Cellular Biomedicine Group Awarded $2.29 Million Grant from the California Institute for Regenerative Medicine (CIRM … – EconoTimes

Cellular Biomedicine Group Awarded $2.29 Million Grant from the California Institute for Regenerative Medicine (CIRM) to Fund AlloJoin Allogeneic Stem Cell Therapy for Knee Osteoarthritis (KOA) in the U.S.

SHANGHAI, China and CUPERTINO, Calif., Feb. 27, 2017 -- Cellular Biomedicine Group Inc. (NASDAQ:CBMG)(CBMG or the Company), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, announced today that the governing Board of the California Institute for Regenerative Medicine (CIRM), California's stem cell agency, has awarded the Company $2.29 million to support pre-clinical studies of AlloJoinTM, CBMGs Off-the-Shelf Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States.

While CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoinTM in Knee Osteoarthritis (KOA), this latest announcement represents CBMGs initial entrance into the United States for its off-the-shelf allogeneic stem cell candidate AlloJoinTM.

The $2.29 million was granted under the CIRM 2.0 program, a comprehensive collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs. After the award, CIRM will be a more active partner with its recipients to further increase the likelihood of clinical success and help advance a pre-clinical applicants research along a funding pipeline towards clinical trials. CBMGs KOA pre-clinical program is considered late-stage, and therefore it meets CIRM 2.0s intent to accelerate support for clinical stage development for identified candidates of stem cell treatments that demonstrate scientific excellence.

"We are deeply appreciative to CIRM for their support and validation of the therapeutic potential of our KOA therapy, said Tony (Bizuo) Liu, Chief Executive Officer of CBMG. We thank Dr. C. Thomas Vangsness, Jr., in the Department of Orthopaedic Surgery at the Keck School of Medicine of the University of Southern California and Dr. Qing Liu-Michael at the Broad Center for Regenerative Medicine and Stem Cell Research at USC, who helped significantly with the grant application process. The CIRM grant is the first step in bringing our allogeneic human adipose-derived mesenchymal stem cell treatment for knee osteoarthritis (AlloJoinTM) to the U.S. market.

Our AlloJoinTM program has previously undergone extensive manufacturing development and pre-clinical studies and is undergoing a Phase I clinical trial in China. In order to demonstrate comparability with cell banks previously produced in China for our U.S. IND filing, we are addressing the pre-clinical answers required for the FDA. With the funds provided by CIRM, we will replicate and validate the manufacturing process and control system at the cGMP facility located at Childrens Hospital Los Angeles to support the filing of an IND with the FDA. The outcome of this grant will enable us to have qualified final cell products ready to use in a Phase I clinical trial with Dr. Vangsness as the Principal Investigator and the Keck School of Medicine of USC as a trial site. Dr. Vangsness is familiar with both stem cell biology and KOA, and has led the only randomized double-blind human clinical study to investigate expanded allogeneic mesenchymal stem cells to date. Our endeavor in the U.S. market will further strengthen our commercialization pipeline.

CBMG recently announced promising interim 3-month safety data from its Phase I clinical trial in China for AlloJoinTM, its off-the-shelf allogeneic stem cell therapy for KOA. The trial is on schedule to be completed by the third quarter of 2017.

About CIRM

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and to act with a sense of urgency commensurate with that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today's most promising stem cell technologies.

With $3 billion in funding and over 280 active stem cell programs in our portfolio, CIRM is the world's largest institution dedicated to helping people by bringing the future of medicine closer to reality.

For more information, please visit http://www.cirm.ca.gov.

