Cell Therapy News Volume 8.31 | Aug 13 2007

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    Volume 8.31, August 13, 2007
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Successful Clinical Outcomes in Stem Cell Heart Trial: Mesoblast Limited has announced the successful conclusion of the Australian Cardiac Pilot Trial it had been conducting together with its United States-based sister company Angioblast Systems Inc. at John Hunter Hospital in New South Wales.
    Article

    Science

    Scientists Move Closer To Bio-engineered Bladders
    Researchers at the University of York are using an understanding of the special cells that line the bladder to develop ways of restoring continence to patients with serious bladder conditions, including cancer.
    Article

    Not All Embryonic Stem Cell Lines Are Created Equal
    When it comes to generating neurons, researchers have found that not all embryonic stem cell lines are equal.
    Article

    UCLA Scientists Produce Functioning Neurons from Human Embryonic Stem Cells
    Scientists with the Institute of Stem Cell Biology and Medicine at UCLA were able to produce from human embryonic stem cells a highly pure, large quantity of functioning neurons that will allow them to create models of and study diseases such as Alzheimer’s, Parkinson’s, prefrontal dementia and schizophrenia.
    Article

    Mechanism Discovered In Adult Stem Cell Regulation
    Forsyth Institute scientists have discovered an important mechanism for controlling the behavior of adult stem cells.
    Article

    Proteins Linked To Stem Cells Could Lead To Alzheimer’s Treatment
    Researchers combined a technique for transplanting stem cells into rats and a newly discovered compound, phenserine.
    Article

    GammaCan Receives FDA Orphan Drug Designation for Lead Product VitiGam(TM) for Stage IIB to Stage IV Melanoma
    GammaCan anticipates filing an IND with the FDA for a Phase I/II clinical trial by year-end, and initiate clinical testing of VitiGam(TM) in early 2008.
    Article

    Treatment Permission Granted for Cancer Therapy in India
    The Berlin-based biotechnology company MOLOGEN AG has been informed by its license partner ONCO Life Sciences Pvt. Ltd., India, that the respective authorities have granted treatment permission for MOLOGEN’S cell-based gene therapy.
    Article

    Stem Cell Transplantation Procedure Results In Long-term Survival For Amyloidosis Patients
    Researchers from the Stem Cell Transplant Program and the Amyloid Treatment and Research Program at Boston University Medical Center have found that high-dose chemotherapy and blood stem cell transplantation can result in long-term survival for patients diagnosed with primary systemic light chain Amyloidosis.
    Article

    Death Points to Risks in Research
    One woman’s experience in a gene therapy trial highlights weaknesses in the patient safety net.
    Article

    Targeted Genetics Defends Handling of Fatal Test Case
    As more details emerged about the recent death of a patient during a clinical trial conducted by Targeted Genetics of Seattle, the company defended its handling of the case.
    Article

    Scientists Seek Test To Detect Gene Doping In Athletes
    Research under way at the University of Florida could help level the playing field by detecting the first cases of gene doping in professional athletes before the practice enters the mainstream.
    Article

    Large-animal Clones Reach Fourth Generation
    A Japanese geneticist has said his research team created the world’s first fourth-generation cloned pig, an achievement that could help scientists in medical and other research.
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Directed Differentiation and Transplantation of Human Embryonic Stem Cell-Derived Motoneurons
    The researchers present a novel in vitro protocol of the directed differentiation of human embryonic stem cells into engraftable motoneurons.
    Abstract

    Complete Spinal Cord Injury Treatment Using Autologous Bone Marrow Cell Transplantation and Bone Marrow Stimulation with Granulocyte Macrophage-Colony Stimulating Factor: Phase I/II Clinical Trial
    To assess the safety and therapeutic efficacy of autologous human bone marrow cell transplantation and the administration of granulocyte macrophage-colony stimulating factor, a phase I/II open-label and nonrandomized study was conducted on 35 complete spinal cord injury patients.
    Abstract

    Stimulation of Peri-Implant Vascularization with Bone Marrow-Derived Progenitor Cells: Monitoring by In Vivo EPR Oximetry
    The researchers developed a cell therapy-type strategy to maintain vascularization around implanted devices using co-administration of bone marrow–derived progenitor cells and demonstrated a novel O2-sensing method to functionally monitor neovascularization in vivo.
    Abstract

    Policy

    The Student Society for Stem Cell Research (SSSCR)
    SSSCR is an international network dedicated to advancing scientific research for cures. Our network spans over 15 countries, 100 institutions, and 35 U.S. states. Our network includes students, professionals, and patient advocates. We are a special project of the Genetics Policy Institute and a member of the Coalition for the Advancement of Medical Research. Get plugged-in and be a part of the future of stem cell research. Join today, http://www.ssscr.org/main/join_now.

