Cell Therapy News Volume 8.30 | Aug 6 2007

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    Volume 8.30, August 6, 2007
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Stem Cell Therapy Rescues Motor Neurons in ALS Model: In a study that demonstrates the promise of cell-based therapies for diseases that have proved intractable to modern medicine, a team of scientists from the University of Wisconsin-Madison has shown it is possible to rescue the dying neurons characteristic of amyotrophic lateral sclerosis.
    Article

    Science

    New Tissue-engineering Research Focuses On Vocal Cords
    Engineering pliable, new vocal cord tissue to replace scarred, rigid tissue in these petite, yet powerful organs is the goal of a new University of Delaware research project.
    Article

    System To Analyze Beating Heart Stem Cells Could Lead To Heart Attack Treatments
    The research, highlighted in the new issue of BBSRC Business, is looking at the process that turns a stem cell into a cardiomyocyte – the beating cell that makes up the heart.
    Article

    Initial Trigger is Not Enough to Determine a Stem Cell’s Fate
    Research uncovering how a signaling pathway regulates stem cell behavior reveals that stem cells, once activated, enter a window of time during which they respond to their environment and retain their ability to alter their developmental path.
    Article

    Gene That Regulates Blood-forming Fetal Stem Cells Identified
    A new University of Michigan study adds to mounting evidence that stem cells in the developing fetus are distinct from both embryonic and adult stem cells.
    Article

    Imaging Islet Cell Transplants
    A new delivery vehicle for the transplanted cells may help overcome rejection, while also allowing clinicians to track the cells once they are inside the body.
    Article

    Under Magnetic Force, Nanoparticles May Deliver Gene Therapy
    The Children’s Hospital of Philadelphia has announced a breakthrough in the method used to deliver gene therapy in an attempt to help blood vessels that have been damaged by artery disease.
    Article

    Bone Marrow Restores Fertility In Female Mice, Study Confirms
    A new study from Massachusetts General Hospital researchers confirms that female mice that receive bone marrow transplantation after fertility-destroying chemotherapy can go on to have successful pregnancies throughout their normal reproductive life.
    Article

    ImmunoCellular Therapeutics Updates Brain Tumor Vaccine Program Status; First Three Patients Enrolled
    The vaccine trial is being conducted at the Johnny L. Cochran, Jr. Brain Tumor Center at Cedars-Sinai Medical Center in Los Angeles.
    Article

    ThermoGenesis Corp. Obtains FDA Clearance to Market CryoSeal(R) Fibrin Sealant (FS) in Liver Resection Surgeries
    ThermoGenesis Corp has announced that the United States Food and Drug Administration has granted clearance for the Company to market the CryoSeal FS System’s autologous fibrin sealant, as an adjunct to hemostasis in liver resection surgery.
    Article

    Sister-to-sister Transplant Offers Fertility Hope
    A previously sterile Belgian woman has successfully received ovarian tissue from her sister in an advance that could offer hope to women with cancer and other women unsuited to normal IVF treatment.
    Article

    Shamed Scientist’s ‘Breakthrough’
    A scientist who faked his research may have actually made a groundbreaking advance – without even realising it.
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Graft-Versus-Host Disease: A Surge of Developments
    The human graft-versus-host reaction continues to both fascinate and frustrate clinical investigation with its lack of predictability, possibly lethal toxicity, but potentially lifesaving anti-tumor effects. Whether new advances will lead to the hoped-for clinical victories will become apparent in the next few years.
    Article

    Policy

    Future of Stem Cell Tests May Hang on Defining Embryo Harm
    With the active encouragement of the Bush administration, U.S. scientists in the past year have developed several methods for creating embryonic stem cells without having to destroy human embryos. But some who now wish to test their alternatively derived cells have found themselves stymied by an unexpected barrier: President Bush’s stem cell policy.
    Article

    Stem Cell Dissent Roils States
    Even where voters have moved to support the embryonic research, opposition is fierce.
    Article

    Even a $400,000 Salary Can’t Woo Stem-Cell Chief to Golden State
    Dogged by salary issues – $400,000 appears to be too low – and questions about who is really in charge at the California Institute for Regenerative Medicine, the recruitment effort has missed its ambitious goal of filling the post by June.
    Article

    Scientists Call For Changes In EU Stem Cell Legislation
    Leading stem cell scientists from across Europe are lobbying European government in an attempt to get embryonic stem cell legislation in Europe changed.
    Article

