Stem cell pioneers win Nobel for medicine

Shinya Yamanaka of Japan and John Gurdon of Britain won the Nobel Prize on Monday for work in cell programming, a frontier that has raised dreams of replacement tissue for people crippled by disease.

The two scientists found that adult cells can be transformed back to an infant state called stem cells, the key ingredient in the vision of regenerative medicine.

"Their findings have revolutionised our understanding of how cells and organisms develop," the Nobel jury declared. "By reprogramming human cells, scientists have created new opportunities to study diseases and develop methods for diagnosis and therapy."

Among those who acclaimed the award were Britain's Royal Society; Ian Wilmut, the "father" of Dolly the cloned sheep; and a leading ethicist, who said it eased a storm about the use of embryonic cells.

Stem cells are precursor cells which differentiate into the various organs of the body.

They have stirred huge excitement, with hopes that they can be coaxed into growing into replacement tissue for victims of Alzheimer's, Parkinson's and other diseases.

Gurdon, born in 1933, said he was grateful but also surprised by the honour, since his main research was done more than 40 years ago.

In 1962, he discovered that the DNA code in the nucleus of an adult frog cell held all the information to develop into every kind of cell.

This meant that an adult cell could in essence be reprogrammed.

His landmark discovery was initially met with scepticism, as the journey from immature to specialised cell was previously deemed irreversible.

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Stem cell pioneers win Nobel for medicine

NeoStem Announces Very Small Embryonic-Like Cells (VSEL(TM)) Publication in Stem Cells and Development

NEW YORK, Oct. 8, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS), an emerging leader in the fast growing cell therapy market, announced today that data from its collaborative studies with the University of Michigan School of Dentistry further expands the therapeutic potential of its proprietary regenerative cell therapy product, "VSELSTM" (very small embryonic-like stem cells), by demonstrating bone regeneration capabilities in a study published online ahead of print1 in the journal Stem Cells and Development (DOI: 10.1089/scd.2012.0327). The paper highlights that human VSEL stem cells form human bone when implanted in the bone tissue of SCID mice.

VSELs are a population of stem cells found in adult bone marrow with potential regenerative properties similar to those of embryonic stem cells. NeoStem has shown that these cells can be mobilized into the peripheral blood, enabling a minimally invasive means for collecting what NeoStem believes to be a population of stem cells that have the potential to achieve the positive benefits associated with embryonic stem cells without the ethical or moral dilemmas or the potential negative effects known to be associated with embryonic stem cells.

This published controlled study, funded by NIH and led by Dr. Russell Taichman, Major Ash Collegiate Professor and Co-Director of the Scholars Program in Dental Leadership Department of Periodontics & Oral Medicine, University of Michigan and Dr. Aaron Havens, Department of Orthodontics and Pediatric Dentistry at University of Michigan, involved isolating G-CSF mobilized VSEL stem cells from the blood of healthy donors and transplanting them into burr holes made in the cranial bones of SCID mice. After three months, it was observed that the implanted VSEL stem cells had differentiated into human bone tissue in the crania of the mice. Dr. Taichman stated, "I believe this work represents a true partnership between Industry and Academic Institutions. Our findings that VSEL cells can generate human bone in animals would not have been feasible without the help and vision that Dr. Denis Rodgerson and his team at NeoStem brought to the table. It was my privilege to have been a part of this collaborative effort, and I see the resulting data as a significant milestone in stem cell therapy development. It is truly inspiring."

Dr. Robin Smith, Chairman and CEO of NeoStem, added, "This is very exciting data that we believe will be the foundation for future VSEL stem cell studies of bone regeneration in humans. We look forward to moving the development work from the laboratory into the clinic to develop a therapeutic stem cell product to enhance bone formation in humans."

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its CDMO business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to (i) the Company's ability to manage its business despite operating losses and cash outflows, (ii) its ability to obtain sufficient capital or strategic business arrangement to fund its operations, including the clinical trials for AMR-001, (iii) successful results of the Company's clinical trials of AMR-001 and other cellular therapeutic products that may be pursued, (iv) demand for and market acceptance of AMR-001 or other cell therapies if clinical trials are successful and the Company is permitted to market such products, (v) establishment of a large global market for cellular-based products, (vi) the impact of competitive products and pricing, (vii) the impact of future scientific and medical developments, (viii) the Company's ability to obtain appropriate governmental licenses and approvals and, in general, future actions of regulatory bodies, including the FDA and foreign counterparts, (ix) reimbursement and rebate policies of government agencies and private payers, (x) the Company's ability to protect its intellectual property, (xi) the company's ability to successfully divest its interest in Erye, and (xii) matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

(1) Human Very Small Embryonic-Like Cells Generate Skeletal Structures, In Vivo. Havens A., et al., Stem Cells and Development.

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NeoStem Announces Very Small Embryonic-Like Cells (VSEL(TM)) Publication in Stem Cells and Development

Oakland University Stem Cell Conference Talks Cures

ROCHESTER At least 300 people attended the weekends Second Midwest Conference On Stem Cell Biology and Therapy Friday through Sunday at Oakland University.

The event was held at Oaklands brand-new health sciences building, which has been certified LEED Platinum for its energy saving, Earth-friendly technology.

The event featured presentations on both regenerative uses of stem cells, and ways in which stem cells may be used to prevent the growth and spread of cancer.

Kicking off the event was Mick Perez-Cruet, M.D., of the Oakland University William Beaumont School of Medicine, who offered his research on successful stem-cell based treatment of spinal degenerative disorders so far, on laboratory rabbits.

Officials with the event say stem cell based cures for diseases ranging from incontinence to macular degeneration are in the laboratory stages, and that the science is moving quickly toward treatments.

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Oakland University Stem Cell Conference Talks Cures

Multiple miRNA Markers Associated with Angiogenesis and Tissue Injury Repair Expressed in Cytori’s Cell Therapy

SAN DIEGO--(BUSINESS WIRE)--

Cytori Therapeutics (CYTX) announced that three oral presentations related to its cell therapy are being presented today at the 10th annual International Federation for Adipose Therapeutics and Sciences meeting. The findings provide insights into the mechanisms-of-action for Cytoris cell therapy. One study identified high levels of micro-RNA (miRNA) markers in human tissue thought to play a role in the repair of tissue injury resulting from ischemia, or lack of blood flow. Two additional characterization and comparative analysis studies on human tissue reaffirmed cellular characteristics of Cytoris cell therapy and distinguished the safety, viability and cell make-up as compared to cell outputs derived from alternate approaches.

