Cell Therapy News Volume 8.29 | Jul 30 2007

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    Volume 8.29, July 30, 2007
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    FDA Suspends Gene Therapy Study: The government has suspended a Seattle company’s gene therapy study – and is reviewing the safety of 28 others around the country – after learning that a patient died this week.
    Article

    Science

    Study Identifies New Gene Therapy Tools for Inherited Blindness
    Researchers have taken initial steps toward filling a gap in the toolkit for treating blindness by identifying DNA elements that control when and where genes linked to blindness are turned on.
    Article

    New Method Of Adult Stem Cell Growth Treats Cornea Disorders
    A new method of adult stem cell growth has demonstrated its efficacy for its capacity to grow cornea stem cells.
    Article

    Pluristem’s PLX Cells Show Promise in Treating Limb Ischemia
    Pluristem Life Systems, Inc. has announced that favorable results have been obtained in pre-clinical testing using the Company’s proprietary PLX cells to treat limb ischemia.
    Article

    Mesoblast Commences Vertebral Disc Cartilage Program to Target Early Disease
    Mesoblast Limited has announced that it has commenced preclinical trials of its patented adult stem cell technology for repair and regeneration of vertebral disc cartilage.
    Article

    Gene Therapy For Parkinson’s Hitches Ride On Virus
    A new clinical trial at Oregon Health & Science University is examining whether therapeutic genes that hitch a ride with a harmless virus attracted to nerve cells can reduce Parkinson’s disease symptoms.
    Article

    Theregen Launches Second Phase One Study of Anginera Cell-Based Patch in Heart Patients
    Theregen, Inc. has announced a second Phase I trial to examine the role of its Anginera(TM) cell-based cardiovascular heart patch on adult patients suffering from heart disease.
    Article

    Acquisitive Ways Paying Off for Genzyme
    Last week biotech powerhouse Genzyme announced that a first phase 3 study of stem cell-stimulating drug Mozobil was successful on the primary and secondary efficacy endpoints.
    Article

    Oxford Biomedica Cleared to Continue Phase III TroVax Cancer Drug Trial
    Oxford Biomedica PLC said the independent Data Safety Monitoring Board has concluded that the Phase III trial of its TroVax drug for renal cancer should continue as planned without modification.
    Article

    Pig To Human Transplantation Getting Closer
    Experiments using pigs genetically engineered for compatibility with the human immune system have raised hopes that cross-species transplantation could soon become an option for patients with diabetes and other currently incurable diseases.
    Article

    China Claims a First with Cloned Rabbit
    China has produced the world’s first cloned rabbit using a biological process that takes cells from a fetus.
    Article

    Back Fractures Common After Stem Cell Transplant
    More than one third of children and adolescents who undergo allogenic stem cell transplantation have thinning of their bones, and one in five had crushed vertebrae in their backs, Finnish researchers report.
    Article

    Authors Retract Science Paper
    A lead author is found guilty of misconduct in embryonic cell lineage paper called into question over a year ago.
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Hematopoietic Stem Cell Transplantation in Multiple Myeloma
    Newer and better induction regimens, rigorous analysis of results with autologous and allogeneic transplantation, and the development of risk-adapted stratification provide the impetus for this critical evaluation of the role of hematopoietic stem cell transplantation in multiple myeloma.
    Abstract

    Aging Hematopoietic Stem Cells Decline in Function and Exhibit Epigenetic Dysregulation
    In highly purified hematopoietic stem cells from mice aged 2 to 21 months, gene expression analysis indicates a deficit in function yet an increase in stem cell number with advancing age.
    Abstract

    Policy

    Corzine Signs $450 Million Stem Cell Bill
    New Jersey voters will decide this November whether to approve borrowing $450 million to pay for stem cell research in the state for 10 years under legislation signed Thursday by Gov. Jon S. Corzine.
    Article

    Stem Cell Movement Faces Setbacks in Missouri
    Eight months ago, Missouri seemed well on its way to becoming a national leader in stem cell research. Now the spotlight is all but gone after a research institute and lawmakers withdrew financial support.
    Article

    North Carolina House Panel Narrowly Passes Embryonic Stem Cell Research
    The largest committee in the state House backed legislation Thursday setting rules for how research can be performed on human embryonic stem cells, even though the bill eliminated funding to encourage research.
    Article

    Business

    ReNeuron Acquires Business Assets of AmCyte Inc. for $4 Million
    ReNeuron Group plc has announced that it has entered into arrangements pursuant to which ReNeuron will acquire the business assets of AmCyte Inc., a development stage cell therapy company based in Santa Monica, California.
    Article

    Osiris and Genzyme Partner to Develop Medical Countermeasures for Nuclear and Radiological Threats
    The initial focus of the partnership will be to develop Prochymal(TM), a formulation of adult stem cells derived from bone marrow, to treat the potentially lethal complications of acute radiation syndrome (ARS).
    Article

    Lonza Hikes Guidance for New Bioscience Unit, Unveils Business Strategy
    Lonza Group AG said it has hiked the targets for its new Bioscience unit with current business strength allowing the group to invest through 2007 and 2008 without impacting current margin levels.
    Article

    MicroIslet Implements Staffing Changes to Further the Company’s New Corporate Strategy
    As previously announced, MicroIslet, Inc. has refocused its efforts to accelerate the clinical testing of the Company’s “MicroIslet-P(TM)” encapsulated islet preparation in persons suffering from Type 1 diabetes.
    Article

    California Stem Cell Company Transplanting Headquarters to Philadelphia or New Jersey
    StemCyte Inc. of Arcadia, California, operates as both an international umbilical stem cell storage bank and a therapeutics company.
    Article

    Premier and His Wife to Run Stem Cell Clinic
    Dr. Ewart Brown, Bermuda’s premier, has entered into a partnership with a Californian firm called Stemedica Cell Technologies.
    Article

    Embryonic Stem Cell Firm Abandons Efforts
    Investors reportedly have lost interest in an embryonic stem cell research lab’s failed efforts to create clinical therapies, according to the company’s former chief executive.
    Article

    Abraxis Licenses Rights To Biosimilar From Indian Firm Biocon
    Abraxis BioScience and Biocon have signed a licensing agreement that gives the Los Angeles firm the right to develop a biosimilar of granulocyte-colony stimulating factor in North America and the European Union.
    Article

    Stem Cell Patent Skeptics Also Filed
    Two of the scientists questioning the Wisconsin Alumni Research Foundation’s key embryonic stem cell patents tried to patent similar discoveries themselves, the foundation said Wednesday.
    Article

    NIH

    NIH Requiring Mandatory Use of the Electronic Financial Status Report System in the eRA Commons Beginning October 1, 2007 (NOT-OD-07-078)
    Link

    NCI-Supported Ruth L. Kirchstein Institutional (T32) National Research Service Award Programs for Transdisciplinary Training in the Chemical Biology of Cancer  (NOT-CA-07-020)
    Link

    Frequently Asked Questions about PAR-06-243, “New Approaches to Non-Viral Systems for Gene Transfer Applications for Heart, Lung, and Blood Diseases (R21/R33)” (NOT-HL-07-114)
    Link

    Lymphatic Biology in Health and Disease (R01) (PAR-07-420)
    Link

    CBER

    Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
    Link

    Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts – Agenda
    Link

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States of America)

    FDA Statement on Gene Therapy Clinical Trial
    Link

    Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996
    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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