StemCell Therapy

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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

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.

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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

ST. LOUIS, Oct. 3, 2012 /PRNewswire/ --Sigma-Aldrich Corporation (SIAL) announced today that Sigma Life Science, its innovative biological products and services research business, has launched Stemline Pluripotent Culture Medium, a novel human pluripotent stem cell culture medium that provides a consistent environment for the long-term maintenance and growth of healthy pluripotent stem cells. The new medium performs equivalently to the industry's leading medium and provides academic and pharmaceutical stem cell research labs with a substantially lower cost alternative to higher priced media. Additional information and sample requests of the Stemline Pluripotent Culture Medium are available at http://www.sigma.com/stemlinepsc.

"The exorbitant cost of media for pluripotent stem cells is a universal complaint from the stem cell research community. Our Stemline Pluripotent Culture Medium performs equivalently to the leading medium for maintaining pluripotency and optimal growth rates, and is produced more efficiently than traditional media, resulting in lower costs. For example, a typical academic lab that consumes three 500 mL bottles of media per week could save at least $12,000 annually using our new Stemline medium. A high-throughput pharmaceutical development team that consumes 20 liters of media weekly could save more than $160,000 annually," said John Listello, Market Segment Manager for Regenerative Medicine at Sigma Life Science.

Culturing pluripotent stem cells can be challenging as many media's undefined, heterogenous mixtures can cause inconsistent growth rates and undesired spontaneous differentiation. The Stemline Pluripotent Stem Cell Culture Medium is serum-free, composed of fully-defined components and has 80% less basic fibroblast growth factor than the leading pluripotent stem cell culture medium. This provides a consistent environment for long-term maintenance of optimal growth rates, viability and pluripotency. Rigorous characterization of the Stemline Pluripotent Stem Cell Culture Medium has demonstrated that cultured pluripotent stem cells display all established pluripotency markers and maintain proper karyotype and the ability to differentiate into each of the three germ layers. The feeder-independent medium also enables culturing with synthetic matricies, thereby eliminating a source of variability that would prohibit later clinical applications.

"Academic and pharmaceutical groups performing toxicology screens, disease-specific stem cell research or studies of the basic mechanisms behind pluripotency and differentiation depend upon a steady supply of consistent, high-performance cell culture medium. This novel Stemline medium extends Sigma's existing position as one of the largest global providers of cell culture media," said Listello.

Existing Stemline stem cell culture media include specialized formulations for expansion of six human adult stem cell and progenitor cell types: hematopoietic, neural, dendritic, mesenchymal, T-cells, and keratinocytes. These six Stemline media are produced under good manufacturing practices (GMP) and have Device Master File certificates from the U.S. Food and Drug Administration.

Sigma Life Science's comprehensive stem cell product portfolio includes custom iPS cell CompoZr ZFN-mediated genetic engineering, Stemgent Reprogramming Lentiviruses, the MISSION shRNA Library with the latest content release from The RNAi Consortium, 3D matrices, growth factors, small molecules, other cell culture media and the industry's most validated antibodies. Sigma Life Science acquired a worldwide license to Kyoto University's iPS cell patent portfolio in February, 2012.

For more information and to request pricing, visit http://www.sigma.com/stemlinepsc.

Cautionary Statement: The foregoing release contains forward-looking statements that can be identified by terminology such as "could," "could expect," "can be," "predictive" or similar expressions, or by expressed or implied discussions regarding potential future revenues from products derived there from. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that pluripotent stem cells, pluripotent stem cell media, or related custom services will assist the Company to achieve any particular levels of revenue in the future. In particular, management's expectations regarding products associated with pluripotent stem cells, pluripotent stem cell media, or related custom services could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Company's assets and liabilities as recorded in its consolidated balance sheet, and other risks and factors referred to in Sigma-Aldrich's current Form 10-K on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sigma-Aldrich is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sigma Life Science: Sigma Life Science is a Sigma-Aldrich business that represents the Company's leadership in innovative biological products and services for the global life science market and offers an array of biologically-rich products and reagents that researchers use in scientific investigation. Product areas include biomolecules, genomics and functional genomics, cells and cell-based assays, transgenics, protein assays, stem cell research, epigenetics and custom services/oligonucleotides. Sigma Life Science also provides an extensive range critical bioessentials like biochemicals, antibiotics, buffers, carbohydrates, enzymes, forensic tools, hematology and histology, nucleotides, amino acids and their derivatives, and cell culture media.