Results from all three studies have important implications for how the cells repair injured tissue and on the safety and viability of cell-based treatments derived from adipose tissue, said John Fraser, Ph.D., Chief Scientist of Cytori Therapeutics. Mechanisms identified in our miRNA analysis are consistent with our prior clinical and preclinical data, which suggest these mechanisms include angiogenesis, immune-modulation, and remodeling and wound repair. The miRNA study provides baseline data, which we can apply to our U.S. ATHENA clinical trial in refractory heart failure patients and other activities including our recently announced contract with BARDA for thermal burns.

In one study, miRNA profiles were assessed in adipose-derived stem and regenerative cells (ADRCs) derived from human tissue samples. The purpose was to determine which miRNA markers are expressed, miRNA variability from patient to patient, cellular functions of miRNA, and to establish a baseline miRNA population on healthy patients to compare against patients with a specific disease. Specifically, miRNA markers associated with angiogenesis, tissue remodeling and wound repair, and modulation of the immune response were found to be highly represented in ADRCs.

Our two additional characterization and comparative analysis studies evaluated alternate processing techniques and reaffirmed our proprietary enzyme-based process using Celution is the clear gold standard, added Dr. Fraser. If the composition of a cell population extracted from adipose tissue by an alternative process is not equivalent to Cytoris ADRC population, one cannot claim equivalence to ADRCs in terms of safety or efficacy in preclinical or clinical outcomes.

The characterization and comparative analysis studies reaffirmed the high cell yield and viability as well as the heterogeneity in Cytoris cell therapy approach. Cytoris cells are derived with a proprietary formulation of clinical grade enzymes which break up the connective tissue and which are removed at the end of the process. Cytoris cell mixture includes adipose-derived stem cells, based on the measure of colony forming units, and a high yield of CD34+ cells. By contrast, data in these studies showed that alternate approaches such as ultrasound or emulsification, contained little to no adipose-derived stem cells, a high concentration of red and white blood cells, and did not meet the key criteria for safe clinical use.

About Cytori

Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple "ischemic" conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution system product family. http://www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements including our ability to apply this data to our ATHENA study and other projects are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, including its annual report on Form 10-K for the year ended December 31, 2011. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.

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Multiple miRNA Markers Associated with Angiogenesis and Tissue Injury Repair Expressed in Cytori’s Cell Therapy

Bernard Siegel to Deliver Keynote Addresses at Midwest Conference on Stem Cell Biology and Therapy and BioFlorida …

PALM BEACH, Fla.--(BUSINESS WIRE)--

Genetics Policy Institute (GPI) announced today that Bernard Siegel, Executive Director of GPI, will make two keynote presentations this month at regional conferences: Midwest Conference on Stem Cell Biology and Therapy October 5-7 in Rochester, Michigan and BioFlorida Conference 2012 October 7-9 in Miami, Florida.

Siegel will present a keynote address titled The Power of Advocacy at the Midwest Conference on Stem Cell Biology and Therapy. The Genetics Policy Institute joined with the Oakland University William Beaumont Institute for Stem Cell and Regenerative Medicine (ISCRM) as a collaborating partner for the event. Researchers from hospitals, medical organizations, academic institutions and the business community throughout the Midwest will discuss not only the latest advances in this rapidly expanding field of medical science, but the ethical and moral issues that surround it.

"I am pleased to participate in these important conferences, which showcase the latest scientific developments in their respective regions and beyond. ISCRM and the World Stem Cell Summit have a strong connection, as the Institute was officially launched at our 2010 Summit in Detroit, said Bernard Siegel, GPI's Executive Director and founder of the annual World Stem Cell Summit.

BioFloridas 15th annual Conference is the premier event for Floridas bioscience community. This years meeting will bring together more than 500 professionals from across Florida, the Southeast and the nation to discuss major trends and issues, including topics related to product development, scientific research, business development, financing and public policy.

Siegels keynote address at BioFlorida is titled: The Mandate to Deliver Cures: Aligning Patient Advocacy, Industry and Science. Former Governor Jeb Bush will deliver the second keynote at BioFloridas annual Conference.

The 2012 World Stem Cell Summit is in West Palm Beach, Florida this December, so we have been working closely with the biotechnology community here. I am delighted to partner with BioFlorida as they advance Floridas bioscience industry," said Siegel, who also serves on the Executive Committee of the Alliance for Regenerative Medicine and Board of the Coalition for Advancement of Medical Research. He serves as spokesperson for the Stem Cell Action Coalition.

ABOUT GPI:The Genetics Policy Institute (GPI) supports stem cell research to develop therapeutics and cures. GPI pursues its mission by honoring leadership through the Stem Cell Action Awards, producing the World Stem Cell Summit, publishing theWorld Stem Cell Report, organizing educational initiatives and fostering strategic collaborations. For more information, visitwww.genpol.org.

ABOUT THE WORLD STEM CELL SUMMIT:The 2012 World Stem Cell Summit is presented by GPI and is co-organized by the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine, Diabetes Research Institute, Beckman Research Institute at City of Hope, Karolinska Institute (home of the Nobel Prize in Physiology and Medicine), International Translational Regenerative Medicine Center (ITRC) and the Institute for Integrated Cell-Material Sciences (iCeMS) at Kyoto University. The Summit is the flagship meeting of the world stem cell community. The 2012 Summit will be held at the Palm Beach County Convention Center in West Palm Beach, Florida, December 3-5, 2012. For more information, visit http://www.worldstemcellsummit.com.

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Bernard Siegel to Deliver Keynote Addresses at Midwest Conference on Stem Cell Biology and Therapy and BioFlorida ...

Study Sheds Light on Bone Marrow Stem Cell Therapy for Pancreatic Recovery

Newswise LOS ANGELES (Oct. 2, 2012) Researchers at Cedars-Sinais Maxine Dunitz Neurosurgical Institute have found that a blood vessel-building gene boosts the ability of human bone marrow stem cells to sustain pancreatic recovery in a laboratory mouse model of insulin-dependent diabetes.

The findings, published in a PLoS ONE article of the Public Library of Science, offer new insights on mechanisms involved in regeneration of insulin-producing cells and provide new evidence that a diabetics own bone marrow one day may be a source of treatment.

Scientists began studying bone marrow-derived stem cells for pancreatic regeneration a decade ago. Recent studies involving several pancreas-related genes and delivery methods transplantation into the organ or injection into the blood have shown that bone marrow stem cell therapy could reverse or improve diabetes in some laboratory mice. But little has been known about how stem cells affect beta cells pancreas cells that produce insulin or how scientists could promote sustained beta cell renewal and insulin production.

