Stem Cell Clinic

Osiris Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent by New Zealand

By Stem Cell Treatment

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), announced today it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. With this decision New Zealand joins Canada, which last month became the worlds first internationally recognized regulatory authority to grant approval to a stem cell drug. Prochymal is also the first therapy approved for GvHD - a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. I would like to thank the professionals at Medsafe for their thoughtful and expeditious review of this complex application. I would also like to thank the team at Osiris that continues to do an outstanding job of making Prochymal available to children around the world suffering from the devastating effects of GvHD."

Osiris submitted a New Medicine Application (NMA) to Medsafe(New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981.

"The incidence of GvHD is likely to rise as the demographic profile of our transplant population evolves," said Hans Klingemann, M.D., Ph.D., a Professor of Medicine and the Director of the Bone Marrow & Hematopoietic Stem Cell Transplant Program at Tufts University School of Medicine. "Effective strategies to manage the often lethal consequences of GvHD reduce the overall risk to transplantation and provide the transplant physician with better options when approaching their most difficult cases.

Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64 percent of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival.

As a mother who watched my son Christian suffer and die from the horrifying effects of GvHD, while waiting for the regulatory approvals necessary to allow him access to Prochymal, words cannot express how happy I am that significant progress is finally being made, said Sandy Barker, President and Co-founder of the Gold Rush Cure Foundation. We are proud to stand side-by-side with Osiris in this historic battle for our children around the world. Our motto is 'not one more child, not one more family' and when it comes to GvHD mortality, zero is the only acceptable number.

Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). It is expected that Prochymal will be commercially available in New Zealand later this year.

About GvHD

GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.

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Osiris Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent by New Zealand

Stem cell stroke trial promising

By Stem Cell Treatment

14 June 2012 Last updated at 10:45 ET By Pallab Ghosh Science correspondent, BBC News

Doctors in Scotland have said five stroke patients involved in an experimental stem cell treatment have shown signs of slight improvement.

They have stressed that it is too soon to tell whether the improvement is due to the therapy.

The medical team has talked about the first results of the treatment at a conference in Japan.

The procedure is controversial as brain cells from a foetus were originally used to create the stem cells.

A team, from Glasgow's Southern General Hospital, has been injecting the stem cells into the brains of stroke patients.

The trial began in November 2010. The participants are all men over the age of 60 who have been severely disabled by a stroke and have shown no sign of improvement for at least a year.

We hope to tease out over the next 18 months whether the improvement is due to the treatment

The doctors hope that the treatment will repair their damaged brain tissue and restore some of their movement and ability to speak.

The trail is at an early stage, and doctors are primarily looking to see that the treatment is safe. But they have found that five of the six patients treated so far have shown some slight signs of improvement.

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Stem cell stroke trial promising

Stem cells 'help' stroke patients

By Stem Cell Treatment

14 June 2012 Last updated at 07:25 ET By Eleanor Bradford BBC Scotland Health Correspondent

The first patients to take part in a clinical trial of a stem cell treatment for stroke have seen reductions in their disability, according to doctors.

Six patients in the west of Scotland had human stem cells inserted close to the damaged part of their brain.

After receiving the treatment, they saw improvements in the limb weakness they suffered as a result of their stroke.

Howeve, doctors have cautioned against reading too much into the early results of the clinical trial.

It is the world's first trial of a neural stem cell therapy for stroke.

Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.

The trial is being conducted at the Institute of Neurological Sciences at the Southern General Hospital in Glasgow, and is being led by Glasgow University neurologist Professor Keith Muir.

He said: "So far we've seen no evidence of any harmful effects. We're dealing with a group of people a long time after a stroke with significant disability and we don't really expect these patients to show any change over time.

"So it's interesting to see that in all the patients so far they have improved slightly over the course of their involvement in the study."

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Stem cells 'help' stroke patients

Linux creator, stem cell scientist win big technology prize

By Stem Cell Medical Center

Agence France-Presse

11:05 pm | Wednesday, June 13th, 2012

Linus Torvalds PHOTO FROM FACEBOOK.COM

HELSINKIUS-Finnish software engineer Linus Torvalds, who created the Linux open source operating system, and Japanese stem cell researcher Shinya Yamanaka on Wednesday won a 1.2-million-euro technology prize in Finland.

