Cell Therapy News Volume 10.38 | Sep 28 2009

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    Cell Therapy News 10.38, September 28, 2009
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Bioheart Inc. Announces Positive Results in the MARVEL Phase II/III Clinical Trial: Bioheart, Inc. recently presented positive efficacy data from part 1 of its Phase II/III clinical trial involving the injection of adult muscle stem cell therapy into patients’ damaged heart muscle. [Bioheart Inc., Sunrise]
    Article

    Science

    Learn to Culture Mesenchymal Stem Cells with The Cell Experts(TM)
    STEMCELL Technologies is offering a 2-day Mesenchymall Stem Cell Training Course to provide hands-on instruction in the in the isolation and culture of human and mouse mesenchymal stem cells.
    October 2-3, Vancouver, Canada
    Link

    Complimentary Webinar: Defined, Serum-Free Culture of MSCs using MesenCult(R)-ACF Medium
    Link

    Researchers Isolates Liver Cancer Stem Cells Prior to Tumor Formation
    Using a unique approach that involves study of individual cells, scientists have demonstrated for the first time a population of cancer stem cells in the liver prior to tumor formation. [Penn State College of Medicine, Pittsburgh]
    Article

    Researchers at Hohenstein Successfully Colonies a Textile Implant with Human Stem Cells
    Researchers have developed a method to embed multipotent mesenchymal stem cells onto the surface fibers of common surgical fabric implants. [Hohenstein Institute, Stuttgart]
    Article

    Math Used As a Tool to Heal Toughest of Wounds
    Scientists expect a new mathematical model of chronic wound healing could replace intuition with clear guidance on how to test treatment strategies in tackling a major public-health problem. [Ohio State University, Columbus]
    Article

    Stem Cell Study Raises Hope for Bone Repair Pastes
    New stem cell studies demonstrate that surgeons could one day routinely use strong, moldable, and injectable pastes to regenerate needed bone tissue to repair broken bones, fractures, genetic defects, even combat bone wounds. [University of Maryland Dental School, Baltimore]
    Article

    Junk DNA May Prove Invaluable in Quest for Gene Therapies
    Scientists have identified how a protein enables sections of so-called junk DNA to be cut and pasted within genetic code – a finding which could speed development of gene therapies. [University of Edinburgh, Edinburgh]
    Article

    Snorting Can Deliver Cells to the Brain
    Researchers have shown that when stem cells suspended in fluid are snorted, they rapidly migrate into the brain. [University of Minnesota, Minneapolis]
    Article

    Immune Cells Offer Hope for Injured Lungs
    New research in mice is shedding light on how a special group of immune cells heal badly injured lungs. [Johns Hopkins University School of Medicine, Baltimore]
    Article

    Pluristem Therapeutics Doses First Patient in U.S. With Placenta-Derived Stem Cell Product PLX-PAD in a Phase I Clinical Trial for Treatment of Peripheral Artery Disease
    Pluristem Therapeutics Inc. recently announced the dosing of the first patient in the U.S. with its placenta-derived stem cell product, PLX-PAD, in a Phase I clinical trial for the treatment of critical limb ischemia. [Pluristem Therapeutics, Haifa]
    Article

    Surgeons Use Artificial Heart, Stem Cells to Save Patient
    A British surgeon saved a dying heart patient by giving him an artificial heart and injecting him with stem cells to rebuild the damaged muscle in a procedure believed to be a world first. [John Radcliffe Hospital, Oxford]
    Article

    Neuralstem Receives FDA Approval to Commence First ALS Stem Cell Trial
    Neuralstem, Inc. recently announced that the U.S. Food and Drug Administration has approved its Investigational New Drug application to commence a Phase I trial to treat Amyotrophic Lateral Sclerosis with its spinal cord stem cells. [Neuralstem Inc., Rockville]
    Article

    Patients’ Legs Saved from Amputation Using Adult Stem Cells
    Researchers have treated 33 patients during the Phase I and Phase II safety/efficacy clinical trials using a combination of the patient’s own endothelial progenitor cells and mesenchymal stem cells for lower limb ischemia. [TCA Cellular Therapy, Covington]
    Article

    Enrolment Complete for Second Group of Heart Failure Patients Treated with “Off-the-Shelf” Adult Stem Cells
    Mesoblast Limited recently announced successful completion of enrolment of the second group of 20 patients randomized to receive an increased dose of Revascor(TM), the proprietary allogeneic, universal adult stem cell product for congestive heart failure. [Mesoblast Limited, Melbourne]
    Article

