised by Michael and Irina Conboy, a husband and wife research team at UC Berkeley known for their pioneering work studying ageing and rejuvenation in mice.

Still, it's hard not to raise an eyebrow at a company that mixes up the name of the scientist who supposedly inspired its work on the "science" tab of the company website. (Inovium referred to scientist Jonathan Tilly as "Dr Roger Tilley". When Gizmodo pointed this out, the company edited the page, but still spelled Tilly's name incorrectly.) More troublingly, Inovium and Genesis are offering women that are desperate for children and willing to pay a very high price a treatment for which they still have published no peer-reviewed data, have done very small studies, and have little more than untested theories to explain how it all actually works.

"I would be very cautious proceeding with such a clinical investigation," said Christos Coutifaris, president-elect of the American Society of Reproductive Medicine. "Infertility patients are very vulnerable," he added, referring to the emotional toll that fertility treatments can take.

Genesis is the biggest private fertility clinic in Greece. Fertility is big business the industry is expected to surpass $US30 billion ($39 billion) by 2023 and Genesis' founder, Kostas Pantos, envisioned turning Greece into a hub for medical tourism in this fast-growing market. Since opening in 1995, the clinic has often been at the forefront of fertility technology, with early forays into genetic screening of embryos and research identifying which embryos are most likely to make it to term.

So far, more than 60 women who were either past menopause or having trouble getting pregnant have received PRP treatment at Genesis, including Tzeni, according to Sfakianoudis. In over 75 per cent of those cases, the clinic claims that hormone levels (AMH, FSH, LH and Estradiol) returned to "youthful levels". The nine women who ultimately wound up pregnant after undergoing PRP and IVF were between 36 and 54, and experienced no complications.

"We're still in the very early process of trying to figure out when it works, how it works, and why it works," Sfakianoudis said.

Ultimately, the end goal is to publish the results of the US trial in a peer-reviewed journal.

Michael and Irina Conboy, the Berkeley scientists who have signed on as advisors and researchers on the project, said that while it's plausible the treatment works and early data is promising, a proper pilot study is needed before anyone can really judge anything.

"What I like most about this trial," Michael Conboy told Gizmodo, "is that it sounds very unlikely it will harm anyone."

Unlike traditional PRP transfusions, which require donor blood, the Greek clinic's procedure uses a patient's own genetic material, removing their blood plasma, enriching it, and then injecting it back into the ovaries in a relatively noninvasive procedure. The study will look at menopausal and perimenopausal women looking to conceive, and follow them through IVF treatment and, if all goes well, birth.

The Conboys said that they were enticed by the clinic and spin-off company seeking to back-up its wild-sounding claims with actual science.

"They specifically mentioned that they don't want to be another Ambrosia," Irina Conboy said, referencing the Silicon Valley startup that offers blood transfusions to youth-seekers based on questionable science. "All of this needs to start with a study," she added.

The Conboy's own lab has found that old blood can be damaging to younger mice, and that young blood is not as effective at rejuvenation as fans of the theory, like billionaire Peter Thiel, have hoped it would be. The couple's work, though, has also indicated that regulating certain blood proteins that change with age to maintain youthful levels can allow stem cells to more effectively repair the body, as they do in youth.

"The idea is that the stem cells themselves are not too old, but it's the environment around them that suppresses them," Conboy said.

PRP, he speculated, could be sending signals to stem cells in the ovaries that produce oocytes to regenerate.

The trial is still in its early stages basic details, like whether or not UC Berkeley will officially oversee it, are still being worked out.

Even if the trial does indicate Inovium's treatment is effective, though, it is not likely to quell all detractors. The treatment raises questions of whether women at or nearing menopause should be having children at all. Because risks of pregnancy complications increase with age, most IVF clinics have an upper age limit under 45 years of age. In some countries, like Israel, performing IVF over a certain age is illegal. Most of the women Sfakianoudis's team have treated so far have been between 45 and 64.

For Tzeni, Sfakianoudis concluded that her pregnancy woes were due to chronic inflammation in the lining of her uterus.

At first, the clinic tried treating the inflammation with several different antibiotic pills. Still, there was significant inflammation. Then they tried PRP. The inflammation disappeared.

"He told me, 'Now it's perfect to have embryos success,'" she said of Sfakianoudis. "He told me, 'Don't worry, you will have children and I'm sure you will have twins.'"

After another round of IVF, on 17 September 2016 she gave birth to twins.

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"It's a disgrace, the way in which your government has treated our state." South Australia's premier, Jay Weatherill, didn't mince his words when he was standing face to face with the federal government's minister for energy Josh Frydenberg on live TV during a press conference about the state's energy policy.

The Federal Government has announced a $2 billion expansion of the Snowy Mountains hydro scheme, increasing the 4,000 megawatt output by 50 per cent - a plan that will power up to 500,000 homes. The decision has been met with much impressed nodding from fellow politicians, and now here's what experts have to say about it.

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The Incredible Plan To Restore A Woman's Fertility And Defy The Limits Of Nature - Gizmodo Australia

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Cold Springs FCCLA brings home state awards – Cullman Times Online

Cold Springs FCCLA students took home an array of honors at state conference, with one student advancing to compete nationally.

On March 9-10, 2017, Cold Springs FCCLA students attended the FCCLA State Meeting in Montgomery. Members throughout Alabama gathered to increase their leadership skills, explore career options, compete in the state FCCLA STAR Events and elect a new team of state officers. With FCCLA there are unlimited opportunities for our youth.

This year Cold Springs had a student, Matthew Blair, to run for the FCCLA Executive Council Officer position. Matthew ran for this office with 10 other young adults from all over Alabama. Only six are chosen for the Executive Council. Matthew gave his speech and answered an on stage question to over 800 members, advisors, and guests. Matthew was voted in by his peers. He will be required to represent the state of Alabama at state and national meetings.

Cold Springs FCCLA had five students to complete the Power of One projects and be recognized at the state meeting: Rachel Haynes, Jessica Roden, Andrew Blair, Matthew Blair, and Stormy Schmidt received a certificate of completion.

Power of One helps students find and use their personal power. Each youth created a Power of One project that relates to one of the following five units:

A better you: Improve personal traits.

Family ties: Get along better with family members.

Working on working: Explore work options, prepare for a career, or sharpen skills useful in business.

Take the lead: Develop leadership qualities.

Speak out for FCCLA: Tell others about positive experiences in FCCLA.

Cold Springs students also competed in the FCCLA STAR Events Competition. These are competitive events in which members are recognized for proficiency and achievement in chapter and individual projects, leadership skills, and career preparation.

Rachel Haynes competed in the Career Investigation category and won gold. Her project title was Labor Lawyer. She will be representing the state of Alabama in this category at Nationals this summer in Nashville.

Matthew Blair, Raegan Lindsey, and Stormy Schmidt won gold in the Illustrated Talk category. They presented about teen depression and suicide.

Jessica Roden placed silver in the Life Event Planning category. Her topic was, Dedication to a Preacher. She planned, organized, and presented her project.

Kylie Gann and Samantha Willcutt won bronze in the Focus on Children category. They discussed and presented the topic of Living with Hypopituitarism. The girls wanted other students to understand what it is like to live with this. One of the girls cousins was born with this.

FCCLA has provided unlimited possibilities for our young adults at Cold Springs and other area schools. Its helps prepare todays teens for tomorrows workforce. It provides personal growth, leadership development, and career preparation opportunities for students in Family and Consumer Sciences. Advisor is Stephanie Blair.

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