Today, millions use computers, smartphones and digital video recorders that run on Linux. Linus Torvaldss achievements have had a great impact on shared software development, networking and the openness of the web, the Millennium Technology Prize organizers said in a statement.

Yamanaka, meanwhile, won for his discovery of a new method to develop induced pluripotent stem cells for medical research, the prize jury said, adding that it was the first time that the award has been split between two scientists.

Using (Yamanakas) method to create stem cells, scientists all over the world are making great strides in research in medical drug testing and biotechnology, it said.

This should one day lead to the successful growth of implant tissues for clinical surgery and combating intractable diseases such as cancer, diabetes and Alzheimers.

Yamanaka himself vowed in the statement to continue to work hard to achieve our goals of developing new drugs and medical treatments to intractable diseases by using iPS cell technology.

Finnish President Sauli Niinistoe presented the prize to the two laureates at a ceremony at the Finnish National Opera in Helsinki Wednesday.

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Linux creator, stem cell scientist win big technology prize

Scientists see new hope for restoring vision with stem cell help

By Uncategorized

This is a human ES cell-derived optic cup generated in our self-organization culture (culture day 26). Bright green, neural retina; off green, pigment epithelium; blue, nuclei; red, active myosin (strong in the inner surface of pigment epithelium). Credit: Nakano et al. Cell Stem Cell Volume 10 Issue 6

Human-derived stem cells can spontaneously form the tissue that develops into the part of the eye that allows us to see, according to a study published by Cell Press in the 5th anniversary issue of the journal Cell Stem Cell. Transplantation of this 3D tissue in the future could help patients with visual impairments see clearly.

"This is an important milestone for a new generation of regenerative medicine," says senior study author Yoshiki Sasai of the RIKEN Center for Developmental Biology. "Our approach opens a new avenue to the use of human stem cell-derived complex tissues for therapy, as well as for other medical studies related to pathogenesis and drug discovery."

During development, light-sensitive tissue lining the back of the eye, called the retina, forms from a structure known as the optic cup. In the new study, this structure spontaneously emerged from human embryonic stem cells (hESCs)cells derived from human embryos that are capable of developing into a variety of tissuesthanks to the cell culture methods optimized by Sasai and his team.

The hESC-derived cells formed the correct 3D shape and the two layers of the optic cup, including a layer containing a large number of light-responsive cells called photoreceptors. Because retinal degeneration primarily results from damage to these cells, the hESC-derived tissue could be ideal transplantation material.

Beyond the clinical implications, the study will likely accelerate the acquisition of knowledge in the field of developmental biology. For instance, the hESC-derived optic cup is much larger than the optic cup that Sasai and collaborators previously derived from mouse embryonic stem cells, suggesting that these cells contain innate species-specific instructions for building this eye structure. "This study opens the door to understanding human-specific aspects of eye development that researchers were not able to investigate before," Sasai says.

The anniversary issue containing Sasai's study will be given to each delegate attending the 2012 ISSCR meeting in Yokohama, Japan. To highlight the ISSCR meeting and showcase the strong advances made by Japanese scientists in the stem cell field, the issue will also feature two other papers from Japanese authors, including the research groups of Akira Onishi and Jun Yamashita. In addition, the issue contains a series of reviews and perspectives from worldwide leaders in stem cell research.

More information: Nakano et al.: "Self-Formation of Optic Cups and Storable Stratified Neural Retina from Human ESCs." DOI 10.1016/j.stem.2012.05.009

Journal reference: Cell Stem Cell

Provided by Cell Press

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Scientists see new hope for restoring vision with stem cell help

Stem cell scientist wins award

By Uncategorized

13 June 2012 Last updated at 08:31 ET

Japanese stem cell scientist Dr Shinya Yamanaka has been awarded the Millennium Technology Prize.

His award is for discovering how to reprogram human cells to mimic embryonic stem cells, which can become any cell in the body.

Called induced pluripotent stem (iPS) cells, these now aid research into regenerative medicine.

He was joint-winner with Linus Torvalds, who created a new open source operating system for computers.

This is the first time the prize has been shared by two scientists - they will split the 1.2m euros ($1.3m; 800,000) award.

