Some Stem-Cells May Not Be The Answer For Heart Disease

June 12, 2012

The use of stem-cells building-block cells that are harvested from embryos or adults to treat heart disease could rely on faith as much as it does science, after billions of dollars in research has not produced the results that researchers have been looking for.

Questions and concerns on the topic arose during the recent opening of the multi-million-dollar Scottish Center for Regenerative Medicine (SCRM) in Edinburgh, chaired by Sir Ian Wilmut, the renowned scientist whose Dolly the sheep clone in 1996, was a groundbreaking step in stem cell technology.

During the opening ceremonies of the Center, Christine Mummery of the Leiden University Medical Center in the Netherlands discussed how a 2001 claim, based on mice experimentation, indicated that bone-marrow cells could mend heart damaged by coronary disease, caused a mad rush of people to the clinics looking for a cure-all.

With nothing in the way of systematic research in animals, the first patients were being treated within a year, prematurely by Mummerys account. She argued that the paper that launched the mass stampede was completely wrong, and subsequent studies proved that. But despite the findings, the 2001 paper has never been withdrawn.

Norwegian professor Harald Arnesen in 2007 voiced his concerns over those heart trials as well. He concluded that they were not convincing and that one German team had achieved striking results only because the control group had done particularly badly. Arnesen called for a moratorium on this kind of stem-cell therapy, based on that research.

But neither Arnesen, nor Mummery, could deter clinicians. Another trial, the largest to date, began in January 2012 and included 3,000 heart-attack patients recruited from across Europe. The trial was funded by the European Union as well.

The idea behind the trials is straightforward. During a heart attack, a clogged blood vessel starves heart muscle of oxygen. Up to a billion heart muscle cells, called cardiomyocytes, can be damaged, and the body responds by replacing them with relatively inflexible scar tissue, which can lead to fatal heart failure.

What is notably surprising, explained Mummery, is that stem cells come in many different forms: Embryonic stem cells are the building-blocks of the body and have the potential to turn into all 200 cell types found in the human body. Adult stem cells, however, are limited in what they can do. For example, bone marrow stem cells only generate blood cells.

So, the 2001 study claiming that bone marrow stem cells could turn into healthy heart muscle was a surprising and exciting claim, although a bold move.

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Some Stem-Cells May Not Be The Answer For Heart Disease

Clues Found to Way Embryonic Kidney Maintains Its Fleeting Stem Cells

Newswise Studying mice and humans, researchers at Washington University School of Medicine in St. Louis and their collaborators in Paris have identified two proteins that are required to maintain a supply of stem cells in the developing kidney.

In the presence of the two proteins, FGF9 and FGF20, mouse kidney stem cells stayed alive outside the body longer than previously reported. Though the cells were maintained only five days (up from about two), the work is a small step toward the future goal of growing kidney stem cells in the lab.

In the developing embryo, these early stem cells give rise to adult cells called nephrons, the blood filtration units of the kidneys.

The results appear online June 11 in Developmental Cell.

When we are born, we get a certain allotment of nephrons, says Raphael Kopan, PhD, the Alan A. and Edith L. Wolff Professor of Developmental Biology. Fortunately, we have a large surplus. We can donate a kidney give away 50 percent of our nephrons and still do fine. But, unlike our skin and gut, our kidneys cant build new nephrons.

The skin and the gut have small pools of stem cells that continually renew these organs throughout life. Scientists call such pools of stem cells and their support system a niche. During early development, the embryonic kidney has a stem cell niche as well. But at some point before birth or shortly after, all stem cells in the kidney differentiate to form nephrons, leaving no self-renewing pool of stem cells.

In other organs, there are cells that specifically form the niche, supporting the stem cells in a protected environment, Kopan says. But in the embryonic kidney, it seems the stem cells form their own niche, making it a bit more fragile. And the signals and conditions that lead the cells to form this niche have been elusive.

Surprisingly, recent clues to the signals that maintain the embryonic kidneys stem cell niche came from studies of the inner ear. David M. Ornitz, MD, PhD, the Alumni Endowed Professor of Developmental Biology, investigates FGF signaling in mice. Earlier this year, Ornitz and his colleagues published a paper in PLoS Biology showing that FGF20 plays an important role in inner ear development.

Mice without FGF20 are profoundly deaf, Ornitz says. While they are otherwise viable and healthy, in some cases we noticed that their kidneys looked small.