About Knee Osteoarthritis

According to the Foundation for the National Institutes of Health, there are 27 million Americans with Osteoarthritis (OA), and symptomatic Knee Osteoarthritis (KOA) occurs in 13% of persons aged 60 and older. The International Journal of Rheumatic Diseases, 2011 reports that approximately 57 million people in China suffer from KOA. Currently no treatment exists that can effectively preserve knee joint cartilage or slow the progression of KOA. Current common drug-based methods of management, including anti-inflammatory medications (NSAIDs), only relieve symptoms and carry the risk of side effects. Patients with KOA suffer from compromised mobility, leading to sedentary lifestyles; doubling the risk of cardiovascular diseases, diabetes, and obesity; and increasing the risk of all causes of mortality, colon cancer, high blood pressure, osteoporosis, lipid disorders, depression and anxiety. According to the Epidemiology of Rheumatic Disease (Silman AJ, Hochberg MC. Oxford Univ. Press, 1993:257), 53% of patients with KOA will eventually become disabled.

About Cellular Biomedicine Group (CBMG)

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMGs scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit http://www.cellbiomedgroup.com.

Forward-looking Statements

This press release contains forward-looking statementsincluding descriptions of plans, strategies, trends, specific activities, investments and other non-historical factsas defined by the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently uncertain, and actual results could differ materially from those anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy (including the devaluation of the RMB by China in August 2015), and other risks detailed in CBMGs reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," "continue" or similar terms or their negations. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

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Cellular Biomedicine Group Awarded $2.29 Million Grant from the California Institute for Regenerative Medicine (CIRM ... - EconoTimes

Gene therapy to fight a blood cancer succeeds in major study – Columbus Ledger-Enquirer


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Gene therapy to fight a blood cancer succeeds in major study - Columbus Ledger-Enquirer

Stem cell therapy can help in treating diabetic heart disease – Business Standard

Recent advancements in stem cells research have given hope for successfully treating diabetic heart disease (DHD), renowned New Zealand-based researcher in cardiovascular diseases Dr Rajesh Katare said today.

DHD affected the muscular tissues of the heart leading to complications and it had been demonstrated that resident stem cells of myocardium can be stimulated to repair and replace e degenerated cardiac myocytes resulting in a novel therapeutic effect and ultimately cardiac regeneration, he said.

Katare, Director of Cardiovascular Research Division in the University of Otago, New Zealand, was delivering the keynote address at the continuing medical education programme on "Role of Micro-RNAs and stem cells in cardiac regeneration in diabetic heart disease" at the Karaikal campus of premier health institute JIPMER.

Presenting clinical evidences, Katare said stem cell therapy certainly presented a new hope for successfully treating DHD.

Jawaharlal Institute of Post Graduate Medical Education (JIPMER) Director Dr Subash Chandra Parija pointed out that it was the first such programme on the role of stem cells in cardiac regeneration in the whole of the country.

He said as diabetes was highly prevalent in the country, providing treatment for DHD had become a big challenge. Patients suffering from the condition have to undergo lifelong treatment and medications. "In this backdrop, advancements in stem cell therapy assume significance," he said.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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Stem cell therapy can help in treating diabetic heart disease - Business Standard

All eyes on Garrett Richards, in hopes stem cells stave off Tommy … – USA TODAY

With MLB spring training underway, there's plenty to talk about. USA TODAY Sports

Garrett Richards is aiming to pitch through a ligament tear via stem cell therapy and other recovery methods.(Photo: Rick Scuteri, USA TODAY Sports)

TEMPE, Ariz. Garrett Richards first thought when he found out about his torn elbow ligament last May was to schedule Tommy John surgery as soon as possible.

It made sense, considering the ligament-replacement procedure has become the standard fix for such injuries. Plus, the Los Angeles Angels ace was familiar with the operating room, having undergone surgery for a ruptured patellar tendon he sustained on Aug. 20, 2014, toward the end of a breakout season.

Richards knew how to handle the seemingly interminable months of rehab, and he wanted to get the clock started on his return.

But a conversation with Angels head physical therapist Bernard Li convinced Richards to consider other alternatives, and in mid-May he tried a relatively novel treatment in which stem cells taken from bone marrow in his pelvis were injected into the damaged area.