My goals over the decade include to develop new drugs to treat intractable diseases by using iPS cell technology and to conduct clinical trials using it on a few patients with Parkinson's diseases, diabetes or blood diseases.

The President of the Republic of Finland, Sauli Niinisto, presented the prize at the Finnish National Opera in Helsinki.

Dr Ainomija Haarla, President of Technology Academy Finland - the foundation which awards the prize every two years - said: "The International Selection Committee has to judge whether an innovation has had a favourable impact on people's lives and assess its potential for further development to benefit humanity in the future.

"The innovations of both this year's winners embody that principle.

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Abunda to try stem cell therapy for mom

By Uncategorized

MANILA, Philippines -- "The Buzz" host Boy Abunda is going to Europe this weekend with his mother, who is suffering from dementia and Alzeimers disease.

In an interview with ABS-CBN News on Tuesday afternoon, Abunda said he will bring his mother to Germany to try stem cell therapy.

"Ako ay pupunta sa Europe hindi para magbakasyon. Dadalhin ko po ang aking ina para magpagamot sa Germany. Ito po 'yung fresh stem cell therapy. Maganda 'yung dini-diretso na dahil napag-uusapan ito," Abunda said.

While Abunda is in Germany, Kris Aquino will take his place on ABS-CBN's entertainment talk show "The Buzz."

In the interview, Abunda also said he's proud of Aquino, who's now open to doing extreme adventures, while continuing to be a good mother to her two sons.

"Ang daming nagbago kay Kris. May mga bagay na hindi ko inakala na gagawin ni Kris like 'yung diving, zipline at marami pang iba. Natutuwa ako that she has become more open to many things. She has become more adventurous. She has retained being the doting mother that she is pero mas malalim ang halakhak niya ngayon sa buhay. She's just so joyful. Natutuwa ako habang pinapanood ko ang kanyang adventure sa 'KrisTV,'" Abunda said.

Abunda said he's also hoping to do a new project with Aquino.

"I'm hoping na someday ay muli kaming magtagpo sa isang palabas dahil marami ang humihiling na kami ay magsama sa isang palabas. Sigurado ako sa puso ko na kami ay gagawa at gagawa dahil magkadugtong ang aming pusod," he said.

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Abunda to try stem cell therapy for mom

The UFC's Supposed Testosterone Epidemic: Critics Living in the Past

By Stem Cell Treatment

Last year Peyton Manning flew to Europe on a private jet, not for tea and crumpets or to see the Louvre, but for an experimental stem-cell treatment on his injured neck.

The procedure, one that isn't even legal in the United States, allegedly took his own fat cells and used them to try to regrow damaged neck tissue:

"There are many proposed therapies that are being tested in clinical trials, and there are more to come," Dr. Lawrence Goldstein, director of the stem cell program at the University of California, San Diego, told ABC News. "But in the absence of reliable evidence, it is impossible to know whether the 'treatment' will make Manning better or worse or merely financially poorer."

TheNFL doesn't have any rules specifically banning illegal procedures that an athlete can have done in foreign locales. Kobe Bryant, the NBA's aging lion, had similarly cutting-edge treatment on his arthritic knee in Germany. It's called "Biologic Medicine,"and in addition to Bryant, super-agent Ari Emanueland the late Pope John Paul II were ardent believers.

There are a ton of controversial treatments possible where science collides with loose regulation. Bone marrow injections filled with those miracle-working stem cells can be injected into the body. Blood can be heated up, spun and spun in an incubator, the healing agents isolated and injected. The 34-year-old Bryant felt like a new man after first undergoing the procedure, like Manning's one not approved by the FDA:

He even recommended the treatment to Alex Rodriguez, which led the baseball star to undergo the same treatment on his knee late last year. Bryant hasn't commented publicly on the treatment, but A-Rod has described the feelings of his friend.

Bryant "was really adamant about how great the procedure was for him," Rodriguez told reporters."I know that he was hurting before, almost even thinking about retirement, that's how much pain he was under. And then he said after he went to Germany he felt like a 27-year-old again. I was still a little apprehensive about it, and he kept staying on me about it."