When the Cedars-Sinai researchers modified bone marrow stem cells to express a certain gene (vascular endothelial growth factor, or VEGF), pancreatic recovery was sustained as mouse pancreases were able to generate new beta cells. The VEGF-modified stem cells promoted growth of needed blood vessels and supported activation of genes involved in insulin production. Bone marrow stem cells modified with a different gene, PDX1, which is important in the development and maintenance of beta cells, resulted in temporary but not sustained beta cell recovery.

Our study is the first to show that VEGF contributes to revascularization and recovery after pancreatic injury. It demonstrates the possible clinical benefits of using bone marrow-derived stem cells, modified to express that gene, for the treatment of insulin-dependent diabetes, said John S. Yu, MD, professor and vice chair of the Department of Neurosurgery at Cedars-Sinai, senior author of the journal article.

Diabetes was reversed in five of nine mice treated with the injection of VEGF-modified cells, and near-normal blood sugar levels were maintained through the remainder of the six-week study period. The other four mice survived and gained weight, suggesting treatment was beneficial even when it did not prompt complete reversal. Lab studies later confirmed that genetically-modified cells survived and grew in the pancreas and supported the repopulation of blood vessels and beta cells.

Anna Milanesi, MD, PhD, working in Yus lab as an endocrinology fellow, is the articles first author. The researchers cautioned that although this and other related studies help scientists gain a better understanding of the processes and pathways involved in pancreatic regeneration, more research is needed before human clinical trials can begin.

Insulin-dependent diabetes occurs when beta cells of the pancreas fail to produce insulin, a hormone that regulates sugar in the blood. Patients must take insulin injections or consider transplantation of a whole pancreas or parts of the pancreas that make insulin, but transplantation carries the risk of cell rejection.

# # #

PLoS ONE: Beta-cell Regeneration Mediated by Human Bone Marrow Mesenchymal Stem Cells.

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Study Sheds Light on Bone Marrow Stem Cell Therapy for Pancreatic Recovery

New stem cell research could bring choices to heart patients

Contributed photo

Dr. Nabil Dib

They're called "no-option patients."

They've endured angioplasty, stent procedures, bypasses and a long line of medications. None of the treatments has fixed the plaque-plugged coronary arteries that trigger angina, starve the heart of blood and force people to hunch in pain after walking twoblocks.

Adult stem cell research at an Oxnard hospital is aimed at giving themchoices.

"A patient who has no hope will have some hope," said Dr. Nabil Dib, a world-renowned researcher partnering with St. John's Regional Medical Center. "It's a hope for potential therapy that will revise the way we treat cardiovasculardisease."

Stem cells are blank cells that function as the body's building blocks. They are able to grow into many different kinds of cells, including blood, muscle and tissue. Dib's work involves adult stem cells harvested from his patients, as opposed to stem cells that come from embryos and trigger ethicaldebates.

In a clinical trial starting at St. John's and 49 other hospitals across the country, the adult stem cells will be isolated and used to create new blood vessels. It's a way of manipulating the body into building new pathways for blood flow impeded by barricadedarteries.

"We're doing like a bypass a biological bypass," Dibsaid.

The trial is part of a genre of research aimed at using the body's own resources to repair the heart. It could reduce consequences ranging from heart transplants and hospitalizations to heart failure anddeath.

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New stem cell research could bring choices to heart patients

Cedars-Sinai study sheds light on bone marrow stem cell therapy for pancreatic recovery

Public release date: 2-Oct-2012 [ | E-mail | Share ]

Contact: Sandy Van sandy@prpacific.com 808-526-1708 Cedars-Sinai Medical Center

LOS ANGELES (Oct. 2, 2012) Researchers at Cedars-Sinai's Maxine Dunitz Neurosurgical Institute have found that a blood vessel-building gene boosts the ability of human bone marrow stem cells to sustain pancreatic recovery in a laboratory mouse model of insulin-dependent diabetes.

The findings, published in a PLOS ONE article of the Public Library of Science, offer new insights on mechanisms involved in regeneration of insulin-producing cells and provide new evidence that a diabetic's own bone marrow one day may be a source of treatment.

Scientists began studying bone marrow-derived stem cells for pancreatic regeneration a decade ago. Recent studies involving several pancreas-related genes and delivery methods transplantation into the organ or injection into the blood have shown that bone marrow stem cell therapy could reverse or improve diabetes in some laboratory mice. But little has been known about how stem cells affect beta cells pancreas cells that produce insulin or how scientists could promote sustained beta cell renewal and insulin production.

When the Cedars-Sinai researchers modified bone marrow stem cells to express a certain gene (vascular endothelial growth factor, or VEGF), pancreatic recovery was sustained as mouse pancreases were able to generate new beta cells. The VEGF-modified stem cells promoted growth of needed blood vessels and supported activation of genes involved in insulin production. Bone marrow stem cells modified with a different gene, PDX1, which is important in the development and maintenance of beta cells, resulted in temporary but not sustained beta cell recovery.

"Our study is the first to show that VEGF contributes to revascularization and recovery after pancreatic injury. It demonstrates the possible clinical benefits of using bone marrow-derived stem cells, modified to express that gene, for the treatment of insulin-dependent diabetes," said John S. Yu, MD, professor and vice chair of the Department of Neurosurgery at Cedars-Sinai, senior author of the journal article.

Diabetes was reversed in five of nine mice treated with the injection of VEGF-modified cells, and near-normal blood sugar levels were maintained through the remainder of the six-week study period. The other four mice survived and gained weight, suggesting treatment was beneficial even when it did not prompt complete reversal. Lab studies later confirmed that genetically-modified cells survived and grew in the pancreas and supported the repopulation of blood vessels and beta cells.

Anna Milanesi, MD, PhD, working in Yu's lab as an endocrinology fellow, is the article's first author. The researchers cautioned that although this and other related studies help scientists gain a better understanding of the processes and pathways involved in pancreatic regeneration, more research is needed before human clinical trials can begin.

Insulin-dependent diabetes occurs when beta cells of the pancreas fail to produce insulin, a hormone that regulates sugar in the blood. Patients must take insulin injections or consider transplantation of a whole pancreas or parts of the pancreas that make insulin, but transplantation carries the risk of cell rejection.

