R. Bolli - Interim Results of the SCIPIO Trial Up to 2 Years After Therapy
R. Bolli - Effect of Cardiac Stem Cells in Patients with Ischemic Cardiomyopathy: Interim Results of the SCIPIO Trial Up to 2 Years After Therapy SCIPIO: (Cardiac) Stem Cell Infusion in Patients with Ischemic cardiomyopathy Annual Session of the American Heart Association November 5, 2012, Los AngelesFrom:CardioletterViews:3 0ratingsTime:09:07More inScience Technology

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R. Bolli - Interim Results of the SCIPIO Trial Up to 2 Years After Therapy - Video

By E.J. Mundell HealthDay Reporter

TUESDAY, Nov. 6 (HealthDay News) -- Updated two-year results from a small trial using cardiac stem cells to repair damaged hearts suggest the treatment's healing effect persists.

Patients with heart failure caused by prior heart attacks who got the treatment continue to see reductions in cardiac scar tissue, improvements in the heart's pumping ability and even a boost in their quality of life, researchers said.

These improvements seem to be continuing as time goes on, suggesting that stem cell therapy's healing power hasn't diminished.

"Now we need to perform larger and randomized, blinded studies ... to confirm this data," said study lead author Dr. Roberto Bolli, director of the Institute of Molecular Cardiology at the University of Louisville.

His team presented its results Tuesday at the American Heart Association's annual meeting, in Los Angeles.

According to the AHA, more than 6 million Americans suffer from heart failure, a gradual weakening of the heart often caused by damage from a prior heart attack. Despite its prevalence and lethality, virtually no advance has been made over the past few decades in doctors' ability to treat or reverse heart failure.

That's why the advent of stem cell therapy has encouraged researchers. Stem cells have the ability to turn into myriad living cells, and the hope is that once infused into the heart they can help repair it.

This trial is the first human trial to test this theory using the patient's own cardiac stem cells. The cells used in the trial were harvested from 33 heart failure patients who were undergoing bypass surgery. The cells were then coaxed to multiply into the millions in the lab and then transplanted back into 20 of the patients. The remaining 13 patients did not receive a stem cell infusion and are the "control" group for comparison purposes.

Results gathered one year after treatment showed improvements for the treated patients, but experts questioned whether those gains would fade over time.

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Two Years On, Stem Cells Still Healing Damaged Hearts

Study Highlights:

LOS ANGELES, Nov. 6, 2012 (GLOBE NEWSWIRE) -- Cardiac stem cells may one day be an effective treatment for heart failure caused by muscle scarring after a heart attack, according to late-breaking clinical trial results presented at the American Heart Association's Scientific Sessions 2012.

In the Effect of Cardiac Stem Cells In Patients with Ischemic CardiOmyopathy (SCIPIO) trial, heart function and quality of life improved in 20 people treated with their own cardiac stem cells (CSCs).

"This is exciting," said Roberto Bolli, M.D., lead author of the trial, chief of Cardiovascular Medicine and director of the Institute of Molecular Cardiology at the University of Louisville in Kentucky. "The effect of these cells has continued for up to two years, and has gotten stronger. There was also a major reduction in heart scarring."

In 33 patients with heart failure who had undergone coronary artery bypass surgery, researchers removed a tiny piece of heart tissue and isolated heart stem cells called c-kit CSCs. Researchers then grew additional cells to infuse into 20 volunteers assigned to treatment.

Among outcomes found two years after treatment:

"We have not seen any deaths among the patients, or any adverse effects that can be ascribed to the stem cells," Bolli said.

About 6.6 million Americans suffer from heart failure, according to the American Heart Association. Life expectancy is about five years after diagnosis. Ischemic heart attacks cause most of the 57,000 U.S. deaths a year due to heart failure.

Larger, multi-center studies are needed to confirm the findings, Bolli said.

The Jewish Hospital, University of Louisville, and the National Institutes of Health funded the study. Co-authors' names are on the abstract.

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Cardiac Stem Cells May Help Treat Heart Failure

Public release date: 16-Oct-2012 [ | E-mail | Share ]

Contact: Bryan Ghosh bghosh@plos.org 44-122-344-2837 Public Library of Science

Researchers at the University of Helsinki believe they have discovered stem cells that play a decisive role in the growth of new blood vessels. If researchers learn to isolate and efficiently produce these stem cells found in blood vessel walls, the cells could offer new opportunities for developing therapeutics to treat diseases, such as cardiovascular disease and cancer. The study reporting the discovery of these stem cells is published in the open access journal PLOS Biology on October 16.

The growth of new blood vessels, known as neoangiogenesis, occurs during the repair of damaged tissue and organs in adults. However, malignant tumours also grow new blood vessels in order to receive oxygen and nutrients. As such, neoangiogenesis is both beneficial and detrimental to health, depending on the context, requiring therapeutic approaches that can either help to stimulate or prevent it. Therapeutics that aim to prevent the growth of new blood vessels are already in use, but the results are often more modest than predicted.

Adjunct Professor Petri Salvn and his team, from the University of Helsinki, now report that these stem cells can be found among the cellsso-called endothelial cellsthat line the inside of blood vessel walls. He explains, "we succeeded in isolating endothelial cells with a high rate of division in the blood vessel walls of mice. We found these same cells in human blood vessels and blood vessels growing in malignant tumours in humans. These cells are known as vascular endothelial stem cells, abbreviated as VESC. In a cell culture, one such cell is capable of producing tens of millions of new blood vessel wall cells".

From their studies in mice, the team are able to show that the growth of new blood vessels weakens, and the growth of malignant tumours slows, if the amount of these cells is below normal. Conversely, new blood vessels form where these stem cells are implanted.

