Stem Cell Clinic

End to stem cell research challenge doesn't calm funding fears for scientists

By Stem Cell Treatment

Even as they celebrate clearing a legal hurdle, worries of stem cell research grant money evaporating constantly weigh on scientists like Dr. Ted Dawson, whose projects at Johns Hopkins Hospital have helped inform treatment of neurological diseases like Parkinson's and Alzheimer's.

A three-year court battle by two researchers to stop stem cell research using human embryos ended Monday when the Supreme Court declined to review the case. Scientists like Dawson say that frees up grant opportunities and are relieved for now.

"It takes some of the uncertainty out," Dawson said. "It takes us back to a situation where we're hopefully only limited by our creativity, our talent in doing the science and the resources available."

The problem is that more limitations appear likely. Research advocates fear a handful of threats to funding for all types of stem cell research and scientific study in general: the so-called "fiscal cliff," more legal challenges, an eventual new administration in Washington and the possibility of a more competitive peer review process.

Altogether, the hazards have tempered researchers' enthusiasm over the high court's non-decision.

"It's good for research in general," said Dan Gincel, director of the Maryland Stem Cell Research Fund. "It doesn't stop any future presidents from having another executive order to go the other way. If the Supreme Court would have discussed that, it would have put an end to it one way or another."

Embryonic stem cell research has long faced hurdles from those who see it as morally wrong, akin to abortion. Generating a line of the cells requires destroying the embryo. President George W. Bush limited federally funded embryonic stem cell research to only projects using lines developed before August 2001.

President Barack Obama reversed the decision in April 2009, opening up new embryonic stem cell lines to federal funding. But a federal court in Washington, D.C., suspended the change in August 2010 when two scientists sued on behalf of "plaintiff embryos." The opponents lost on appeal. The Supreme Court's refusal to hear the case means the appeals court's ruling in support of the policy stands.

Proponents of the research argue that the cells can be key in the treatment of many diseases because they have the potential to develop into many different cell types in the body. The scientists who challenged the Obama policy, and others like them, argue that research should be limited to using stem cells derived from adult tissue, though some scientists question whether the adult cells have the same potential.

Uncertainty over how courts might have handled appeals of the lawsuit meant few options for stem cell research projects for the past decade. Scientists are reluctant to take on any project for which funding is or might become scarce, Gincel said.

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End to stem cell research challenge doesn't calm funding fears for scientists

Research and Markets: Stem Cell Therapy Market in Asia-Pacific to 2018

By Stem Cell Treatment

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/dd7jnv/stem_cell_therapy) has announced the addition of the "Stem Cell Therapy Market in Asia-Pacific to 2018 - Commercialization Supported by Favorable Government Policies, Strong Pipeline and Increased Licensing Activity" report to their offering.

Commercialization Supported by Favorable Government Policies, Strong Pipeline and Increased Licensing Activity

Stem Cell Research in Asia-Pacific a Growth Engine for Region's Scientific Ambitions

The stem cell therapy market in Asia-Pacific is poised to offer significant contributions in the future, thanks to renewed interest by the respective governments of India, China, Japan, South Korea and Singapore to provide cures for a range of diseases, states a new report by healthcare experts GBI Research.

Stem cells are unique body cells that possess the ability to divide and differentiate into diverse cell types, and can be used to produce more stem cells. The use of adult stem cells has been successfully employed to treat bone and blood related disorders such as leukemia, through bone marrow transplants. Stem cell therapy is used to repair and regenerate the damaged tissue, though the actual mechanism of action is largely unknown.

The growth in the stem cell therapy market will not only provide treatment options but will also contribute significantly to the countries' Gross Domestic Product (GDP), with the President of South Korea only last year referring to stem cell research as a new growth engine for the nation's economy. In order to support the stem cell industry, regulatory guidelines in Asia-Pacific countries allow stem cell research, and this has led to its commercialization. India and South Korea are the leaders in the commercialization of stem cell therapy, with approved products for Acute Myocardial Infarction (AMI), osteoarthritis and anal fistula in Crohn's disease, amongst others. The countries allow the use of human embryonic stem cells and provide adequate funding support for the research.

Stem cell therapy is an emerging field, and a large amount of research is currently being carried out by institutions such as hospitals, universities and medical colleges. According to GBI Research's analysis of the stem cell therapy research in Asia-Pacific, 63% of pipeline molecules were being researched by academia. The emergence of institutional research has boosted stem cell discoveries, as companies can be put off conducting research due to uncertain therapeutic outcomes. China and Japan witness only a negligible industry presence in stem cell research, as academic institutions dominate - however in contrast, India has the presence of both industry and academia. The major institutions engaged in stem cell research in India are LV Prasad Eye Institute (LYPEI) for Limbal Stem Cell Technology (LSCT), and the Post Graduate Institute of Medical Education and Research (PGIMER) for stem cell therapy for type 2 diabetes mellitus.

