Archive for the ‘Bone Marrow Stem Cells’ Category

Stem Cell Therapy market describes in-depth assessments and professional studies of the current and future status of the market worldwide, including valuable facts and figures. Stem Cell Therapy markets enhance this growth trend by providing information on new opportunities and market drivers, trends and future technologies. This report defines scope, coverage, production and CAGR (%) according to type, share, revenue status and outlook, capacity, consumption, market drivers, production status and outlook and opportunities, exports, imports, emerging market / national growth rates. This report provides a 360-degree overview of the industrys competitive environment. The Stem Cell Therapy market report evaluates key regions (countries) with a large market share during the forecast period.

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Furthermore, Report provides the deep analysis about the impact of domestic and global players on market, trade regulation, value chain optimization, and opportunities analysis for new present as well as new players, recent developments, strategic market growth analysis, area marketplace expanding, product launches, technological innovations and many more. The study report of global Stem Cell Therapy market can be split on the basis of key segments such as product type, application, key companies and key regions. Also the growth of the global Stem Cell Therapy market can be projected on the basis of segments and calculation for sales by application and type of the product in terms of volume and value.

Global Stem Cell Therapy market is segmented based by type, application and region.

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

This market ready research offering on Stem Cell Therapy market is a go-to synopsis that highlights on all the core developments simultaneously dominant across all regional hubs in the Stem Cell Therapy market and their subsequent implications on holistic growth trajectory of Stem Cell Therapy market globally. The report is aimed at answering all the relevant queries pertaining to the target market based on which successful business decisions could be rapidly applied, favoring uncompromised growth in the Stem Cell Therapy market.

The report also lends light on competition spectrum, highlighting core market participants who are identified as frontline players in Stem Cell Therapy market as highlighted by this research. In its bid to equip players with real time understanding of the various operational factors dominant across regions, the research elaborating on Stem Cell Therapy market also houses crucial data on various geographical hubs identified in Stem Cell Therapys market as presented.

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Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 - Latest Herald

Thursday, May 7, 2020, 8:30 a.m. EDT

NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- BrainStorm-Cell Therapeutics Inc.(NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today, that the Company will hold a conference call to update shareholders on financial results for the first quarter endedMarch 31, 2020, and provide a corporate update, at 8:30 a.m, Eastern Daylight Time, onThursday, May 7, 2020.

BrainStorms CEO,Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will beRalph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PhD, MBA, Executive Vice President and Chief Operating Officer andPreetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to:q@brainstorm-cell.com. Questions should be submitted by5:00 p.m. EDT, Tuesday, May 5, 2020.

Teleconference Details BRAINSTORM CELL THERAPEUTICS 1Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

ABOUT NUROWNNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

ABOUT BRAINSTORM CELL THERAPEUTICS INC.:BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in theU.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

SAFE HARBOR STATEMENT:Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate Update - Yahoo Finance

Even in times of the COVID-19 crisis, life-saving blood stem cells are brought to patients - by committed people like Maria

Originally published by DKMS

Maria Schmiing is a DKMS employee and has also been a volunteer stem cell courier for about two years. A few days ago, she took a transplant from Germany to the US - a particularly difficult challenge in times of the COVID-19 crisis. Currently, entry to the US is only possible because DKMS, with the support of the US Stem Cell Donor Register: National Marrow Donor Program (NMDP/Be the Match), has obtained a special permit for stem cell couriers to enter the country - so that patients can receive urgently needed transplants.

"It was through an acquaintance of mine that I became aware of it several years ago. She is a teacher and carries out stem cell transports during the school holidays - I was immediately enthusiastic about it and signed up for it," says Maria Schmiing from Cologne. She applied to Ontime Onboard Courier GmbH, one of the transport companies that DKMS works with to bring life-saving blood stem cells to the recipients.

Maria's first assignment took her to Leiden in the Netherlands - an important place in the fight against blood cancer, as the World Marrow Donor Association (WMDA) has its headquarters there. "I was really excited before I even started the journey," she recalls.

Afterwards many further assignments followed, and it was because of this job as a courier that her desire to work at DKMS was born. "For me, the circle is complete; I'm doing something meaningful with my life. I am very aware of what I am doing this for: for the patients who need our help. What I think is great is that I am also really supported by my team and my managers, especially in the current situation."

Blood stem cell couriers like Maria Schmiing are currently in great demand to ensure that blood stem cell donations reach their recipients all over the world safely, even during the COVID-19 crisis. A few days ago the latest task for the 34-year-old was to travel to the US. "The procedure for a courier mission is actually always the same," she explains, "During the briefing the day before, we go through all documents together and the entire itinerary is discussed. Everything important detail is marked and addressed." But something is different at the moment: the couriers must carry a special permit that allows them to enter the US. "This must be presented upon entry and exit."

The next stop for Maria was the collection centre the next morning. There she received the life-saving blood stem cells from specially trained staff. These had previously been collected from a DKMS donor and prepared for transport. All documents and data were double checked based on the 4 eye principle before the transplant was handed over. "We especially look at the donor number and compare it, because we have to make sure that the patient receives the right transplant".

Afterwards Maria could start her journey. Stem cell couriers are allowed one additional piece of hand luggage only to be able to stay flexible on the way. "Most important are the blood stem cells or the bone marrow. We must not lose sight of the transplant during the entire journey. I look after this suitcase like my own personal treasure, like a mother who looks after her children. I am aware of the responsibility I carry and this stays with me until I have delivered the blood stem cells safely to the patient's clinic."

Before the departure to the US, she made sure that at the Frankfurt Airport the suitcase with the stem cells was not X-rayed. "I always explain that this is harmful to the transplant something most people know. Only after an officer has brought the suitcase through the security area, do I then follow. This is the only time we hand the suitcase over to somebody else. Fortunately, there were no problems either at the security check or at customs.

Once on the plane she informed the crew - an important and regular task for her - and did not let the suitcase out of her sight during the flight. "Sleep, of course, is out of the question. We are not allowed to drink alcohol 24 hours before and during the flight and we of course have to take the suitcase everywhere with us."

Upon arrival in the US, Maria noticed two differences "After landing, several security officers entered the plane and talked to the crew - only then were we allowed to disembark. In addition to this, they took the temperature of all passengers.

She then continued her journey by taxi to the transplant clinic. "Everything went really well, and I was met at the clinic by a member of staff. Again there, we double checked everything and went through the documents according to the four eye principle. Once we get back to Germany, there is also a debriefing and I then return the suitcase."

After handing a transplant over, there is always a moment of great relief for Maria: "The tension disappears. Afterwards she has a ritual, which is very important for her. "I go to the hotel, have a shower and then go out and raise a glass of beer for the patient. I think about how they are doing and what is still ahead of them. I then tell myself that from my side I've done everything I can to help them and I wish them all the best."

Going out and having a beer was not possible this time, as neither shops nor bars were open in the American city - even the hotel restaurant was closed. "I changed my ritual and toasted the unknown patient with a glass of tap water in my room!"

The next day she went back to Germany and soon the next flight will be scheduled for her - couriers are rare in this COVID-19crisis-ridden time. "My learning from this journey: I will take an emergency ration of trail mix with me, you never know," she says with a wink. She reflects on her commitment to patients. "I am still available when my help is needed. I am aware of the risk and take the best possible care and comply with all safety precautions. It is also clear that patients cannot wait - and despite everything with the current situation they should still be given a chance at life.

Learn more about how you can help deleteblood cancer atDKMS.org

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On the Road As a Stem Cell Courier - CSRwire.com

The novel coronavirus might not have a cure right now, but its still worth acknowledging the massive research effort that goes into discovering treatments that can limit COVID-19 complications and prevent death. Doctors have observed the positive effects of a garden variety of drugs that are supposed to treat other illnesses, and some of these medicines are included in massive trials around the world. Scientists are also working on over 70 vaccine candidates for COVID-19, with some of them already showing promising results. On top of that, theres plasma from survivors thats rich in antibodies that can help people with weaker immune systems. And doctors think theyve discovered another promising treatment for COVID-19: Stem cells.

You often hear about stem cells and those reports are often miraculous in nature. Stem cells are human cells that have the superpower to transform into almost any cell of the body and they can be used to treat some medical conditions. Stem cells could regenerate lung tissue, fight inflammation, and help severe COVID-19 patients breathe on their own again. The problem with this line of thinking is that we just dont know.

Doctors at Mount Sinai treated 12 patients with stem cell therapy, and 10 of them came off their ventilators soon after, CBSNews reports. The doctors themselves have no idea what helped the patients improve, and cant definitively say that its the stem cells that saved their patients.

What we saw in the very first patient was that within four hours of getting the cells, a lot of her parameters started to get better, Dr. Karen Osman told CBS. The doctor made it clear that they cant claim the stem cell treatments are what saved the patients. We dont know, she said. And we would never dare to claim that it was related to the cells.

The doctor explained that only a randomized controlled trial would be able to tell them whether the stem cells can help with the recovery of COVID-19 patients. Thankfully, one such study is about to get underway. Mesoblast will trial stem cell treatments on 300 patients suffering from severe lung inflammation.

Osman and her team believe that stem cells extracted from bone marrow could suppress the inflammation in COVID-19 patients, and thats why they attempted the therapy. One such patient was 60-year-old Luis Naranjo who spent 14 days unconscious on a ventilator and lost 25 pounds while hospitalized of COVID-19. Naranjo has completely recovered following stem cell therapy, and hes at home working on regaining his strength.

If it works, stem therapy would still not be a miracle treatment, Osman says. The miracle treatment will be a vaccine. While we wait for any sort of efficient COVID-19 treatment, heres a simple explainer for stem cells:

Image Source: Darko Vojinovic/AP/Shutterstock

Chris Smith started writing about gadgets as a hobby, and before he knew it he was sharing his views on tech stuff with readers around the world. Whenever he's not writing about gadgets he miserably fails to stay away from them, although he desperately tries. But that's not necessarily a bad thing.