"The identification and isolation of an entirely new adult stem cell type is a significant discovery in stem cell biology." explains Salvn. "Endothelial stem cells in blood vessels are particularly interesting, because they offer great potential for applications in practical medicine and the treatment of patients."

If an efficient method of vascular endothelial stem cell production could be developed, it could offer new treatment opportunities in situations where damaged tissue or diseases call for new blood vessel growth, or where the constriction or dysfunction of blood vessels deprives tissues of oxygen, for example in cardiac disease. These cells also offer new opportunities for developing therapeutics that seek to prevent new blood vessel growth in malignant tumours.

###

Funding: The work was supported by the Finnish Academy of Sciences. The funders had no role in study design, data collection and analysis, decision to publish,or preparation of the manuscript.

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Researchers discover new blood vessel-generating cell with therapeutic potential

It has been a crazy week for stem cell research. After the high of a Nobel prize for Japan's Shinya Yamanaka, the pioneer of cellular reprogramming, events took an alarming and surreal turn when a little-known compatriot Hisashi Moriguchi claimed to have already run a clinical trial in which similarly reprogrammed cells were injected into people.

But Moriguchi's claims quickly unravelled. "I have not found a single person to say anything concrete indicating that this has really happened," says Paul Knoepfler, a stem cell researcher at the University of California, Davis, who tracked the unfolding story on his blog.

In a poster presented at a meeting of the New York Stem Cell Foundation, Moriguchi who claimed to work at Harvard Medical School and the University of Tokyo described results from a trial in which cardiac muscle cells were grown from induced pluripotent stem (iPS) cells, and transplanted into six US patients with severe heart failure.

The Yomiuri Shimbun newspaper Japan's biggest splashed the story, based on an interview with Moriguchi, who claimed he had received ethical approval from Harvard Medical School's Institutional Review Board (IRB).

This was surprising, given the safety concerns that surround iPS cells adult cells that have been reprogrammed to an embryonic state. Support for the claim quickly disintegrated: within hours, Harvard released a statement noting that Moriguchi had no current affiliation with the university, nor any ethical approval to run a clinical trial.

Moriguchi's poster describing the clinical trial was taken down after the New York Stem Cell Foundation learned of Harvard's statement but a summary was published on Knoepfler's blog. This suggested an improvement of 41.5 per cent in "ejection fraction" a measure of heart output in patients whose hearts were injected with iPS-derived cells, compared to 4.1 per cent in a placebo group.

That would have been an astonishing claim, says Michael Laflamme at the University of Washington in Seattle, who is working to develop cell therapies for heart attack: "I'm not aware of any clinical trial that reported anything of this magnitude."

Indeed, similar studies involving adult stem cells have typically found improvements of less than 5 per cent (European Journal of Hearth Failure, doi.org/crq5k6).

Moriguchi did not respond to emails from New Scientist. But on Saturday he admitted to reporters that for five of the patients he was actually describing "planned" procedures. Still, Moriguchi maintained that he had transplanted cells into one patient at an unidentified hospital in Boston.

New Scientist's enquiries raise further questions about Moriguchi's work. In papers published earlier this year, he described experiments on freezing human ovarian tissue (Scientific Reports, doi.org/jht), and a remarkable claim to be able to eliminate liver tumour cells using a reprogramming technique (Scientific Reports, doi.org/jhv). Both gave Harvard and University of Tokyo affiliations, and claimed ethical approval from each institution.

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Claim of first human stem cell trial unravels

Friday, Oct. 12, 2012

Harvard University said neither it nor Massachusetts General Hospital have ever authorized any iPS-related clinical studies by Hisashi Moriguchi, who claims to have achieved the first clinical application using the revolutionary stem cell technology.

"No clinical trials related to Moriguchi's work have been approved by institutional review boards at either Harvard University or Massachusetts General Hospital," a statement issued by Harvard and related institutes said Thursday.

The statement confirmed that Moriguchi "was a visiting fellow at Massachusetts General Hospital from 1999-2000," but added that he "has not been associated with (the institution) or Harvard since that time."

Moriguchi, a researcher at University of Tokyo Hospital, claimed to be a visiting lecturer at Harvard and to have conducted clinical trials at Massachusetts General Hospital with other researchers to transplant artificial cardiac muscle cells developed from iPS cells into six patients with heart disease.

The claim came just after Shinya Yamanaka of Kyoto University and a British scholar were jointly awarded this year's Nobel Prize in physiology or medicine for their research on iPS cells. Yamanaka and John Gurdon were credited with the discovery that mature human cells can be reprogrammed as immature cells capable of developing into all types of body parts.

"Research has been conducted after going through due procedures, such as consultations with a university ethics committee," Moriguchi claimed. "I have been told my method of creating iPS cells is different from the one used by Yamanaka (and Gurdon), but I have been doing it my way and no problems have been identified after transplants."

Moriguchi, who is thought to have asked a heart surgeon to carry out cell transplants, unveiled details about the treatment at a meeting of annual stem-cell research conference at Rockefeller University in New York held Wednesday and Thursday.

But the event's organizer, the nonprofit New York Stem Cell Foundation, subsequently said it "has received information from Harvard University that raises legitimate questions concerning a poster presentation" by Moriguchi, and has withdrawn it from the conference.

Moriguchi graduated from Tokyo Medical and Dental University with a degree in nursing science and does not have a license to practice medicine, according to a professor who taught him as an undergraduate.