About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 38 countries and has nearly 9,100 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich, please visit its website at http://www.sigma-aldrich.com.

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Sigma® Life Science Launches Novel, Affordable Pluripotent Stem Cell Culture Medium

Washington, October 2 (ANI): A new study has suggested that induced pluripotent stem (iPS) cells - which are derived from adult human skin cells but have embryonic properties - could soon be used to restore vision in people with macular degeneration and other diseases that affect the eye's retina.

In the study conducted by Columbia ophthalmologists and stem cell researchers, adult stem cells developed from a patient's skin cells improved the vision of blind mice.

"With eye diseases, I think we're getting close to a scenario where a patient's own skin cells are used to replace retina cells destroyed by disease or degeneration," said the study's principal investigator, Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology and cell biology.

"It's often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here," he stated.

The advent of human iPS cells in 2007 was greeted with excitement from scientists who hailed the development as a way to avoid the ethical complications of embryonic stem cells and create patient-specific stem cells.

Like embryonic stem cells, iPS cells can develop into any type of cell. Thousands of different iPS cell lines from patients and healthy donors have been created in the last few years, but they are almost always used in research or drug screening.

In Tsang's new preclinical iPS study, human iPS cells - derived from the skin cells of a 53-year-old donor - were first transformed with a cocktail of growth factors into cells in the retina that lie underneath the eye's light-sensing cells.

The primary job of the retina cells is to nourish the light-sensing cells and protect the fragile cells from excess light, heat, and cellular debris. If the retina cells die - which happens in macular degeneration and retinitis pigmentosa - the photoreceptor cells degenerate and the patient loses vision.

Macular degeneration is a leading cause of vision loss in the elderly, and it is estimated that 30 percent of people will have some form of macular degeneration by age 75.

In their study, the researchers injected the iPS-derived retina cells into the right eyes of 34 mice that had a genetic mutation that caused their retina cells to degenerate.

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Patients' own skin cells could restore vision in elderly with macular degeneration

WALTHAM, Mass.--(BUSINESS WIRE)--

Histogenics, a regenerative medicine company combining cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration, announced today that it has been named to the FierceMedicalDevices Fierce 15 list, designating it as one of the leading medical device and diagnostic companies of 2012. FierceMedicalDevicesEditors Mark Hollmer and Damian Garde, in conjunction with Editor-in-Chief John Carroll and Executive Editor Ryan McBride, chose this years winners based on their top management teams, notable financial backing, and promising technologies and market opportunities.

We have worked hard over the past year, securing $49 million in financing and adding key new staff, investors and board members, so that we are now in the position to focus our full attention on continued successful clinical and regulatory execution for NeoCart cartilage regeneration implant, which is currently enrolling patients into the Phase 3 IND clinical study, and the EU regulatory development of our VeriCart cartilage repair scaffold, said Patrick ODonnell, President and Chief Executive Officer of Histogenics. We believe our product candidates have the potential to transform the treatment of cartilage injury with the goal of returning some of the estimated 1.8 million patients each year in the U.S. and E.U. that undergo arthroscopy for knee cartilage defects to their pre-injury level of activity.

Nailing down $49 million in financing in July reinforces the notion that this regenerative medicine company stands out for doing things differently.One example how: The company is well underway enrolling patients in a Phase 3 trial for NeoCart, a cartilage implant that uses a patients own cells to build it before treating cartilage lesions in the knee, said Hollmer.

NeoCart is an autologous neocartilage tissue implant in an ongoing Phase 3 clinical program that utilizes the patients own cells to regenerate cartilage in patients suffering from cartilage lesions in the knee.VeriCart, is a single-step, cell-free collagen scaffold uniquely designed to be used in conjunction with the patients own stem cells to repair small cartilage defects frequently observed in meniscal and anterior cruciate ligament repair procedures. Histogenics is seeking regulatory clearance in the European Union for VeriCart.

An internationally recognized e-newsletter reaching more than 34,000 medical device and diagnostic industry professionals, FierceMedicalDevices provides subscribers with a quick authoritative briefing on the days top stories, with a special focus on clinical studies, FDA/EMEA regulations and post-marketing. Sign up is free at http://www.fiercemedicaldevices.com/signup.