The rest is here:
Doctors think theyve discovered another potential coronavirus cure - BGR

Home Departments Men's Health Update

Mesoblast announced data from a phase 2/3 trial evaluating remestemcel-L, an allogeneic mesenchymal stem cell product candidate, in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).

Remestemcel-L consists of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to work by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The randomized, placebo-controlled trial is being conducted at Mount Sinai hospital in New York City. Patients were treated with a variety of experimental agents prior to receiving remestemcel-L. Findings from the study showed 83% survival in ventilator-dependent COVID-19 patients with moderate/severe ARDS (n=10/12) following 2 intravenous infusions of remestemcel-L within the first 5 days; 75% of patients (n=9/12) were able to successfully come off ventilator support at a median of 10 days. There have been 7 patients discharged from the hospital as of now.

Mesoblast Chief Executive Dr Silviu Itescu stated: The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

Additionally, the Food and Drug Administration recently accepted for Priority Review the Biologics License Application of remestemcel-L for the treatment of steroid-refractory acute graft vs host disease. The Company expects to launch remestemcel-L in 2020 if approved.

For more information mesoblast.com.

This article originally appeared on MPR

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Remestemcel-L Looks Promising in COVID-19 Patients With Moderate to Severe ARDS - Renal and Urology News

Capping decades of research, a new study may offer a breakthrough in treatingdyskeratosis congenitaand other so-called telomere diseases, in which cells age prematurely.

Using cells donated by patients with the disease, researchers at theDana-Farber/Boston Childrens Cancer and Blood Disorders Centeridentified several small molecules that appear to reverse this cellular aging process.Suneet Agarwal, the studys senior investigator, hopes at least one of these compounds will advance toward clinical trials. Findings werepublished Tuesday in the journal Cell Stem Cell.

If so, it could be the first treatment for dyskeratosis congenita, or DC, that could reverse all of the diseases varying effects on the body. The current treatment, bone marrow transplant, is high-risk, and only helps restore the blood system, whereas DC affects multiple organs.

The compounds identified in the study restore telomeres, protective caps on the tips of our chromosomes that regulate how our cells age. Telomeres consist of repeating sequences of DNA that get shorter each time a cell divides.

The bodys stem cells, which retain their youthful qualities, normally make an enzyme called telomerase that builds telomeres back up again. But when telomeres cant be maintained, tissues age before their time. A spectrum of diseases can result not just DC, but also aplastic anemia, liver cirrhosis, and pulmonary fibrosis.

The discovery of telomerase 35 years ago, earninga Nobel Prize in 2009, galvanized the scientific world. Subsequent studies suggested the enzyme could be a key to reversing aging, as well as treating cancer, in which malignant cells become immortal and divide indefinitely.

For years, researchers have tried to find a simple and safe way to manipulate telomerase, preserve telomeres, and create cures for telomere diseases.

Once human telomerase was identified, there were lots of biotech startups, lots of investment, says Agarwal, who has researched the biology of telomerase for the past decade. But it didnt pan out. There are no drugs on the market, and companies have come and gone.

DC can be caused by mutations in any of multiple genes. Most of these mutations disrupt telomerase formation or function in particular, by disrupting two molecules called TERT and TERC that join together to form telomerase. TERT is an enzyme made in stem cells, and TERC is a so-called non-coding RNA that acts as a template to create telomeres repeating DNA sequences. Both TERT and TERC are affected by a web of other genes that tune telomerases action.

One of these genes is PARN. In 2015, Agarwal and colleagues showed inNatureGeneticsthat PARN is important for processing and stabilizing TERC. Mutations in PARN mean less TERC, less telomerase, and prematurely shortened telomeres.

Thenew study, led by Harvard Medical School postdoctoral fellow Neha Nagpal, delved further, focusing on an enzyme that opposes PARN and destabilizes TERC, called PAPD5.

We thought if we targeted PAPD5, we could protect TERC and restore the proper balance of telomerase, says Nagpal, first author on the paper.

Nagpal and her colleagues first conducted large-scale screening studies to identify PAPD5 inhibitors, testing more than 100,000 known chemicals. They got 480 initial hits, which they ultimately narrowed to a small handful.

They then tested the inhibitors in stem cells made from the Martins cells and those of other patients with DC. To the teams delight, the compounds boosted TERC levels in the cells and restored telomeres to their normal length.

But the real challenge was to see if the treatment would be safe and specific, affecting only the stem cells bearing TERT. To test this, the team introduced DC-causing PARN mutations into human blood stem cells, transplanted those cells into mice, then treated the mice with oral PAPD5 inhibitors. The compounds boosted TERC and restored telomere length in the transplanted stem cells, with no adverse effect on the mice or on the ability to form different kinds of blood cells.

This provided the hope that this could become a clinical treatment, says Nagpal.

In the future, Agarwal, Nagpal, and colleagues hope to validate PAPD5 inhibition for other diseases involving faulty maintenance of telomeres and perhaps even aging itself. They are most excited about two compounds, known as BCH001 and RG7834 that are under further development.

We envision these to be a new class of oral medicines that target stem cells throughout the body, Agarwal says. We expect restoring telomeres in stem cells will increase tissue regenerative capacity in the blood, lungs, and other organs affected in DC and other diseases.

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Breakthrough to halt premature aging of cells - ScienceBlog.com

A Co Armagh cancer survivor is inspiring people to Race for Life at Home and carry on the fight against the disease in these unprecedented times.

Clare Crossey (33), a care worker from Lurgan who was diagnosed with leukaemia in February 2018, had hoped to take part in Cancer Research UK's Race for Life in Belfast on Sunday, May 24.

Unfortunately the Belfast Race for Life is among events which organisers Cancer Research UK have postponed this spring and summer to protect the country's health during the coronavirus outbreak.

But as the nation's lockdown continues, undeterred women and men are already vowing to carry on and complete a Race for Life at Home challenge in their garden or their nearest green space.

Clare is unable to take up the challenge right now, as she is recovering from a bone marrow transplant, but is determined to lend her support and has recruited her sister Alison and daughters Meabh (8) and Lily (11) - who are limbering up with Joe Wicks on YouTube every morning.

The mum-of-two's life changed very suddenly in February 2018 when she was diagnosed with acute myeloid leukaemia, a cancer that starts inside bone marrow, the soft tissue inside bones that helps form blood cells.

She has faced a tough battle for survival over the past two years and this time last year was in isolation receiving treatment and a stem cell transplant.

As she now faces isolation again to protect herself from coronavirus, Clare is remaining upbeat.

She says: "I now have a brand new immune system, almost like I have been reborn, so I need to have all the injections a new baby has.

"This places me at especially high risk from the coronavirus. It is frightening, but with the help of family, I am being very careful.

"We're all going to be spending a lot of time indoors this spring, so it feels good to take back some control and plan something positive to help me and to help people who are going through cancer right now.

"That's why I am happy to ask people to please join in the fun and still feel part of the Race for Life community."

Clare recalls how her life changed virtually overnight two years ago.

She had just finished night duty as a domiciliary care assistant when she started to feel very tired and unwell.

She then developed a rash on her chest and bruising on her legs.

Concerned, she looked up her symptoms and was alarmed to discover she could have leukaemia and immediately made an appointment with at the local health centre. A doctor felt that she was being over-anxious and she was sent home with details of the Samaritans helpline but within two days she was being told in hospital she was lucky to be alive.

Clare recalls: "I had a feeling in the back of my head that things weren't right.

"The doctor obviously did not agree with my suspicions as they gave me the number for the Samaritans, a prescription for beta blockers and told me to make an appointment for the following Tuesday for blood tests. This was on a Friday and Tuesday seemed so far away.

"As I left the surgery in tears, my younger daughter Meabh's school called me to say she had fallen and hit her head. That was the last thing I needed, but thankfully she was okay.

"I described my symptoms to my boss and we thought perhaps I just needed a week off work as I was over-tired.

"My mother was helping with the girls, who were just five and nine at the time, and she was completely dumbfounded to find me having a bath at 2.30am on the Saturday morning. I had thought perhaps the heat would help with the pains I was having."

After her bath Clare did fall asleep but was stunned when she woke to discover she had lost a whole day, sleeping for 24 hours straight.

She was further alarmed on waking to discover she had blood round her mouth as her gums were bleeding and she also found a huge bruise on her thigh, which was swollen.

She rang Craigavon hospital and was advised to come to A&E where blood tests were taken.

She recalls: "A short time after arriving at the hospital I was called to the yellow area and I knew from my job that was the admissions area. My bloods came back very quickly and when both a doctor and nurse came to talk to me, I just knew it was serious."

Clare was advised to go to the City Hospital right away and on arrival was met by a consultant and nurse who admitted her immediately and broke the news that she might have leukaemia.

Clare recalls: "I cried and the first stupid question I asked was, 'Am I going to lose my hair?' My thinking was that if I lost my hair the girls would know I was really ill, so I would have to tell them the truth."

Chemotherapy treatment started immediately and Clare was told that had she waited until the following Tuesday for blood tests, she may not have been alive. The cancer was 85% through her body and she was given around 16 hours to live.

She was offered a place on a Cancer Research UK trial called AML 19, which involved 10 days of chemo, day and night, from February 4 until the end of March.

She says: "I was in hospital for six to eight weeks at a time and sometimes didn't even see the kids. That was really difficult as they were so young, but my parents Margaret and Pat were a great help."

From February to September 2018, Clare had intense chemotherapy and tests showed her bone marrow was clear.

However, there was another blow in December when further tests revealed the leukaemia was back.

"I was devastated," said Clare. "I was readmitted to hospital on January 5 last year and remained there until March 7. I was allowed out for my daughter Lily's confirmation and we had a party before I went back into hospital that night."

Clare was forced to remain in quarantine in a stem cell room while receiving full body radiation and chemotherapy injections.

She needed a stem cell transplant to save her life. Her brother Darren and sister Alison - both musicians living in America at the time - had already been tested for stem cell transplant and Alison was relieved to be a 100% match.

On April 15 of last year, Clare went through her stem cell transplant.

Two weeks later she suffered a severe reaction and her body went into toxic shock.

She recalls: "I was told it was rare to have side effects but I had them all.