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Doubt cast on clinical stem cell tests

Friday, Oct. 12, 2012

NEW YORK A team of researchers has transplanted artificial cardiac muscle cells developed from multipurpose stem cells into six patients in the United States in the world's first clinical application of iPS cells, one of the researchers said Wednesday.

Shinya Yamanaka, who won this year's Nobel Prize in medicine or physiology for his development of iPS cells, declined comment on the transplants, while other experts said details about the medical performance should be carefully evaluated.

The researchers developed the muscle cells from induced pluripotent stem cells produced from the patients' livers and transplanted them to the patients, said Hisashi Moriguchi, a visiting professor at Harvard University.

A 34-year-old American male patient who was the first to receive the transplant in February now has normal heart functions and has been discharged from the hospital, Moriguchi said.

The patient suffered from liver cancer and received a liver transplant in February 2009. He developed ischemic cardiomyopathy this February, prompting the researchers to conduct the heart surgery.

The researchers took cells from the patient's original liver, which was kept after removal for the 2009 transplant, and developed iPS cells by adding protein and other medical agents from which they produced cardiac muscle cells. The muscle cells were placed in 30 locations in the patient's heart.

No rejection or cancer development was found in the heart, and his heart function gradually recovered to normal levels 10 days after the surgery, they said.

"We need to improve the efficacy and safety of such medical treatment . . . and think of ways to reduce economic burden on patients," Moriguchi said.

The researchers used an improved technique to produce iPS cells developed by Yamanaka, the professor from Kyoto University who jointly won this year's Nobel with John Gurdon of Britain. Such cells have the potential to grow into any type of body tissue.

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U.S. marks first iPS clinical applications

Public release date: 10-Sep-2012 [ | E-mail | Share ]

Contact: Bill Seiler bseiler@umm.edu 410-328-8919 University of Maryland Medical Center

Baltimore, MD September 10, 2012 Researchers at the University of Maryland School of Medicine, who are exploring novel ways to treat serious heart problems in children, have conducted the first direct comparison of the regenerative abilities of neonatal and adult-derived human cardiac stem cells. Among their findings: cardiac stem cells (CSCs) from newborns have a three-fold ability to restore heart function to nearly normal levels compared with adult CSCs. Further, in animal models of heart attack, hearts treated with neonatal stem cells pumped stronger than those given adult cells. The study is published in the September 11, 2012, issue of Circulation.

"The surprising finding is that the cells from neonates are extremely regenerative and perform better than adult stem cells," says the study's senor author, Sunjay Kaushal, M.D., Ph.D., associate professor of surgery at the University of Maryland School of Medicine and director, pediatric cardiac surgery at the University of Maryland Medical Center. "We are extremely excited and hopeful that this new cell-based therapy can play an important role in the treatment of children with congenital heart disease, many of whom don't have other options."

Dr. Kaushal envisions cellular therapy as either a stand-alone therapy for children with heart failure or an adjunct to medical and surgical treatments. While surgery can provide structural relief for some patients with congenital heart disease and medicine can boost heart function up to two percent, he says cellular therapy may improve heart function even more dramatically. "We're looking at this type of therapy to improve heart function in children by 10, 12, or 15 percent. This will be a quantum leap in heart function improvement."

Heart failure in children, as in adults, has been on the rise in the past decade and the prognosis for patients hospitalized with heart failure remains poor. In contrast to adults, Dr. Kaushal says heart failure in children is typically the result of a constellation of problems: reduced cardiac blood flow; weakening and enlargement of the heart; and various congenital malformations. Recent research has shown that several types of cardiac stem cells can help the heart repair itself, essentially reversing the theory that a broken heart cannot be mended.

Stem cells are unspecialized cells that can become tissue- or organ-specific cells with a particular function. In a process called differentiation, cardiac stem cells may develop into rhythmically contracting muscle cells, smooth muscle cells or endothelial cells. Stem cells in the heart may also secrete growth factors conducive to forming heart muscle and keeping the muscle from dying.

To conduct the study, researchers obtained a small amount of heart tissue during normal cardiac surgery from 43 neonates and 13 adults. The cells were expanded in a growth medium yielding millions of cells. The researchers developed a consistent way to isolate and grow neonatal stem cells from as little as 20 milligrams of heart tissue. Adult and neonate stem cell activity was observed both in the laboratory and in animal models. In addition, the animal models were compared to controls that were not given the stem cells.

Dr. Kaushal says it is not clear why the neonatal stem cells performed so well. One explanation hinges on sheer numbers: there are many more stem cells in a baby's heart than in the adult heart. Another explanation: neonate-derived cells release more growth factors that trigger blood vessel development and/or preservation than adult cells.

"This research provides an important link in our quest to understand how stem cells function and how they can best be applied to cure disease and correct medical deficiencies," says E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs, University of Maryland; the John Z. and Akiko K. Bowers Distinguished Professor; and dean, University of Maryland School of Medicine. "Sometimes simple science is the best science. In this case, a basic, comparative study has revealed in stark terms the powerful regenerative qualities of neonatal cardiac stem cells, heretofore unknown."

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University of Maryland study: Neonatal heart stem cells may help mend kids' broken hearts

Johns Hopkins researchers have discovered that a single protein molecule may hold the key to turning cardiac stem cells into blood vessels or muscle tissue, according to a release from the university. This finding may lead to better ways to treat heart attack patients.

Human heart tissue typically forms scars rather than healing well after an attack. However, stem cells have been shown improve the repair process by turning into the cells that make up healthy heart tissue, including heart muscle and blood vessels. The recent discovery of a master molecule that guides the destiny of these stem cells has the potential to result in even more effective treatments for heart patients, the Johns Hopkins researchers say.