Past work from his own lab and others suggested that FGF9, a close chemical cousin of FGF20, might also participate in kidney development. FGF20 and FGF9 are members of a family of proteins known as fibroblast growth factors. In general, members of this family are known to play important and broad roles in embryonic development, tissue maintenance, and wound healing. Mice lacking FGF9 have defects in development of the male urogenital tract and die after birth due to defects in lung development.

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Clues Found to Way Embryonic Kidney Maintains Its Fleeting Stem Cells

A Better Way to Grow Bone: Fresh, Purified Fat Stem Cells Grow Bone Better, Faster

Newswise UCLA stem cell scientists purified a subset of stem cells found in fat tissue and made from them bone that was formed faster and was of higher quality than bone grown using traditional methods, a finding that may one day eliminate the need for painful bone grafts that use material taken from the patient during invasive procedures.

Adipose, or fat, tissue is thought to be an ideal source of cells called mesenchymal stem cells - capable of developing into bone, cartilage, muscle and other tissues - because they are plentiful and easily attained through procedures such as liposuction, said Dr. Chia Soo, vice chair for research at UCLA Plastic and Reconstructive Surgery. The co-senior authors on the project, Soo and Bruno Pault, 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 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 arent capable of becoming bone.

Pault and Soos 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 the bone formation in their animal model.

People have shown that culture-derived cells could grow bone, but these are a fresh cell population and we didnt 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 appears June 11, 2012 in the early online edition of the peer-reviewed journal Stem Cells Translational Medicine, a new journal that seeks to bridge stem cell research and clinical trials.

In the animal model, Soo and Paults 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.

Soo said if everything goes well, patients may one day have rapid access to high quality bone graft material by which doctors get their fat tissue, purify that into hPSCs and replace their own stem cells with NELL-1 back into the area where bone is required. The hPSC with NELL-1 could grow into bone inside the patient, eliminating the need for painful bone graft harvestings. The goal is for the process to isolate the hPSCs and add the NELL-1 with a matrix or scaffold to aid cell adhesion to take less than an hour, Soo said.

Excitingly, recent studies have already demonstrated the utility of perivascular stem cells for regeneration of disparate tissue types, including skeletal muscle, lung and even myocardium, said Pault, a professor of orthopedic surgery Further studies will extend our findings and apply the robust osteogenic potential of hPSCs to the healing of bone defects.

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A Better Way to Grow Bone: Fresh, Purified Fat Stem Cells Grow Bone Better, Faster

Scientists Discover A Stem Cell That Causes Heart Disease

Editor's Choice Main Category: Heart Disease Also Included In: Stem Cell Research Article Date: 09 Jun 2012 - 2:00 PDT

Current ratings for: 'Scientists Discover A Stem Cell That Causes Heart Disease'

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The research is profound because it contradicts much of the generally accepted theories of what causes arterial hardening, and the concept may also relate to many other diseases could the associated stem cells be pinpointed.

What senior author Song Li, a bioengineering professor at UC Berkeley and a researcher at the Berkeley Stem Cell Center, and his team have uncovered is a dormant stem cell in blood vessel walls, that seems to sit inactive for most of a person's lifetime, before coming to life and causing less functional cells to begin to grow. Li says these new types of cells that start growing in later life, are the root cause of arterial hardening and clogging that are associated with deadly strokes and heart attacks.

Originally, it was thought that the smooth muscle cells in the arteries lining become scarred over time, and this leads to the narrow and brittle arteries that play a major part in causing cardiovascular disease. Not so says Liu: Essentially, what the scientists are saying is that the smooth muscle cells are not to blame. Rather a different kind of stem cell, that Li calls multipotent vascular stem cells, kicks in, and begins growing cells that look much like the smooth muscle cells, but don't function correctly. The cells were not found previously, because there are so few of them, that they were hard to isolate.

Li continues:

It almost sounds like something from Blade Runner, where the replicant humans have been deliberately designed to deteriorate and die at a much faster rate than the natural ones. What purpose would it serve the body under standard evolutionary terms to have cells activating later in life that effectively lead to its demise? With the arteries poorly formed, with wrong cell types, the blood flow becomes slowed and can then stopped completely. This causes strokes or heart attacks, depending on the location of the blockage. Strokes and heart attacks are one of the leading causes of death in the United States.