    Stem Cell Institute Names Interim President
    The governing board of the California Institute for Regenerative Medicine named Richard A. Murphy, Ph.D. as its interim president.
    Article

    New York Promotes Stem Cell Education
    According to an August 7th, 2007, press release, Governor Spitzer of New York signed into law a bill sponsored by Lentol that requires the New York Health Department to develop a program for making expectant parents and others aware of the value of storing umbilical cord blood and the potential uses for such banked cord blood.
    Article

    For Missouri, Stem Cell Amendment Changes Little
    The expected expansion of stem cell research in Missouri has since run into political and financial roadblocks, putting the future of the research in doubt.
    Article

    Bill Calls for FDA to End All Conflicts of Interest
    The Food and Drug Administration could face a tough new assignment from Congress: Eliminate all conflicts of interest on outside advisory panels whose votes heavily guide the agency’s decision-making.
    Article

    New South Wales Offers $500,000 for Stem Cell Breakthrough
    Sydney could become the first city in the world to produce stem cells from cloned human embryos with a $500,000 grant being offered by Premier Morris Iemma to the first scientist to do it.
    Article

    Business

    Invitrogen Introduces Disposable Stem Cell Passaging Tool
    Invitrogen has launched a new disposable device to simplify manual passaging, the process of dividing human embryonic stem cell (hESC) colonies.
    Article

    Lonza Announces the Availability of Poietics(R) Human Adipose-Derived Stem Cells for Use in Adult Stem Cell Research
    The Adipose-Derived Stem Cells system provides research laboratories with ready to use cells and media for research in areas such as tissue repair, wound healing, cell differentiation, osteoporosis, insulin resistance or obesity.
    Article

    Integra LifeSciences and IsoTis to Combine Creating a Global Leader in Orthobiologics
    Integra LifeSciences Holdings Corporation and IsoTis, Inc. have announced a definitive agreement whereby Integra would acquire IsoTis in an all cash transaction.
    Article

    Alnylam Awarded $38.6 Million U.S. Government Contract to Develop RNAi Therapeutics for Biological Threats
    Alnylam Pharmaceuticals, Inc. has announced that it has been awarded a $38.6 million contract over 33 months from the United States Defense Threat Reduction Agency to develop a broad spectrum RNAi anti-viral therapeutic for the treatment of viral hemorrhagic fever.
    Article

    Proposed Joint Program Would Train Research Staffers
    The California State University and Community College systems will appear before the state stem cell institute, hoping to wrangle $31 million from the state’s $3 billion stem cell initiative.
    Article

    Opexa Therapeutics Receives European Patent Notification for T-Cell Vaccine
    Opexa Therapeutics, Inc. has announced that it has received notification under Rule 51(4) from the Examining Division of the European Patent Office (EPO) that the EPO intends to issue a patent for “Autologous T Cell Vaccine Materials and Method.”
    Article

    NeoStem Announces Approval for Listing on American Stock Exchange Under Ticker Symbols NBS and NBS.U Starting Thursday August 9, 2007
    NeoStem, Inc. announces its common stock and units have been approved to be listed on the American Stock Exchange under the ticker symbols – NBS and NBS.U – and will start trading August 9, 2007.
    Article

    NIH

    Full Implementation to Shorten the Review Cycle for New Investigator R01 Applications Reviewed in Center for Scientific Review (CSR) Recurring Study Sections (NOT-OD-07-083)
    Link

    Extended Comment Period for the Request for Information on the NIH System to Support Biomedical and Behavioral Research and Peer Review (NOT-OD-07-084)
    Link

    Revision: Streamlined Review Process to be used for Ruth L. Kirschstein National Research Service Awards (NRSA) Postdoctoral Fellowship Applications (F32) (NOT-OD-07-085)
    Link

    Genome-wide Association Studies in the Genes, Environment, and Health Initiative – Study Investigators (U01) (RFA-HG-07-012)
    Link

    CBER

    Guidance for Industry: Eligibility Determination for Donors of Human Cells,Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
    Link

    Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes
    Link

    Approved Biological NDA and ANDA Applications – Update
    Link

    Licensed Products and Establishments List – Update
    Link

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States of America)

    Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
    Link

    Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Submitting and Reviewing Complete Responses to Clinical Holds
    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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