In a study published in the June 5 online edition of journal Science Signaling, the Johns Hopkins team reported that tinkering with a protein molecule called p190RhoGAP shaped the development of cardiac stem cells and prodded them to become the building blocks for either blood vessels or heart muscle. The scientists said that by altering levels of this protein, they were able to affect the future of these stem cells. In biology, finding a central regulator like this is like finding a pot of gold, said Andre Levchenko, a biomedical engineering professor and member of the Johns Hopkins Institute for Cell Engineering, who supervised the research effort.

The lead author of the journal article, Kshitiz, a postdoctoral fellow who uses only his first name, said, Our findings greatly enhance our understanding of stem cell biology and suggest innovative new ways to control the behavior of cardiac stem cells before and after they are transplanted into a patient. This discovery could significantly change the way stem cell therapy is administered in heart patients.

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"Master Molecule" May Help Heart Treatment

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

Osiris Therapeutics, Inc. (OSIR), announced today interim one-year results from its groundbreaking clinical trial evaluating Prochymal (remestemcel-L) for the treatment of patients experiencing first-time acute myocardial infarction. The trial is the largest study of allogeneic or "off-the-shelf" stem cells ever conducted in heart attack patients. A total of 220 patients were given a single infusion of either Prochymal or placebo through a standard intravenous line within seven days of an acute heart attack.

Cardiac MRI assessments were conducted for six months following infarct to evaluate cardiac remodeling. Patients receiving Prochymal had significantly less cardiac hypertrophy, as measured by cardiac MRI, compared to patients receiving placebo (p<0.05). Patients treated with Prochymal also experienced significantly less stress-induced ventricular arrhythmia (p<0.05). Cardiac hypertrophy and ventricular arrhythmia are indicators of pathological remodeling following heart injury and provide insight into the mechanism by which mesenchymal stem cells attenuate heart injury following a myocardial infarction.

The mechanistic data is complemented by clinical data showing treatment with Prochymal resulted in a statistically significant reduction in heart failure. In the study, seven patients who were treated with placebo have progressed to heart failure requiring treatment with intravenous diuretics, compared to none of the Prochymal patients (p=0.01). Furthermore, patients receiving placebo tended to require re-hospitalization for cardiac issues sooner than the patients receiving Prochymal (median 27.5 days vs. 85.5 days).

This study is the largest of its kind and provides key insights into the mechanism of action of mesenchymal stem cells in the setting of acute myocardial infarction, said Lode Debrabandere, Ph.D., Senior Vice President of Therapeutics at Osiris. These important mechanistic observations are consistent with data obtained from our preclinical models and from the first placebo-controlled human trial with Prochymal published in the Journal of the American College of Cardiology. Given the quality of the data and highly encouraging results observed thus far, we are extending the trial's duration to capture a better understanding of the long-term clinical benefits of MSCs."

The trial also demonstrated that treatment with Prochymal was safe. There were no infusional toxicities observed in patients receiving Prochymal. Serious adverse events occurred with equal frequency in both treatment groups (31.8%). To date, there have been 5 deaths in the trial, 2 in the Prochymal group and 3 in the placebo group.

For interventional cardiologists, keeping our myocardial infarction patients from progressing to heart failure is central to our mission, said Mark Vesely, M.D., Principal Investigator on the Study and Assistant Professor of Medicine (Interventional Cardiology) at the University of Maryland School of Medicine. It is remarkable and very encouraging to see significant changes in clinically meaningful parameters this early in the study. We look forward to the additional data that will be gathered as the study progresses, which will help us to better understand both the magnitude and durability of the benefit to treatment.

Prochymal, the worlds first and only stem cell drug approved by an internationally recognized regulatory authority, is used for the treatment of graft vs. host disease (GvHD). GvHD is a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected. 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).

About the Trial

This Phase 2, multi-center, randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of Prochymal (ex-vivo cultured adult human mesenchymal stem cells) intravenous infusion following acute myocardial infarction. A total of 220 patients were randomized (1:1) at 33 centers in the United States and Canada and received a single intravenous infusion of Prochymal or placebo within 7 days following first acute myocardial infarction. In addition to screening and baseline visits prior to the infusion, initially follow-up evaluations were scheduled to be conducted through 2 years. Given the encouraging results observed at the one year time-point, the trial is being extended to include 5 years of follow-up. Both male and female subjects between 21 and 85 years of age were enrolled. Patients had to have a left ventricular ejection fraction (LVEF) between 20% and 45% as determined by quantitative echocardiography or cardiac MRI at least 24 hours after successful reperfusion of the culprit vessel. In addition, troponin levels must have been greater than 4 times the upper limit of normal during the first 72 hours of hospitalization for the MI.

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Prochymal Significantly Reduces Hypertrophy, Arrhythmia and Progression to Heart Failure in Patients Suffering a Heart ...

Editor's Choice Main Category: Muscular Dystrophy / ALS Also Included In: Transplants / Organ Donations Article Date: 29 Jun 2012 - 11:00 PDT

Current ratings for: Stem Cells From Muscular Dystrophy Patients Transplanted Into Mice

A new study published in Science Translational Medicine reveals that researchers have, for the first time, managed to turn fibroblast cells, i.e. common cells within connective tissue, from muscular dystrophy patients into stem cells and subsequently changed these cells into muscle precursor cells. After modifying the muscle precursor cells genetically, the researchers transplanted them into mice.

In future, this new technique could be used in order to treat patients with the rare condition of limb-girdle muscular dystrophy, which primarily affects the shoulders and hips, and maybe other types of muscular dystrophies. The method was initially developed in Milan at the San Raffaele Scientific Institute and was completed at UCL.

