Japan approves landmark stem cell trials

Japan's government has given its approval to the world's first clinical trials using stem cells harvested from a patient's own body.

Health Minister Norihisa Tamura signed off on Friday on a proposal by two research institutes that will allow them to begin tests aimed at treating age-related macular degeneration (AMD), a common medical condition that causes blindness in older people, using "induced Pluripotent Stem (iPS) cells".

Stem cell research is a pioneering field that may offer a cure for conditions that are currently incurable, and scientists hope these clinical trials on a treatment for AMD may offer hope to millions of people robbed of their sight.

The tests will be jointly conducted by the Riken Center for Developmental Biology and the Institute of Biomedical Research and Innovation (IBRI) Hospital in Japan.

Riken will harvest stem cells, using skin cells taken from patients, a spokesman said.

The trial treatment will attempt to create retinal cells that can be transplanted into the eyes of six patients suffering from AMD, replacing the damaged part of the eye.

The transplant may be conducted as early as the middle of next year at the IBRI Hospital, he said.

AMD, a condition that is incurable at present, affects mostly middle-aged and older people and can lead to blindness. It afflicts around 700,000 people in Japan alone.

Groundbreaking work

Stem cells are infant cells that can develop into any part of the body.

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Japan approves landmark stem cell trials

Japan approves stem cell clinical trials

Japan's government on Friday gave its seal of approval to the world's first clinical trials using stem cells harvested from a patient's own body.

Health Minister Norihisa Tamura signed off on a proposal by two research institutes that will allow them to begin tests aimed at treating age-related macular degeneration (AMD), a common medical condition that causes blindness in older people, using "induced Pluripotent Stem (iPS) cells".

Stem cell research is a pioneering field that may offer a cure for conditions that are presently incurable, and scientists hope these clinical trials on a treatment for AMD may offer hope to millions of people robbed of their sight.

A government committee last month approved proposals for the tests, which will be jointly conducted by the Riken Center for Developmental Biology and the Institute of Biomedical Research and Innovation (IBRI) Hospital in the western city of Kobe.

Riken will harvest stem cells, using skin cells taken from patients, a spokesman said.

The trial treatment will attempt to create retinal cells that can be transplanted into the eyes of six patients suffering from AMD, replacing the damaged part of the eye.

The transplant may be conducted as early as the middle of next year at the IBRI Hospital, he said.

AMD, a condition that is incurable at present, affects mostly middle-aged and older people and can lead to blindness. It afflicts around 700,000 people in Japan alone.

Stem cells are infant cells that can develop into any part of the body.

Until the discovery of iPS cells several years ago, the only way to obtain stem cells was to harvest them from human embryos.

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Japan approves stem cell clinical trials

Japan govt approves stem cell clinical trials

TOKYO (AFP) Japan's government on Friday gave its seal of approval to the world's first clinical trials using stem cells harvested from a patient's own body.

Health Minister Norihisa Tamura signed off on a proposal by two research institutes that will allow them to begin tests aimed at treating age-related macular degeneration (AMD), a common medical condition that causes blindness in older people, using "induced Pluripotent Stem (iPS) cells".

Stem cell research is a pioneering field that may offer a cure for conditions that are presently incurable, and scientists hope these clinical trials on a treatment for AMD may offer hope to millions of people robbed of their sight.

A government committee last month approved proposals for the tests, which will be jointly conducted by the Riken Center for Developmental Biology and the Institute of Biomedical Research and Innovation (IBRI) Hospital in the western city of Kobe.

Riken will harvest stem cells, using skin cells taken from patients, a spokesman said.

The trial treatment will attempt to create retinal cells that can be transplanted into the eyes of six patients suffering from AMD, replacing the damaged part of the eye.

The transplant may be conducted as early as the middle of next year at the IBRI Hospital, he said.

AMD, a condition that is incurable at present, affects mostly middle-aged and older people and can lead to blindness. It afflicts around 700,000 people in Japan alone.

Stem cells are infant cells that can develop into any part of the body.

Until the discovery of iPS cells several years ago, the only way to obtain stem cells was to harvest them from human embryos.

