Cell Therapy News Volume 9.03 | Jan 28 2008

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    Cell Therapy News 9.03, January 28, 2008
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Stem Cell Therapy Eases Muscular Dystrophy: This is the first time transplanted embryonic stem cells have been shown to restore defective muscles in mice models of the wasting disease, according to the study.
    Article

    Gene Therapy’s ‘Side-Effect Free Pain Relief’: Millions could benefit from the discovery of a gene therapy that can deliver the pain relief benefits of morphine-like drugs without the side effects of abuse and addiction.
    Article

    Science

    VIDEO – Derivation of Human Embryonic Stem Cells by Immunosurgery
    Link

    Protein that Controls Hair Growth Also Keeps Stem Cells Slumbering
    New research from Rockefeller University has unveiled the protein that puts the brakes on stem cell division and shows that stem cells may not need such guarded protection to maintain their potency.
    Article

    Blood’s Hydrodynamics Used To Manipulate Stem, Cancer Cells
    A tiny, implantable device has pulled adult stem cells out of a living rat with a far greater purity than any present technique.
    Article

    Stem Cells Finally Found in Pancreas
    An international team of researchers has finally managed to locate stem cells in the pancreas – in mice, at least.
    Article

    Turning On Adult Stem Cells May Help Repair Bone
    The use of a drug to activate stem cells that differentiate into bone appears to cause regeneration of bone tissue and be may be a potential treatment strategy for osteoporosis, according to a new report.
    Article

    Stem Cells May Gradually Replace Antirejection Drugs For Kidney Transplant Patients
    A team led by Joshua Miller, MD, a researcher at Northwestern University’s Feinberg School of Medicine, is working with Northwestern Memorial Hospital’s department of organ transplantation to enroll qualifying subjects in a new research study that seeks to transplants stem cells from a kidney donor’s bone marrow into the recipient, with the hope of gradually eliminating the need for anti-rejection drugs.
    Article

    Surgeons Attempt to Repair Hearts with Stem Cell Injections
    British scientists have been given the go-ahead to begin potentially ground-breaking experiments using injections of stem cells to repair patients’ damaged hearts. The team hopes to repair the organs of people who have suffered the most severe heart attacks.
    Article

    Researcher Transplants Stem Cells to Try to Save Patients’ Legs
    A Northwestern University Feinberg School of Medicine researcher has launched the first U.S. trial in which a purified form of subjects’ own adult stem cells was transplanted into their leg muscles with severely blocked arteries to try to grow new small blood vessels and restore circulation in their legs.
    Article

    Adult Stem Cell Application Effective in Treatment of Peripheric Vascular Disease
    Multipotent adult progenitor stem cells extracted from bone marrow, and known as MAPCs, have proved to be effective in the regeneration of blood vessel tissue and also in muscle tissue when treating peripheric vascular disease.
    Article

    Alnylam Reports Positive Phase II Data for ALN-RSV01, an RNAi Therapeutic for the Treatment of Respiratory Syncytial Virus (RSV) Infection
    Top-line results show that ALN-RSV01 was safe and well tolerated and demonstrated statistically significant anti-viral activity.
    Article

    Apthera Files a Phase III Special Protocol Assessment with FDA for NeuVax(TM) in Early-Stage Breast Cancer Patients
    Apthera, Inc. has announced that it has submitted a Phase III clinical protocol and statistical analysis plan for registration of its lead cancer therapeutic, NeuVax(TM) to the FDA for review under a Special Protocol Assessment.
    Article

    MolMed Gets Regulatory Approval to Start a Phase III Trial in Italy of its TK Therapy for High Risk Acute Leukaemia
    MolMed S.p.A., a biotech company focused on novel anti-tumour therapies, announced that the AIFA, the Italian Health authority, authorised the start in Italy of a Phase III trial (TK008) of MolMed’s TK cell therapy in patients affected by high risk acute leukaemias and receiving haematopoietic stem cell transplantation from a partially compatible family donor (haplo-HSCT).
    Article

    Australian Girl Switched Blood Type After Transplant
    An Australian girl spontaneously changed blood groups and adopted her donor’s immune system after a liver transplant, in what doctors treating her said Thursday was the first known case of its type.
    Article

    ProtoKinetix’ AAGP(TM) More Than Doubles Stem Cell Recovery
    ProtoKinetix reports that repeated tests have confirmed that the addition of AAGP(TM) to the cryopreservation process more than doubles the useable inventory of these very delicate and valuable cells.
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Sensory Neuron Targeting by Self-complementary AAV8 Via Lumbar Puncture for Chronic Pain
    The researchers report that gene transfer by lumbar puncture may be suitable for developing gene therapy-based treatments for chronic pain.
    Abstract