About FierceMarkets

FierceMarkets, a wholly owned subsidiary of Questex Media Group, is a leader in B2B emedia, providing information and marketing services in the telecommunications, life sciences, healthcare, IT, energy, government and finance industries through its portfolio of email newsletters, websites, webinars and live events. Every business day, FierceMarkets wide array of publications reaches more than 1.3 million executives in more than 100 countries.

About Histogenics

Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company ProChon BioTech. Histogenics flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implants effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visitwww.histogenics.com.

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Histogenics Honored as a 2012 “Fierce 15” Company by FierceMedicalDevices

SILVER SPRING, Md. and SINGAPORE, Oct. 2, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), an international biotechnology provider of cell and gene therapy solutions, announced today its wholly-owned subsidiary, Austrianova Singapore Pte Ltd (ASPL) will attend this year's AusBiotech event.

The annual AusBiotech event this year will be held from October 30 - November 2 at the Melbourne Convention and Exhibition Centre, Melbourne, Australia. It has earned a reputation as the industry's premier biotechnology conference for the Asia Pacific region and has successfully expanded its relevance to the Australian and International Biotechnology industries by attracting more than 1100 participants from over 20 countries.

Dr Brian Salmons, CEO of ASPL said, "AusBiotech has grown in stature over the past several years. In prior years, we entered agreements with companies and found it to be one of the most valuable events for networking with new contacts. We anticipate meeting with companies with proprietary therapeutic cells, such as stem cells, that can leverage their technology with our Cell-in-a-Box(R) delivery system. We believe the new contacts we make will expand our customer base and increase the use of cell and gene therapy for making therapeutic products and treating diseases. We will also be promoting our Bac-in-a-Box(R) technology for the first time at this meeting and anticipate generating interest around its potential."

The Chief Executive of Nuvilex, Dr. Robert Ryan, stated "Attendance at this important biotech event in Australia and within easy reach of Southeast Asia will enable us to have increased exposure for our Cell-in-a-Box(R) and Bac-in-a-Box(R) live cell encapsulation technology and to showcase its immense versatility, thus providing our companies greater visibility at a time that such capabilities are becoming more important in the marketplace. It is our goal to bring more projects to fruition from this meeting as more companies today are looking to bring cellular-based therapy and product creation from the drawing board to reality and into regular use."

About Nuvilex

Nuvilex, Inc. (NVLX) is an international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. A great deal of work is ongoing to move Nuvilex and its Austrianova Singapore subsidiary forward. This was clearly apparent during Dr. Ryan's trip to Singapore and the advent of new developments in the company as a whole. Our company's own offerings will include cancer, diabetes, other treatments and capabilities using the company's cell and gene therapy expertise and live-cell encapsulation technology.

The Nuvilex, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13494

Safe Harbor Statement

This press release contains forward-looking statements described within the 1995 Private Securities Litigation Reform Act involving risks and uncertainties including product demand, market competition, and meeting current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, reflect events or circumstances afterward, or disclose unanticipated occurrences, except as required under applicable laws.

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Nuvilex Subsidiary Austrianova Singapore to Participate in AusBiotech 2012

ScienceDaily (Oct. 2, 2012) The team led by Manel Esteller, director of the Cancer Epigenetics and Biology Program in the Bellvitge Biomedical Research Institute (IDIBELL), Professor of Genetics at the University of Barcelona and ICREA researcher, has identified epigenetic changes that occur in adult stem cells to generate different body tissues.

The finding is published this week in The American Journal of Pathology.

The genome of every single cell in the human body is the same, regardless of their appearance and function. Therefore the activity of the tissues and organs and its disorders in complex diseases, such as cancer, cannot be fully explained by the genome. It is necessary something more, and part of the explanation is provided by epigenetics, which is defined as "the inheritance of DNA activity that does not depend on strict sequence of it." That is, if genetics is the alphabet, spelling would be the epigenetics, which refers to chemical changes in our genetic material and their regulatory proteins. The most known epigenetic mark is the addition of a methyl group to DNA. Thus, the epigenome is getting all the epigenetic marks of a living being.