The market is poised for significant growth in the future, due to the anticipated launch of JCR Pharmaceuticals' JR-031 in Japan in 2014, and FCB Pharmicell's Cerecellgram (CCG) in South Korea in 2015. GBI Research therefore predicts that the stem cell therapy market will grow in value from $545m in 2012 to $972m in 2018, at a Compound Annual Growth Rate (CAGR) of 10%.

Companies Mentioned

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Research and Markets: Stem Cell Therapy Market in Asia-Pacific to 2018

Stem cells found to heal damaged artery in lab study

By Stem Cell Treatment

Public release date: 10-Jan-2013 [ | E-mail | Share ]

Contact: Joseph Carey jcarey@txbiomed.org 210-258-9437 Texas Biomedical Research Institute

Scientists at the Texas Biomedical Research Institute have for the first time demonstrated that baboon embryonic stem cells can be programmed to completely restore a severely damaged artery. These early results show promise for eventually developing stem cell therapies to restore human tissues or organs damaged by age or disease.

"We first cultured the stem cells in petri dishes under special conditions to make them differentiate into cells that are the precursors of blood vessels, and we saw that we could get them to form tubular and branching structures, similar to blood vessels," said John L. VandeBerg, Ph.D., Texas Biomed's chief scientific officer.

This finding gave VandeBerg and his team the confidence to do complex experiments to find out if these cells could actually heal a damaged artery. Human embryonic stem cells were first isolated and grown in 1998.

The results are presented in a manuscript, co-authored by Texas Biomed's Qiang Shi, Ph.D., and Gerald Shatten, Ph.D., of the University of Pittsburgh, published in the January 10, 2013 issue of the Journal of Cellular and Molecular Medicine.

The scientists found that cells derived from embryonic stem cells could actually repair experimentally damaged baboon arteries and "are promising therapeutic agents for repairing damaged vasculature of people," according to the authors.

Researchers completely removed the cells that line the inside surface from a segment of artery, and then put cells that had been derived from embryonic stem cells inside the artery. They then connected both ends of the arterial segment to plastic tubing inside a device called a bioreactor which is designed to grow cells and tissues. The scientists then pumped fluid through the artery under pressure as if blood were flowing through it. The outside of the artery was bathed in another fluid to sustain the cells located there.

Three days later, the complex structure of the inner surface was beginning to regenerate, and by 14 days, the inside of the artery had been perfectly restored to its complex natural state. It went from a non-functional tube to a complex fully functional artery.

"Just think of what this kind of treatment would mean to a patient who had just suffered a heart attack as a consequence of a damaged coronary artery. And this is the real potential of stem cell regenerative medicinethat is, a treatment with stem cells that regenerates a damaged or destroyed tissue or organ," VandeBerg said.

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Stem cells found to heal damaged artery in lab study

Stem cells found to heal damaged artery in lab study in baboons

By Stem Cell Treatment

Jan. 10, 2013 Scientists at the Texas Biomedical Research Institute in San Antonio have for the first time demonstrated that baboon embryonic stem cells can be programmed to completely restore a severely damaged artery. These early results show promise for eventually developing stem cell therapies to restore human tissues or organs damaged by age or disease.

"We first cultured the stem cells in petri dishes under special conditions to make them differentiate into cells that are the precursors of blood vessels, and we saw that we could get them to form tubular and branching structures, similar to blood vessels," said John L. VandeBerg, Ph.D., Texas Biomed's chief scientific officer.

This finding gave VandeBerg and his team the confidence to do complex experiments to find out if these cells could actually heal a damaged artery. Human embryonic stem cells were first isolated and grown in 1998.

The results are presented in a manuscript, co-authored by Texas Biomed's Qiang Shi, Ph.D., and Gerald Shatten, Ph.D., of the University of Pittsburgh, published in the January 10, 2013 issue of the Journal of Cellular and Molecular Medicine.

The scientists found that cells derived from embryonic stem cells could actually repair experimentally damaged baboon arteries and "are promising therapeutic agents for repairing damaged vasculature of people," according to the authors.

Researchers completely removed the cells that line the inside surface from a segment of artery, and then put cells that had been derived from embryonic stem cells inside the artery. They then connected both ends of the arterial segment to plastic tubing inside a device called a bioreactor which is designed to grow cells and tissues. The scientists then pumped fluid through the artery under pressure as if blood were flowing through it.

The outside of the artery was bathed in another fluid to sustain the cells located there. Three days later, the complex structure of the inner surface was beginning to regenerate, and by 14 days, the inside of the artery had been perfectly restored to its complex natural state. It went from a non-functional tube to a complex fully functional artery.