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Japan govt approves stem cell clinical trials

Medistem and Cytori Therapeutics Enter Into Licensing Agreement

SAN DIEGO, CA--(Marketwired - Jul 18, 2013) - Medistem, Inc. (PINKSHEETS: MEDS), today announced that it entered into an agreement granting Cytori Therapeutics, Inc. (NASDAQ: CYTX) a license and the exclusive rights to use Medistem's U.S. Patent No. 8,241,621, "Stem Cell Mediated Treg Activation" in the United States.

The licensed patent pertains to Cytori's Adipose-Derived Regenerative Cell (ADRC) based platform for the treatment of autoimmune diseases.

"We are delighted to have formalized a licensing agreement with an adult stem cell leader like Cytori and look forward to working with them in the future," said Alan J. Lewis, Ph.D., CEO of Medistem.

"We are pleased to have licensed this patent from Medistem because it strengthens our patent portfolio in the area of immune disease," said Marc H. Hedrick, President of Cytori Therapeutics.

About Medistem, Inc.

Medistem, Inc., is focused on the development of the Endometrial Regenerative Cell (ERC), a universal donor adult stem cell product. ERCs possess specialized abilities to stimulate new blood vessel growth and can differentiate into lung, liver, heart, brain, bone, cartilage, fat and pancreatic tissue. These unique properties have applications for treatment of critical limb ischemia (CLI), congestive heart failure (CHF), neurodegenerative diseases, liver failure, kidney failure, and diabetes. ERCs have been cleared by the FDA to begin studies in the United States.In January 2012, we announced the initiation of our RECOVER-ERC (Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy) Phase II clinical trial.This trial is being conducted at the Bakulev Scientific Center for Cardiovascular Surgery, Moscow, Russia.The trial is a 60 patient double blind placebo controlled study evaluating safety and efficacy of ERCs in end stage CHF patients.

Certain statements herein may be forward-looking and involve risks and uncertainties.Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Medistem, Inc.These can be identified by the use of forwardlooking words, such as "believes", "expects", "may", "intends", "anticipates", "plans", "estimates", or any other analogous or similar expressions intended to identify forwardlooking statements. These forwardlooking statements and estimates as to future performance, estimates, and other statements contained herein regarding matters that are not historical facts, are only predictions and actual events or results may differ materially. We cannot assure or guarantee that any future results described in this presentation will be achieved, and actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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Medistem and Cytori Therapeutics Enter Into Licensing Agreement

Stem cell research yields Down syndrome breakthrough

Two UMass Medical School researchers used a naturally occurring off switch to shut down the chromosomes that cause Down syndrome during laboratory experiments that used human stem cells, according to a press release from the school.

This discovery could lead to treatment and therapy based on the chromosome that causes the condition, rather than treatment based on its symptoms, the researchers said.

Our hope is that for individuals living with Down syndrome, this proof-of-principal opens up multiple exciting new avenues for studying the disorder now, and brings into the realm of consideration research on the concept of chromosome therapy in the future, said lead researcher Jeanne B. Lawrence, professor of cell and developmental biology.

The news was met with guarded applause by a Bay State advocacy group which praised the research, but warned of ethical concerns for parents of children with Down syndrome.

This appears to be one of the most important scientific advancements in the field since French physician Jerome Lejeune identified Down syndrome as a chromosomal condition in 1959, Maureen Gallagher, executive director of the Massachusetts Down Syndrome Congress said in a statement. Its important for us to understand that any direct therapeutic implications as a result of this new research is many years away and that although it is an exciting discovery, it will bring with it many ethical and emotional issues for the Down syndrome community.

People without Down syndrome are born with 23 pairs of chromosomes in each cell. Down syndrome occurs when one pair of those chromosomes, No. 21, appears three times rather than in a pair. To stop this from happening in their stem cell samples, the researchers used a gene that silences the X chromosome in females, and moved it to a spot on the chromosome where it repressed the growth of that third No. 21 chromosome.

Dr. Lawrence has harnessed the power of a natural process to target abnormal gene expression in cells that have an aberrant number of chromosomes, said Anthony Carter, of the National Institutes of Health, which partly supported the study. Her work provides a new tool that could yield novel insights into how genes are silenced on a chromosomal scale, and into the pathological processes associated with chromosome disorders such as Down syndrome.

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Stem cell research yields Down syndrome breakthrough

Stem Cell Therapy Market in Asia-Pacific to 2018

DUBLIN, July 18, 2013 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/qc7zk2/stem_cell_therapy) has announced the addition of the "Stem Cell Therapy Market in Asia-Pacific to 2018 - Commercialization Supported by Favorable Government Policies, Strong Pipeline and Increased Licensing Activity" report to their offering.

