Cell Therapy News Volume 10.27 | Jul 20 2009

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    Cell Therapy News 10.27, July 20, 2009
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Novel Stem Cell Trial Targets Heart Disease: Vanderbilt Heart and Vascular Institute recently enrolled its first patient in the FOCUS clinical trial in hopes of reversing damage to the patient’s cardiac muscle caused by heart disease. [Vanderbilt Heart and Vascular Institute, Vanderbilt University, Nashville]
    Article

    Science

    Complimentary Wallchart: Guide to Hematopoietic Colonies Derived from Human Cord Blood Progenitors
    Request your copy
    Link

    Study Reveals Major Genetic Differences Between Blood and Tissue Cells
    Research by a group of Montreal scientists calls into question one of the most basic assumptions of human genetics: that when it comes to DNA, every cell in the body is essentially identical to every other cell. [Department of Medicine, McGill University, Montreal]
    Article

    Microscopic “Beads” Could Help Create “Designer” Immune Cells that Ignore Transplanted Organs
    The future of organ transplantation could include microscopic beads that create “designer” immune cells to help patients tolerate their new organ. [Medical College of Georgia, Augusta]
    Article

    Kids Shunned for Hair Loss Get Help from Their Own Stem Cells
    Children with alopecia areata, a condition that causes extensive, sometimes complete hair loss, grew hair after being injected with stem cells drawn from their own scalp in a small study. [University of Cairo]
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Correction of Murine Hemophilia a Following Nonmyeloablative Transplantation of Hematopoietic Stem Cells Engineered to Encode an Enhanced Human Factor VIII Variant Using a Safety-augmented Retroviral Vector
    In this study, the researchers used the RMSinOFB vector to evaluate the efficacy of a newly bioengineered factor VIII (fVIII) variant (efVIII) toward successful treatment of murine hemophilia A. [Blood]
    Article

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    Policy

    House Approves $2.99 Billion FDA Budget
    The House on Thursday overwhelmingly approved a $373 million budget increase for the Food and Drug Administration, the largest boost in the agency’s history.
    Article

    Business

    Connexon Creative Launches Cord Blood News
    Cord Blood News is a weekly e-newsletter that keeps members of the cord blood community informed by providing the latest news from all areas of the field, including its science, research, policy, and business.
    Link

    ImmunoCellular Therapeutics Retains Services of Torrey Pines Institute for Molecular Studies and Renowned Immunologist to Evaluate Lead Product Candidate
    ImmunoCellular Therapeutics, Ltd. announced recently that it has retained the services of the Torrey Pines Institute for Molecular Studies in San Diego, CA, to evaluate the immunogenicity of peptides to target cancer stem cells relating to the Company’s lead product candidate ICT-121.
    Article

    Yissum Licenses Stem Cell Technologies for Spinal Therapy to TheraCell, Inc.
    Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., recently announced that it has licensed a novel package of stem cell related technologies to TheraCell, Inc., which will further develop and commercialize the technology for advanced regenerative medicine procedures such as spinal fusion.
    Article

    Alnylam Announces Extension of RNAi Therapeutics Collaboration with Novartis
    Alnylam Pharmaceuticals, Inc. announced recently that Novartis has elected to extend the company’s RNAi therapeutics collaboration for a fifth and final planned year, through October 2010.
    Article

    Case Western Reserve University Receives $5M from Third Frontier Commission for the Center for Stem Cell and Regenerative Medicine
    The Center for Stem Cell and Regenerative Medicine, comprised of Case Western Reserve University, Cleveland Clinic, University Hospitals, and Athersys, Inc. has received $5 million from Ohio’s Third Frontier Commission under the Research Commercialization Program.
    Article

    UK to Channel EUR $21M into Regenerative Medicine
    The UK’s Office for Life Sciences will invest EUR $21M into the development of stem cell therapies via its “Life Sciences Blueprint” program.
    Article

    Cytori’s Celution(R) 700 System to be Regulated as a Medical Device by U.S. FDA
    Cytori Therapeutics was informed by the U.S. Food and Drug Administration that the Celution(R) 700 System will be regulated as a medical device under the Federal Food, Drug, and Cosmetic Act.
    Article

    Canadian Biotechnology Feels the Pinch as Funds Dry Up
    Canada will lose up to 7,000 high-skilled research and development jobs within one year if short-term financing cannot be obtained, results from the most recent BIOTECanada survey show
    Article

    Cellular Dynamics International In-Licenses Key Patent Portfolio for Using Stem Cell-Derived Cells in Drug Testing
    Cellular Dynamics International recently announced that it has exclusively in-licensed a US-issued patent portfolio on optimizing the stem cell differentiation selection process and on using heart cells in drug testing.
    Article

    Cytori Expands Patent Protection for the Celution(R) System and Uses for Adipose Derived Stem and Regenerative Cells
    Cytori Therapeutics, Inc. recently received a Notice of Allowance from the U.S. Patent and Trademark Office related to uses of the Celution(R) System for the treatment of bone related disorders.
    Article

    Aastrom Biosciences Receives Notification That NASDAQ to Continue Temporary Suspension of Certain Continued Listing Requirements
    Aastrom Biosciences, Inc. announced that the Company received Issuer Alert #2009-004, which states that NASDAQ is continuing the temporary suspension of the rules requiring a minimum $1.00 per share closing bid price and a minimum market value of publicly held shares for approximately two additional weeks.
    Article

    NIH

    Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research (NOT-OD-09-123)
    Link

    Clarification, Institutional Clinical and Translational Science Award (U54), RFA-RM-09-004 (NOT-RM-09-016)
    Link

    NHLBI Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD Fellows (F30) (PA-09-232)
    Link

    CBER

    2009 CBER Foreign Regulators Seminar
    Link

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States)

    Guidance for Institutional Review Boards, Frequently Asked Questions-Institutional Review Board Registration; Availability
    Link

    Food and Drug Administration Regulation and Licensure of Whole Blood and Blood Components, Including Source Plasma; Public Workshop; Request for Comments
    Link

    MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

    Guidance on the Maintenance of Regulatory Compliance in Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples
    Link


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