Cell Therapy News Volume 7.28 | Jul 24 2006

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    Volume 7.28, July 24, 2006
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Bush Vetoes Stem Cell Bill: The House failed to muster enough votes to override President Bush’s veto of a bill to expand federally funded embryonic stem cell research.
    Article

    Science

    Breast Stem Cells Have Features Similar To ‘Basal’ Tumours
    Scientists have discovered that breast stem cells do not express receptors for the female hormones oestrogen or progesterone. These and other features of the stem cell resemble the aggressive ‘basal’ subtype of breast cancer.
    Article

    Scientists Isolate Leukemia Stem Cells in a Model of Human Leukemia
    The leukemia stem cells isolated proved to be surprisingly different from normal blood stem cells, a finding that may be good news for developing a drug that selectively targets them.
    Article

    Probable Cause of Deadly Brain Cancers Established
    New evidence adds weight to the theory that one of the most deadly forms of brain cancer, called malignant glioma, is caused when stem cells deep within the brain begin to proliferate abnormally.
    Article

    Massachusetts General Hospital Study Finds Potential Ovarian Cancer Stem Cells
    These cells may underlie tumor recurrence and resistance and suggest new treatment approaches.
    Article

    Cytori Therapeutics Reports Safety and Efficacy of its Celution System (TM) in a Preclinical Study of Coronary Artery Disease
    Cytori Therapeutics, Inc. reported top-line preliminary results demonstrating that adipose-derived stem and regenerative cells from its proprietary Celution (TM) System were safe and improved heart function in a chronic ischemia model, representing a severe form of coronary artery disease.
    Article

    Study Establishes Safety of Spinal Cord Stem Cell Transplantation
    Transplanting human embryonic stem cells does not cause harm and can be used as a therapeutic strategy for the treatment of acute spinal cord injury
    Article

    Gene Therapy Overcomes Muscular Dystrophy
    Focusing on the muscleblind protein, scientists eliminated muscle hyperexcitability in a mouse model of the most common form of muscular dystrophy.
    Article

    Research Finds Antibodies Seem to Stop Alzheimer’s in its Tracks
    Treatment with antibodies naturally produced in the body appears to halt the memory-robbing progression of Alzheimer’s disease.
    Article

    Cell Genesys, Inc. Launches Expanded Multiple-Dose Phase 1 Trial Of CG0070 In Recurrent Bladder Cancer
    The expanded trial was prompted by encouraging interim safety and efficacy data recently reported for single-dose administration of CG0070 and will include up to 45 additional patients.
    Article

    Facial Rejuvenation Product Successfully Completes Phase I Study
    Intercytex, the cell therapy company developing products for the advanced woundcare and aesthetic medicine markets, today announces the successful completion of a Phase I study of ICX-RHY, its novel cell therapy product for facial rejuvenation.
    Article

    Biovest International Gains Key Regulatory Approval for Clinical Trial Sites in Russia
    Biovest International, Inc. has received regulatory approval for its ongoing Phase 3 clinical trial of BiovaxID(TM) for the treatment of indolent follicular non-Hodgkin’s lymphoma (NHL).
    Article

    FDA Grants Intracel Special Protocol Assessment (SPA) for Confirmatory, Pivotal Phase III Study of OncoVAX(R) Colon Cancer Vaccine
    The OncoVAX(R) vaccine is designed to prevent recurrence in Stage II colon cancer patients following surgical tumor resection.
    Article

    Stem Cell Process to Aid Kidney Transplant Sans Drugs
    The Kidney Hospital in Ahmedabad has announced a major breakthrough by which embryonic stem cell-aided transplant will enable a kidney patient to accept a donor organ with minimal dose of drugs.
    Article

    Human Stem Cells Can Contribute to a Developing Mouse Embryo, Despite Evolutionary Differences
    Using a newly derived line of human embryonic stem cells, Rockefeller University researchers have coaxed human cells to grow in mouse tissue.
    Article

    ABSTRACTS, REVIEWS & SPECIAL REPORTS

    Stem Cells: The Real Culprits in Cancer?
    A dark side of stem cells – their potential to turn malignant – is at the root of a handful of cancers and may be the cause of many more. Eliminating the disease could depend on tracking down and destroying these elusive killer cells
    Article

    Policy

    Schwarzenegger Gives $150 million Loan to Stem Cell Agency
    A day after President Bush vetoed expanded federal funding of embryonic stem cell research, Governor Arnold Schwarzenegger authorized a $150 million loan to fund California’s stem cell institute.
    Article

    California Panel Against Forcing Biotechs to Share Stem Cell Research
    The intellectual property task force of the California stem cell agency board recommended against requiring the biotech industry to share its state-supported stem cell research with research institutions in the state.
    Article

    Germany Seeks EU Ban on Stem Cell Research Funding
    Germany urged its fellow European Union members to impose a ban on supporting embryonic stem cell research with EU science program funds.
    Article

    Business

    DomaniCell Launches Hospital-based Cord Blood Banking Business
    The program involves hospitals partnering with DomaniCell to develop their own cord blood stem cell banking program that is built on DomaniCell infrastructure and technology.
    Article