"Just think of what this kind of treatment would mean to a patient who had just suffered a heart attack as a consequence of a damaged coronary artery. And this is the real potential of stem cell regenerative medicine -- that is, a treatment with stem cells that regenerates a damaged or destroyed tissue or organ," VandeBerg said.

To show that the artery couldn't heal itself in the absence of stem cells, the researchers took a control arterial segment that also was stripped of the cells on its interior surface, but did not seed it with stem cells. No healing occurred.

Stains for proteins that indicate functional characteristics showed that the healed artery had completely normal function and could do everything that a normal artery does in a healthy individual.

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Stem cells found to heal damaged artery in lab study in baboons

Mesoblast's NeoFuse Stem Cell Product Shows Positive Results in Phase 2 Lumbar Spinal Fusion Trial

By Stem Cell Treatment

Key points:

MELBOURNE, Australia, Jan. 11, 2013 (GLOBE NEWSWIRE) -- Regenerative medicine company Mesoblast Limited (ASX:MSB) (MBLTY) today announced that its Phase 2 clinical trial for lumbar spinal fusion had successfully met its safety and efficacy endpoints.

The results suggest that Mesoblast's NeoFuse product comprising allogeneic Mesenchymal Precursor Cells (MPCs) is as effective for interbody lumbar fusion as the gold standard, bone autograft, without the need for a second surgical procedure and its attendant morbidity risks. These results support the progression of clinical development of NeoFuse to a Phase 3 trial in interbody lumbar fusion.

The results were highlighted during a presentation to the 31 st annual JP Morgan Healthcare Conference in San Francisco by Mesoblast Chief Executive Professor Silviu Itescu.

Twenty four (24) patients were enrolled and randomized over 5 sites in the United States with 8 patients in each treatment arm -- bone autograft standard of care (Control), 25 million MPCs (25M), and 75 million MPCs (75M). Patients underwent the surgical procedure, one or two level fusions using a posterior approach to the spine, and were evaluated for safety and efficacy. The median follow-up times for the three treatment groups were 23.9, 20.7, and 22.9 months for the bone autograft, 25M, and 75M groups, respectively.

MPCs were well tolerated with no cell-related serious adverse events and no ectopic bone formation at all. Notably, MPC treated groups had 30-43% lower mean estimated blood loss during surgery compared to the autograft treatment group (p less than 0.05 for the 25M group).

At 12 months, fusion was achieved in 85.7% of patients in the 25M treatment group compared to 62.5% in the 75M and 75% in the control patient groups. Overall, patients from all three treatment groups had a clinically significant and comparable decrease in low back and leg pain, assessed on the Visual Analogue Scale and functional improvement, assessed by the Oswestry Disability Index questionnaire.

Dr Randall Dryer, an orthopedic surgeon with the Central Texas Spine Institute and an investigator in Mesoblast's study, said: "For patients whose spinal discs have degenerated too extensively for repair, bony fusion of adjacent vertebra is the primary option to eliminate chronic and debilitating pain.

"Other than autograft, there is no approved product for posterior spinal fusion, a surgical approach which accounts for 62% of all lumbar fusion procedures. There is a critical unmet need for new technologies to achieve fusion that are safe, effective, and that eliminate the need for bone autograft.

"Based upon my experience in the Phase 2 study, Mesoblast's cells may provide a significant and valuable option to achieve fusion in patients with severe spinal disc degeneration and these results warrant progressing to a Phase 3 study," Dr Dryer added.

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Mesoblast's NeoFuse Stem Cell Product Shows Positive Results in Phase 2 Lumbar Spinal Fusion Trial

Stem cell treatment for spine tested

By Stem Cell Treatment

AN Australian-invented stem cell treatment for spinal surgery has been successfully used for the first time in the United States.

The patented stem cells product created by Melbourne-based company Mesoblast was trialled in a small group of patients with spinal discs that had degenerated beyond repair.

The bone marrow-derived stem cells - called mesenchymal precursor cells (MPCs) - were used to promote bone growth to fuse together spinal vertebrae, to eliminate debilitating leg and back pain.

If the procedure ultimately passes the final stage of clinical trials and is approved by America's drug regulator, it would potentially provide patients worldwide with a quicker and less invasive procedure.

The Food and Drug Administration (FDA)-approved trial compared the use of stem cells to fuse vertebrae with bone harvested from the patient's own hip, the current gold standard for this common operation.

The stem cells were used in conjunction with two chemicals to encourage bone growth, said Texas surgeon Dr Randall Dryer, who performed a number of surgical procedures in the trial.

The chemicals, hydroxyapatite and tricalcium phosphate, are non-cellular components of bone that tell the stem cells to turn into bone-forming cells, rather than other tissues, Dr Dryer said.