Muscular dystrophy is a genetic disorder, which typically affects skeletal muscles. The condition leads to severely impaired mobility and can, in severe cases result in respiratory and cardiac dysfunction. At present, there is no effective treatment for the condition. A number of new potential therapies, including cell therapy, are entering clinical trials.

The scientists of this study concentrated their research on genetically modifying mesoangioblasts, i.e. a self-renewing cell that originates from the dorsal aorta and differentiates into most mesodermal tissues, which demonstrated its potential for treating muscular dystrophy in earlier studies.

Given that the muscles of patients with muscular dystrophy are depleted of mesonangioblasts, the researchers were unable to obtain sufficient numbers of these cells from patients with limb-girdle muscular dystrophy, and therefore "reprogrammed" adult cells from these patients into stem cells, which enabled them to prompt them to differentiate into mesoangioblast-like cells.The team then genetically corrected these 'progenitor' cells by using a viral vector, and injected them into mice with muscular dystrophy so that the cells targeted damaged muscle fibers.

In a mice study, the same process demonstrated that dystrophic mice were able to run on a treadmill for longer a longer time than dystrophic mice that did not receive the cells.

Research leader, Dr Francesco Saverio Tedesco, from UCL Cell & Developmental Biology, who led the study, explained:

Professor Giulio Cossu, also an author at UCL, concluded:

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Stem Cells From Muscular Dystrophy Patients Transplanted Into Mice

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

Osiris Therapeutics, Inc. (OSIR), announced today the expansion of its intellectual property protection around Prochymal (remestemcel-L). The United States Patent and Trademark Office recently granted Osiris two patents that cover multiple mechanisms of action related to cardiac tissue repair. Additionally, Osiris has enhanced its mesenchymal stem cell (MSC) patent estate with the issuance of patents across Europe and Australia covering stem cells expressing all therapeutically useful levels of cell surface receptors for TNF-alpha, a receptor essential to the cell's ability to counteract inflammation. These patents further support Osiris' considerable intellectual property position, which includes 48 issued U.S. patents around the production, composition, testing and use of the mesenchymal stem cell from both allogeneic and autologous sources.

"These recent additions to Osiris patent estate, combined with the existing broad coverage of our pioneering MSC platform technology, reinforce our industry leading IP portfolio and bolster our dominant position regarding the manufacture and use of mesenchymal stem cells for the treatment of a broad range of diseases, said Chris Alder, Chief Intellectual Property Counsel of Osiris. We have invested significant time and resources building our intellectual property estate, and with the commercialization of Prochymal, we are preparing to take the necessary action to enforce our considerable rights.

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. With Prochymal (remestemcel-L) entering commerce, Osiris has initiated the process of identifying entities that may be infringing upon its intellectual property rights and will take appropriate action as necessary.

About Prochymal (remestemcel-L)

Prochymal is the worlds first approved drug with a stem cell as its active ingredient. Developed by Osiris Therapeutics, Prochymal is an intravenous formulation of MSCs, which are derived from the bone marrow of healthy adult donors between the ages of 18 and 30 years. The MSCs are selected from the bone marrow and grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor. Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is approved in Canada and New Zealand for the management of acute graft-versus-host disease (GvHD) in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in a Phase 3 trial for refractory Crohns disease and is also being evaluated in clinical trials for the treatment of myocardial infarction (heart attack) and type 1 diabetes.

About Osiris Therapeutics

Osiris Therapeutics, Inc. is the leading stem cell company, having developed the worlds first approved stem cell drug, Prochymal. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. In Biosurgery, Osiris currently markets Grafix for burns and chronic wounds, and Ovation for orthopedic applications. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 48 U.S. and 144 foreign patents.

Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, http://www.Osiris.com. (OSIRG)

Forward-Looking Statements

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Osiris Bolsters its Stem Cell Intellectual Property Estate

ScienceDaily (June 27, 2012) Stem cells from patients with a rare form of muscular dystrophy have been successfully transplanted into mice affected by the same form of dystrophy, according to a new study published June 27 in Science Translational Medicine.

For the first time, scientists have turned muscular dystrophy patients' fibroblast cells (common cells found in connective tissue) into stem cells and then differentiated them into muscle precursor cells. The muscle cells were then genetically modified and transplanted into mice.

The new technique, which was initially developed at the San Raffaele Scientific Institute of Milan and completed at UCL, could be used in the future for treating patients with limb-girdle muscular dystrophy (a rare form in which the shoulders and hips are primarily affected) and, possibly, other forms of muscular dystrophies.

Muscular dystrophies are genetic disorders primarily affecting skeletal muscle that result in greatly impaired mobility and, in severe cases, respiratory and cardiac dysfunction. There is no effective treatment, although several new approaches are entering clinical testing including cell therapy.

In this study, scientists focused on genetically modifying a type of cell called a mesoangioblast, which is derived from blood vessels and has been shown in previous studies to have potential in treating muscular dystrophy. However, the authors found that they could not get a sufficient number of mesoangioblasts from patients with limb-girdle muscular dystrophy because the muscles of the patients were depleted of these cells.

Instead, scientists in this study "reprogrammed" adult cells from patients with limb-girdle muscular dystrophy into stem cells and were able to induce them to differentiate into mesoangioblast-like cells. After these 'progenitor' cells were genetically corrected using a viral vector, they were injected into mice with muscular dystrophy, where they homed-in on damaged muscle fibres.

The researchers also showed that when the same muscle progenitor cells were derived from mice the transplanted cells strengthened damaged muscle and enabled the dystrophic mice to run for longer on a treadmill than dystrophic mice that did not receive the cells.