Adult stem cells have an enormous potential to regenerate damaged organs and their use also avoids ethical complications involving embryonic stem cells, as well as technical problems arising from induced stem cells. In this study, researchers have isolated stem cells from body fat and transformed them into muscle and bone cells. Then, it was necessary to know how much resembled are the cells created in the laboratory with those present in one individual and if they were biologically secured enough to be implanted in patients. The study shows that the epigenome of the cells obtained in culture closely resembles that of skeletal muscle cells and they are spontaneously present in nature, although not completely identical.

A key point of the study is that muscle and bone cells produced in the laboratory do not have the tumour epigenome derived from these tumour tissues (rhabdomyosarcoma and osteosarcoma, respectively) so they are safe from a biological perspective. The study coordinator, Manel Esteller, stresses that the research "demonstrates the usefulness of epigenetics in determining the degree of maturity and biosecurity of differentiated tissues used in regenerative medicine against different diseases."

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The above story is reprinted from materials provided by IDIBELL-Bellvitge Biomedical Research Institute.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

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Adult stem cells change their epigenome to generate new organs

April Flowers for redOrbit.com Your Universe Online

Columbia University ophthalmologists and stem cell researchers have developed an experimental treatment for blindness using the patients skin cells, which has improved the vision of blind mice in testing.

The findings of this research, published online in the journal Molecular Medicine, suggest that induced pluripotent stem cells (iPS) could soon be used to improve vision in people with macular degeneration and other eye retina diseases. iPS cells are derived from adult human skin cells but have embryonic qualities.

With eye diseases, I think were getting close to a scenario where a patients own skin cells are used to replace retina cells destroyed by disease or degeneration, says Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology & cell biology. Its often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here.

Scientists were very excited by the advent of human iPS cells when they were discovered in 2007, as they provide a way to avoid the ethical complications of embryonic stem cells. Another advantage is that the iPS cells are created from the patients own skin, eliminating the need for anti-rejection medications. Like the ethically challenged embryonic cells, iPS cells can develop into any type of cell. To-date, no iPS cells have been implanted into people, but many ophthalmologists say that the eye would prove to be ideal testing ground for iPS therapies.

The eye is a transparent and accessible part of the central nervous system, and thats a big advantage. We can put cells into the eye and monitor them every day with routine non-invasive clinical exams, Tsang said. And in the event of serious complications, removing the eye is not a life-threatening event.

Professor Tsang is running a new preclinical iPS study using human iPS cells derived from the skin cells of a 53-year-old donor. The cells were first transformed with a cocktail of growth factors into cells in the retina that lie underneath the eyes light-sensing cells.

Retina cells nourish the light-sensing cells and protect the fragile cells from excess light, heat and cellular debris. In macular degeneration and retinitis pigmentosa, retina cells die, which allows the photoreceptor cells to degenerate causing the patient to lose their vision. It is estimated that 30 percent of people will have some form of macular degeneration by the time they are 75 years old, as it is the leading cause of vision loss in the elderly. Currently, it affects 7 million Americans and that is expected to double by 2020.

The Columbia research team injected the iPS-derived retina cells into the right eyes of 34 mice that had a genetic mutation that caused their retina cells to degenerate. In many of the mice, the iPS cells assimilated into the retina without disruption and functioned as normal retina cells well into the animals old age. Mice in the control group, who received injections of saline or inactive cells, showed no improvement in retina tests.

Our findings provide the first evidence of life-long neuronal recovery in a preclinical model of retinal degeneration, using stem cell transplant, with vision improvement persisting through the lifespan, Tsang says. And importantly, we saw no tumors in any of the mice, which should allay one of the biggest fears people have about stem cell transplants: that they will generate tumors.

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Blind Mice Get Experimental Stem Cell Treatment For Blindness

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.

Read the original here:
Cedars-Sinai 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

April Flowers for redOrbit.com Your Universe Online

Columbia University ophthalmologists and stem cell researchers have developed an experimental treatment for blindness using the patients skin cells, which has improved the vision of blind mice in testing.

The findings of this research, published online in the journal Molecular Medicine, suggest that induced pluripotent stem cells (iPS) could soon be used to improve vision in people with macular degeneration and other eye retina diseases. iPS cells are derived from adult human skin cells but have embryonic qualities.