"My oesophagus was burned with the radiation and I couldn't walk or talk.

"I couldn't breathe and began vomiting blood. I woke up with an ICU team at my bedside that had to literally cut my clothes off due to swelling. I apparently had put on 4st in fluid due to the toxic shock. I remember asking, 'Am I going to die?'"

It was at this point an unusual encounter in the hospital changed things. A man visiting another patient with a religious relic from the saint Padre Pio enclosed in a frame asked if he could leave it with Clare, believing it might be something that would give her strength.

She decided that if she was to survive she had to be positive.

She says: "That was on May 2 and as I held the frame I was in tears, but next morning I got up and began physio, although I wasn't able to wear either shoes or slippers after gaining 4st in fluid due to toxic shock.

"I started to eat shortly after and nobody could believe it. I was discharged on May 15."

Today she feels indebted to her family and the staff at 10 North in Belfast City Hospital for their amazing care.

"I would also like to say a special thank-you to all my cousins and close friends for their love and support throughout my journey," she says. "My sister flew home from the US to be with me for the second round of treatment but my close friends, cousins and aunt Bernadette were with me the whole time."

And after everything she has been through, she is hoping to give something back by calling on people to support Cancer Research UK's Race for Life at Home event.

Last year Race for Life participants in Northern Ireland raised 98,646 to support vital research to develop gentler and more effective treatments for cancer.

Many of the scientists and researchers funded by Cancer Research UK are currently being redeployed to help in the fight against Covid-19, including assisting with testing.

By helping to beat coronavirus, the charity can lessen the impact it is having on the care of cancer patients.

Jean Walsh, Cancer Research UK's spokesperson for Northern Ireland, said: "At a time when it feels like everything is at a standstill, there is one thing that hasn't stopped - cancer.

"Our priority as a charity is ensuring that people affected by cancer are getting the support they need right now.

"But we are already getting people asking about doing Race for Life at Home because they don't want to see the charity lose out on vital funding. It's truly humbling to see the response.

"So, from their homes, we'd love for supporters to join us and Race for Life at Home in these challenging times. From a run or 5K walk around the garden to limbo in the living room, there is no wrong way to Race for Life at Home.

"With no entry fee, people might choose to twerk, limbo, star jump, squat, skip, dance, or come up with their own novel way of taking part and share it with friends. The message is very much that 'while we might be apart, we're doing this together'. There is no wrong way to get involved and join our community."

You can visit raceforlife.org and sign up free for ideas on how to create your own Race for Life at Home challenge.

And the Cancer Research UK Race for Life Facebook page will help people feel energised with weekly live workout sessions.

Organisers are also inviting participants to join the Race for Life at Home community by sharing photos and videos on social media using the hashtag #RaceForLifeAtHome.

Cancer Research UK was able to spend over 2m last year in Belfast on some of the UK's leading scientific and clinical research.

A new date for Race for Life Belfast has been set for Wednesday, October 7.

Participants who have already signed up for a Race for Life event which is now postponed will be contacted directly by the charity. Participants will be transferred to the new date but if they can't make it there is the option to request a refund or donate the entry fee to help fund cancer research.

Visit raceforlife.org or call 0300 123 0770. Join in and share with #RaceForLifeAtHome

Belfast Telegraph

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Co Armagh mum diagnosed with leukaemia and told that she had just 16 hours to live now inspiring people to sign up and do the Race for Life at Home in...

GlobalStem Cell Therapy Market, delivering a must-read report for industry stakeholders wanting to understand the strategic landscape of this burgeoning sector. Readers will find an in-depth analysis of the market and how it will impact existing traditional markets, as well as insights into future development and opportunities across the globe.

MarketInsightsReports has announced the addition of the Global Stem Cell Therapy Market Research Report 2020 The report focuses on global major leading players with information such as company profiles, product picture and specification.

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Key Players:

Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed, Takeda (TiGenix), request free sample for complete list of companies.

The leading players of industry, their market share, product portfolio, company profiles are covered in this report. The competitive market scenario among players will help the industry aspirants in planning their strategies.

Summary

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use.

In the last several years, global stem cell therapy market developed fast at a average growth rate of 46.81%.

Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost 100 countries around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Stem Cell Therapy market in 2020.

COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.

The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.This report also analyses the impact of Coronavirus COVID-19 on the Stem Cell Therapy industry.

Stem Cell Therapy Market Segmentation by types, Applications and regions:

Market Segment by Type covers:

Autologous

Allogeneic

Market Segmented by Applications:

Musculoskeletal Disorder

Wounds & Injuries

Cornea

Cardiovascular Diseases

Others

Market Segment by Regions:

North America (the United States, Canada, and Mexico)Europe (Germany, France, UK, Russia, and Italy)Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)South America (Brazil, Argentina, Colombia, etc.)

Available [emailprotected] (Exclusive new year offer Flat 20%- Use code MIR 20):

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These segments are thoroughly evaluated on an individual basis and a team of analysts has ensured to give a crystal clear idea about various lucrative segments of the industry. This detailed analysis using segmentation by providing precise results on industry-related markets.

The report also analyzed the evolution of industry trends. Several macroeconomic factors such as Gross domestic product (GDP) and the increasing inflation rate is expected to affect directly or indirectly in the development of the industry.

Frequently Asked Questions about global market:

Customization of the Report:This report can be customized as per your needs for additional data up to 3 companies or 3 countries or nearly 40 analyst hours.

Note:

All the reports that we list have been tracking the impact of COVID-19 the market. Both upstream and downstream of the entire supplychain has been accounted for while doing this. Also, where possible, we will provide an additional COVID-19 update supplement/report to the report in Q3, please check for with the sales team.

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Stem Cell Therapy Market Revenue, Demands and Gross Margin, Forecasts to 2026 (Based on 2020 COVID-19 Worldwide Spread) - Jewish Life News

Central to a lot of scientific research into aging are tiny caps on the ends of our chromosomes called telomeres. These protective sequences of DNA grow a little shorter each time a cell divides, but by intervening in this process, researchers hope to one day regulate the process of aging and the ill health effects it can bring. A Harvard team is now offering an exciting pathway forward, discovering a set of small molecules capable of restoring telomere length in mice.

Telomeres can be thought of like the plastic tips on the end of our shoelaces, preventing the fraying of the DNA code of the genome and playing an important part in a healthy aging process. But each time a cell divides, they grow a little shorter. This sequence repeats over and over until the cell can no longer divide and dies.

This process is linked to aging and disease, including a rare genetic disease called dyskeratosis congenita (DC). This is caused by the premature aging of cells and is where the Harvard University team focused its attention, hoping to offer alternatives to the current treatment that involves high-risk bone marrow transplants and which offers limited benefits.

One of the ways dyskeratosis congenita comes about is through genetic mutations that disrupt an enzyme called telomerase, which is key to maintaining the structural integrity of the telomere caps. For this reason, researchers have been working to target telomerase for decades, in hopes of finding ways to slow or even reverse the effects of aging and diseases like dyskeratosis congenita.

Once human telomerase was identified, there were lots of biotech startups, lots of investment, says Boston Childrens Hospital's Suneet Agarwal, senior investigator on the new study. But it didnt pan out. There are no drugs on the market, and companies have come and gone.

Agarwal has been studying the biology of telomerase for the past decade, and back in 2015 he and his team discovered a gene called PARN that plays a role in the action of the telomerase enzyme. This gene normally processes and stabilizes an important component of telomerase called TERC, but when it mutates, it results in less of the enzyme being produced and, in turn, the telomeres becoming shortened prematurely.

For the new study, Harvard researchers screened more than 100,000 known chemicals in search of compounds that could preserve healthy function of PARN. This led them to small handful that seemed capable of doing so by inhibiting an enzyme called PAPD5, which serves to unravel PARN and destabilize TERC.

We thought if we targeted PAPD5, we could protect TERC and restore the proper balance of telomerase, says Harvard Medical Schools Neha Nagpal, first author on the new paper.

These chemicals were tested on stem cells in the lab, made from the cells of patients with dyskeratosis congenita. These compounds boosted TERC levels in those stem cells and restored telomeres to their normal length. However, rather than a scattergun approach, the team really wanted to test for safety and see if the treatment could precisely target stem cells carrying the right ingredients for telomerase formation.

More specifically, the team wanted to see if this could be achieved by having the PAPD5-inhibiting drugs recognize and respond to another important component of telomerase, a molecule called TERT. To do so, in the next round of experiments the team used human blood stem cells and triggered mutations in the PARN gene that give rise to dyskeratosis congenita. These were then implanted into mice that were treated with the compounds, with the team finding the treatment boosted TERC, restored telomere length in the stem cells and had no ill effects on the rodents.

This provided the hope that this could become a clinical treatment, says Nagpal.

The team will now continue its work in an effort to prove these small molecules are a safe and effective way to apply the brakes to dyskeratosis congenita, other diseases, and possibly aging more broadly.

We envision these to be a new class of oral medicines that target stem cells throughout the body, Agarwal says. We expect restoring telomeres in stem cells will increase tissue regenerative capacity in the blood, lungs, and other organs affected in DC and other diseases.

The research was published in the journal Cell Stem Cell.

Source: Boston Childrens Hospital via Harvard University

See the original post here:
Molecules identified that reverse cellular aging process - New Atlas

Doctors are hoping stem cell therapy could be a weapon in the fight against coronavirus. On Friday, regenerative medicine company Mesoblast announced a 300-person trial to determine whether stem cell treatments will work in COVID-19 patients suffering from severe lung inflammation.

One hospital in New York tried it as an experiment with 12 patients, 10 of whom were able to come off of ventilators.

"What we saw in the very first patient was that within four hours of getting the cells, a lot of her parameters started to get better," Dr. Karen Osman, who led the team at Mount Sinai, told CBS News' Adriana Diaz.

The doctor said she was encouraged by the results, though she was hesitant to link the stem cell procedure to her patients' recovery.

"We don't know" if the 10 people removed from ventilators would not have gotten had they not gotten the stem cells, she said. "And we would never dare to claim that it was related to the cells."