Dr Francesco Saverio Tedesco, UCL Cell & Developmental Biology, who led the study, said: "This is a major proof of concept study. We have shown that we can bypass the limited amount of patients' muscle stem cells using induced pluripotent stem cells and then produce unlimited numbers of genetically corrected progenitor cells.

"This technique may be useful in the future for treating limb-girdle muscular dystrophy and perhaps other forms of muscular dystrophy."

Professor Giulio Cossu, another UCL author, said: "This procedure is very promising, but it will need to be strenuously validated before it can be translated into a clinical setting, also considering that clinical safety for these "reprogrammed" stem cells has not yet been demonstrated for any disease."

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Successful transplant of patient-derived stem cells into mice with muscular dystrophy

SUNRISE, Fla., June 25, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that Kristin Comella, the company's Chief Science Officer presented at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan June 13 - 16, 2012. One of the world's premier stem cell research events, the ISSCR format includes international research and poster presentations from invited speakers, exceptional peer-to-peer learning and unparalleled networking opportunities.

Comella presented a poster on clinical applications of adipose or fat derived stem cells (ADSCs).

The ISSCR annual meeting serves as the largest forum for stem cell and regenerative medicine professionals from around the world. Through lectures, symposia, workshops, and events attendees experience innovative stem cell and regenerative medicine research, advances and what's on the horizon. The meeting features more than 1,000 abstracts, nearly 150 speakers and provides numerous networking and professional development opportunities and social events. For additional information, visit http://www.isscr.org.

Kristin Comella has over 14 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development and senior management including more than 10 years of cell culturing experience. She has made a significant contribution to Bioheart's product development, manufacturing and quality systems since she joined the company in September 2004.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

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Bioheart's Chief Science Officer Kristin Comella Presents at 10th Annual Meeting of International Society for Stem ...

23-06-2012 01:57 I have become so worried about my health because without health I will never get to experience the happiness of falling in love. I now do a Roberg test after every gym workout along with a couple of other tests. I also found out my cousin may be having his pacemaker removed from his heart because there is a surgery to correct his heart without the need for this implanted machine. He has had a pacemaker since his early 20s. It is a possibility I could have what my cousin has and that could possibly explain some of my symptoms. I do feel many doctors in Colombia will do a better job at diagnosing and treating someone with my symptoms. I am seriously considering going for examinations in Colombia and may even seek out treatment there or in another country. I do believe a radical and aggressive approach to both my physical and mental health will definitely enable me to find love in life and make massive amount of friends to share my activities with. I get so jealous of seeing guys in the gym with their girlfriend and friends. I just want to be happy and loved. I basically believe I can still be salvaged!

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Romberg Test/ Cardiac Pacemaker Removal?/Finding Love in Life/Stem Cell Treatment - Video

ScienceDaily (June 20, 2012) Johns Hopkins researchers have discovered that a single protein molecule may hold the key to turning cardiac stem cells into blood vessels or muscle tissue, a finding that may lead to better ways to treat heart attack patients.

Human heart tissue does not heal well after a heart attack, instead forming debilitating scars. However, for reasons not completely understood, stem cells can assist in this repair process by turning into the cells that make up healthy heart tissue, including heart muscle and blood vessels. Recently, doctors elsewhere have reported promising early results in the use of cardiac stem cells to curb the formation of unhealthy scar tissue after a heart attack. But the discovery of a "master molecule" that guides the destiny of these stem cells could result in even more effective treatments for heart patients, the Johns Hopkins researchers say.

In a study published in the June 5 online edition of journal Science Signaling, the team reported that tinkering with a protein molecule called p190RhoGAP shaped the development of cardiac stem cells, prodding them to become the building blocks for either blood vessels or heart muscle. The team members said that by altering levels of this protein, they were able to affect the future of these stem cells.

"In biology, finding a central regulator like this is like finding a pot of gold," said Andre Levchenko, a biomedical engineering professor and member of the Johns Hopkins Institute for Cell Engineering, who supervised the research effort.

The lead author of the journal article, Kshitiz, a postdoctoral fellow who uses only his first name, said, "Our findings greatly enhance our understanding of stem cell biology and suggest innovative new ways to control the behavior of cardiac stem cells before and after they are transplanted into a patient. This discovery could significantly change the way stem cell therapy is administered in heart patients."

Earlier this year, a medical team at Cedars-Sinai Medical Center in Los Angeles reported initial success in reducing scar tissue in heart attack patients after harvesting some of the patient's own cardiac stem cells, growing more of these cells in a lab and transfusing them back into the patient. Using the stem cells from the patient's own heart prevented the rejection problems that often occur when tissue is transplanted from another person.

Levchenko's team has been trying to figure out what, at the molecular level, causes the stem cells to change into helpful heart tissue. If they could solve this mystery, the researchers hoped the cardiac stem cell technique used by the Los Angeles doctors could be altered to yield even better results.

During their research, the Johns Hopkins team members wondered whether changing the surface on which the harvested stem cells grew would affect the cells' development. The researchers were surprised to find that growing the cells on a surface whose rigidity resembled that of heart tissue caused the stem cells to grow faster and to form blood vessels. This cell population boom had occurred far less often in the stem cells grown in the glass or plastic dishes typically used in biology labs. This result also suggested why formation of cardiac scar tissue, a structure with very different rigidity, can inhibit stem cells naturally residing there from regenerating the heart.

Looking further into this stem cell differentiation, the Johns Hopkins researchers found that the increased cell growth occurred when there was a decrease in the presence of the protein p190RhoGAP. "It was the kind of master regulator of this process," Levchenko said. "And an even bigger surprise was that if we directly forced this molecule to disappear, we no longer needed the special heart-matched surfaces. When the master regulator was missing, the stem cells started to form blood vessels, even on glass."