With eye diseases, I think were getting close to a scenario where a patients own skin cells are used to replace retina cells destroyed by disease or degeneration, says Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology & cell biology. Its often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here.

Scientists were very excited by the advent of human iPS cells when they were discovered in 2007, as they provide a way to avoid the ethical complications of embryonic stem cells. Another advantage is that the iPS cells are created from the patients own skin, eliminating the need for anti-rejection medications. Like the ethically challenged embryonic cells, iPS cells can develop into any type of cell. To-date, no iPS cells have been implanted into people, but many ophthalmologists say that the eye would prove to be ideal testing ground for iPS therapies.

The eye is a transparent and accessible part of the central nervous system, and thats a big advantage. We can put cells into the eye and monitor them every day with routine non-invasive clinical exams, Tsang said. And in the event of serious complications, removing the eye is not a life-threatening event.

Professor Tsang is running a new preclinical iPS study using human iPS cells derived from the skin cells of a 53-year-old donor. The cells were first transformed with a cocktail of growth factors into cells in the retina that lie underneath the eyes light-sensing cells.

Retina cells nourish the light-sensing cells and protect the fragile cells from excess light, heat and cellular debris. In macular degeneration and retinitis pigmentosa, retina cells die, which allows the photoreceptor cells to degenerate causing the patient to lose their vision. It is estimated that 30 percent of people will have some form of macular degeneration by the time they are 75 years old, as it is the leading cause of vision loss in the elderly. Currently, it affects 7 million Americans and that is expected to double by 2020.

The Columbia research team injected the iPS-derived retina cells into the right eyes of 34 mice that had a genetic mutation that caused their retina cells to degenerate. In many of the mice, the iPS cells assimilated into the retina without disruption and functioned as normal retina cells well into the animals old age. Mice in the control group, who received injections of saline or inactive cells, showed no improvement in retina tests.

Our findings provide the first evidence of life-long neuronal recovery in a preclinical model of retinal degeneration, using stem cell transplant, with vision improvement persisting through the lifespan, Tsang says. And importantly, we saw no tumors in any of the mice, which should allay one of the biggest fears people have about stem cell transplants: that they will generate tumors.

See the original post here:
Blind Mice Get Experimental Stem Cell Treatment For Blindness

NEW YORK, Oct. 2, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that Company management and management of its subsidiary, Progenitor Cell Therapy ("PCT"), have been invited to present at multiple conferences in October.

RetailInvestorConferences.com

The RedChip 15th Annual Fall Small-Cap Conference

Regenerative Medicine Foundation 2012 Conference

2012 Stem Cell Meeting on the Mesa, 2nd Annual Investor and Partnering Forum

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.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

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NeoStem to Present at Multiple Conferences in October

A beautiful, fresh face, Sabrina Cohen can stun you with her charm.

But she is far more. This 24-year-old, who has spent 10 years in a wheelchair as a result of a car accident, is battling to raise money for research and therapies that may eventually reverse paralysis and treat central nervous system impairments.

A native of Miami Beach, she is one of five leaders being honored by the Palm Beach-based Genetic Policy Institute at its eighth annual World Stem Cell Summit Dec. 4 at the Palm Beach County Convention Center in West Palm Beach. She is receiving the Inspirational Award.

This award brings a lot of meaning to my life and the path I have chosen to follow, she says of her founding of the nonprofit Sabrina Cohen Foundation.

This provides a platform for my foundation to inspire others and to share my hope for (stem cell) regeneration.

Other honorees include CBS 60 Minutes for its hard-hitting programs on unproven stem cell treatments; Susan Solomon, CEO of the New York Stem Cell Foundation; Alliance for Regenerative Medicine; and the Nebraska Coalition for Lifesaving Cures.

We recognize the dedicated individuals and organizations that positively impact the cause of stem-cell advancement aimed at finding cures and alleviating human suffering, said Bernard Siegel, executive director of GPI.

Through their positive actions, our honorees have moved the regenerative medicine needle, bringing closer the day when patients will be safely treated through these innovative technologies.

Previous Stem Cell Action awardees have included Maryland Governor Martin OMalley, Research!America, Juvenile Diabetes Research Foundation, Michael J. Fox, Robert Klein, Sherry Lansing, Palm Beacher A. Alfred Taubman and the National Association of Biology Teachers.