She explained that only a "randomized controlled trial" would be the only way "to make a true comparison."

Luis Naranjo, a 60-year-old COVID-19 survivor, was one of Mount Sinai's stem cell trial success stories. He told Diaz in Spanish that he was feeling "much better."

Naranjo's daughter, Paola, brought him to the emergency room, fearful she would not see her father again. Like so many families struck by the coronavirus, she was not allowed inside with him.

"I forgot to tell him that I love him," she said. "All I said was go inside, I hope you feel better."

During his hospital stay, Naranjo was unconscious and on a ventilator for 14 days.

Doctors proposed giving him stem cells from bone marrow in hopes it would suppress the severe lung inflammation caused by the virus.

Now, Naranjo credits the doctors who treated him for his survival. Though income from his family's jewelry business has been cut off and they found themselves falling behind on rent, Naranjo said he is focused primarily on his recovery and regaining the 25 pounds he lost at the hospital.

Although stem cell treatment, usually reserved for other diseases like rheumatoid arthritis, might end up being another step toward helping coronavirus patients recover, Dr. Osman was quick to say it would not be a "miracle treatment."

"The miracle treatment will be a vaccine," she said.

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Coronavirus Doctors experiment with stem cell therapy on COVID-19 patients CBS News 9:39 AM - KTVQ Billings News

I dont know why people pay attention only to vaccines and treatments against the new coronavirus. Stem cell therapies are more useful to treat Covid-19.

So claimed Lee Hee-young, president of the Korean Association of Stemcell Therapy, at a news conference in Seoul, Monday. He called for active use of stem cell therapies to treat Covid-19 patients.

Several studies have proved the effects of autologous stem cells in treating acute respiratory distress syndrome (ARDS), which is the leading cause of death in Covid-19 patients, Lee said. The concept of stem cell therapy is the same as that of blood transfusion or bone marrow transplantation. Decades of cell therapies have proved that stem cell therapy is safe.

While the development of a treatment or a vaccine against Covid-19 takes a long time and it may not be able to treat patients immediately because of virus mutation possibilities, stem cell therapies can restore damaged lungs directly, Lee claimed.

It is more important to restore damaged lungs than to fight the virus. Stem cell therapy restores the lungs, giving patients time to beat the virus, he went on to say. However, people are paying attention to vaccine or treatment candidates only. This is why I am holding a news conference.

Lee pointed out that the local environment makes it difficult to use stem cell therapies. Thus, the government should ease regulations on the management and use of cell culture facilities so that doctors can perform stem cell therapies with simple cell culture, he said.

As long as physicians have a positive pressure facility and a culture kit, they can separate and culture cells with simple training, he said. If the authorities allow doctors to perform stem cell therapies with a disposable mobile culture autonomously, the cost of stem cell therapies will go down significantly.

Lee added that he asked related officials to include such rules in the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, which is to take effect in the second half of the year.

same@docdocdoc.co.kr

< Korea Biomedical Review, All rights reserved.>

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'Stem cell therapy more effective on Covid-19' - Korea Biomedical Review - Korea Biomedical Review

In some patients, COVID-19 has triggered a cytokine storm, an immune system response in which the body attacks its own cells. Jung painted a picture of a boxing match in which "fighter" immune cells are being called upon to battle the virus. This battle generates lots of fluid, waste and pus, making it difficult for the alveoli to pick up the oxygen a person breathes in, leading to multi-organ failure.

"These immune cells, neutrophils and other fighter immune cells, are like that. They don't care if it's a virus or our own cells. If you're infected, they're all enemies," Jung said. "So what they're going to do is they're going to start to kill everybody, basically."

Why exactly some people's immune systems go into overdrive, Jung said, is unknown, but he said it can happen to anybody.

"If we are up to the level where we can fight well without going into a coma or anything, then 14 days later, our body can provide an antibody," Jung said. "An antibody will neutralize this virus very quietly."

Strengthening the immune system

Eating certain foods can help keep your immune cells strong. Jung said vegetables, for example, stimulate the circulation of blood cells from bone marrow.

"Those bioactive reagents can support our immune systems by sending them the appropriate amount of stem cells, just in case some tissue cells are damaged and we need to replenish them. For example, if your lung cell has been damaged and they need to be replaced, that could be done by the stem cell that has been moved from the bone marrow and located around the lung area," said Jung, who encourages eating a variety of different colored vegetables.

Read the original post:
BCU biology professor offers tips to prevent COVID-19 infection - Sioux City Journal

Mount Sinai Health System announced that they will be using remestemcel-L (Ryoncil), an innovative allogeneic stem cell therapy, in patients with coronavirus disease 2019 (COVID-19).

Additionally, Mount Sinai indicated that they will play a central role in a clinical trial for patients with severe acute respiratory distress syndrome, which affects individuals with severe cases of COVID-19.

Remestemcel-L has previously been tested in patients who have had a bone marrow transplant, who can experience an overactive immune response similar to that observed in severe cases of COVID-19.

Mount Sinai began administering remestemcel-L to patients in late March under the FDAs compassionate use program. The therapy was given to 10 patients with moderate to severe cases of COVID-19-related acute respiratory distress syndrome (ARDS), most of whom were on ventilators, and the doctors saw encouraging results.

We are encouraged by what we have seen so far and look forward to participating in the randomized controlled trial starting soon that would better indicate whether this is an effective therapy for patients in severe respiratory distress from COVID-19, Keren Osman, MD, medical director of the Cellular Therapy Service in the Bone Marrow and Stem Cell Transplantation Program at The Tisch Cancer Institute at Mount Sinai and associate professor of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai, said in a press release.

The randomized clinical trial evaluating the therapeutic benefit and safety of remestemcel-L will be conducted at Mount Sinai, which will serve as the clinical and data coordinating center. The stem cell therapy will be evaluated in 240 patients with COVID-19-related ARDS in the US and Canada. Moreover, the trial will be conducted as a public-private partnership between the Cardiothoracic Surgical Trials Network.

The coronavirus pandemic has caused exponential increases of people suffering with acute respiratory distress syndrome, requiring intubation and mechanical ventilation with many dying, Annetine Gelijns, PhD, the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai, said in a press release. We have designed a clinical trial that will expeditiously determine whether the stem cell therapy will offer a life-saving therapy for a group of patients with a dismal prognosis.

Remestemcel-L consists of mesenchymal stem cells. The therapy was previously assessed in a phase III trial in children who had graft-versus-host disease (GVHD), which can occur after bone marrow transplants. Further, the inflammation that occurs in GVHD is the result of a cytokine storm. A similar cytokine storm has been found to take place in patients with COVID-19 who develop acute respiratory distress syndrome.

These stem cells have shown excellent response rates in severe graft-versus-host disease in children, John Levine, MD, professor of Hematology, Medical Oncology, and Pediatrics at the Icahn School of Medicine at Mount Sinai, who is also the co-director of the Mount Sinai Acute GVHD International Consortium (MAGIC), said in a press release. Mesenchymal stem cells have a natural property that dampens excessive immune responses.

Some institutions have also begun testing anti-IL-6 agents, such as tocilizumab (Actemra), for the treatment of cytokine release syndrome in patients with COVID-19 who develop acute respiratory distress syndrome.

Reference:

Mount Sinai Leading the Way in Innovative Stem Cell Therapy for COVID-19 Patients [news release]. New York, NY. Published April 9, 2020. newswise.com/coronavirus/mount-sinai-leading-the-way-in-innovative-stem-cell-therapy-for-covid-19-patients/?article_id=729684&sc=dwhr&xy=10019792. Accessed April 15, 2020.

Read the rest here:
Planned Clinical Trial of Allogeneic Stem Cell Therapy Remestemcel-L in Patients with COVID-19 - Cancer Network

Alumni members of National Institute of Technology - Tiruchi (NIT-T) holding key positions in tech companies across the globe have responded overwhelmingly through their knowledge support, innovative devices, fund mobilisation, and production of personal protection equipment for dealing with the COVID-19 pandemic.

An associate of Global Consortium of Cell Therapy Companies, Stempeutics, an Indian stem cell company of which B. N Manohar, an alumnus of ECE 1977 batch is the Chief Executive Officer, will shortly be supplying clinical-grade Mesenchymal Stem Cells (multi-potent stem cells found in the bone marrow used for making and repairing skeletal tissues) to those in need. Manufactured in the Manipal GMP facility under approval of Drug Controller General of India, the multi-potent stem cells have been found to reduce the symptoms of pneumonia induced by COVID-19 and halt its advancement to Acute Respiratory Distress Syndrome, NIT-T Director Mini Shaji Thomas said.

S. K. Ramesh, an alumnus of 1981 batch ECE holding a senior position in California State University, Northridge, is involved along with his colleagues in creation of life saving face shields and other personal protection equipment for donating the same to healthcare workers in hospitals throughout Southern California.

Blooom Energy, founded by K. R. Sridhar, who had completed his mechanical engineering degree from the then Regional Engineering College Tiruchi, and subsequently did his masters degree in Nuclear Engineering, and Ph.D. in Mechanical Engineering from the University of Illinois, Urbana-Champaign, has undertaken the task of repairing ventilators on a bulk scale in partnership with Stanford Health Care.

Chief Innovation Officer at Dulso, United Arab Emirates, Madhumohan Sreeram, an alumnus of NIT-T who had completed B.Tech in Chemical Engineering in 1982, has been in the forefront in carrying out sanitisation of the municipality of Dubai after identifying a suitable disinfectant QUATPLUS TB, which is a Quaternary Ammonium Compound product approved by United States Environmental Protection Agency and American chemistry councils Center Biocide Chemistry (CBC) and has been listed in their recommended EPA pre-approved products for COVID-9 disinfection application.

Richard Sekar, an alumnus who had completed Production Engineering in 1983 leads Warriors Against Virus a team of 371 volunteers in the Bay Area, USA, for stitching facial masks for hospital requirement. IcarusNova, of which Sapna Behar, an alumna (1990, EEE), is the Director and Founder, has partnered with LifeSignals to design a wireless biosensor-based patch, with ISO 13485 accreditation, for early detection and continuous monitoring of COVID-19 symptoms. The patches when affixed on the chest area can monitor the temperature, breathing rate, trace ECG and heart rate as a real time data. The data can be transferred to the users phone through an app. The system reduces the risk of contamination between patients and other individuals.