A final surprise occurred when the team decided to increase the presence of p190RhoGAP, instead of making it disappear. "The stem cells started to turn into cardiac muscle tissue, instead of blood vessels," Levchenko said. "This told us that this amazing molecule was the master regulator not only of the blood vessel development, but that it also determined whether cardiac muscles and blood vessels would develop from the same cells, even though these types of tissue are quite different."

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'Master molecule' may improve stem cell treatment of heart attacks

A new camera system allows researchers to measure multiple cardiac signals at once to understand how they interact to control heart function.

THE DEVICE: A complex interplay of signals governs the hearts rhythm. Voltage changes and calcium flux are both important in controlling heart muscle function, with each signal influencing the others dynamics. Scientists at the University of Oxford have created a single camera system that can capture the dynamics of these signals simultaneously, yielding important insight into their relationship.

Peter Lee and colleagues combined several colors of light emitting diodes (LEDs) with a multi-band emission filter so that one very high speed camera could capture the different wavelengths of light emitted by various fluorescent dyes. By using different colors of LEDs, they were able to stimulate different dyes to measure changes in calcium and voltage across cardiac tissue or single layers of human cardiomyocytes (created from induced pluripotent stem cells).

WHATS NEW:The new setup took advantage of advances in lighting technology, explained Lee. While many older systems used xenon lamps, LEDs are cheap, cover the spectrum from infrared to ultraviolet, and reach peak intensity almost immediatelyallowing for ultra-rapid switching between excitation colors. Many previous systems also relied on a moving wheel to switch between colors, and thus measure different signals, explained Guy Salama, who researches cardiac arrhythmias at the University of Pittsburgh, but was not involved in the new cameras development. The wheels needed to move uniformly without wobbling, which would throw off its precision measurements, said Salama, and meant that each parameter had to be recorded for exactly the same amount of time. But Lees system, which uses electronics to control the length of time each LED shines, allows for different excitation times for each parameter of interestwhich is important as not all physiological changes happen on the same time scale, said Salama. Lees system has also jettisoned the need for moving parts, which can require careful alignment.

Single camera and LED system. Peter Lee

IMPORTANCE: Because calcium and voltage changes interact to control cardiac function, and perturbations in either leading to dysfunctions like arrhythmia, Lees camera system provides researchers with a tool to further investigate the interaction between the two signals, and thus gain a deeper understanding of cardiac function.

Using a single camera with multiple emission filters also allowed Lee and his collaborators to measure calcium properly, Lee explained. Many previous experiments used high-affinity calcium dyes, which bound strongly but could perturb the signal. The strong LEDs allowed for weaker-binding dyes, and ratiometric calcium measurement, meaning the dyes display shifts in emission wavelength upon binding calcium. Researchers can then quantify the concentration of calcium based on the light emissions they detect and calcium flux simultaneously.

Additionally, explained Lee, the simplicity of the system makes it more easily scalable. LEDs are cheap and perform well, and the lack of moving parts makes setup much easier than multi-camera systems that need careful calibration.

NEEDS IMPROVEMENT: As appealingly simple as a one-camera setup is, a single camera and multiple light sources can also introduce new hurdles, explained Salama. Because one camera is being used to capture multiple parameters, this cuts down on the number of image frames that can be devoted to each signal, noted Salama. For example, if a camera is running at 1,000 frames per second, but imaging four signals, only 250 of those frames would capture each parameter.

Salama also feared that lining up the LEDs and camera might result in the different light sources hitting the cardiac tissue at different angles, and bouncing off at different angles, making it difficult for the camera to capture them all. When visualizing the voltage and calcium propagations over a single layer of cells, scientists need to make sure the emissions theyre comparing are coming from the same locationso they arent trying to match voltage changes in one set of cells with calcium fluxes in another. When imaging microscopic-scale changes, Lee works around this problem by merging the lights into one path and using an optical fiber to direct all the colors to one site.

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Next Generation: The Heart Camera

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Stem cells tested for heart attack repair

This finding can help researchers model diseases in the lab, and allow these diseases to be studied

Researchers from the University of Wisconsin-Madison have found a way to turn both embryonic and induced pluripotent stem cells into cardiomyocytes.

Sean Palecek, study leader and professor of chemical and biological engineering at the University of Wisconsin-Madison, along with Timothy Kamp, professor of cardiology at UW School of Medicine and Public Health, and Xiaojun Lian, a UW graduate student, have developed a technique for abundant cardiomyocyte production, which will allow scientists to better understand and treat diseases.

Cardiomyocytes are important cells that make up the beating heart. These cells are extremely difficult to obtain, especially in large quantities, because they only survive for a short period of time when retrieved from the human heart.

But now, the UW researchers have found an inexpensive method for developing an abundance of cardiomyocytes in the laboratory. This finding can help researchers model diseases in the lab, and allow these diseases to be studied. Researchers will also be able to tests drugs that could help fight these diseases, such as heart disease.

"Many forms of heart disease are due to the loss or death of functioning cardiomyocytes, so strategies to replace heart cells in the diseased heart continue to be of interest, said Kamp. "For example, in a large heart attack up to 1 billion cardiomyocytes die. The heart has a limited ability to repair itself, so being able to supply large numbers of potentially patient-matched cardiomyocytes could help."

The UW research team found that changing a signaling pathway called Wnt can help guide stem cell differentiation to cardiomyocytes. They just turned the Wnt pathway on and off at different times using two small molecule chemicals.