Creating drugs or other genetic treatments to shut down these stem cells or even deactivate them while a person is still young has the potential in the future to prevent arteriole hardening, reverse the damage already done, and even make this type of cardiovascular disease a thing of the past. Perhaps the futuristic Woody Allen movie "Sleeper" where people smoke tobacco and eat a high fat diet because it's healthier is not so far fetched after all.

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Scientists Discover A Stem Cell That Causes Heart Disease

Mechanism that maintains stem cells readiness identified

ScienceDaily (May 31, 2012) An immune-system receptor plays an unexpected but crucially important role in keeping stem cells from differentiating and in helping blood cancer cells grow, researchers at UT Southwestern Medical Center report today in the journal Nature.

"Cancer cells grow rapidly in part because they fail to differentiate into mature cells. Drugs that induce differentiation can be used to treat cancers," said Dr. Chengcheng "Alec" Zhang, assistant professor in UT Southwestern's departments of physiology and developmental biology. "Our research identified a protein receptor on cancer cells that inhibits differentiation, and knowing the identity of this protein should facilitate the development of new drugs to treat cancers."

The family of proteins investigated in the study could help open a new field of biology integrating immunology with stem cell and cancer research, he added.

"The receptor we identified turned out to be a protein called a classical immune inhibitory receptor, which is known to maintain stemness of normal adult stem cells and to be important in the development of leukemia," he said.

Stemness refers to the blood stem cells' potential to develop into a range of different kinds of cells as needed, for instance to replenish red blood cells lost to bleeding or to produce more white blood cells to fight off infection. Once stem cells differentiate into adult cells, they cannot go back to being stem cells. Current thinking is that the body has a finite number of stem cells and it is best to avoid depleting them, Dr. Zhang explained.

Prior to this study, no high-affinity receptors had been identified for the family of seven proteins called the human angiopoetic-like proteins. These seven proteins are known to be involved in inflammation, supporting the activity of stem cells, breaking down fats in the blood, and growing new blood vessels to nourish tumors. Because the receptor to which these proteins bind had not been identified, the angiopoetic-like proteins were referred to as "orphans," he said.

The researchers found that the human immune-inhibitory receptor LILRB2 and a corresponding receptor on the surface of mouse cells bind to several of the angiopoetic-like proteins. Further studies, Dr. Zhang said, showed that two of the seven family members bind particularly well to the LILRB2 receptor and that binding exerts an inhibitory effect on the cell, similar to a car's brakes.

In the case of stem cells, inhibition keeps them in their stem state. They retain their potential to mature into all kinds of blood cells as needed but they don't use up their energy differentiating into mature cells. That inhibition helps stem cells maintain their potential to create new stem cells because in addition to differentiation, self-renewal is the cells' other major activity, Dr. Zhang said. He stressed that the inhibition doesn't cause them to create new stem cells but does preserve their potential to do so.

In future research, the scientists hope to find subtle differences between stem cells and leukemia cells that will identify treatments to block the receptors' action only in leukemia.

Other UT Southwestern researchers involved in the study from the departments of physiology and developmental biology include postdoctoral researchers Dr. ChangHao Cui, Dr. Xiaoli Chen, Dr. Chaozheng Zhang, Dr. HoangDinh Huynh, and Dr. Xunlei Kang; senior research associates Robert Silvany and Jiyuan Li; and graduate student Xuan Wan. Researchers from the department of immunology include former technician Alberto Puig Cant and Dr. E. Sally Ward, professor of immunology.

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Mechanism that maintains stem cells readiness identified

UT Southwestern Researchers Identify Mechanism That Maintains Stem-Cell Readiness, Helps Leukemia Cells Growth

Newswise DALLAS May 31, 2012 An immune-system receptor plays an unexpected but crucially important role in keeping stem cells from differentiating and in helping blood cancer cells grow, researchers at UT Southwestern Medical Center report today in the journal Nature.

Cancer cells grow rapidly in part because they fail to differentiate into mature cells. Drugs that induce differentiation can be used to treat cancers, said Dr. Chengcheng Alec Zhang, assistant professor in UT Southwesterns departments of physiology and developmental biology. Our research identified a protein receptor on cancer cells that inhibits differentiation, and knowing the identity of this protein should facilitate the development of new drugs to treat cancers.

The family of proteins investigated in the study could help open a new field of biology integrating immunology with stem cell and cancer research, he added.

The receptor we identified turned out to be a protein called a classical immune inhibitory receptor, which is known to maintain stemness of normal adult stem cells and to be important in the development of leukemia, he said.