    United Kingdom MPs Back Human-animal Hybrid Embryos
    The creation of human-animal hybrid embryos should be allowed for research, and parents should register donor conception on a child’s birth certificate, a parliamentary committee has said.
    Article

    Business

    Personalized Stem Cell Lines Available Through Leading Fertility Clinics
    StemLifeLine announced that under its new partnership agreements, three United States fertility clinics will now offer individuals who have undergone in vitro fertilization the opportunity to use StemLifeLine’s service to develop personal stem cell lines from their unused, stored embryos.
    Article

    Stem Cell Therapy International Acquires Exclusive Worldwide Rights to New, Anti-Rejection Stem Cell Technology
    Stem Cell Therapy International, Inc. has announced that it has acquired the exclusive worldwide rights to a new, U.S. Patent Pending anti-rejection umbilical cord blood stem cell technology.
    Article

    Advanced Cell Technology Enters Into Definitive Merger Agreement With Mytogen, Inc.
    Advanced Cell Technology, Inc. has announced that it has entered into a definitive merger agreement to acquire all of the outstanding capital stock of Mytogen, Inc.
    Article

    Cytori Therapeutics Expands International Distribution Network for the Celution(TM) System
    The four additional distributors will cover Belgium, Greece, Israel, Luxembourg, The Netherlands, and Taiwan.
    Article

    Alnylam Extends Collaboration on RNAi Research
    Alnylam Pharmaceuticals Inc. has extended a collaboration with a major medical device company in a bid to combine an RNAi treatment with a device.
    Article

    Pressure for Provenge Approval
    A prostate cancer patient group has filed a suit, demanding an FDA green light of Dendreon’s vaccine. Investors are on board, too
    Article

    BrainStorm Cell Therapeutics Completes Restructuring
    BrainStorm Cell Therapeutics Inc. is pleased to announce that it has come to a restructured research and license agreement with Ramot at Tel Aviv University with respect to payment obligations for its technology license, and that the Double U Fund, a lender to the Company, has also come to an agreement over funds owed to it by BrainStorm.
    Article

    Sernova Files Worldwide Patent Application for Innovative Component of Diabetes Cell Therapy
    Sernova Corp. is pleased to announce it has filed a patent application for the therapeutic use of adult Sertoli cells.
    Article

    Medistem Announces Autism Stem Cell Therapy Paper and Filing of IP
    Medistem Laboratories, Inc. has announced the filing of IP and publication of a peer reviewed paper describing a novel method of selecting specific subsets of autistic patients for treatment with a combination of cellular therapies.
    Article

    ThermoGenesis President Named CEO
    ThermoGenesis Corp. announced that President and Chief Operating Officer William Osgood has been named chief executive and board member, effective July 30.
    Article

    Million-pound Injection into Biosciences
    The Wellcome Trust, the UK’s largest medical research charity, has awarded almost £1 million to an innovative biosciences company based in Nottingham.
    Article

    NIH

    NIH Offers SBIR Niche Assessment Program to Phase I Awardees (NOT-OD-07-080)
    Link

    Notice of Release of the NIH/CDC Small Business Innovation Research (SBIR) Contract Solicitation (PHS 2008-1) (NOT-OD-07-081)
    Link

    NIH Offers Commercialization Assistance Program to SBIR Phase II Awardees (NOT-OD-07-082)
    Link

     

    Data Ontologies for Biomedical Research (R01) (PAR-07-425)
    Link

    CBER

    Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update
    Link

    Premarket Approval – CryoSeal FS System – ThermoGenesis Corp
    Link

    Substantially Equivalent 510(k) Device – AlbaQ-Chek Simulated Whole Blood Controls – Alba Bioscience
    Link

    Workshop: Licensure of Apheresis Blood Products – Updated Information Regarding On-site Registration
    Link

    Regulatory

    WORLD HEALTH ORGANIZATION (International)

    China, India Join WHO Clinical Trial Registry System
    China and India have joined the World Health Organization (WHO)’s clinical trial registry system in order to ensure the transparency and good quality of their research activities, the UN agency said on Wednesday.
    Article

    MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

    Good Laboratory Practice Section Expanded and Restructured
    Link

    ISCT

    7th Annual Somatic Cell Therapy Symposium
    September 26-28, 2007
    Hyatt Regency Bethesda, Maryland

    Registration now open!  Click here to register.

    ISCT Membership
    Renew your ISCT Membership for 2007 now!
    Not a member?  Visit the ISCT website to learn about the benefits of membership.
    Link


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