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Thread: NIH Breaking News

  1. #1

    Default NIH Breaking News

    NIH stem-cell programme closes

    Director resigns as just one clinical-trial award is made.

    Sara Reardon

    08 April 2014
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    Bradley J. Fikes

    Stem-cell biologist Mahendra Rao expected five projects to receive support to set up clinical trials.

    Stem-cell researchers at the US National Institutes of Health (NIH) have been left frustrated and confused following the demise of the agency’s Center for Regenerative Medicine (CRM). The intramural programme’s director, stem-cell biologist Mahendra Rao, left the NIH, in Bethesda, Maryland, on 28 March, and the centre’s website was taken down on 4 April. Although no official announcement had been made at the time Nature went to press, NIH officials say that they are rethinking how they will conduct in-house stem-cell research.

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    Researchers affiliated with the centre say that they have been left in the dark. When contacted by Nature on 7 April, George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts, and a member of the centre’s external advisory board, said that he had not yet been told of Rao’s departure or the centre’s closure.

    The CRM was established in 2010 to centralize the NIH’s stem-cell programme. Its goal was to develop useful therapies from induced pluripotent stem (iPS) cells — adult cells that have been converted into embryonic-like stem cells — and shepherd them towards clinical trials and regulatory approval. Its budget was intended to be $52 million over seven years.

    Rao took the helm in 2011. Relations seem to have soured last month owing to an NIH decision to award funding to only one project aiming to move iPS cells into a clinical trial. Rao says he resigned after this became clear. He says that he had hoped that five trials would be funded, especially because the centre had already sorted out complex issues relating to tissue sources, patents and informed consent.

    James Anderson, director of the NIH’s Division of Program Coordination, Planning, and Strategic Initiatives, which administered the CRM, counters that only one application — that made by Kapil Bharti of the National Eye Institute in Bethesda and his colleagues — received a high enough score from an external review board to justify continued funding. The team aims to use iPS cells to treat age-related macular degeneration of the retina, and hopes to commence human trials within a few years. Several other proposals, which involved the treatment of cardiac disease, cancer and Parkinson’s disease, will not receive funding to ready them for clinical trials. Anderson stresses that Bharti’s trial will not be affected by the CRM’s closure.


    Therapies based on induced pluripotent stem cells, here differentiating into retinal cells on a scaffold, were the focus of the Center for Regenerative Medicine.

    Other human iPS-cell trials are further along. For example, one on macular degeneration designed by Masayo Takahashi at the RIKEN Center for Developmental Biology in Kobe, Japan, began recruiting patients last August.

    Anderson says that the CRM will not continue in its current form. “The field is moving so fast that we need to rethink.” To that end, the NIH plans to hold a workshop in May to gather stem-cell researchers together and decide what to do with the programme and its remaining budget. “To me that’s just smart science,” he says. “If something’s not on track you don’t keep spending money on it.”
    One option could be to allow CRM projects to be absorbed by the National Center for Advancing Translational Sciences, an NIH institute established in 2011 to translate basic research into therapies. But Anderson says that participants at the workshop will also discuss whether the NIH needs to replace the CRM with another dedicated stem-cell programme.

    Rao says he is not yet sure what his plans are. He has already joined the boards of two stem-cell-therapy companies, and eventually hopes to find a company that will allow him to proceed with clinical trials of iPS-cell treatments for Parkinson’s disease.

    He says that despite what has happened, he is proud of the CRM’s accomplishments: its researchers have generated more than 400 lines of iPS cells, and the centre has funded two contractors to create 12 lines of clinical-grade iPS cells that will be available later this year. But, he adds, “It’s a little disappointing. The NIH is at a stage where it can be a world leader.”

    (10 April 2014)

  2. #2
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    May 2007
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    Default Stemedica Appoints NIH Center for Regenerative Medicine Founding Director to Board

    I guess the grass must be GREENER $$$$ on the other side.

    Stemedica Appoints NIH Center for Regenerative Medicine Founding Director Dr. Mahendra Rao to Its Scientific and Medical Advisory Board

    Renowned Stem Cell and Regenerative Medicine Authority Will Help Stemedica in Its Plans to Meet the Global Demand for Stem Cell Technology


    Stemedica Cell Technologies Inc., a leading manufacturer of adult, allogeneic stem cells and stem cell factors, welcomes to its Scientific and Medical Advisory Board prominent stem cell and regenerative medicine expert Dr. Mahendra Rao, M.D., Ph.D. As a Founding Director of the National Institute of Health (NIH) Center for Regenerative Medicine (CRM), he has built the Center into a world-class organization recognized for its excellence in the clinical translation of stem cell technology, and his expertise will help Stemedica shape its strategy to meet global demand for its stem cell technology.

    “I look forward to a long and beneficial relationship with Stemedica,” Dr. Mahendra Rao says. “In my various professional assignments and industry engagements, I have had an opportunity to extensively review the stem cell technology that is available in the marketplace. I decided to join the Stemedica team because Stemedica has developed an elegant manufacturing process and is committed to cell-based therapies for multiple medical diseases that are difficult to treat.”

    Dr. Rao is internationally renowned for his research in stem cells and regenerative medicine. He has worked in the stem cell field for more than 20 years, with positions in academia, government, regulatory affairs and industry, and he has authored more than 300 publications. He received his M.D. from Bombay University and his Ph.D. in developmental neurobiology from the California Institute of Technology. Following postdoctoral training at Case Western Reserve University, he established his research laboratory in neural development at the University of Utah. He next joined the National Institute on Aging as Chief of the Neurosciences Section, where he studied neural progenitor cells. Most recently, he was Vice President of Regenerative Medicine at Life Technologies.

    “We are very fortunate to have someone of Dr. Rao’s caliber join the Stemedica Team,” says Maynard A. Howe, Ph.D., Vice Chairman and CEO of Stemedica. “His experience and expertise are already proving invaluable as Stemedica strengthens its global leadership position in manufacturing multiple stem cell products for use in various clinical trials in the United States and internationally.”

    Throughout his career, Dr. Rao has served internationally on advisory boards for companies involved in stem cell processing and translational applications. He has also participated on committees including Chairman of the U.S. Food and Drug Administration’s Cellular Tissue and Gene Therapies Advisory Committee, the California Institute of Regenerative Medicine, International Society for Stem Cell Research and as the liaison to the International Society for Cellular Therapy.

    “Based on his extensive stem cell and regenerative medicine accomplishments, Dr. Rao is the ideal candidate to advise Stemedica during this period of rapid growth,” states Alex Kharazi, M.D., Ph.D., CTO of Stemedica Cell Technologies Inc.

    About Stemedica Cell Technologies Inc.

    Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the manufacturing and development of best-in-class, allogeneic, adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government-licensed manufacturer of clinical-grade stem cells and is approved by the FDA for clinical trials in acute myocardial infarction, chronic heart failure, cutaneous photoaging and ischemic stroke. Stemedica is currently developing regulatory pathways for a number of other medical indications using adult, allogeneic stem cells. The company has headquarters in San Diego, Calif., and can be found online at
    First treatment in 2007. Pioneering ever since.


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