Stemness refers to the blood stem cells potential to develop into a range of different kinds of cells as needed, for instance to replenish red blood cells lost to bleeding or to produce more white blood cells to fight off infection. Once stem cells differentiate into adult cells, they cannot go back to being stem cells. Current thinking is that the body has a finite number of stem cells and it is best to avoid depleting them, Dr. Zhang explained.

Prior to this study, no high-affinity receptors had been identified for the family of seven proteins called the human angiopoetic-like proteins. These seven proteins are known to be involved in inflammation, supporting the activity of stem cells, breaking down fats in the blood, and growing new blood vessels to nourish tumors. Because the receptor to which these proteins bind had not been identified, the angiopoetic-like proteins were referred to as orphans, he said.

The researchers found that the human immune-inhibitory receptor LILRB2 and a corresponding receptor on the surface of mouse cells bind to several of the angiopoetic-like proteins. Further studies, Dr. Zhang said, showed that two of the seven family members bind particularly well to the LILRB2 receptor and that binding exerts an inhibitory effect on the cell, similar to a cars brakes.

In the case of stem cells, inhibition keeps them in their stem state. They retain their potential to mature into all kinds of blood cells as needed but they dont use up their energy differentiating into mature cells. That inhibition helps stem cells maintain their potential to create new stem cells because in addition to differentiation, self-renewal is the cells other major activity, Dr. Zhang said. He stressed that the inhibition doesnt cause them to create new stem cells but does preserve their potential to do so.

In future research, the scientists hope to find subtle differences between stem cells and leukemia cells that will identify treatments to block the receptors action only in leukemia.

Other UT Southwestern researchers involved in the study from the departments of physiology and developmental biology include postdoctoral researchers Dr. ChangHao Cui, Dr. Xiaoli Chen, Dr. Chaozheng Zhang, Dr. HoangDinh Huynh, and Dr. Xunlei Kang; senior research associates Robert Silvany and Jiyuan Li; and graduate student Xuan Wan. Researchers from the department of immunology include former technician Alberto Puig Cant and Dr. E. Sally Ward, professor of immunology.

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UT Southwestern Researchers Identify Mechanism That Maintains Stem-Cell Readiness, Helps Leukemia Cells Growth

Researchers identify mechanism that maintains stem cells readiness

An immune-system receptor plays an unexpected but crucially important role in keeping stem cells from differentiating and in helping blood cancer cells grow, researchers at UT Southwestern Medical Center report today in the journal Nature.

"Cancer cells grow rapidly in part because they fail to differentiate into mature cells. Drugs that induce differentiation can be used to treat cancers," said Dr. Chengcheng "Alec" Zhang, assistant professor in UT Southwestern's departments of physiology and developmental biology. "Our research identified a protein receptor on cancer cells that induces differentiation, and knowing the identity of this protein should facilitate the development of new drugs to treat cancers."

The family of proteins investigated in the study could help open a new field of biology integrating immunology with stem cell and cancer research, he added.

"The receptor we identified turned out to be a protein called a classical immune inhibitory receptor, which is known to maintain stemness of normal adult stem cells and to be important in the development of leukemia," he said.

Stemness refers to the blood stem cells' potential to develop into a range of different kinds of cells as needed, for instance to replenish red blood cells lost to bleeding or to produce more white blood cells to fight off infection. Once stem cells differentiate into adult cells, they cannot go back to being stem cells. Current thinking is that the body has a finite number of stem cells and it is best to avoid depleting them, Dr. Zhang explained.

Prior to this study, no high-affinity receptors had been identified for the family of seven proteins called the human angiopoetic-like proteins. These seven proteins are known to be involved in inflammation, supporting the activity of stem cells, breaking down fats in the blood, and growing new blood vessels to nourish tumors. Because the receptor to which these proteins bind had not been identified, the angiopoetic-like proteins were referred to as "orphans," he said.

The researchers found that the human immune-inhibitory receptor LILRB2 and a corresponding receptor on the surface of mouse cells bind to several of the angiopoetic-like proteins. Further studies, Dr. Zhang said, showed that two of the seven family members bind particularly well to the LILRB2 receptor and that binding exerts an inhibitory effect on the cell, similar to a car's brakes.