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Cedars-Sinai study sheds light on bone marrow stem cell therapy for pancreatic recovery

New study sheds light on bone marrow stem cell therapy for pancreatic recovery

ScienceDaily (Oct. 2, 2012) Researchers at Cedars-Sinai's Maxine Dunitz Neurosurgical Institute have found that a blood vessel-building gene boosts the ability of human bone marrow stem cells to sustain pancreatic recovery in a laboratory mouse model of insulin-dependent diabetes.

The findings, published in a PLoS ONE article of the Public Library of Science, offer new insights on mechanisms involved in regeneration of insulin-producing cells and provide new evidence that a diabetic's own bone marrow one day may be a source of treatment.

Scientists began studying bone marrow-derived stem cells for pancreatic regeneration a decade ago. Recent studies involving several pancreas-related genes and delivery methods -- transplantation into the organ or injection into the blood -- have shown that bone marrow stem cell therapy could reverse or improve diabetes in some laboratory mice. But little has been known about how stem cells affect beta cells -- pancreas cells that produce insulin -- or how scientists could promote sustained beta cell renewal and insulin production.

When the Cedars-Sinai researchers modified bone marrow stem cells to express a certain gene (vascular endothelial growth factor, or VEGF), pancreatic recovery was sustained as mouse pancreases were able to generate new beta cells. The VEGF-modified stem cells promoted growth of needed blood vessels and supported activation of genes involved in insulin production. Bone marrow stem cells modified with a different gene, PDX1, which is important in the development and maintenance of beta cells, resulted in temporary but not sustained beta cell recovery.

"Our study is the first to show that VEGF contributes to revascularization and recovery after pancreatic injury. It demonstrates the possible clinical benefits of using bone marrow-derived stem cells, modified to express that gene, for the treatment of insulin-dependent diabetes," said John S. Yu, MD, professor and vice chair of the Department of Neurosurgery at Cedars-Sinai, senior author of the journal article.

Diabetes was reversed in five of nine mice treated with the injection of VEGF-modified cells, and near-normal blood sugar levels were maintained through the remainder of the six-week study period. The other four mice survived and gained weight, suggesting treatment was beneficial even when it did not prompt complete reversal. Lab studies later confirmed that genetically-modified cells survived and grew in the pancreas and supported the repopulation of blood vessels and beta cells.

Anna Milanesi, MD, PhD, working in Yu's lab as an endocrinology fellow, is the article's first author. The researchers cautioned that although this and other related studies help scientists gain a better understanding of the processes and pathways involved in pancreatic regeneration, more research is needed before human clinical trials can begin.

Insulin-dependent diabetes occurs when beta cells of the pancreas fail to produce insulin, a hormone that regulates sugar in the blood. Patients must take insulin injections or consider transplantation of a whole pancreas or parts of the pancreas that make insulin, but transplantation carries the risk of cell rejection.

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New study sheds light on bone marrow stem cell therapy for pancreatic recovery

Experimental Stem Cell Therapy May Help Burn Victims

For more than 40 years, Lesley Kelly of Glasgow, Scotland, lived with third-degree burns that stretched over 60 percent of her body.

Kelly was 2 years old when she fell into a bathtub filled with hot water that scorched most of the right side of her body. She lost full range of motion around many of her joints.

"When you have bad scarring, the buildup is very thick and has no elasticity," said Kelly, 45, whose right elbow was most affected by the buildup of scar tissue. "The problem with thermal burn scarring [is that] it's hard to get the range of motion."

Kelly underwent numerous reparative surgeries through the years, but the scar tissue continued to grow back. The procedures did not lessen the look of her scars.

In 2011, Kelly underwent a new, experimental procedure that used stem cells from her own fat tissue to repair the buildup around her right elbow.

Surgeons cleaned the scar buildup around the elbow and used liposuction to pull fat from off Kelly's waist. They separated the fat cells from the stem and regenerative cells, which were then injected into the wound on Kelly's arm. The procedure took less than two hours.

Within months, Kelly was able to regain 40 degrees of motion that she had lost more than 40 years ago.

"If this technology was available earlier in my life, my scars would not have been as bad," said Kelly.

There are an estimated 50,000 to 70,000 burn cases each year in the U.S., according to the American Burn Association.

The stem cell therapy, approved in the U.K. to treat soft tissue wounds, is now gaining traction in the U.S.

Original post:

Experimental Stem Cell Therapy May Help Burn Victims

New Therapy May Help Burn Victims

Lesley Kelly, 45, underwent stem cell therapy to repair scar tissue buildup in her right arm. (Cytori Therapeutics, Inc.)

By Lara Salahi, ABC News For more than 40 years, Lesley Kelly of Glasgow, Scotland, lived with third-degree burns that stretched over 60 percent of her body.

Kelly was 2 years old when she fell into a bathtub filled with hot water that scorched most of the right side of her body. She lost full range of motion around many of her joints.

"When you have bad scarring, the buildup is very thick and has no elasticity," said Kelly, 45, whose right elbow was most affected by the buildup of scar tissue. "The problem with thermal burn scarring [is that] it's hard to get the range of motion."

Kelly underwent numerous reparative surgeries through the years, but the scar tissue continued to grow back. The procedures did not lessen the look of her scars.

In 2011, Kelly underwent a new, experimental procedure that used stem cells from her own fat tissue to repair the buildup around her right elbow.

Surgeons cleaned the scar buildup around the elbow and used liposuction to pull fat from off Kelly's waist. They separated the fat cells from the stem and regenerative cells, which were then injected into the wound on Kelly's arm. The procedure took less than two hours.

Within months, Kelly was able to regain 40 degrees of motion that she had lost more than 40 years ago.

"If this technology was available earlier in my life, my scars would not have been as bad," said Kelly.

There are an estimated 50,000 to 70,000 burn cases each year in the U.S., according to the American Burn Association.

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New Therapy May Help Burn Victims

FDA Approves Stemedica Phase II Clinical Trial for Acute Myocardial Infarction With Ischemia Tolerant Mesenchymal Stem …

SAN DIEGO, Calif., Oct. 2, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the clinical effects of Stemedyne-MSC (Stemedica's human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with a myocardial infarct. The Phase IIa double-blinded randomized clinical trial will study approximately forty (40) patients. All patients will initially receive standard care including percutaneous transluminal coronary angioplasty (PTCA) and stenting and, upon completion, will be randomized to receive Stemedyne-MSC intravenously or placebo.