This year, panels will address advancing treatments for specific diseases and conditions including cancer, diabetes, HIV/AIDS, cardiovascular disease, spinal cord injury, paralysis, multiple sclerosis, ALS, Parkinsons, eye diseases and others.

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Stem-cell advocacy ‘moved the needle’

SAN DIEGO--(BUSINESS WIRE)--

Medistem Inc (Pink Sheets:MEDS) announced today the initiation of a collaboration with Superview Biotechnology Co. Ltd, a subsidiary of Yinhuan Holding Co from Yixing, China. The joint work will be aimed at using proprietary stem cell lines developed by Medistem for screening of monoclonal antibodies for therapeutic activity in the area of regenerative medicine. As part of the collaboration, the two companies will evaluate various candidates jointly, as well as apply for grants and share research data.

To date, the majority of stem cell companies are focusing on the stem cell itself being a product. By collaborating with Superview Biotechnology, we aim to assess the feasibility of developing antibodies that can modulate the activity of stem cells that already exist in the body, said Thomas Ichim, CEO of Medistem. This approach not only provides methods of activating stem cells but also allows for the development of stem cell adjuvant therapies that could be used to resurrect stem cell candidates that failed in clinical trials.

Superview Biotechnology has developed proprietary methods of rapidly generating monoclonal antibodies to esoteric protein targets. Medistem has a history of success in the area of stem cells, being the only company to take a stem cell product from discovery to FDA clearance in the short span of 4 years.

One of the significant driving forces behind our company is to develop innovative targets for our monoclonal antibodies. Although monoclonal antibodies have generated sales of billions of dollars in areas ranging from rheumatoid arthritis, to cancer, to preventing blindness, we feel that the potential of this therapeutic tool is only beginning to be recognized, said Jiong Wu, CEO of Superview Biotechnology. Our opinion is that the barriers to entry for monoclonal antibody-based therapies modulating endogenous stem cells is lower than stem cell based therapies. We are eager to work with the Medistem team at exploring this hypothesis.

A joint grant is expected to be filed with the National Natural Science Foundation of China to support part of the proposed collaboration by end of October, 2012.

Cautionary Statement

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

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Medistem and Superview Biotechnology Co. Ltd. Initiate Collaboration on Therapeutics Development Using Antibody and ...

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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

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

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.

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Experimental Stem Cell 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

HOUSTON, Oct. 1, 2012 /PRNewswire/ --Celltex Therapeutics Corp. announced today that it has received a letter, dated Sept. 24, 2012, from the U.S. Food and Drug Administration. The letter stated the agency's opinion that the process Celltex uses to multiply adult stem cells is subject to FDA regulation as biological drug manufacturing. The issue is a key one as stem cell therapy for patient care outside of an academic institution is a new frontier, yet there are a variety of technologies being used throughout the United States, often creating complex legal and regulatory questions.

David Eller, CEO and President of Celltex, stated:

Celltex makes identical copies of an individual's own stem cells and therefore should not be subject to FDA regulation as drugs. However, the FDA said our process causes the cells to be considered biological drugs and thus is subject to those regulations. We respectfully but firmly disagree with the FDA and intend to contest the agency's opinion within its administrative procedures. We are considering all options as we work with the agency toward a resolution.

FDA's letter also repeats its earlier observations from an April inspection of Celltex's laboratory. While Celltex provided detailed responses in April, May, June, July and August, now FDA tells us it needs more information. We will answer FDA's questions in whatever detail the agency requests."

We will meet FDA's requirements, no matter how high the hurdles may be, to ensure access to this technology. Celltex remains fully committed to advance the most promising new field in human health in decades regenerative medicine. We also remain committed to doing so safely, and we will continue to comply with federal and state agency requirements.

As we work with the FDA, Celltex will continue to make advances on the frontier of regenerative medicine, and we expect to have several significant announcements in the coming weeks on these matters:

"Celltex is committed to developing the promise of regenerative medicine into a reality for doctors and their patients," Mr. Eller said. "We sponsor clinical trials to better understand the therapeutic impact and monitor the safety of adult stem cell therapy, and we are confident that our research will help implement effective treatments for patients suffering from a variety of medical conditions."

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Celltex To Initiate New Clinical Program As It Responds To FDA Letter