    Beta Cells Can Be Generated from Endogenous Progenitors in Injured Adult Mouse Pancreas
    Guided by the expression of Neurogenin 3 (Ngn3), the earliest islet cell-specific transcription factor in embryonic development, the researchers show that beta cell progenitors can be activated in injured adult mouse pancreas and are located in the ductal lining.
    Article

    JOB OPPORTUNITIES

    Cell Therapy Business Development Leader
    Portland, OR (Invitrogen)
    Link

    Scientist
    Irvine, CA (Global Biopharmaceutical Company)
    Link

    Policy

    UK Ministers Will Rethink Bill that Could Block Stem Cell Experiments
    Tough new consent laws that would block cloning experiments involving embryonic stem cells are to be reviewed by the Government after a protest by leading scientists.
    Article

    Pig Organs OK, But Not for Dinner
    Most Australians would be happy to receive a life-saving organ from a pig or a cow as long as that animal was never destined for their dinner plate, a survey shows.
    Article

    Business

    Venture Capital Investments Climb
    Venture capital investments in U.S. startups climbed to a six-year high of $29.4 billion in 2007, raising hope that ample money will still be available to back promising new ideas even if the staggering economy falls into a recession.
    Article

    StemCells, Inc. Enters Research Collaboration with Casey Eye Institute
    StemCells, Inc. has announced that it has entered into a research collaboration with the Oregon Health & Science University Casey Eye Institute to evaluate the Company’s proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) as a potential treatment for retinal degeneration, a leading cause of blindness.
    Article

    GenVec Announces Manufacturing Agreement for TNFerade(TM)
    GenVec, Inc. has announced that it has entered into a manufacturing development agreement with Cobra Biomanufacturing Plc for TNFerade(TM), GenVec’s lead product candidate. The agreement will cover technology transfer, scale-up, and validation of the manufacturing process for TNFerade through cGMP consistency lots that will be produced at Cobra’s facility in Oxford, United Kingdom.
    Article

    ImmuneRegen BioSciences Signs Material Transfer Agreement with Celgene Cellular Therapeutics
    ImmuneRegen BioSciences has announced it has finalized a Material Transfer Agreement with Celgene Cellular Therapeutics. As part of the agreement, ImmuneRegen will ship its potential therapeutic Homspera(R) to CCT for testing.
    Article

    Biovest Secures Worldwide Exclusive License to Late-Stage Technology for Elimination of Transplant Rejection
    Biovest International, Inc. has announced that it has secured the worldwide, exclusive license to Revimmune(TM) for the treatment and prevention of transplant rejection including rejection following a bone marrow transplant.
    Article

    International Stem Cell Corporation Chairman Adds CEO Role
    International Stem Cell Corporation has announced with great regret the untimely death of its CEO, Mr. Jeff Krstich. The Chairman of the Board, Kenneth C. Aldrich has assumed the additional responsibilities of Chief Executive Officer, effective immediately.
    Article

    Dr. Charles A. Sims of California Cryobank’s Family Cord Blood Services Named to National Stem Cell Advisory Council
    Family Cord Blood Services has announced that its co-founder and medical director Charles A. Sims, MD, has been appointed to the Department of Health and Human Services’ Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation.
    Article

    HepaLife Announces Appointment of Dr. Christopher W. Kemp, Vice President of Research & Development
    Christopher W. Kemp brings three decades of experience with cell biology, bioreactors, and vaccines, key to development of HepaLife’s novel, cell-based technologies.
    Article

    MicroIslet Announces Management Change and Receives Working Capital Loan
    MicroIslet Inc. has announced that Jonathan R. T. Lakey, PhD is no longer the Company’s president and chief scientific officer. Dr. Lakey remains a member of the Board of Directors.
    Article

    Celprogen Launches Cancer Stem Cells
    Celprogen Inc. has announced that they have successfully isolated and propagated 11 major cancer stem cells.
    Article

    NIH

    PHS 2008-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) (PA-08-050)
    Link

    PHS 2008-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42]) (PA-08-051)
    Link

    CBER

    Regulatory Site Visit Training Program
    Link

    Federal Register: Human Cells, Tissues, and Cellular and Tissue-Based Products – CFR Correction
    Link

    Massachusetts Biotechnology Council’s Annual Luncheon – Slide Presentation
    Link

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States)

    Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
    Link

    Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees
    Link

    MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

    Advanced Therapies and EU Regulatory Issues Conference
    February 22, 2008, London
    Link

    ISCT

    14th ISCT Annual Meeting

    May 17-20, 2008
    Downtown Miami, Florida

    Abstract Submission and Early Registration Deadline: January 31, 2008

    Full details at: http://www.celltherapysociety.org


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