The clinical trial will address the prevalence of cardiovascular disease estimated to carry a global disease burden in excess of $400 billion each year. More than one million patients undergo PTCA and stenting in the Untied States annually; another 800,000 have the procedures each year in Europe.

Nabil Dib, M.D., MSc., F.A.C.C., Director of Cardiovascular Research at Mercy Gilbert and Chandler Regional Medical Centers, and an Associate Professor of Medicine and Director of Clinical Cardiovascular Cell Therapy at the University of California, San Diego, will serve as the principal investigator of the FDA-approved study. Dr. Nib commented, "We've learned from bench top research that not all stem cells are created equally. We believe that the ischemic tolerance of Stemedica's MSCs and the robustness of their protein array will translate into significant patient benefits post myocardial infarction."

Stemedica's interest in this indication was triggered by a successful randomized study in acute myocardial infarction conducted by the National Scientific Medical Center (NSMC) in Astana, Kazakhstan using Stemedyne-MSCs. The study was conducted under clinical protocol and in compliance with the ICH-E6 (Good Clinical Practice) guidelines and local laws. All patients signed an informed consent. Nineteen (19) patients in this study received Stemedyne-MSCs after PTCA and stenting. Administration of Stemedyne-MSC resulted in a statistically-significant decrease in inflammation as judged by the level of C-reactive protein, significant decrease in end-systolic and end-diastolic volume of left ventricle, as well as significant increase in the left ventricular ejection fraction (LVEF) from 38.4% to 54.7% at 6 months post administration, bringing this parameter to a normal range for healthy individuals (50-65%).

Professor Daniyar Jumaniyazov, M.D. Ph.D., principal investigator of the NSMC study commented, "The stem cell transplantation was safe and the procedure was well tolerated. No product-related adverse events were reported. Treatment of patients in this study resulted in improvement of overall and local contractive myocardium functions and also normalization of systolic and diastolic filling of the left ventricle as compared to the control group. Based upon the safety and efficacy results, we will soon conduct a Phase III myocardial infarct clinical trial at the NSMC with Stemedica's ischemia tolerant mesenchymal stem cells."

Lev Verkh, Ph.D., Stemedica Chief Regulatory and Clinical Development Officer commented, "Stemedica's FDA submission included data from the NSMC clinical trial, the results of which were also reported at the annual American College of Cardiology meeting in April, 2012. These results contrasted with reports, at the same conference, of minimal improvement in studies with autologous stem cells. In addition to the United States sites, the study will be duplicated at leading hospitals in Europe, Asia and the Middle East." With regard to the spectrum of stem cell treatment for cardiovascular disease, Dr. Verkh noted that, "Stemedyne-MSC has been approved for the treatment of chronic heart failure at Hospital Angeles, Tijuana, Mexico by COFEPRIS (the Mexican equivalent of the FDA)."

Jackie See, M.D., F.A.C.C., founder of interventional cardiology at the University of California, Irvine, noted, "In the days and weeks following a myocardial infarction we may have the ability to intervene with stem cells to minimize scarring, enhance the amount of functional heart tissue, and restore the microcirculation. Stemedica's ischemia tolerant mesenchymal stem cells are ideal for this purpose. I can foresee the day when all coronary stenting is accompanied by stem cell injection. It is not unreasonable to postulate that the anti-inflammatory and anti-fibrotic effects of the mesenchymal stem cells may have an impact on the incidence of restenosis, a common condition caused by blockage of the stents."

The Stemedyne-MSC product is uniquely manufactured to contain increased amounts of the important growth factors that combat ischemic damage. According to Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica, "Our ischemia tolerant MSCs secrete increased amounts of vascular endothelial growth factor (VEGF), which is necessary for new blood vessel development and stromal cell-derived factor (SDF), which is responsible for rescuing dying cells. Stemedyne-MSCs also demonstrate significantly higher migratory abilities. As a company we are unique in our unparalleled scalability, with our master bank at two passages and the cells that go into patients having only been expanded four times. We have the ability to treat more than 500,000 patients with cells created from a single organ donation."

Stemedyne-MSC is one of the three adult allogeneic stem cell products developed by the Company. Other products include Stemedyne-NSC neural human stem cells and Stemedyne-RPE, retinal progenitor epithelial cells available in early 2013. All Stemedica products are unique in their ability to tolerate ischemic conditions.

About Stemedica Cell Technologies, Inc. http://www.stemedica.com

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FDA Approves Stemedica Phase II Clinical Trial for Acute Myocardial Infarction With Ischemia Tolerant Mesenchymal Stem ...

Immune system harnessed to improve stem cell transplant outcomes

ScienceDaily (Oct. 1, 2012) A novel therapy in the early stages of development at Virginia Commonwealth University Massey Cancer Center shows promise in providing lasting protection against the progression of multiple myeloma following a stem cell transplant by making the cancer cells easier targets for the immune system.

Outlined in the British Journal of Hematology, the Phase II clinical trial was led by Amir Toor, M.D., hematologist-oncologist in the Bone Marrow Transplant Program and research member of the Developmental Therapeutics program at VCU Massey Cancer Center. The multi-phased therapy first treats patients with a combination of the drugs azacitidine and lenalidomide. Azacitidine forces the cancer cells to express proteins called cancer testis antigens (CTA) that immune system cells called T-cell lymphocytes recognize as foreign. The lenalidomide then boosts the production of T-cell lymphocytes. Using a process called autologous lymphocyte infusion (ALI), the T-cell lymphocytes are then extracted from the patient and given back to them after they undergo a stem cell transplant to restore the stem cells' normal function. Now able to recognize the cancer cells as foreign, the T-cell lymphocytes can potentially protect against a recurrence of multiple myeloma following the stem cell transplant.

"Every cell in the body expresses proteins on their surface that immune system cells scan like a barcode in order to determine whether the cells are normal or if they are foreign. Because multiple myeloma cells are spawned from bone marrow, immune system cells cannot distinguish them from normal healthy cells," says Toor. "Azacitidine essentially changes the barcode on the multiple myeloma cells, causing the immune system cells to attack them," says Toor.

The goal of the trial was to determine whether it was safe, and even possible, to administer the two drugs in combination with an ALI. In total, 14 patients successfully completed the investigational drug therapy. Thirteen of the participants successfully completed the investigational therapy and underwent a stem cell transplant. Four patients had a complete response, meaning no trace of multiple myeloma was detected, and five patients had a very good partial response in which the level of abnormal proteins in their blood decreased by 90 percent.