(Logo: http://photos.prnewswire.com/prnh/20130307/600769 )

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

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

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

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

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

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

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

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Stem Cell Therapy Market in Asia-Pacific to 2018

Cell Therapy – Technologies, Markets and Companies – Updated 2013 with New Companies and Profiles

DUBLIN, July 16, 2013 /PRNewswire/ --

Research and Markets ( http://www.researchandmarkets.com/research/dhdp3r/cell_therapy) has announced the addition of Jain PharmaBiotech's new report "Cell Therapy - Technologies, Markets and Companies" to their offering.

(Logo: http://photos.prnewswire.com/prnh/20130307/600769 )

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

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

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

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

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

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

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 287 of these are profiled in part II of the report along with tabulation of 273 alliances. Of these companies, 158 are involved in stem cells. Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 55 Tables and 12 Figures. The bibliography contains 1,050 selected references, which are cited in the text.

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Cell Therapy - Technologies, Markets and Companies - Updated 2013 with New Companies and Profiles

Dr. Leslie Miller Named Chief Science Officer of Okyanos Heart Institute's Cardiac Stem Cell Therapy Treatment for …

Freeport, Bahamas (PRWEB) July 17, 2013

Okyanos Heart Institute, whose mission it is to bring a new standard of care and better quality of life to patients with coronary artery disease using cardiac stem cell therapy, has named Leslie Miller, M.D., F.A.C.C. as its chief science officer. Dr. Miller is a leading heart failure specialist and experienced thought leader in cardiac stem cell therapy. He is director of the University of South Florida (USF) Heart Institute, professor of cardiovascular sciences at the USF Health Morsani College of Medicine, and was formerly the director of cardiology at Georgetown University. Dr. Miller has been an investigator in over 80 clinical trials.

The use of adult stem cells derived from adipose (fat) tissue to treat congestive heart failure has the potential to change the game for the millions of patients suffering from this disease, said Miller. These stem and regenerative cells have been shown to stimulate the growth of new blood vessels, are anti-inflammatory and prevent at-risk cells from dying. These combined mechanisms can provide important therapeutic benefit to heart failure patients.

As a current member of Okyanos medical advisory council, Dr. Miller has actively advised us on patients criteria for cardiac stem cell therapy, says Okyanos Chief Medical Officer Howard Walpole. In this additional role as Chief Science Officer, he will be evaluating new research protocols and reporting on findings from the patient registry that will help advance the field of cardiac stem cell therapy. His experience and track record in leading academic research is outstanding. This integrated approach in research and clinical application in The Bahamas makes Okyanos Heart Institute one of the first places patients can receive new treatments.

Dr. Leslie Miller is a well-respected visionary in the field of cardiovascular disease says Okyanos CEO Matt Feshbach. This role will further advance our quality measures and the structure of our patient registry. We look forward to his contribution to improving the lives of patients using adult stem cells derived from their own fat tissue who, up until now, have exhausted their options with conventional treatments.

ABOUT OKYANOS HEART INSTITUTE: (Oh key AH nos) Based in Freeport, The Bahamas, Okyanos Heart Institutes mission is to bring a new standard of care and a better quality of life to patients with coronary artery disease using cardiac stem cell therapy. Okyanos adheres to U.S. surgical center standards and is led by Chief Medical Officer Howard T. Walpole Jr., M.D., M.B.A., F.A.C.C., F.A.C.A.I. Okyanos Treatment utilizes a unique blend of stem and regenerative cells derived from ones own adipose (fat) tissue. The cells, when placed into the heart via a minimally-invasive catheterization, stimulates the growth of new blood vessels, a process known as angiogenesis. The treatment facilitates blood flow in the heart and supports intake and use of oxygen (as demonstrated in rigorous clinical trials such as the PRECISE trial). The literary name Okyanos (Oceanos) symbolizes flow. For more information, go to http://www.okyanos.com/.

NEW MEDIA CONTENT: Okyanos LinkedIn page: http://www.linkedin.com/company/okyanos-heart-institute

Okyanos Facebook page: https://www.facebook.com/OKYANOS

Okyanos Twitter page: https://twitter.com/#!/OkyanosHeart

END

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