Richards did not pitch again the rest of the year except for a stint in the instructional league, but he has been back on the mound throwing bullpen sessions since the first day of the Angels camp and reported no problems.

This weekend, Richards anticipates pitching in a game for the first time since May 1, when his aching elbow forced him from a start after just four innings.

Its nice to know Ill be able to start the season this year and kind of pick up where I left off, Richards said.

A couple of lockers away, fellow starter Andrew Heaney had a different tale to tell.

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The promising left-hander also went down with a torn ulnar collateral ligament early in the season, after making only one start. Their ailments were the two biggest blows to an Angels rotation that was decimated by injuries, dooming the club to a 74-88 record and a fourth-place finish in the AL West.

Heaney also tried stem cell therapy, two weeks before Richards, both under the supervision of team doctor Steve Yoon. Heaneys ligament didnt heal, though, and after experiencing discomfort throwing following his rehab, he had Tommy John surgery July 1. He has been ruled out for the 2017 season.

They tell you its 50-50. It either works or it doesnt, Heaney said of the stem cell procedure. Obviously, me and Garrett are pretty much the proof of that rule.

Even with less-favorable odds than reconstructive surgery, which has an 80% success rate for returning to action and 67% for pitching 10 games or more, stem cell therapy is gaining acceptance as an option for pitchers with partial UCL tears. The recovery time is shorter 3-5 months instead of 12-18 and the treatment less invasive.

There are limitations. Biological approaches based on stem cells or platelet-rich plasma (PRP) wont repair a complete tear of the ligament. The location of the injury and its extent factor into the chances of success. And players whose ligament doesnt recover, then have to undergo surgery, extend their window of time for returning to action.

Even then, the idea of healing without going under the knife is becoming increasingly appealing. New York Yankees ace Masahiro Tanaka treated the small tear in his elbow ligament with PRP and rehabilitation in 2014, sitting out 10 weeks but coming back to pitch in late September.

Hes 26-11 with a 3.26 ERA over the last two seasons, raising the profile of PRP a procedure in which the players own blood is used to promote healing of the injury as a non-surgical alternative.

Now Richards looms as the test case for stem cell treatment to fix partial UCL tears, which make up about 60-70% of these injuries. If the hard-throwing right-hander can return to his old form he was a Cy Young Award candidate before his knee injury in August 2014 other pitchers in his situation are bound to at least consider the route he took.

I hope this opens another path for guys, Richards said. Obviously, if you can prevent being cut on and having surgery, thats the No. 1 priority. I hope guys dont just jump right into Tommy John, that they at least explore this option.

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Ageless veteran Bartolo Colon was the first pitcher widely known to have undergone stem cell therapy as he sought to recover from elbow and shoulder ailments in 2010. At the time, the ethics of the procedure were questioned, especially because the doctor who performed it, South Florida-based Joseph Purita, acknowledged using human growth hormone in previous treatments, though not in Colons.

Since then, the use of stem cells has become more mainstream. They are the focus of Yoons practice.

As more and more people start to use it, youre getting a better sense for what it can and cant do, Yoon said. Baseball definitely has opened up to it quite a bit, and as we see some of the successes like with Garrett, were getting a better understanding that theres a lot of potential here with these types of treatment.

Yoon calls stem cell therapy a super PRP because it combines the curative properties of that treatment with more healing agents, and said it can be used on tendon tears, muscle tears and strains and even to address degenerative joint disease.

However, much remains unknown about the benefits of stem cells. Lyle Cain, an orthopedist who has performed both Tommy John surgeries and stem cell treatments at the Andrews Sports Medicine & Orthopaedic Center in Birmingham, Ala., said most of the research has been anecdotal, not scientific.

We still dont have a good understanding even four or five years into it exactly what the stem cells do, what their method is, Cain said. The theory is theres probably a chemical reaction where it releases chemicals in the cell that help the healing process. The stem cells arent necessarily put in there with the thought theyre going to become ligament, but theres probably a cellular chemical mechanism that helps the healing response.