    Historic Gene Therapy Trial to Treat Alzheimer’s Disease Underway
    Researchers are now recruiting volunteers for a national gene therapy trial for the treatment of patients with dementia due to Alzheimer’s disease. [Georgetown University, Washington]
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    A Luminal Epithelial Stem Cell that is a Cell of Origin for Prostate Cancer
    This study shows that a known regulator of prostate epithelial differentiation, the homeobox gene Nkx3-1, marks a stem cell population that functions during prostate regeneration. [Nature]
    Article

    The Tumor Suppressor p53 Regulates Polarity of Self-Renewing Divisions in Mammary Stem Cells
    Using the ErbB2 transgenic model of breast cancer, this paper found that self-renewing divisions of cancer stem cells are more frequent than their normal counterparts, unlimited and symmetric, thus contributing to increasing numbers of stem cells in tumoral tissues. [Cell]
    Article

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    Policy

    Maryland, California Team on Stem Cell Research
    Maryland stem cell researchers are teaming up with their counterparts in California to form a new research collaboration state officials hope will lead to more grant money and scientific breakthroughs.
    Article

    Canadians to Present Ethics Code for Stem Cell Studies
    The Stem Cell Charter is a collective call to action in support of stem cell research detailing how that science should be advanced.
    Article

    Business

    Florida Biologix(R) Announces Manufacturing Agreement with America Stem Cell Inc.
    America Stem Cell and Florida Biologix team up to get an important cancer therapy to the clinic that can potentially making a life-changing difference for patients with blood-related cancers such as Leukemia, Lymphoma and Myeloma.
    Article

    Opexa Triggers Milestone Payment Under Recently Announced Stem Cell Agreement
    Opexa Therapeutics, Inc. announced that it has achieved its first technology transfer milestone in connection with the company’s recently announced exclusive stem cell agreement with Novartis for $500,000.
    Article

    BioTime Sets Up Subsidiary in China to Develop Stem Cell Therapeutics
    BioTime is setting up an Asian subsidiary based at the Nanshan Memorial Medical Institute in Hong Kong focusing on ophthalmologic, skin, musculoskeletal, and hematologic diseases.
    Article

    Stem Cell Therapy International, Inc. Announces Merger With Histostem and Launching of AmStem International, Inc.
    Terms of the deal called for Stem Cell Therapy to acquire a 90 percent controlling interest in the securities of Histostem, and for Histostem to acquire a 60% controlling interest in the securities of Stem Cell Therapy.
    Article

    Johns Hopkins Passes $100 Million Mark in Stimulus Funds
    The Johns Hopkins University has won 250 research grants, totaling $114 million, through provisions in the federal stimulus package designed to advance scientific and medical knowledge while jump-starting the U.S. economy.
    Article

    Pitt Researchers Net $5 Million from NIH to Explore Better Ways to Grow Cells for Regenerative Medicine
    Regenerative medicine researchers at the University of Pittsburgh received two grants totaling more than $5 million from the National Institutes of Health to explore new methods for cultivating replacement cells from existing tissues and organs.
    Article

    Buying Binge Hits Biotech Firms
    That appears to be the new mantra for the Massachusetts life sciences industry, where the strengthening economy and rising stock market have sparked a small wave of acquisitions.
    Article

    NIH

    NIH Opens Website for Human Embryonic Stem Cell Lines for Approval and Announces Members of Working Group
    Link

    NIH Clinical Center Testing Automated Cell Expansion System
    The ease and security of automation is coming to bone marrow stromal cell expansion in a new machine in the National Institutes of Health Clinical Center’s Department of Transfusion Medicine.
    Article

    Extension of the Expiration Date for PA-06-042 the Academic Research Enhancement Award (AREA):R15 (NOT-OD-09-152)
    Link

    CBER

    2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee – Summary
    Link

    Waivers for Conflict of Interest for the October 9, 2009 Cellular, Tissue and Gene Therapies Advisory Committee
    Link

    Regulatory

    Von Eschenbach Takes New Job — Trying to Overhaul FDA
    Former FDA Commissioner Andrew von Eschenbach has joined Newt Gingrich’s health think tank, the Center for Health Transformation, as an adviser.
    Article

    American College of Physicians Offers Series of Recommendations to Expand Authority
    A new policy paper notes that the FDA has been chronically underfunded, has limited regulatory authority, and insufficient organizational structure to effectively undertake the complex task of regulating the safety and effectiveness of new and approved drugs.
    Article

    Complete List of Licensed Products and Establishments
    List

    Roster of the Cellular, Tissue and Gene Therapies Advisory Committee
    List


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