Admiral Superintendent of Naval Dockyard, Vishakapatnam, Sreekumar Nair (ECE, 1986), has led a team to design an innovative portable multi-feed oxygen manifold using a six-way radial header fitted to a single cylinder. This becomes essential when the existing hospital facilities for critical care management becomes limited and a need arises for catering to multiple patients. Rapid trials have been done at Naval Hospital INHS Kalyani. The entire assembly could be set up within 30 minutes.

Appreciating the efforts of the alumni members, Prof. Mini Shaji Thomas said the various contributions in diverse sectors was a matter of pride.

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Robust response by NIT-T alumni to tackle Covid-19 pandemic - The Hindu

SILVER SPRING, Md., April 22, 2020 /PRNewswire/ --Today, the U.S. Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body. Patients must have received at least two prior therapies before taking Trodelvy.

"Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. "There is intense interest in finding new medications to help treat metastatic triple-negative breast cancer. Today's approval provides patients who've already tried two prior therapies with a new option."

Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, meaning that the drug targets the Trop-2 receptor that helps the cancer grow, divide and spread, and is linked to topoisomerase inhibitor, which is a chemical compound that is toxic to cancer cells. Approximately two of every 10 breast cancer diagnoses worldwide are triple-negative. Triple-negative breast cancer is a type of breast cancer that tests negative for estrogen receptors, progesterone receptors and human epidermal growth factor receptor 2(HER2) protein. Therefore, triple-negative breast cancer does not respond to hormonal therapy medicines or medicines that target HER2.

"As part of FDA's ongoing and aggressive commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease," said Pazdur. "At this critical time, we continue to expedite oncology product development. This application was approved more than a month ahead of the FDA goal date an example of that commitment. Our staff is continuing to meet with drug developers, academic investigators, and patient advocates to push forward the coordinated review of treatments for cancer."

The FDA approved Trodelvy based on the results of a clinical trial of 108 patients with metastatic triple-negative breast cancer who had received at least two prior treatments for metastatic disease. The efficacy of Trodelvy was based on the overall response rate (ORR) which reflects the percentage of patients that had a certain amount of tumor shrinkage. The ORR was 33.3%, with a median duration of response of 7.7 months. Of the patients with a response to Trodelvy, 55.6% maintained their response for 6 or more months and 16.7% maintained their response for 12 or more months.

The prescribing information for Trodelvy includes a Boxed Warning to advise health care professionals and patients about the risk of severe neutropenia (abnormally low levels of white blood cells) and severe diarrhea. Health care professionals should monitor patient's blood cell counts periodically during treatment with Trodelvy and consider treatment with a type of therapy called granulocyte-colony stimulating factor (G-CSF), which stimulates the bone marrow to produce white blood cells called granulocytes and stem cells and releases them into the bloodstream, to help prevent infection, and should initiate anti-infective treatment in patients with febrile neutropenia (development of fever when white blood cell are abnormally low).

Additionally, health care professionals should monitor patients with diarrhea and give fluid, electrolytes, and supportive care medications, as needed. Trodelvy may need to be withheld, dose reduced or permanently discontinued for neutropenia or diarrhea. Trodelvy can cause hypersensitivy reactions including severe anaphylactic (allergic) reactions. Patients should be monitored for infusion-related reactions and health care professionals should discontinue Trodelvy if severe or life-threatening reactions occur. If patients experience nausea or vomiting while taking Trodelvy, health care professionals should use antiemetic preventive treatment, to prevent nausea and vomitting. Patients with reduced uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) activity are at increased risk for neutropenia following initiation of Trodelvy treatment.

The most common side effects for patients taking Trodelvy were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia (hair loss), constipation, decreased appetite, rash and abdominal pain.

Women who are pregnant should not take Trodelvy because it may cause harm to a developing fetus or newborn baby. The FDA advises health care professionals to inform females of reproductive age to use effective contraception during treatment with Trodelvy and for 6 months after the last dose. Male patients with female partners of reproductive potential should also use effective contraception during treatment with Trodelvy and for three months after the last dose.

Trodelvy was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Trodelvy's clinical benefit.

The FDA granted this application Priority Review andBreakthrough Therapydesignation, which expedites the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Trodelvy was also granted Fast Trackdesignation, which expedites the review of drugs to treat serious conditions and fill an unmet medical need.

The FDA granted approval of Trodelvy to Immunomedics, Inc.

Additional Resources:

Media Contact:Nathan Arnold, 301-796-6248Consumer Inquiries: Emailor 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Here is the original post:
FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments - Herald-Mail Media

WILMINGTON, Del.(BUSINESS WIRE)Incyte (Nasdaq:INCY) today announced that data from the Phase 3 REACH2 study have been published in The New England Journal of Medicine demonstrating that ruxolitinib (Jakafi) improves outcomes across a range of efficacy measures in patients with steroid-refractory acute graft-versus-host disease (GVHD) compared to best available therapy (BAT). The results of REACH2, the first Phase 3 study of ruxolitinib in acute GVHD to have met its primary endpoint, reinforce findings from the previously-reported Phase 2 REACH1 study.

In REACH2, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) vs. BAT (62% vs. 39%; p<0.001) at Day 28, the primary endpoint of the study. For the key secondary endpoints, patients treated with ruxolitinib maintained significantly higher durable ORR (40% vs. 22%; p<0.001) at Day 56. In addition, ruxolitinib was associated with longer median failure free survival (FFS) than BAT (5.0 months vs. 1.0 months; hazard ratio 0.46, 95% CI, 0.35 to 0.60) and showed a positive trend with other secondary endpoints, including duration of response1,2.

No new safety signals were observed, and the ruxolitinib safety profile in REACH2 was consistent with that seen in previously reported studies in steroid-refractory acute GVHD. The most frequently reported adverse events among study participants were thrombocytopenia and anemia. While 38% and 9% of patients required ruxolitinib and BAT dose modifications, the number of patients who discontinued treatment due to AEs was low (11% and 5%, respectively)1,2.

The results from the REACH2 study reinforce findings from the pivotal REACH1 trial and demonstrate the potential that ruxolitinib has to effectively and safely improve outcomes for patients with GVHD, said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. We are committed to continuing our research in GVHD with the goal of providing more effective treatment options for patients living with this disease, and look forward to the results of the REACH3 study in steroid-refractory chronic GVHD later this year.

The REACH2 data were also accepted as an oral presentation as part of the Presidential Symposium at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting to be held 30 August to 2 September in Madrid, Spain.

Patients with acute graft-versus-host disease face life-threatening challenges with limited treatment options, particularly for the nearly half of individuals who do not respond to initial steroid therapy, said Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany. These new data from REACH2 showing superiority of ruxolitinib over current standard-of-care therapies add to a growing body of evidence on how targeting the JAK pathway can be an effective strategy in this difficult-to-treat condition.

In 2019, Jakafi (ruxolitinib) was approved by the U.S. Food and Drug Administration for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older, based on the positive results of the Phase 2 REACH1 trial6. The Phase 3 REACH3 study in patients with steroid-refractory chronic GVHD is ongoing and results are expected in the second half of this year. Jakafi is marketed by Incyte in the U.S.; ruxolitinib (Jakavi) is licensed to Novartis ex-U.S.

The NEJM publication of the REACH2 results is available online.

About REACH2

REACH2 (NCT02913261), a randomized, open-label, multicenter Phase 3 study sponsored by Novartis and conducted in collaboration with and co-funded by Incyte , is evaluating the safety and efficacy of ruxolitinib compared with best available therapy in patients with steroid-refractory acute GVHD.

The primary endpoint was overall response rate (ORR) at Day 28, defined as the proportion of patients demonstrating a best overall response (complete response or partial response). Secondary endpoints include durable ORR at Day 56, ORR at Day 14, duration of response, overall survival and event-free survival, among others. For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT02913261.

About REACH

The REACH clinical trial program evaluating ruxolitinib in patients with steroid-refractory GVHD, includes the randomized pivotal Phase 3 REACH2 and REACH3 trials, conducted in collaboration with Novartis. The ongoing REACH3 trial is evaluating patients with steroid-refractory chronic GVHD with results expected later this year. For more information about the REACH3 study, please visit https://clinicaltrials.gov/ct2/show/NCT03112603.

The REACH program was initiated with the Incyte-sponsored REACH1 trial, a prospective, open-label, single-cohort, multicenter, pivotal Phase 2 trial (NCT02953678) evaluating Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD. For more information about the study, including trial results, please visit https://clinicaltrials.gov/show/NCT02953678.

About Jakafi (ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: for certain types of MF and PV low platelet or low red blood cell counts, bruising, dizziness, headache, and diarrhea; and for acute GVHD low platelet, red or white blood cell counts, infections, and fluid retention.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have a high level of fat in your blood (high blood cholesterol or triglycerides), had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider.

Women should not take Jakafi while pregnant or planning to become pregnant. Do not breast-feed during treatment with Jakafi and for 2 weeks after the final dose.

Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at http://www.jakafi.com.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements about the REACH2 data, when results from the REACH3 study will be available, the effect of the REACH2 results on patients with GVHD, and the overall REACH program, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Companys current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Companys dependence on its relationships with its collaboration partners; the efficacy or safety of the Companys products and the products of the Companys collaboration partners; the acceptance of the Companys products and the products of the Companys collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Companys reports filed with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019. The Company disclaims any intent or obligation to update these forward-looking statements.

References

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Pivotal REACH2 Study Data Published in NEJM Highlight Superior Efficacy of Ruxolitinib versus Best Available Therapy in Patients with Acute GVHD -...

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The benefits of Stem cells therapy vary, some of the benefits of stem cells are because of their potential in the treatment of medical conditions, but it is not the only way they can be utilized. A few of the benefits are as follows: To know what is a Stem Cell Therapy.