And as Heaney discovered, theyre not always effective. His tear was located farther down the arm, which reduced his chances of success with stem cell therapy. Richards was a better candidate because his injury, though deemed high grade, was located within the ligament, like a slit on a rubber band.

But because Heaney was looking at likely missing most or all of 2017 even if he had surgery right away, he decided to try stem cells. The timing of the injury plays a major role in whether pitchers contemplate alternatives to surgery, with the more conservative approach often recommended if it happens early in the season.

Heaney said he doesnt regret taking that route, and would have been upset if he had undergone the ligament-replacement operation right away, only to find out he could have returned to action quicker through another means.

Im glad it worked for him, he said of Richards. It would have been really awful if it hadnt worked for either of us. Then wed both look like idiots.

Their peers are paying attention. In a major league pitching community where about a quarter of its members have undergone Tommy John surgery, interest in the effectiveness of alternative cures is high.

The Los Angeles Dodgers Brandon McCarthy was not a candidate because his ligament tore clear off the bone, but said he had heard positive reports about stem cell treatment, not so much about PRP.

The Pittsburgh Pirates Daniel Hudson, a veteran of two Tommy Johns, is encouraged as well.

Its supposed to help repair the tissue. Before, ligaments just wont repair themselves, Hudson said. It might keep a lot of guys from going under the knife.

Thats Cains hope. He regularly treats UCL tears on high school, college and minor-league players with stem cells or PRP, but realizes theres heightened pressure on major leaguers to return to the field.

If more of them can do it without visiting an operating room, it would represent a major advancement for both the players and the industry.

I think overall the biologic treatment of these injuries will certainly progress and it will be somewhat the wave of the future, Cain said. There will be certain ligaments that are damaged enough that we dont have an answer; they have to reconstruct. But I think overall, if you look 15 years down the road, I suspect well be doing a lot more non-surgical treatment than surgical treatment.

Contributing: Gabe Lacques in Bradenton, Fla.

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All eyes on Garrett Richards, in hopes stem cells stave off Tommy ... - USA TODAY

Poorly Jack Christmas, 8, needs 20k to get vital stem cell research – Hull Daily Mail

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A little boy with a rare genetic condition which left him unable to walk or talk could be one of just five people to contribute to vital research.

But Jack Christmas' family need to raise 20,000 to send the eight-year-old to America for the stem cell research in June.

Jack, of Gainford Grove, east Hull, was diagnosed with Mowat Wilson Syndrome in April 2012, and is one of only 171 children across the world to have the condition, caused by a gene deficiency or mutation.

Jack's mum, Dawn, said while the little boy is totally dependent on adults, he is making good progress.

"Jack doesn't talk, has to have all food pureed, can't feed or dress himself, is doubly incontinent, in fact he is totally dependent on adults," she said.

"All this said and done and he can now crawl, clap his hands and waves hello and goodbye as well as signing money and bird. Jack can also drink out of a feeder cup and on Christmas Eve 2015 Jack took his first unsteady independent steps."

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As well as Mowat Wilson Syndrome, the Tweendykes School pupil has also been diagnosed with Global Development Delays, Gross Motor Disorder and Brain Atrophy. He also suffers from life-threatening seizures.

But now his family hope Jack can help doctors work towards finding a treatment for the condition by taking part in the research.

Dad Tony said: "For Jack, the gene that's affected is mutated, it is there, so there might be something doctors can do to manipulate it is.

"They might not be able to do anything and even if they can it might not be for 10 years, but Jack taking part in the research might help them find the answers.

"It also means if they do manage to find something, he will be able to have the treatment."

Tony said even if doctors were able to find a treatment, it probably wouldn't completely cure Jack's condition. He said: "He will always have Mowat Wilson Syndrome.

"But they might be able to find ways to make it easier for him."

The family have already raised 8,000 to fund the costs of travelling to the USA, but still need to raise 12,000 to foot the bill. And as part of their fundraising, they are hosting a fundraiser for the Life For A Kid Foundation a Hull charity supporting the family.