In the case of stem cells, inhibition keeps them in their stem state. They retain their potential to mature into all kinds of blood cells as needed but they don't use up their energy differentiating into mature cells. That inhibition helps stem cells maintain their potential to create new stem cells because in addition to differentiation, self-renewal is the cells' other major activity, Dr. Zhang said. He stressed that the inhibition doesn't cause them to create new stem cells but does preserve their potential to do so.

In future research, the scientists hope to find subtle differences between stem cells and leukemia cells that will identify treatments to block the receptors' action only in leukemia.

Journal reference: Nature

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Researchers identify mechanism that maintains stem cells readiness

LA BioMed's Dr. Patricia Dickson researching treatments for neurodegenerative disorders

Public release date: 30-May-2012 [ | E-mail | Share ]

Contact: Diana Soltesz diana@dsmmedia.com 818-592-6747 Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed)

LOS ANGELES (May 30, 2012) Patricia Dickson, M.D., principal investigator at The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed), is co-principal investigator of a project that was just awarded a $5.5 million grant from the California Institute for Regenerative Medicine (CIRM). The goal of the project is to develop a stem cell based therapy for the treatment of mucopolysaccharidosis I (MPS I), a fatal pediatric lysosomal storage disease that causes neurodegeneration as well as defects in other major organ systems. Dr. Dickson is working with lead investigator Philip H. Schwartz, Ph.D., senior scientist at the CHOC Children's Research Institute and managing director of the facility's National Human Neural Stem Cell Resource.

For nearly a decade, Dr. Dickson's research at LA BioMed has focused on enzyme replacement therapy for mucopolysaccharidosis, a group of metabolic disorders caused by the absence or malfunctioning of enzymes needed to break down molecules - called glycosaminoglycans - which help build bone, cartilage, connective tissue and other essential parts of the body. As part of this study, she and her colleagues will begin with proof-of-principle experiments for MPS I.

"Dr. Dickson has been at the forefront of mucopolysaccharidosis research for many years, working tirelessly to help develop therapies for MPS I," said David I. Meyer, Ph.D., president and CEO of LA BioMed. "We congratulate her on her continued success, and for her role in this project which could be an important breakthrough for children suffering from neurodegenerative disorders."

"The unique aspect of this research is that it uses a single donor for the transplantation of stem cells into the body and the brain, which allows the best treatment for both physical and neurological disease and avoids rejection of neural stem cell grafts by the host immune system," said Dr. Dickson. "Pediatric neurodegenerative diseases are generally neglected in stem cell research, but stand the greatest chance of success. The high probability of success, along with the need to alleviate suffering in children, is why we believe the first applications of stem cell therapies should be for these kids."

Dr. Schwartz, Dr. Dickson and project collaborators are working to address two critical issues in the development of a therapeutic candidate based on stem cells: that early intervention is not only required but is indeed possible in this patient population, and that the concept of immune tolerance is also required, where the immune system is trained to attack only real threats in the body but not the body's own cells or tissues.

To date, there is still a significant unmet medical need to better impact and prevent the neurodegenerative processes in this disease. If successful in MPS I, this technique can be expanded to help treat other neurodegenerative disorders due to lysosomal storage.

###

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LA BioMed's Dr. Patricia Dickson researching treatments for neurodegenerative disorders

Stemedica Stem Cells Approved for Clinical Trials in Mexico for Chronic Heart Failure

SAN DIEGO, May 29, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica Cell Technologies, Inc. announced today that its strategic partner in Mexico, Grupo Angeles Health Services, has received approval from Mexico's regulatory agency, COFEPRIS, for a Phase I/II single-blind randomized clinical trial for chronic heart failure. COFEPRIS is the Mexican equivalent of the United States FDA. The clinical trial, to be conducted at multiple hospital sites throughout Mexico, will utilize Stemedica's adult allogeneic ischemia tolerant mesenchymal stem cells (itMSC) delivered via intravenous infusion. The trial will involve three safety cohorts at different dosages, followed by a larger group being treated with the maximum safe dosage. The COFEPRIS approval is the second approval for the use of Stemedica's itMSCs. COFEPRIS approved Stemedica's itMSCs in 2010 for a clinical trial for ischemic stroke. These two trials are the only allogeneic stem cell studies approved by COFEPRIS.