Medically, stem cells are used in therapies to treat certain diseases and conditions, many treatments require a transplant of organs and tissues but the organs and tissues are donated and the waiting list for donation is quite long. People stay on the transplant lists for years and many dont live to see their name move up the list or are not viable to receive donor organs or tissues, and in such cases stem cells can provide an effective and faster and better alternative in some diseases. The most popular form of stem cell therapy is the bone marrow transplant, and many others are considered safe in treatments of conditions and diseases like:

There are many other stem cell therapies but not all of them have been approved as safe and effective. But like in the case of a burn victim, the replacement of the burned area with stem cells can be utilized to make new tissues and save the trouble of finding a tissue donor. It is a very painful experience and everything that can be done should be done to lessen the pain and start the healing process quickly for the sake of the patient.

Research done on animals like dogs and horses and cats showed us that this form of research not only advances the development of stem cell therapies and treatments; for the benefit of veterinary medicine, but also resulted to be very beneficial for human treatments as well.

Animals that have diseases that nearly mimic the ones humans have as well are used as ideal models to experiment the development of stem cell therapies in medical conditions that humans and animals both have, like ligament injuries or stroke etc.

Diseases like cancer and conditions like birth defects are quite common these days so, many clinical and experimental trials are popping up to better fight these diseases. Scientists are now looking for ways that they can use to come up with stem cell treatments to better develop the human body when it is suffering from conditions like birth defects.

They are trying to study how the stem cells transform or separate into a wide range of specialized cells so that they can be utilize them in the treatment of certain diseases and conditions.

Stem cells have a huge potential in the testing of drugs as they are relatively safe and dont put anyone in harms way, drugs are now first tested on stem cells and then on animals and humans if the test on stem cells goes well.

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The success of approved stem cell therapies has caused a surge in interest of biopharma developers in this field; many innovator companies are currently progressing proprietary leads across different phases of clinical development, with cautious optimism

LONDON, March 4, 2020 /PRNewswire/ -- Roots Analysishas announced the addition of "Global Stem Cells Market: Focus on Clinical Therapies, 20202030 (Based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent))" report to its list of offerings.

There is a growing body of evidence supporting the vast applicability and superiority of treatment outcomes of stem cell therapies, compared to conventional treatment options. In fact, the unmet needs within this domain have spurred the establishment of many start-ups in recent years.

To order this 500+ page report, which features 185+ figures and 220+ tables, please visit this link

Key Market Insights

Over 280 stem cell therapies are under development, most of which are allogeneic products

More than 50% of the pipeline candidates are in the mid to late phase trials (phase II and above), and allogenic therapies (majority of which are derived from the bone marrow) make up 65% of the pipeline.

70% of pipeline candidates are based on mesenchymal stem cells

It is worth highlighting that the abovementioned therapies are designed to treat musculoskeletal (22%), neurological (21%) and cardiovascular (15%) disorders. On the other hand, hematopoietic stem cell-based products are mostly being evaluated for the treatment of oncological disorders, primarily hematological malignancies.

Close to 85% stem cell therapy developers are based in North America and Asia-Pacific regions

Within these regions, the US, China, South Korea and Japan, have emerged as key R&D hubs for stem cell therapies. It is worth noting that majority of the initiatives in this domain are driven by small / mid-sized companies

Over 1,500 grants were awarded for stem cell research, since 2015

More than 45% of the total amount was awarded under the R01 mechanism (which supports research projects). The NCI, NHLBI, NICHD, NIDDK, NIGMS and OD emerged as key organizations that have offered financial support for time periods exceeding 25 years as well.

Outsourcing has become indispensable to R&D and manufacturing activity in this domain

Presently, more than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing services to cater to the unmet needs of therapy developers. Examples include (in alphabetical order) Bio Elpida, Cell and Gene Therapy Catapult, Cell Tech Pharmed, GenCure, KBI Biopharma, Lonza, MEDINET, Nikon CeLL innovation, Roslin Cell Therapies, WuXi Advanced Therapies and YposKesi.

North America and Asia-Pacific markets are anticipated to capture over 80% share by 2030

The stem cell therapies market is anticipated to witness an annualized growth rate of over 30% during the next decade. Interestingly, the market in China / broader Asia-Pacific region is anticipated to grow at a relatively faster rate.

To request a sample copy / brochure of this report, please visit this link

Key Questions Answered

The USD 8.5 billion (by 2030) financial opportunity within the stem cell therapies market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom stem cell therapies are currently considered to be a promising alternatives for the treatment of a myriad of disease indications, with the potential to overcome challenges associated with conventional treatment options. The report includes detailed transcripts of discussions held with the following experts:

The research covers brief profiles of several companies (including those listed below); each profile features an overview of the company, financial information (if available), stem cell therapy portfolio and an informed future outlook.

For additional details, please visit

https://www.rootsanalysis.com/reports/view_document/stem-cells-market/296.html email sales@rootsanalysis.com

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Contact:Gaurav Chaudhary+1(415)800-3415+44(122)391-1091Gaurav.Chaudhary@rootsanalysis.com

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SOURCE Roots Analysis

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With Over 280 Therapies Under Evaluation, the Stem Cell Therapy Market is Estimated to be Worth USD 8.5 Billion by 2030, Claims Roots Analysis - PR...

Sleep, diet, exercise, and stress: these are factors known to change a persons risk of developing numerous non-communicable diseases. Such lifestyle impacts on healthbeneficial or harmfulexert much of their influence via inflammation. About 10 years ago, Matthias Nahrendorf began wondering just how inflammation and lifestyle might be linked biologically, and started thinking about how to pinpoint the mechanism in the cardinal case of cardiovascular disease.

A persons level of inflammation can easily be measured with a simple white blood cell test. White blood cells fight off bacterial invasions and repair damaged tissues, but they can also damage healthy tissue when they become too abundant. You can find them in atherosclerotic plaques, and you can find them in acute infarcts, says Nahrendorf, a professor of radiology who conducts high-resolution imaging research at Massachusetts General Hospital. You can find them in failing hearts and the brain, where they increase the risk of stroke.

By linking exercise to reduced white blood cell production, Nahrendorf shows how a lifestyle factor can modulate cardiovascular risk.

When Nahrendorf learned that the most potent, toxic, and pro-inflammatory white blood cells live only a few hours, or at most a day, he immediately realized that the paramount questionsgiven that they die off quickly yet remain abundant in the bloodare, where and why are they produced? What is their source? Perhaps, he hypothesized, lifestyle factors regulate hematopoiesis (blood production).

To test this idea, he decided to study the effects of exercise on the production of these leukocytes in healthy mice. First, though, he consulted the scientific literature on exercise in mice. Previous researchers, he learned, had found that exercise increases production of inflammatory immune cellswhich I thought was counterintuitive, Nahrendorf recalls. When he looked more carefully, he discovered that the type of exercise used in the studies was forced and thus possibly stressful because it was induced by electric shocks. He therefore decided to test only voluntary exercise. He and his colleagues put a wheel in each mouses cage, so the animals could choose to run if they were interested.

The mice never ran during the day. That is when they rest, Nahrendorf explains. But in the dark, they ran a lot, averaging six to seven miles every night. After three weeks, the exercising mice had measurably lower levels of circulating white blood cells. Exercise, he found, had pushed their blood stem cells (cells that can produce all the different types of blood cells) into a state of quiescence: a kind of dormancy in which they generate fewer pro-inflammatory white blood cells and platelets, without decreasing the number of oxygen-carrying red blood cells. Soon the exercising mice had fewer circulating white blood cells than their sedentary counterparts, dampening inflammationan effect that persisted for weeks.

The local signals within bone marrow that induce quiescence in blood stem cells were already well known, but the fact that exercise could trigger them was not. Nahrendorf next wanted to learn the identity of the trigger linking exercise to blood stem cell quiescence. Further investigation revealed that the only receptors with enhanced activity in the bone marrow niche where most blood stem cells exist were binding to a well-known hormone called leptin; it is produced by fat cells and regulates hunger.

Leptin is like the fuel gauge in a car. When the tank is fullmeaning energy (and food) are abundantleptin levels run high. As exercise uses up the gas in the tank, this lowers leptin levels, which signal that reserves are running low, thereby inducing hunger and the urge to eat in order to replenish depleted energy stores. Nahrendorf and his co-authors speculate in their 2019 Nature Medicine paper that leptins role in regulating energetically costly hematopoiesis may have evolved to produce blood cells only when whole body energy was abundantnot when people are exerting themselves. Contemporary sedentary behavior, they continue, which increases leptin and consequently hematopoiesis, may have rendered this adaptation a risk factor for cardiovascular disease (CVD) and perhaps also for other diseases with inflammatory components.

But with fewer circulating immune cells, would exercising mice be more vulnerable to infection? Nahrendorf challenged them with a protocol designed to induce infection in the blood, and found just the opposite: exercising mice had a more robust immune response, as semi-dormant blood stem cells swiftly sprang into activity and produced infection-fighting leukocytes, improving survival of the active mice as compared to those with no running wheels in their cages. Next, they investigated whether exercise would help mice with established atherosclerosis, and found that exercise was not only protective, it also reduced the size of existing plaques in the aorta.

Whether these associations would hold up in humans remained an open question. For answers, Nahrendorf turned to a study known as CANTOS, which had measured levels of inflammation in 4,892 patients who suffered heart attacks (see Raw and Red Hot, May-June 2019, page 46). When he approached the studys co-authors, Mallinckrodt professor of medicine Peter Libby and Braunwald professor of medicine Paul Ridker, he learned, serendipitously, not only that they possessed self-reported exercise levels for the participants, but also that they had tested leptin levels as well. They analyzed their raw data and found the same relationship among exercise, leptin, and leukocytes as in the mice. Data from a second human study cemented the result.

By identifying a previously unknown molecular mechanism linking voluntary exercise to reduced white blood cell production, Nahrendorf and his colleagues have highlighted how a lifestyle factor can modulate cardiovascular risk. Their discovery, the researchers hope, will point the way to wider adoption of healthy exercise regimens, and health-enhancing anti-inflammatory drugs.