Dawn said the evening at Wawne Ferry pub, in Bransholme, would be a "night of singing, dancing, bingo, yes BINGO and a raffle."

Tickets for the 'Get ya dabbers ready' event, from 7.30pm on March 11, cost 5. You can also donate to Jack's cause on the family's Virgin Money Giving page.

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Poorly Jack Christmas, 8, needs 20k to get vital stem cell research - Hull Daily Mail

Canadian Pacific makes a $1 million gift to fund stem cell research at the CHU Sainte-Justine – New hope for … – Canada NewsWire (press release)

From left to right: Dr. Fabrice Brunet, The Honorable Michael M Fortier, Mr. Keith Creel, President and CEO of Canadian Pacific, Dr. Gregor Andelfinger, Ms. Maud Cohen, Ms. Janice Pierson, Mr. Richard Lanoue, Mher Mike Stepanian, Samuel Gauthier, Mariama Hawa Barry, Samy Touati, Tyler Lanoue and Olivier Boissonneault. (CNW Group/CHU Sainte-Justine Foundation)

MONTRAL, Feb. 27, 2017 /CNW Telbec/ -An extraordinary $1 million commitment from Canadian Pacific (CP) towards stem cell research will allow the CHU Sainte-Justine to lead the way in developing new treatments to transform the lives of children suffering from complex congenital heart defects. Currently, there is no treatment available to provide a permanent means of repairing the heart. Today, patients and cardiac experts gathered to recognize the major impact of such strong support for research at the CHU Sainte-Justine, as well as the national importance of research in the development of innovative new stem cell technologies.

Thanks to this exceptional gift, CP is making possible the creation of Quebec's first platform for stem cell research and pediatric regenerative medicine. "These funds will allow us to purchase new equipment and recruit an additional researcher, which will significantly accelerate essential research, namely the identification of the mechanisms that form the heart and the types of intervention that can halt the progression of cardiac illnesses in children," stated Dr.Gregor Andelfinger, pediatric cardiologist at the CHU Sainte-Justine and associate research professor in the Department of Pediatrics at the Universit de Montral. "Our aim is to put in place biological factory, capable of producing cardiac tissues from stem cells," he added.

Research remains the best means of understanding, improving the treatment of, and curing congenital heart defects, which are the most commonly occurring birth defects in the world. They affect one in 80 children in Canada every year, many of whom eventually develop fatal heart failure.

"For over a decade, knowledge and understanding about heart defects have grown considerably at the CHU Sainte-Justine, along with the development of new tools for the genetic analysis of families where several family members suffer from a heart defect. Thanks to its team of experts specializing in pediatrics, cardiology, and congenital malformations, the CHU Sainte-Justine is a leader in providing better diagnoses and better targeted therapies to treat congenital heart defects," stated Mr. Fabrice Brunet, CEO of the CHUM-CHU Sainte-Justine.

Ms. Maud Cohen, CEO of the CHU Sainte-Justine Foundation, expressed gratitude for CP's generous support, which provides the hope of regenerating cardiac tissue in babies affected by congenital heart defects. "I am thrilled that the CHU Sainte-Justine is showing such leadership in pediatric regenerative medicine in Quebec, while also increasing our national and international outreach. The CHU Sainte-Justine Foundation is very proud to have the support of CP as a major donor to the Healing More Better campaign. Not only does this remarkable $1 million gift allow for the development of new cures to help save the lives of thousands of children suffering from cardiovascular diseases, but it will also serve as a driver for future funding. This support will enable Dr. Andelfinger's team to quickly undertake activities that show promising early results," she said.