In order to determine whether the azacitidine caused an increased expression of CTA in the multiple myeloma cells, Toor collaborated with Masoud Manjili, D.V.M., Ph.D., assistant professor of microbiology and immunology at VCU Massey, to conduct laboratory analyses on bone marrow biopsies taken from trial participants before and after treatments. Each patient tested showed an over-expression of multiple CTA, indicating the treatment was successful at forcing the cancer cells to produce these "targets" for the immune system.

"We designed this therapy in a way that could be replicated, fairly inexpensively, at any facility equipped to perform a stem cell transplant," says Toor. "We plan to continue to explore the possibilities of immunotherapies in multiple myeloma patients in search for more effective therapies for this very hard-to-treat disease."

In addition to Manjili, Toor collaborated with John McCarty, M.D., director of the Bone Marrow Transplant Program at VCU Massey, and Harold Chung, M.D., William Clark, M.D., Catherine Roberts, Ph.D., and Allison Hazlett, also all from Massey's Bone Marrow Transplant Program; Kyle Payne, Maciej Kmieciak, Ph.D., from Massey and the Department of Microbiology and Immunology at VCU School of Medicine; Roy Sabo, Ph.D., from VCU Department of Biostatistics and the Developmental Therapeutics program at Massey; and David Williams, M.D., Ph.D., from the Department of Pathology at VCU School of Medicine, co-director of the Tissue and Data Acquisition and Analysis Core and research member of the Developmental Therapeutics program at Massey.

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Immune system harnessed to improve stem cell transplant outcomes

World Renowned Scientists and Advocates to Celebrate and Shine Light on Stem Cell Breakthroughs

IRVINE, CA--(Marketwire - Oct 1, 2012) - Oct. 3 marks International Stem Cell Awareness Day, a global celebration where leading scientists, researchers and supporters will acknowledge the scientific advances of stem cell research and its ability to potentially treat a variety of diseases and injuries in the 21st century. This dedicated community is committed to unlocking the potential of stem cells and has made significant strides since the discovery of a method to grow human stem cells less than 15 years ago.

"This is a critical and historic time for stem cell research," said Peter Donovan, Ph.D., director, Sue & Bill Gross Stem Cell Research Center, UC Irvine. "We're literally on the brink of developing new treatments for some of the world's most devastating diseases and injuries. The act of simply raising awareness about this research is one of the best things people can do to help accelerate the process. This event is a great opportunity for everyone to help spread the word and build momentum through a timely mass effort."

Scientists at UC Irvine and other research facilities around the globe continue to work diligently to develop therapies to treat life threatening and debilitating conditions such as Alzheimer's disease, multiple sclerosis, macular degeneration, cancer, Huntington's disease, Parkinson's disease, brain disorders and paralysis caused by spinal cord injuries. These efforts continue to give hope to millions who suffer from these devastating conditions by offering revolutionary treatments and potential cures.

There are several research programs taking place at the Sue & Bill Gross Stem Cell Research Center at UC Irvine that continue to break down barriers and open doors to new treatments for major diseases and injuries:

Spinal Cord and Traumatic Brain Injuries: Neurobiologist Hans Keirstead, Ph.D., as well as husband and wife scientists Aileen Anderson, Ph.D., and Brian Cummings, Ph.D., are conducting stem cell studies to develop treatments for the more than 1.3 million Americans who suffer from spinal cord injuries. Their advancements have led to the world's first clinical trial of human neural stem cell-based therapy for chronic spinal cord injuries (Anderson/Cummings) and the first FDA approved clinical trials using embryonic stem cells (Keirstead). Their research is significant because no drug or other forms of treatment have been able to restore function for those suffering from paralysis. In addition, Cummings and Anderson are applying their stem research to traumatic brain injury, a leading cause of death and disability worldwide, especially in children and young adults.

Alzheimer's Disease: An estimated 35 million people worldwide suffer from Alzheimer's disease, five million of whom live in the U.S. Frank LaFerla, Ph.D., director of UC Irvine's Institute for Memory Impairments and Neurological Disorders, and Matthew Blurton-Jones, Ph.D., of the Sue & Bill Gross Stem Cell Research Center, UC Irvine, have shown for the first time that neural stem cells can rescue memory in mice with advanced Alzheimer's disease, raising hope for a potential treatment in humans. Their work is expected to move to clinical trials in less than five years.

Huntington's Disease: Huntington's disease is a degenerative and ultimately fatal brain disorder that takes away a person's ability to walk, talk and reason. It affects about 30,000 people in the U.S. with another 200,000 or more likely to inherit the disorder. Leslie Thompson, Ph.D., and her team of researchers are currently investigating new stem cell lines and techniques to support the area of the brain that is susceptible to the disease with the hope of developing a cure for future generations.

Macular Degeneration, Retinitis Pigmentosa and Inherited Blindness: Henry Klassen, M.D., Ph.D. has focused his stem cell research on regenerating damaged retinal tissue to restore sight to people suffering from retinitis pigmentosa (an inherited form of degenerative eye disease) and macular degeneration which usually affects older people and leads to loss of vision. Macular degeneration affects millions of Americans. His work hopes to find cures and treatments for corneal and retinal eye disease.

New Website Helps Spread the Word Online To commemorate International Stem Cell Awareness Day and encourage support of stem cell research, an interactive website has been created. Advocates are asked to visit http://www.StemCellsOfferHope.com and share online a wide range of key facts, downloadable images and links to other valuable resources within their social networks.

International Stem Cell Awareness Day Events at UC Irvine The Sue & Bill Gross Stem Cell Research Center at UC Irvine will celebrate International Stem Cell Awareness Day by hosting three special events. An open house will take place on Oct. 1 for high school students. A UC Irvine student, faculty and staff open house will take place on Oct. 2. Finally, an all-day science symposium on Oct. 3 will feature a "Meet the Scientist" interactive forum. The forum and symposium are open to all UC Irvine scientists, clinicians, graduate students, post-docs and members of the community. To RSVP for any these events or for more information, include the name of the event in the subject line and email stemcell@research.uci.edu.

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World Renowned Scientists and Advocates to Celebrate and Shine Light on Stem Cell Breakthroughs

Houston Stem Cell Summit Announces Extraordinary Lineup of Keynote Speakers

HOUSTON, Oct. 1, 2012 /PRNewswire/ --The Houston Stem Cell Summit will host an extraordinary lineup of keynote speakers who represent the most accomplished stem cell scientists, clinicians and entrepreneurs in the United States. Joining these distinguished speakers will be Governor of Texas, Rick Perry, consistent champion of adult stem cell therapies.