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Two-year-old Livia, the child of a Hong Kong mother and German father, is among patients in a London hospital as Britain grapples with a lockdown wrought by the coronavirus. But she is fighting a disease much rarer and even deadlier.

Livia was diagnosed in early March with acute myeloid leukaemia (AML). Because of the coronavirus pandemic, visits to her bedside have been restricted to reduce infection risks.

Only her father can stay with her. Her aunt and grandparents in Hong Kong cannot travel there for fear of exposing the child to more health risks.

Mother Olive Yu, who has been trying every means possible to save her daughter with access to donor registrations delayed during the lockdown told the Post in a phone interview: I still think that I'm in a really bad dream. I still find it very hard to accept that this is happening. Livia is everything to us because shes the only grandchild in the family, and our only child.

We need to be thinking about how we can help give her [as much time] as she can get

Olive Yu, mother

The family has called on those aged between 18 and 60 in Hong Kong to register as a bone marrow donor with the Hong Kong Bone Marrow Donor Registry, led by the Hong Kong Red Cross. The information is shared with the World Marrow Donor Association (WMDA), a global database of volunteer donors.

There are three options to save Livia, and the most ideal one is for a matching donor to be found and a bone marrow transplant to be conducted by June, according to Livias family.

Livias parents are appealing for bone marrow donors. Photo: Handout

Yu said: Everything takes time, especially now with the coronavirus. But the fact is, we are talking about the life of a two-year-old.

Everything is against us, but it doesn't mean that we should just stop and not do anything about it. So were going to try our best and do whatever we can to give her the best chance at life.

As of Wednesday, Britain had recorded more than 93,000 Covid-19 cases, with a death toll of over 12,000. Police enforced a lockdown on March 23, allowing people only to leave their homes for very limited purposes, such as for food and health reasons, and public gatherings of more than two people have been banned, while places such as restaurants, schools, pubs and gyms are closed.

In general, for bone marrow transplants, the donors human leucocyte antigens (HLA), proteins found on the surface of the blood and in tissue cells, must be closely matched so that the recipients body can accept the new stem cells into their bone marrow.

The second option is that the hospital also, at the same time, reaches out to stem cells from mothers who give birth and donate their umbilical cord, Yu added.

The third option is what they call a non-matching donor, which is either from the mother or father.

The blood samples of Livias parents are being analysed for matches, with results pending.

AML is a form of cancer involving the rapid growth of abnormal cells in the bone marrow and blood. This cancer type accounted for less than 1 per cent of all new cancer cases in Britain in 2017, and often occurs in adults, according to Cancer Research UK.

Livia, two, is now warded in a London hospital. Photo: Handout

A haematologist in Hong Kong, who spoke on condition of anonymity, said the incidence of cancer among children aged under 15 is around 1.2 per million. Fewer than 200 children are diagnosed with cancer in Hong Kong each year and about five out of the 200 have AML, according to him.

Story continues

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Coronavirus: We need bone marrow donors to save my baby girls life from leukaemia, Hong Kong mother of two-year-old pleads amid London lockdown -...

The "Orphan Drugs Market Global Report 2020-30" report has been added to ResearchAndMarkets.com's offering.

The global orphan drugs market was worth $132.61 billion in 2019. North America is expected to be the largest region during the period 2015-2023. Major players in the market are Bristol-Myers Squibb Company, Celgene Corporation, F. Hoffmann-La Roche, Amgen, Biogen, Bayer, Novartis, GlaxoSmithKline, Johnson & Johnson and AbbVie.

This report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography. It places the market within the context of the wider orphan drugs market, and compares it with other markets.

The rising prevalence of rare diseases is a key factor driving the growth of the orphan drugs market.

Orphan diseases or rare diseases occur rarely among the people (i.e. 7 out of 10,000). However, globally, the prevalence of rare diseases is increasing in recent years. In 2017, there were 7,000 identified rare diseases, including hemophilia, Gaucher disease, Hunter syndrome and many types of rare cancer. Some cases of aplastic anemia, caused by damage to stem cells in the bone marrow that are diagnosed in around 500 to 1,000 individuals in the USA each year, are inherited. Thus, the rising prevalence of rare diseases is driving the growth of the orphan drugs market.

Lack of supportive government policies hinders the orphan drugs market.

Due to the lack of relevant policies for orphan drug, certain drugs do not receive any special recognition or priorities for approval by regulatory authority. Medgenome Labs Ltd., global research partner in accelerating insights into complex genetic diseases, pointed out that companies manufacturing orphan drugs frequently drop out in foreign markets due to a lack of government funding. For example, orphan medical products (OMPs) in India, due to lack of proper regulations and clear guidelines, do not obtain tax cuts or exemptions from customs duties. Therefore, lack of supportive government policies limits the growth of the orphan drugs market.

Approval of biological orphan drugs for multiple indication act as a key trend driving the growth of the orphan drugs market.

The biological drugs are used for treating rare diseases such as cancer with fewer side effects that have a high prevalence rate in the developed world. For Instance, in 2018, in order to launch the company's biological orphan drug development program Cardax, Inc. announced that it has been engaged with biological orphan drug expert Frederick D. Sancilio, Ph.D. For the development of commercial products, the companies are focused on obtaining biological orphan drugs to increase their revenue.

In November 2019, Bristol-Myers Squibb, a biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines, acquired Celgene for an undisclosed amount. Through this acquisition, Celgene shareholders received for each share, 1 share of Bristol-Myers Squibb common stock, $50.00 in cash without interest and one tradeable Contingent Value Right (CVR), which will entitle the holder to receive a payment of $9.00 in cash if certain future regulatory milestones are achieved. Celgene, a biopharmaceutical company positioned to address the needs of the patients with serious diseases.

Key Topics Covered

1. Executive Summary

2. Orphan Drugs Market Characteristics

3. Orphan Drugs Market Size and Growth

3.1. Global Orphan Drugs Historic Market, 2015-2019, $ Billion

3.1.1. Drivers Of The Market

3.1.2. Restraints On The Market

3.2. Global Orphan Drugs Forecast Market, 2019-2023F, 2025F, 2030F, $ Billion

3.2.1. Drivers Of The Market

3.2.2. Restraints On the Market

4. Orphan Drugs Market Segmentation

4.1. Global Orphan Drugs Market, Segmentation By Therapy Area, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.2. Global Orphan Drugs Market, Segmentation By Distribution Channel, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

5. Orphan Drugs Market Regional and Country Analysis

5.1. Global Orphan Drugs Market, Split By Region, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Story continues

5.2. Global Orphan Drugs Market, Split By Country, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/vm9iey

View source version on businesswire.com: https://www.businesswire.com/news/home/20200417005515/en/

Contacts

ResearchAndMarkets.comLaura Wood, Senior Press Managerpress@researchandmarkets.com

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(CNN) Weve heard that elderly people and those with underlying health conditions are most at risk if theyre infected with coronavirus, but those can seem like really general terms. Who does that include? And why can they face more serious illness?

According to the [Centers for Disease Control and Prevention], some of the underlying conditions that may put you at higher risk include: chronic lung disease and asthma, heart disease and undergoing cancer treatment, said CNN Chief Medical Correspondent Dr. Sanjay Gupta in anepisode of CNNs Coronavirus: Fact vs. Fiction podcast. Anyone with diabetes, kidney failure or liver failure may also be at higher risk.

The role of the immune system is to protect against disease or other potentially damaging pathogens. A strong one is needed to help stave off coronavirus infection.

Think of it like this, Dr. Gupta suggested. In your everyday life, youre always fighting off pathogens. Most of the time you dont even realize it. If you have an underlying condition, it makes it more challenging to fight off a virus like this. You may develop a fever, shortness of breath or a cough more easily than someone who doesnt have a preexisting illness.

Additionally, there are more specific reasons why each condition has its own vulnerabilities. Heres a guide to underlying conditions affected by coronavirus and why, and how you can protect yourself or an at-risk loved one.

Eight out of 10 deaths reported in the US have been in adults ages 65 and older, according to theCDC. Older adults have also been more likely to require hospitalization and admission to an intensive care unit.

Older adults are more likely to have long-term health problems that can increase their risk for infection and serious disease. And, our immune systems usually weaken with age, making it more difficult for people to fight off infections, according toJohns Hopkins Medicine.

The quality of our lung tissue also declines over time, becoming more elastic and making respiratory diseases such as Covid-19 of important concern because of the potential for lung damage.

Inflammation in older adults can be more intense, leading to organ damage.

People with chronic airway and lung diseases such as chronic obstructive pulmonary disease (COPD), asthma, pulmonary fibrosis and interstitial lung disease can lay the foundations for more severe infection with coronavirus because of the inflammation, scarring and lung damage those conditions cause,Johns Hopkins Medicine reported.

Covid-19 affects a persons airway and lungs, but those organs work together to provide the body with oxygen. When the lungs are overburdened with an infection, the heart has to work harder, which exacerbates the challenges of people already living with heart disease.

According to the CDC, many conditions can cause a person to be immunocompromised, including cancer treatment, smoking, bone marrow or organ transplantation and immune deficiencies. Poorly controlled HIV or AIDS and prolonged use of man-made steroid hormones or otherimmune-weakening medicationscan also hamper a persons immune function.

Cancer can weaken immunity by spreading into the bone marrow, which makes blood cells that help fight infection, according toCancer Research UK. Cancer prevents bone marrow from making enough blood cells.

Some cancer treatments can temporarily weaken the immune system, too. Because cancer treatments such as chemotherapy, cancer drugs, radiotherapy or steroids are targeted toward cancer cells, they can also diminish the number of white blood cells created in the bone marrow.

A2017 studyfound cigarette smoking can harm the immune system by either causing extreme immune responses to pathogens or rendering the body less effective at fighting disease. This may occur by smoking, negatively altering the cellular and molecular mechanisms responsible for keeping an immune system strong.

When a person undergoes a bone marrow transplant using stem cells from a donor, or they receive an organ, a doctor may prescribe medications to prevent graft-versus-host disease andmitigate the immune systems reactionby suppressing its function. After the operation, it takes time for your immune system to be up and running again.