"Since 2014, through our CP Has Heart program, we have been committed to making communities stronger and healthier thanks to research, treatment and prevention. With today's announcement, we have now donated nearly $10 million to this important cause" said Mr. Keith Creel, CP's President and CEO. "When we learned that the CHU Sainte-Justine was seeking to accelerate stem cell research, an extremely promising avenue for the repair of congenital heart defects, we immediately felt that it was an initiative we wanted to support. We firmly believe that a partnership with such a renowned institution as the CHU Sainte-Justine to create the first pediatric research platform in Quebec will significantly improve upon current treatments. This will ensure that the thousands of babies born with heart defects every year will have a chance to grow up with healthy hearts and live healthy lives," Mr. Creel concluded.

For CP, this generous support for stem cell research is a way to pursue its mission to improve heart health throughout North America, and is a natural fit with a cause so close to the company's heart.

The CHU Sainte-Justine Foundation is grateful for CP's invaluable contribution, which will allow the teams at the CHU Sainte-Justine to continue to heal more children, better.

About the CHU Sainte-Justine FoundationThe CHU Sainte-Justine Foundation's mission is to engage the community and support the CHU Sainte-Justine in its pursuit of excellence and its commitment to providing children and mothers with one of the highest levels of healthcare in the world, now and in the future. fondation-sainte-justine.org/en/

About the CHU Sainte-JustineThe Sainte-Justine university hospital centre (CHU Sainte-Justine) is the largest mother-child centre in Canada and the second largest pediatric hospital in North America. A member of the Universit de Montral extended network of excellence in health (RUIS), Sainte-Justine has 5,664 employees, including 1,578 nurses and nursing assistants; 1,117 other healthcare professionals; 502 physicians, dentists and pharmacists; 822 residents and over 200 researchers; 300 volunteers; and 3,400 interns and students in a wide range of disciplines. Sainte-Justine has 484 beds, including 35 at the Centre de radaptation Marie Enfant (CRME), the only exclusively pediatric rehabilitation centre in Quebec. The World Health Organization has recognized CHU Sainte-Justine as a "health promoting hospital." chusj.org

About Canadian PacificCanadian Pacific (TSX:CP)(NYSE: CP) is a transcontinental railway in Canada and the United States with direct links to eight major ports, including Vancouver and Montreal, providing North American customers a competitive rail service with access to key markets in every corner of the globe. CP is growing with its customers, offering a suite of freight transportation services, logistics solutions and supply chain expertise. Visit cpr.ca to see the rail advantages of CP.

About CP Has HeartAt CP, we know that a railroad may serve as the arteries of a nation, but at its heart is community. That's why, through CP Has Heart, we've already committed nearly $10 million to help improve the heart health of men, women and children across North America. And along the way, we're showing heart whenever we can. Find out more on http://www.cpr.ca or @CPhasHeart.

SOURCE CHU Sainte-Justine Foundation

For further information: CHU Sainte-Justine Foundation, Delphine Brodeur, Director, Communication, public relations and donor relations, 514 345-4931, ext. 4356, dbrodeur@fondationSainteJustine.org

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Canadian Pacific makes a $1 million gift to fund stem cell research at the CHU Sainte-Justine - New hope for ... - Canada NewsWire (press release)

Stem cell therapy can help in treating diabetic heart disease – India.com

Karaikal, Feb 28 (PTI) Recent advancements in stem cells research have given hope for successfully treating diabetic heart disease (DHD), renowned New Zealand-based researcher in cardiovascular diseases Dr Rajesh Katare said today.

DHD affected the muscular tissues of the heart leading to complications and it had been demonstrated that resident stem cells of myocardium can be stimulated to repair and replace e degenerated cardiac myocytes resulting in a novel therapeutic effect and ultimately cardiac regeneration, he said.

Katare, Director of Cardiovascular Research Division in the University of Otago, New Zealand, was delivering the keynote address at the continuing medical education programme on Role of Micro-RNAs and stem cells in cardiac regeneration in diabetic heart disease at the Karaikal campus of premier health institute JIPMER.

Presenting clinical evidences, Katare said stem cell therapy certainly presented a new hope for successfully treating DHD.