Grupo Angeles is a Mexican company that is 100% integrated into the national healthcare development effort. The company is comprised of 24 state-of-the-art hospitals totaling more than 2,000 beds and 200 operating rooms. Eleven thousand Groupo Angeles physicians annually treat nearly five million patients a year. Of these, more than two million are seen as in-patients. In just over two decades, Groupo Angeles has radically transformed the practice of private medicine in Mexico and contributed decisively to reform in the country's health system. Grupo Angeles hospitals conduct an estimated 100 clinical trials annually, primarily with major global pharmaceutical and medical device companies.

"We are pleased that we will be working with the largest and most prestigious private medical institution in Mexico to study Stemedica's product for this indication. If successful, our stem cells may provide a treatment option for the millions of patients, both in Mexico and internationally, who suffer from this condition," said Maynard Howe, PhD, CEO of Stemedica Cell Technologies, Inc.

Roberto Simon, MD, CEO of Grupo Angeles Health Services, noted, "We are proud to be the first organization to bring regulatory-approved allogeneic stem cell treatment to the people of Mexico. We envision that this type of treatment may well become a standard for improving cardiac status for chronic heart failure patients and are pleased to be partnering with Stemedica, one of the leading companies in the field of regenerative medicine."

Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica commented, "For the more than five million North Americans who suffer from chronic heart failure, this is an important trial. Our ischemia tolerant mesenchymal stem cells hold the potential to improve ejection fraction--the amount of blood pumped with each heart beat--and therefore, dramatically improve quality of life."

For more information about Stemedica please contact Dave McGuigan at dmcguigan(at)stemedica(dot)com. For more information about Grupo Angeles and the chronic heart failure trial please contact Paulo Yberri at pyberri(at)angelesehealth(dot)com.

About Stemedica Cell Technologies, Inc. Stemedica Cell Technologies, Inc.(http://www.stemedica.com) is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

This article was originally distributed on PRWeb. For the original version including any supplementary images or video, visit http://www.prweb.com/releases/stemedica-clinical-trial/chronic-heart-failure/prweb9550806.htm

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Stemedica Stem Cells Approved for Clinical Trials in Mexico for Chronic Heart Failure

Osiris Receives Medicare Reimbursement Codes for Grafix®

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

Osiris Therapeutics, Inc. (OSIR), the leading stem cell company focused on developing and commercializing products to treat medical conditions in inflammatory, cardiovascular, orthopedic, and wound healing markets, announced today that it has received transitional pass-through status from the Center for Medicare & Medicaid Services (CMS), with C-Codes being designated for Grafix. Further, the product has been assigned pass-through status under Medicare's outpatient prospective payment system (OPPS), effective July 1, 2012. These codes will assist in facilitating reimbursement when Grafix products are used to treat Medicare patients with acute and chronic wounds in the hospital outpatient department and ambulatory surgical center settings.

We are very pleased with CMS, and their decision to assign pass-through codes for our Grafix line of Biosurgery products, said Frank Czworka, Executive Director, Wound Care of Osiris Therapeutics. This step will allow more Medicare patients and their providers to have greater access to these next-generation regenerative medicine products."

CMS also issued a preliminary positive decision for the assignment of permanent Healthcare Common Procedure Coding System (HCPCS) Q-codes for Grafix. If the decision is made permanent, it is anticipated that the Q-codes would be available starting in January 2013. The assignment of unique Q-codes will assist in facilitating reimbursement in the physician office setting, offering additional access for Medicare patients.

Non-healing wounds remain a serious unmet medical need and result in over 100,000 amputations each year in the United States alone. Current treatment options include growth factors and bioengineered dressings. However, when chronic wounds fail to respond to current standards of care, new advances are needed. Research shows that mesenchymal stem cells (MSCs) in normal skin play a critical role in the wound healing process. Grafix is the only commercially available product that provides viable, endogenous MSCs together with growth factors and an optimal tissue matrix, making it well suited to promote active dermal healing.

About Grafix

Grafix is a three-dimensional cellular matrix designed for application directly to acute and chronic wounds, including diabetic foot ulcers and burns. Flexible, conforming and immune neutral, this cellular repair matrix provides a rich source of viable, mesenchymal stem cells (MSCs) and growth factors directly to the site of the wound, while the matrix protects the area from inflammation, scarring, and infection. Grafix is manufactured using a unique proprietary process that preserves the matrix, cells and growth factors needed for successful healing.

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. Osiris currently markets Prochymal for pediatric refractory GvHD in Canada, Grafix for burns and chronic wounds, and Ovation for orthopedic applications. The companys pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee. 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)

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Osiris Receives Medicare Reimbursement Codes for Grafix®