Athletes at the highest levels will do almost anything to maintain that edgeto feel younger, sprier and as explosive as they did in their primes. And with the right money and resources, they are extending their careers further than any of their predecessors would have dared dream. Is it any wonder athletes in mixed martial arts are doing the same?

Frank Mir on TRT

In that sport, some of the UFC's top aging stars have undergone Testosterone Replacement Therapy (TRT), looking to bring their bodies' natural level of testosterone back to the levels they enjoyed in their 20s. Top contenders like Dan Henderson (41), Chael Sonnen (35) and Frank Mir (33)have all undergone the procedure. Former middleweight champion Rich Franklin (37)is considering it.

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The UFC's Supposed Testosterone Epidemic: Critics Living in the Past

New Applications in Drug Discovery Platforms to Fuel Advance of Stem Cells, Says Frost & Sullivan

By Stem Cell Treatment

Ethical, Clinical and Commercial Issues to be Navigated before Full Potential of Stem Cell Therapies can be Unleashed

LONDON, June 13, 2012 /PRNewswire-Asia/ -- Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics, finds that the market will be driven by stem cell applications in drug discovery platforms and by successful academia commercial company partnership models.

"The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," notes Frost & Sullivan Consulting Analyst Vinod Jyothikumar. "Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies."

Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies.

Key challenges to market development relate to reimbursement, ethics and the complexity of clinical trials.

Securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success. However, stem cell therapies are likely to be expensive. Insurers, therefore, may be unwilling to pay for the treatment. At the same time, patients are unlikely to be able to afford these treatments.

"The use of embryonic stem cells raises a host of thorny ethical, legal, and social issues," adds Jyothikumar. "As a result, market prices for various products may be affected."

Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues. Such policies are hindering the overall research process for several companies working in collaboration with these institutes.

"In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies," cautions Jyothikumar. "Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics."

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New Applications in Drug Discovery Platforms to Fuel Advance of Stem Cells, Says Frost & Sullivan

Fresh, purified fat stem cells grow bone faster, better

By Stem Cell Medical Center

LOS ANGELES UCLA stem cell scientists who purified a subset of stem cells from fat tissue and used the stem cells to grow bone discovered that the bone formed faster and was of higher quality than bone grown using traditional methods.

The finding may one day eliminate the need for painful bone grafts that use material taken from patients during invasive procedures.

Adipose, or fat, tissue is thought to be an ideal source of mesenchymal stem cells cells capable of developing into bone, cartilage, muscle and other tissues because such cells are plentiful in the tissue and easily obtained through procedures like liposuction, said Dr. Chia Soo, vice chair of research for the UCLA Division of Plastic and Reconstructive Surgery.

Soo and Bruno Pault, the co-senior authors on the project, are members of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA.

Traditionally, cells taken from fat had to be cultured for weeks to isolate the stem cells which could become bone, and their expansion increases the risk of infection and genetic instability. A fresh, non-cultured cell composition called stromal vascular fraction (SVF) also is used to grow bone. However, SVF cells taken from adipose tissue are a highly heterogeneous population that includes cells that aren't capable of becoming bone.

Pault and Soo's team used a cell-sorting machine to isolate and purify human perivascular stem cells (hPSC) from adipose tissue and showed that those cells worked far better than SVF cells in creating bone. They also showed that a growth factor called NELL-1, discovered by Dr. Kang Ting of the UCLA School of Dentistry, enhanced bone formation in their animal model.

"People have shown that culture-derived cells could grow bone, but ours are a fresh cell population, and we didn't have to go through the culture process, which can take weeks," Soo said. "The best bone graft is still your own bone, but that is in limited supply and sometimes not of good quality. What we show here is a faster and better way to create bone that could have clinical applications."

The study was published Monday (June 11) in the early online edition of Stem Cells Translational Medicine, a new peer-reviewed journal that seeks to bridge stem cell research and clinical trials.

In the animal model, Soo and Pault's team put the hPSCs with NELL-1 in a muscle pouch, a place where bone is not normally grown. They then used X-rays to determine that the cells did indeed become bone.

"The purified human hPSCs formed significantly more bone in comparison to the SVF by all parameters," Soo said. "And these cells are plentiful enough that patients with not much excess body fat can donate their own fat tissue."

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Fresh, purified fat stem cells grow bone faster, better

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