Jawaharlal Institute of Post Graduate Medical Education (JIPMER) Director Dr Subash Chandra Parija pointed out that it was the first such programme on the role of stem cells in cardiac regeneration in the whole of the country.

He said as diabetes was highly prevalent in the country, providing treatment for DHD had become a big challenge.

Patients suffering from the condition have to undergo lifelong treatment and medications. In this backdrop, advancements in stem cell therapy assume significance, he said.

This is published unedited from the PTI feed.

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Stem cell therapy can help in treating diabetic heart disease - India.com

MHRA Unveils ‘Regulatory Ready’ Stem Cell Lines – Regulatory Focus

MHRA Unveils 'Regulatory Ready' Stem Cell Lines Posted 27 February 2017 By Michael Mezher

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it is looking to boost the development of cell therapies through the availability of what it calls "regulatory ready" embryonic stem cell lines.

"The UK Stem Cell Bank (UKSCB) at the National Institute for Biological Standards and Control (NIBSC) is releasing its first stem cell lines suitable for development into novel cell-based medicines to researchers wishing to bring new and innovative therapies to clinical trial," MHRA said on Monday.

The stem cell lines are intended to serve as qualified starting materials for cell therapies looking to enter clinical trials.

"The availability of EUTCD [EU Tissue and Cell Directives]-grade human embryonic stem cell lines via the UKSCB provides an invaluable 'gold standard' starting material; ensuring high quality and ethically-sourced stem cells are widely available to the research community to use in human clinical studies," said Rob Buckle, chief science officer at the UK's Medical Research Council, which is a co-sponsor of the UKSCB.

The stem cell lines will be produced by a handful of UK-based universities and deposited at the UKSCB in compliance with the EUTCD, which establishes quality and safety standards for human tissue and cells.

According to the UKSCB, "EUTCD-grade cell lines undergo a process known as due diligence to ensure they meet the requirements of the EU Tissue and Cell Directives before they are accepted for banking and distribution for human application. The EUTCD-grade cell lines have been derived from embryos under the informed consent requirements of the UK Fertilisation and Embryology Authority (HFEA) and have been reviewed by an independent UK Steering Committee."

In the coming months, MHRA says that stem cell lines produced by the University of Sheffield, University of Manchester and King's College London will be made available, followed by additional stem cell lines from Newcastle University and Roslin Cells by the end of the year.

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Dying to live (A young woman with a rare disease pushes to find a cure) – Rio Rancho Observer

A thin-green, extra-long oxygen tube bends and swirls across the tile floor of a kitchen in one nondescript Rio Rancho home.

On one end of the tube is a giant collection of heavy oxygen tanks lined up by the front door. On the other end gasping for her next breath is 25-year-old Anna Wenger.

Wenger has Systemic Diffuse Scleroderma, a rare disease that affects the skin, organs and immune system.

Its an auto-immune illness and theres two different kinds, Wenger said expertly. One is the diffuse and theres the limited; the diffuse is the worst kind because it hits your organs and limited just means its on the outside.

According to Wenger, this disease causes the body to produces too much collagen, which tightens the skin on the outside of many external body parts. Diffuse means the disease tightens the organs causing many internal health problems.

My lungs and all of my arteries are hardening, Wenger said. For a while, I was only experiencing the external symptoms, but when I turned 22 it started hurting me internally.

Wenger said this disease affects around 300,000 people nationwide and, of those diagnosed, many only have the external or limited symptoms.

Before Wengers diagnosis, she says she was an active child who enjoyed swimming, cheerleading, and playing soccer.

We would go to the lake every weekend and I had just started roller-blading, Wenger said. All of a sudden I lost a dramatic amount of weight, and started slowing down. I didnt notice it but those around me noticed it and thats when I went to the doctor.

Doctors diagnosed Wenger with Systemic Diffuse Scleroderma at 12 years of age, and told her mother she wouldnt live past 20. But Wenger said she didnt feel much different until a year later, when she noticed ulcers forming on her elbows.