HIV and AIDS attack the bodys immune system, specifically the bodys T cells, which help the immune system fight off infection. When the diseases are untreated, HIV reduces the number of those cells, making the person more likely to contract other infections or infection-related cancer, according to theCDC.

People with severe obesity, or a body mass index of 40 or higher, are athigher risk of serious disease.

Obesity shares with most chronic diseases the presence of an inflammatory component, a2012 studysaid. Inflammatory responses were linked between the immune system and body fat. Obesity is known to impair immune function by altering white blood cell count as well as the cells that control immune responses.

People with type 1 or type 2 diabetes face an increased risk of getting really sick with Covid-19, as both cause a blood sugar spike. If blood sugar is poorly managed, viral diseases can be more dangerous as high blood sugar may give viruses a place to thrive, according toDiabetes in Control, a news and information resource for medical professionals.

Higherlevels of inflammationhave been discovered in the bodies of people with diabetes, weakening the immune system and making it more difficult for those affected to stave off sickness in general.

The kidneysproduce several hormonesthat affect immune responses. Having kidney disease and failure can weaken your immune system, making it easier for infections to take hold. According to theNational Kidney Foundation, doctors and researchers have found that most infections are worse in people with kidney disease.

The liver is an integral member of the bodysline of defense, helping to regulate the number of white blood cells utilized in immune responses and defend against harmful pathogens. Someone with liver disease is experiencing abnormalities in the function of the immune system, giving rise to more serious illness.

Neurological and neurodevelopmental conditions may also increase the risk of serious Covid-19 for people of any age.

These include disorders of the brain, spinal cord, peripheral nerve and muscle such as cerebral palsy, epilepsy, stroke and intellectual disability, according to theCDC. Those with moderate to severe developmental delay, muscular dystrophy or spinal cord injury are also more at-risk.

People with neurological conditions may not be more at risk due to solely their condition, but because medications they might take to control their condition could hamper their immune system. However, some neurological conditions, such as Parkinsons, have been recognized to haveinflammatory components, which may harm the immune system.

Others including muscular dystrophy, multiple sclerosis or amyotrophic lateral sclerosis (ALS) could cause paralysis to the diaphragm, which leaves those affected very at risk for respiratory failure if they were to be sick with Covid-19.

If you see yourself on the list of those at higher risk for severe illness, there are several things you can do to protect yourself. First, make sure you are contact your doctor or doctors about your risk level. Second, be extra vigilant about the recommendations that most people are being asked to follow.

Stay home whenever possible and avoid close contact with people, theCDC suggests. Wash your hands often to prevent transferring the virus from a surface to your face, and try to clean and disinfect frequently touched surfaces as often as you can.

If you dont have an underlying condition, doing your part by practicing these cautionary measures can help protect not only you, but your loved ones with existing conditions.

Click here for more coronavirus coverage.

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What exactly are underlying conditions? And why people with them may experience more serious illness from coronavirus - Boston News, Weather, Sports |...

In 1994, I thought the biggest challenge in life would be finding a balance between a career as a Senior Trial Partner at a big Dallas firm and raising three children. In 1999, it became clear that the real challenge in my life was much more ominous. I was diagnosed with Multiple Sclerosis. There was no explanation as to why I contracted this devastating disease, what symptoms I would develop, or how fast I would become disabled. Would I be confined to a wheelchair or a bed? Would I become blind or simply have double vision? Would I have pain or just tingling? Would I die? I already had bladder problems, but would I also face bowel dysfunction? Over 2.5 million people are afflicted with MS, so why hasnt anyone found a cure? How could drug companies justify charging over $60,000 a year for medicines that dont improve a patients condition?

For the next fifteen years, I managed the kids and the disease with relative success. I learned what a bladder spasm is and the true definition of the word urgency. I learned that my husband really meant it when he said in sickness and health. I learned that pain from MS included the pain associated with doing a face plant into a door, and spilling boiling water on my leg but being unable to remove my pants before suffering 2nd degree burns. I learned that there were a few advantages to having MS, including speeding through airport security lines because I was in a wheelchair, and always being able to find a parking space.

In 2014 I fell and broke my leg. I was in a wheelchair for 6 weeks. It became obvious that it was time to become more aggressive with treatments. After scouring the internet for every treatment for MS in the world, I identified Dr. Dimitrios Karussis at Hadassah Medical Organization in Israel as my best hope. His approach was still experimental. He used the patients own stem cells, obtained through bone marrow extraction, grew the cells, and then infused the cells through a spinal tap.

After eight infusions the benefits of the treatment are unmistakable. Because I still walk with a walker, people realize that Im not cured. What they dont know is that I have my life back. Ive written three books, volunteer regularly at a hospital, travel around the country to raise awareness and financial support for the incredible work of Hadassah, the Womens Zionist Organization of America, Inc. (HWZOA) who operate Hadassah Hospital in Israel. I cook every week for my daughter in medical school. I have attended the graduation ceremonies of each of my three children from college, and I attended the wedding of my oldest son recently. This past year, we celebrated Thanksgiving at my house with 37 relatives.

Having MS has allowed me to stop sweating the small stuff. I have come to realize that what makes me happiest is making others happy. At the Dallas Childrens Hospital where I volunteer, my disability gives me the advantage of having an immediate connection to the kids. Making people smile is the best job at the hospital.

David Ben Gurion said: In Israel, in order to be a realist, you must believe in miracles.

I am a realist. I didnt simply wish to be cured of MS. I researched the possible options for treatment and used my best judgment to select one. Dr. Karussis is also a realist. Hes devoted over 30 years researching stem cell treatment of neurological diseases. He has published more than 120 peer reviewed scientific papers, given more than 150 lectures, served on editorial boards of major medical journals, was elected as the President of the Israeli Neuroimmunological Society and hosted an International Neurological Meeting. He has published the amazing results of the stem cell therapy he formulated for the treatment of MS and ALS.

I also believe in miracles. The miracle is that the people of Hadassah Hospital in Israel have given of their time, talent, and money to make this treatment possible and available to me. The miracle is that studies that I volunteered for twenty years ago in Dallas made me an attractive candidate for Dr. Karussis research. The miracle is that the Israeli Ministry of Health approved me to be treated in their Compassionate Care program. The miracle is that all MS patients can now have hope that an effective treatment is here and Hadassah Hospital is sharing it with the world.

VIDEO LINKS:

Watch MS patient Malia Litman dance at her sons wedding

Learn how MS patient Malia Litman got her life back

Learn more about Hadassah Medical Organization

Learn more about Dr. Dimitrios Karussis and his revolutionary stem cell treatment

CBS/Dallas News coverage of Malia Litmans MS treatment

Follow ushereand subscribeherefor all the latest news on how you can keep Thriving.

Stay up to date or catch-up on all our podcasts with Arianna Huffingtonhere.

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A Realist Who Believes in Miracles - Thrive Global

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You're my type: The donor lottery - RT

Would you like to be involved in cutting edge research to develop novel solutions for smart resorbable bone implants for controllable and fast bone restoration, and to testa new generation acellular scaffold with bone-like architecture? Are you interested in acquiring and/or developing your skills to develop new tissue engineering solutions for in vitro reprogramming of adult stem cells for embedding into the smart implant?

Applications are invited for a Postdoctoral Fellow position working with Prof Peter Giannoudis and Dr Elena Jones on the Horizion 2020project SBR Smart Resorbable Bone and a small industry funded project Greenbone. Based on the St. James Campus, you will co-ordinate projects related to several SBR Work Packages (WPs).

More specifically you will be working on the WPs 6 with the aims to:

You will also be responsible for delivering Greenbone project to assess the biological support that GreenBone scaffold can provide for MSCs and endothelial cells.

Reporting to Dr Jones, your work will be carried out in collaboration with consortium members based in Patras, Greece and Munich, Germany.

Capitalising on the infrastructure and samples collected through the Leeds Institute of Rheumatic and Musculoskeletal medicine based across St Jamess University Hospital and LGI, you will generate primary MSC cells to be used by other consortium partners. You will develop and validate assays to assess the behaviour of MSCs on electrospun biocompatible scaffolds, as well as optimise the MSCs uptake of several bioactive DDRs. In collaboration with partners in Greece and Germany, you will also develop and validate assays for the assessment of MSC functionality on bioactive implants. In Greenbone project, you will be testing the attachment and growth of human bone marrow cells onGreenBone scaffold, as well as the endothelial cell-MSC interactions on the scaffold surface.

The post holder will also liaise with the research group, specifically dedicated to this project, and based in the School of Chemical and Process Engineering, as required.

To explore the post further or for any enquiries you may have, please contact:

Dr Elena Jones, Associate Professor (Non-Clinical)

Tel: +44 (0)113 2065647; email:e.jones@leeds.ac.uk

OR

Professor Peter Giannoudis, Professor of Orthopaedic Surgery

Tel + 44 (0) 113 0113-20-67068; email:P.Giannoudis@leeds.ac.uk.

Further Information

The University of Leeds is committed to providing equal opportunities for all and offers a range offamily friendly policies. The University is a charter member of Athena SWAN and holds the Bronzeaward. The School of Medicine holds theGoldaward. We are committed to being an inclusive medical school that values all staff, and we are happy to consider job share applications and requests for flexible working arrangements from our employees.

Location:Leeds - St James University HospitalFaculty/Service:Faculty of Medicine & HealthSchool/Institute:Leeds Institute of Rheumatic & Musculoskeletal Medicine (LIRMM)Section:Section of Experimental RheumatologyCategory:ResearchGrade:Grade 7Salary:33,797 to 40,322 p.a.Working Time:100% FTEPost Type:Full TimeContractType:Fixed Term (Available immediately on a fixed term basis for 27 months or until 31 December 2023 (wichever is sooner))ClosingDate:Tuesday 21 April 2020Reference:MHLRM1130Downloads:CandidateBrief

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Horizon Research Fellow job with UNIVERSITY OF LEEDS | 203439 - Times Higher Education (THE)