(Logo: http://photos.prnewswire.com/prnh/20120831/NY66463LOGO )

The Houston Stem Cell Summit will be held October 26 27 in its namesake city and will highlight the latest therapeutic research regarding the use of adult stem and progenitor cell therapies. The Summit will also provide a forum for entrepreneurs to discuss their latest efforts to commercialize stem cell therapies, and to debate and discuss FDA and other legal and regulatory issues impacting stem cell research and commercialization.

Opening Keynote Address October 26, 2012 Arnold I. Caplan, PhD, Professor of Biology and Professor of General Medical Sciences (Oncology) Case Western Reserve University

Dr. Caplan has helped shape the direction and focus of adult stem cell research and commercialization. Virtually every adult stem cell company and literally tens of thousands of research papers are based on Dr. Caplan's original and ground breaking research. Professor Caplan is considered to be the "father" of the mesenchymal stem cell and first described this progenitor cell in his landmark paper; "Mesenchymal stem cells", Journal of Orthopaedic Research 1991;9(5):641-650. Since that foundational study, Dr. Caplan has published over 360 manuscripts and articles in peer reviewed journals. Dr. Caplan has been Chief Scientific Officer at OrthoCyte Corporation since 2010. In addition, Dr. Caplan co-founded Cell Targeting Inc. and has served as President of Skeletech, Inc. as its founder. He is the recipient of several honors and awards from the orthopedic research community. Dr. Caplan holds a Ph. D. from Johns Hopkins University Medical School and a B.S. in chemistry from the Illinois Institute of Technology.

Summit Keynote Address October 26, 2012 Texas Governor Rick Perry

Governor Perry is the 47th and current Governor of Texas. Governor Perry has long championed the role of medical technologies in building the future of not only Texas, but also the United States. In many ways, his strong advocacy on behalf of research and advanced medical technologies is one of his strongest and as yet underappreciated legacies. In addition to his service to the state of Texas, Governor Perry has also served as Chairman of the Republican Governors Association in 2008 and again in 2011. Despite a rigorous schedule, particularly in the teeth of this election season, Governor Perry has graciously made time to speak and encourage the researchers, patients, companies and physicians who form the fabric and future of the stem cell therapy community.

Texas Medical Center Keynote Address, October 27, 2012 James T. Willerson, MD

Over the course of his career, Dr. James T. Willerson has served as a medical, scientific and administrative leader for each of the major institutions that are the foundation of the Texas Medical Center. Dr. Willerson is currently President and Medical Director, Director of Cardiology Research, and Co-Director of the Cullen Cardiovascular Research Laboratories at Texas Heart Institute (THI). Dr. Willerson was appointed President-Elect of THI in 2004 and became President and Medical Director in 2008. He is also an adjunct professor of Medicine at Baylor College of Medicine and at The University of Texas MD Anderson Cancer Center. He is the former chief of Cardiology at St. Luke's Episcopal Hospital and the former chief of Medical Services at Memorial Hermann Hospital.

Dr. Willerson has served as a visiting professor and invited lecturer at more than 170 institutions.

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Houston Stem Cell Summit Announces Extraordinary Lineup of Keynote Speakers

The great stem cell dilemma

By Jeffrey M. O'Brien, contributor

Stem cells stored in liquid nitrogen at Advanced Cell Technology in Marlborough, Mass.

FORTUNE -- Imagine yourself the proud but rueful owner of an ancient Jaguar. Every day you dread the uncertainty that comes with trying to get from here to there -- there, more often than not, being the shop. No sooner does one ailment find repair than another appears. At best, it's a slow, uncomfortable ride. Lonely too. There's really no one around who fully understands your plight.

That is how Patricia Riley describes life in a 95-year-old body. Riley, who reached that milestone birthday last St. Patrick's Day, lives alone in the same 1,100-square-foot house in Plainfield, Conn., that she's called home for 64 years, having survived her husband (heart disease), a daughter (breast cancer), and every friend she ever had. "All the people I knew have all gone, Jeffrey," she says in a quivering voice laced with melancholy. "They've all died. I go to church and I never see people my age." Her remaining family includes two daughters, five grandchildren, and eight great-grandchildren, including my two young sons. In a nod to her French-Canadian heritage, we call her Mme.

Mme attributes her longevity to good genes, but she clearly owes a debt to modern medicine. Over the years she's had a cholecystectomy, a hysterectomy, esophageal surgery, a stroke, and ulcerative colitis. Lately she relies on a cane and a walker, and her daily regimen includes pain pills for arthritis, two inhalers for asthma, high-blood-pressure meds, a statin, vitamins, digestion aids, and an anti-anxiety drug that she calls "my nerve pill." Her vision also comes courtesy of medical science. Three years ago Mme was diagnosed with a form of age-related macular degeneration, or AMD, a disease of the back of the retina that is the leading cause of vision loss in the developed world. The ophthalmologist gave her a choice: a needle into her eyeballs every six weeks, or blindness. Mme opted for the injections and now receives shots of an off-label cancer drug called Avastin, which has demonstrated efficacy in halting the progress of her type of AMD. Holding the ailment at bay is all she can hope for. "I'll have to go for as long as I live," she says. "It's just a treatment -- it's not a cure."

Treatments, not cures. This, in a nutshell, is the MO of our health care system, and it's precisely the reason that regenerative medicine -- and stem cell therapy in particular -- has been the subject of so much hope and hype over the past decade or so. Stem cell therapies promise to empower a body to fight ailments by enabling it to build new parts. Think about growing new neurons or heart tissue. Think about the difference between perpetually slathering that old Jag with Bondo and having it heal itself overnight in the garage.

MORE:Stem cell dollars: California leads the way

While stem cells have ignited plenty of religious outrage and political grandstanding, behind the headlines the underlying science has been advancing the way science often does -- by turns slowly and dramatically. To be clear, the earliest stem cell therapies are almost certainly years from distribution. But so much progress has been made at venerable research institutions that it now seems possible to honestly discuss the possibility of a new medical paradigm emerging within a generation. Working primarily with rodents in preclinical trials, MDs and Ph.D.s are making the paralyzed walk and the impotent virile. A stem cell therapy for two types of macular degeneration recently restored the vision of two women. Once they were blind. Now they see! Some experts assert that AMD could be eradicated within a decade. Other scientists are heralding a drug-free fix for HIV/AIDS. Various forms of cancer, Parkinson's, diabetes, heart disease, stroke, and ALS have already been eradicated in mice. If such work translates to humans, it will represent the type of platform advancement that comes along in medicine only once in a lifetime or two. The effect on the economy would be substantial. Champions of stem cell research say it would be on the order of the Internet or even the transistor.