Because of the rapid movement of the disease I lost some of my fingers and toes, Wenger said. The doctors gave me prednisone and methotrexate, which just wasnt helping.

Going to school became almost impossible at this point in her life, she said. After dropping out of school and trying to take her medication, Wenger noticed she was rapidly getting worse.

After 10 years of external symptoms only, it started hitting my organs really bad, Wenger said.

She was living on her own in Arizona dealing with her symptoms, she said, when everything changed.

I was happy I had outlived the date doctors said I would die, when I became so ill I had to move to New Mexico to receive help from my mom, Wenger said.

One day, after moving in with her mother, Wenger said she felt really cold and could not breathe very well.

We went to the hospital and they put me on oxygen, then I got really hungry and ate some (fast food) and went into heart failure, Wenger said. Then I had to be incubated and woke up five days later on life support and 33 liters of oxygen.

Every day has been different for Wenger since that fateful incident, she said. Now Wenger has to prepare a specific low sodium diet from scratch on a regular basis that does not interfere with her symptoms. Wenger also has to be hooked up to oxygen everywhere she goes to compensate for her lung functions due to the reaction of her disease.

Although many people would be devastated by this sudden lifestyle change, Wenger stays optimistic, because she says she knows of a possible cure.

With a stem cell transplant, doctors take out your stem cells, and then they harvest them to get them healthier, Wenger said. Then you go through five days of intense chemotherapy and then they put the cells back into your body to re-start your immune system.

The cost of the procedure that may cure Wenger is $150,000, plus an additional $25,000 for the evaluations from a specialist, she said.

Thats not even including lodging and food and everything else, Wenger said.

This procedure, which is still in trial, is not covered by Medicare, she said. Add in the fact that Wenger has heart issues puts her at-risk for many of the clinics providing stem cell replacement.

Stretching resources is a daily battle for Wenger, who lives on $700 a month, she said.

If I hadnt moved in with my mom, there is no way I would make it through, Wenger said.

Theresa Johnson, Wengers mother and main caregiver, said she fell to the ground after hearing her daughters initial diagnosis.

I really had a hard time getting my head around it, Johnson said. At that time, when she was 12, she was barely walking because the symptoms got so bad.

Johnson said her daughter was a natural competitor that excelled in sports and loved dancing.

When this disease hit her body, it hit her skin very rapidly and she tightened up and could not move. Johnson said. For a long time the disease stopped at her skin and did not go into her organs, so we were hopeful.

Now, with full understanding of the seriousness of her daughters disease, Johnson said she is looking for ways to help find a cure.

Sacrifice is the main thing, Johnson said. I dont want anything for myself everything is for her and my son. I will do anything to see her get better. If I have to lose my home I will lose it whatever.

Although Wenger is limited on her mobility, she said she likes to stay busy and active working on many projects.

I like a lot of different things. I like to put together furniture, I love painting and thats pretty cool that I can still do it even though half my right hand is missing, she said, laughing at that.

Wenger has also put together a Scleroderma support group that meets the second Saturday of every month at Sabana Grande Recreation Center, just down the street from her home.

I had 15 people meet up at my last support group, Wenger said. I am the main person who does this, but the people help me put up the chairs.

Family members and people dealing with Scleroderma are in attendance, she said.

I love doing this; it makes me feel good and all of the members are so sweet to me, Wenger said.

Wenger kept her diagnosis a secret for a long time because she was afraid people would treat her differently, she said.

I just wanted to be a normal teenager, Wenger said. Now that I look back, I shouldve raised awareness of my disease to help others with the same symptoms out, thats what I am doing now.

Wenger said she feels blessed to still be able to do things because she knows of so many with the disease that cant.

I can still make my own food, change my clothes, take a shower and do daily tasks, Wenger said. I still count my blessings.

Read the rest here:
Dying to live (A young woman with a rare disease pushes to find a cure) - Rio Rancho Observer