"Our protocol is more efficient and robust," said Palecek. "We have been able to reliably generate greater than 80 percent cardiomyocytes in the final population while other methods produce about 30 percent cardiomyocytes with high batch-to-batch variability.

"The biggest advantage of our method is that it uses small molecule chemicals to regulate biological signals. It is completely defined, and therefore more reproducible. And the small molecules are much less expensive than protein growth factors."

This study was published in the journal Proceedings of the National Academy of Sciences.

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New Method Turns Embryonic/Induced Pluripotent Stem Cells into Cardiac Muscle Cells

LAGUNA HILLS, Calif., May 29, 2012 /PRNewswire/ --LoneStar Heart Inc., today announced the advancement of a new therapeutic strategy aimed at genetic reprogramming of cardiac fibroblasts into functioning heart muscle cells to treat damage following a heart attack and other forms of heart disease. The announcement follows a study conducted by researchers at the University of Texas Southwestern Medical Center (UT Southwestern), published in the on-line May 13th issue of the journal Nature, demonstrating feasibility of the approach. The company has acquired exclusive worldwide rights to the new technology.

The adult human heart has almost no regenerative capacity. Instead of rebuilding muscle tissue after a heart attack, or myocardial infarction, the injured human heart forms fibrous, non-contractile scar tissue lacking muscle or blood vessels. Fibroblasts account for a majority of cells in the heart and are activated following injury to form this fibrotic scar tissue. Fibrosis impedes regeneration of cardiac muscle cells, and contributes to loss of contractile function, ultimately leading to heart failure and death. Therapeutic strategies to promote new muscle formation, while limiting fibrosis, represent an attractive approach for heart repair.

As reported in Nature, Eric N. Olson, Ph.D., and colleagues from UT Southwestern show that four gene-regulatory proteins GATA4, HAND2, MEF2C, and TBX5 (GHMT) can convert cardiac fibroblasts into beating cardiac-like muscle cells. Introduction of these proteins into proliferating fibroblasts in mice reprograms them into functional cardiac-like myocytes, improving cardiac function and reducing fibrosis and adverse remodeling of the heart following myocardial infarction. Using cell lineage-tracing techniques, the investigators conclude that newly formed cardiac-like muscle cells in GHMT-treated hearts arose from pre-existing cardiac fibroblasts. Cardiac imaging studies confirmed the new technique promoted a dramatic increase in cardiac function that was sustained for at least three months following myocardial infarction.

"These studies establish proof-of-concept for in vivo cellular reprogramming as a new approach for heart repair," said Dr. Olson, professor and chair of molecular biology at UT Southwestern, and a co-founder of LoneStar Heart. "However, much work remains to be done to determine if this strategy might eventually be effective in humans. We are working hard toward that goal."

The new reprogramming strategy may provide a novel means of improving cardiac function following injury, bypassing many of the obstacles associated with cellular transplantation. Prior work by Dr. Olson's group and others has shown that GHMT proteins fulfill similar roles in cardiac gene regulation in a wide range of organisms, including humans, highlighting the potential of these proteins to augment function of the injured human heart. While cellular replacement strategies via the introduction of stem cells or other cell types into injured hearts have shown promise, there have been numerous technical and biological hurdles associated with such approaches.

About LoneStar Heart, Inc.LoneStar Heart, Inc. is developing cardiac restorative therapies for patients with heart failure that stimulate the heart's ability to repair itself. Based on its integrated cardiomechanical and biomolecular technologies, the privately held company is advancing a broad portfolio of products to restore the failing heart's structure and function in collaboration with the Texas Heart Institute, UT Southwestern, and a global network of leading clinicians. These products include Algisyl-LVR,cardiac stem-cell modulators, and cellular and genetic therapies delivered as stand-alone treatments, or in combination with the company's biopolymer matrix system.

LoneStar Heart's lead product, Algisyl-LVR, is a single-use, self-gelling biopolymer implanted into the heart's left ventricle during surgery. Providing internal tissue support, Algisyl-LVR is aimed at preventing the progression of heart failure and restoring the heart's normal structure and function with a significant improvement in the patient's quality of life. Classified as a medical device, the product is undergoing a randomized controlled clinical study (AUGMENT-HF) in Europe to evaluate its safety and efficacy in patients with advanced heart failure.

About UT Southwestern Medical CenterUT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its faculty has many distinguished members, including five who have been awarded Nobel Prizes since 1985. Numbering more than 2,600, the faculty is responsible for groundbreaking medical advances and is committed to quickly translating science-driven research to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to more than 100,000 hospitalized patients, and oversee nearly 2 million outpatient visits a year.

Physicians care for patients in the Dallas-based UT Southwestern Medical Center; in Parkland Health & Hospital System, which is staffed primarily by UT Southwestern physicians; and in its affiliated hospitals, Children's Medical Center Dallas, Texas Scottish Rite Hospital for Children and the VA North Texas Health Care System. UT Southwestern programs are offered in Waco, Wichita Falls, Plano/Frisco and Fort Worth. Three degree-granting institutions UT Southwestern Medical School, UT Southwestern Graduate School of Biomedical Sciences and UT Southwestern School of Health Professions train nearly 4,600 students, residents and fellows each year. UT Southwestern researchers undertake more than 3,500 research projects annually, totaling more than $417 million.

Dr. Olson holds the Pogue Distinguished Chair in Research on Cardiac Birth Defects, the Robert A. Welch Distinguished Chair in Science, and the Annie and Willie Nelson Professorship in Stem Cell Research at UT Southwestern.

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Heart Damage Repaired By Reprogramming Resident Fibroblasts into Functioning Heart Cells