The obstacles along the road from lab rat to human patients are many, of course, but the biggest by far is money. With the dramatic events in the lab, you might think that a gold rush would be under way. That's far from true. Long time horizons, regulatory hurdles, huge R&D costs, public sentiment, and political headwinds have all scared financiers. Wall Street isn't interested in financing this particular dream. Most stem cell companies that have dared go public are trading down 90% or more from their IPOs. Sand Hill Road is AWOL. The National Venture Capital Association doesn't even have a category to track stem cell investments.

Big Pharma would seem to be the most obvious benefactor. The drug companies understand the complexities (and billion-dollar outlays) involved in bringing therapies to market. A few drug companies have kicked the tires on stem cells over the years, but waiting for them to undo the current model is akin to banking on Big Oil to rethink energy. They may do it, but it's unlikely to be by choice. Which leaves stem cell researchers begging for state and federal grants at a time scientific funding is under siege.

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The great stem cell dilemma

Cytori’s Stem Cell Therapy for Burns Wins U.S. Contract

By Ryan Flinn - 2012-09-28T16:23:41Z

Cytori Therapeutics Inc. (CYTX), a biotechnology company with $10 million in annual revenue, rose the most in more than a year after the company won a $4.7 million U.S. government contract to develop a stem cell therapy to treat burns caused by thermal or radioactive bombs.

Cytori jumped 19 percent to $4.58 at 12:11 p.m. New York time, after earlier reaching $4.93 for the biggest intraday increase since August 2011. The shares of the San Diego-based company rose 75 percent this year through yesterday.

Were seeing a lot of momentum, Chief Executive Officer Christopher Calhoun said today in an interview with Bloomberg Television. This contract is one more major thing that we are delivering on, and there is more to come. This is an important year for us.

The two-year contract with the Department of Health and Human Services Biomedical Advanced Research and Development Authority may be worth $106 million over five years if certain milestones are met, Cytori said today in a statement. The company had a net loss last year of $32 million, according to data compiled by Bloomberg.

Cytoris experimental therapy takes adipose tissue, or body fat, from a patient and through its device separates the adult stem and regenerative cells before transferring them to a burn wound. Money from the contract will be used to develop the device and take it through the U.S. regulatory approval process with the Food and Drug Administration, Calhoun said.

These cells help to facilitate the healing of the injury, he said in a telephone interview earlier this week. They release growth factors that stimulate new blood flow.

Testing the technology in a clinical trial and getting approval may take five years, Calhoun said. The company is currently testing its therapy for other soft tissue damage, as well as cardiovascular disease.

Once approved, the device will be deployed in hospitals across the country, and can be used for routine burns as well as a treatment for patients in wake of a mass casualty event that could injure 10,000 people, Cytori said in the statement.

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

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Cytori’s Stem Cell Therapy for Burns Wins U.S. Contract

Purging Stem Cells To Make Therapy Safer

Featured Article Academic Journal Main Category: Stem Cell Research Also Included In: Biology / Biochemistry Article Date: 28 Sep 2012 - 1:00 PDT

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The study appears in a 27 September issue of the journal Stem Cells Translational Medicine.

iPS cells have properties similar to embryonic stem cells, which are "master cells" with an unlimited capacity to differentiate into any type of tissue in the body, such as brain, lung, skin, heart, and liver. Thus their potential in regenerative medicine, where damaged or diseased tissue can be repaired or replaced by growing new tissue, is huge, as senior author Timothy Nelson explains in a press release:

"Pluripotent stem cells show great promise in the field of regenerative medicine; however, the risk of uncontrolled cell growth will continue to prevent their use as a therapeutic treatment."

Nelson is Assistant Professor of Medicine and Pharmacology and works in the General Internal Medicine department and the Transplant Center at the Mayo.

The idea of using iPS cells is for doctors to be able to take some adult tissue, for example skin cells, from the patient who needs the treatment, and then turn the cells from that tissue into iPS cells.

Then, those iPS cells are coaxed to turn into the target type of cell, for instance lung cells. As a result of the coaxing the iPS cells turn into (differentiate) the target tissue type.

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Purging Stem Cells To Make Therapy Safer

Mayo Clinic finds way to weed out problem stem cells, making therapy safer

Public release date: 27-Sep-2012 [ | E-mail | Share ]

Contact: Jennifer Schutz newsbureau@mayo.edu 507-284-5005 Mayo Clinic

ROCHESTER, Minn. -- Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells. However, during the differentiation process, some residual pluripotent or embryonic-like cells may remain and cause them to grow into tumors.

"Pluripotent stem cells show great promise in the field of regenerative medicine; however, the risk of uncontrolled cell growth will continue to prevent their use as a therapeutic treatment," says Timothy Nelson, Ph.D., M.D., lead author on the study, which appears in the October issue of STEM CELLS Translational Medicine.

Using mouse models, Mayo scientists overcame this drawback by pretreated stem cells with a chemotherapeutic agent that selectively damages the DNA of the stem cells, efficiently killing the tumor-forming cells. The contaminated cells died off, and the chemotherapy didn't affect the healthy cells, Dr. Nelson says.

"The goal of creating new therapies is twofold: to improve disease outcome with stem cell-based regenerative medicine while also ensuring safety. This research outlines a strategy to make stem cell therapies safer for our patients while preserving their therapeutic efficacy, thereby removing a barrier to translation of these treatments to the clinic," says co-author Alyson Smith, Ph.D.

Stem cell therapies continue to be refined and improved. Researchers are finding that stem cells may be more versatile than originally thought, which means they may be able to treat a wider variety of diseases, injuries and congenital anomalies. Stem cell therapy is an emerging regenerative strategy being studied at Mayo Clinic.

"By harnessing the potential of regenerative medicine, we'll be able to provide more definitive solutions to patients," says Andre Terzic, M.D., Ph.D., co-author and director of Mayo Clinic's Center for Regenerative Medicine.

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Other members of the Mayo research team included Clifford Folmes, Ph.D., Katherine Hartjes, Natalie Nelson and Saji Oommen, Ph.D. The research was supported by the Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome, National Institutes of Health New Innovator Award OD007015-01, and a Mayo Clinic Center for Regenerative Medicine accelerated research grant.

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Mayo Clinic finds way to weed out problem stem cells, making therapy safer