"If you put these cells into an environment that stimulates them to grow into bone, they do," Dr Dryer told AAP.

"That eliminates us having to take the patient's own bone from a different location to pack in there."

Dr Dryer, an orthopedic surgeon at the Central Texas Institute in Austin, said eight of the 24 patients enrolled in the trial had the surgery using their own bone.

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Stem cell treatment for spine tested

Research and Markets: Cell Therapy – Technologies, Markets and Companies – 2013 Report

By Uncategorized

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/4gllbg/cell_therapy) has announced the addition of Jain PharmaBiotech's new report "Cell Therapy - Technologies, Markets and Companies" to their offering.

This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.

Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.

Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

The cell-based markets was analyzed for 2012, and projected to 2022.The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 285 of these are profiled in part II of the report along with tabulation of 272 alliances. Of these companies, 156 are involved in stem cells. Profiles of 70 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 55 Tables and 11 Figures. The bibliography contains 1,050 selected references, which are cited in the text.

Key Topics Covered:

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Research and Markets: Cell Therapy - Technologies, Markets and Companies - 2013 Report

DOH: Stem cell therapy dangerous

By Stem Cell Treatment

By JENNY F. MANONGDO

Manila, Philippines Doctors yesterday warned against fatal complications of the use of stem cell therapy.

According to the Philippine Society for Stem Cell Medicine (PSSCM), a stem cell transplant poses a host of complications, including fatal complications that depend on several factors such as the type of blood disorder, type of transplant and the age and health of the person receiving the transplant. If the stem cell that you received is not from your own body, it could lead to fatal complications, PSSCM said.

The Philippine Medical Association (PMA) also warned that a patients body may reject the transplant stem cells from a donor.

Although some people experience few problems with a transplant, others may develop complications that may require treatment or hospitalization. Some complications could even be life-threatening, said Dr. Leo Olarte, PMA vice-president.

According to Olarte, the complications that can arise with a stem cell transplant include graftversus-host disease, stem cell (graft) failure, organ injury, infections, cataracts, infertility, new cancers, and even death.

According to Olarte, a person who will undergo a stem cell transplant from a donor (allogeneic stem cell transplant) may be at risk of graft-versus-host disease.

This condition occurs when a donors transplanted stem cells attack your body. Graft-versushost disease can be mild or severe. It can occur soon after your transplant or months to years later. Aside from the graft-versushost disease, stem cell transplant from a donor can likewise affect any organ, commonly the skin (rash, often like sunburn), gut (mouth sores, abdominal pain, diarrhea, nausea or vomiting), liver (jaundice or yellowing of the skin), lungs (blocked airways) or eyes (irritation and light sensitivity).

Olarte said it could also lead to chronic disability arising from organ injury or infections that are potentially life-threatening.

Commercial establishments offering stem cell treatments have increased following its popularity in the treatment of various diseases.

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DOH: Stem cell therapy dangerous

Stem cell could lead to complications, death

By Stem Cell Treatment

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Stem cell could lead to complications, death

Doctors Warn Against Fatal Stem Cell Complications

By Stem Cell Treatment

MANILA Philippines --- Doctors yesterday warned against the fatal complications of the use of stem cell therapy.

According to the Philippine Society for Stem Cell Medicine (PSSCM), a stem cell transplant poses a host of complications, including fatal complications that depend on several factors such as the type of blood disorder, type of transplant, and the age and health of the person receiving the transplant.

"If the stem cell that you received is not from your own body, it could lead to fatal complications," PSSCM said.

The Philippine Medical Association (PMA) also warned that a patient's body may reject the transplant stem cells from a donor.

"Although some people experience few problems with a transplant, others may develop complications that may require treatment or hospitalization. Some complications could even be life-threatening," Dr. Leo Olarte, PMA vice president said.

According to Olarte, the complications that can arise from a stem cell transplant include graft-versus-host disease, stem cell (graft) failure, organ injury, infections, cataracts, infertility, new cancers, and even death.

According to Olarte, a person who will undergo a stem cell transplant from a donor (allogeneic stem cell transplant) may be at risk of graft-versus-host disease.

"This condition occurs when a donor's transplanted stem cells attack your body. Graft-versus-host disease can be mild or severe. It can occur soon after your transplant or months to years later. Aside from the graft-versus-host disease, stem cell transplant from a donor can likewise affect any organ, commonly the skin (rash, often like sunburn), gut (mouth sores, abdominal pain, diarrhea, nausea or vomiting), liver (jaundice or yellowing of the skin), lungs (blocked airways) or eyes (irritation and light sensitivity)."

Olarte said it could also lead to chronic disability arising from organ injury or infections that are potentially life-threatening.

Commercial establishments offering stem cell treatments have increased following its popularity in the treatment of various diseases.

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Doctors Warn Against Fatal Stem Cell Complications

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