    Millipore Completes Acquisition of Serologicals
    Acquisition will transform Millipore into a $1.4 billion life science leader with leading positions in rapidly growing markets.
    Article

    Netcare Buys Stake in Stem Cell Firm
    South African healthcare group Netcare acquired a 75 percent stake in stem cell storage company Biocells Ltd, which markets and collects umbilical cord blood.
    Article

    Cord Blood America Announces it is Nearing Collection of Adipose Tissue Stem Cells for Future Medical Use
    The Company is moving forward in developing one of the nation’s first private storage companies to collect adult stem cells from adipose tissue for future medical use.
    Article

    US Patent Office Upholds Neuralstem Patent
    Neuralstem, Inc. has announced the issuance of a certificate of reexamination from the USPTO confirming the validity of one of its core patents covering both process and composition of matter claims for it’s proprietary human neural stem cells.
    Article

    Request to Re-Examine WARF Stem Cell Patents Escalates War of Words
    The Public Patent Foundation, on behalf of the California-based Foundation for Taxpayer and Consumer Rights, filed a formal request with the United States Patent and Trademark Office to re-examine three patents held by WARF.
    Article

    NIH

    Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research (PA-06-481)
    Link

    Regulatory

    The Australia New Zealand Therapeutic Products Authority Project (Australia and New Zealand)

    The Australia New Zealand Therapeutic Products Authority Project July Newsletter
    Link

    Medsafe (New Zealand)

    Regulatory Consultants
    Link

    GMP Certified Contract Testing Laboratories
    Link

    Medicines and Healthcare Products Regulatory Agency (United Kingdom)

    Implementation of the Good Clinical Practice Directive
    Link

    ISCT

    AABB-ISCT Cellular Therapy Audioconference Series
    Link

    For more information on the Somatic Cell Therapy Symposium, see www.celltherapysociety.org.

    European branch of the International Society for Cellular Therapy (ISCT-Europe) and German Society for Transfusion Medicine and Immunohematology (DGTI) Joint meeting “Regulatory Framework for Advanced Medicinal Products in Europe”
    Link

    Profiled Journal

    Current Issue: Volume 15, No. 4

    CONTENTS

    Original Contribution

    Neural Transplantation in Huntington’s Disease: The NEST-UK Donor Tissue Microbiological Screening Program and Review of the Literature
    M. Farrington, T. G. Wreghitt, A. M. L. Lever, S. B. Dunnett, A. E. Rosser, and R. A. Barker

    Review

    Chemokines and Their Receptors in Islet Allograft Rejection and as Targets for Tolerance Induction
    Shaheed Merani, Wayne Truong, Wayne W. Hancock, Colin C. Anderson, and A. M. James Shapiro

    Original Contributions

    Porcine Islet Graft Function Is Affected by Pretreatment With a Caspase-3 Inhibitor
    Daniel Brandhorst, Vidya Kumarasamy, Adel Maatoui, Alexandra Alt, Reinhard G. Bretzel, and Heide Brandhorst

    Survival and Function of Transplanted Islet Cells on an In Vivo, Vascularized Tissue Engineering Platform in the Rat: A Pilot Study
    David L. Brown, Peter J. Meagher, Kenneth R. Knight, Effie Keramidaris, Rosalind Romeo-Meeuw, Anthony J. Penington, and Wayne A. Morrison

    Maintenance of Mouse, Rat, and Pig Pancreatic Islet Functions by Coculture With Human Islet-Derived Fibroblasts
    Atsushi Miki, Michiki Narushima, Teru Okitsu, Yuichi Takeno, Alejandro Soto-Gutierrez, Jorge David Rivas-Carrillo, Nalú Navarro-Alvarez, Yong Chen, Kimiaki Tanaka, Hirofumi Noguchi, Shinichi Matsumoto, Michinori Kohara, Jonathan R. T. Lakey, Eiji Kobayashi, Noriaki Tanaka, and Naoya Kobayashi

    Differentiation of Human Embryonic Stem Cells to Hepatocytes Using Deleted Variant of HGF and Poly-amino-urethane-Coated Nonwoven Polytetrafluoroethylene Fabric
    Alejandro Soto-Gutierrez, Nalú Navarro-Alvarez, Jorge David Rivas-Carrillo, Yong Chen, Tomoki Yamatsuji, Noriaki Tanaka, and Naoya Kobayashi

    The Development and Characterization of an HEK293-Derived Cell Line for Use in an Intratumoral Cytokine Delivery System
    M. J. Hamilton, Q. X. Huang, C. L. Li, and K. A. O. Ellem

    Short-Term Heart Retention and Distribution of Intramyocardial Delivered Mesenchymal Cells Within Necrotic or Intact Myocardium
    Nguyen Tran, Yan Li, Fatiha Maskali, Laurent Antunes, Pablo Maureira, Marie-Helene Laurens, Pierre-Yves Marie, Gilles Karcher, Frederique Groubatch, Jean-François Stoltz, and Jean-Pierre Villemot

    Brief Communication

    Survival of Microencapsulated Islets at 400 Days Posttransplantation in the Omental Pouch of NOD Mice
    Tsunehiro Kobayashi, Yukio Aomatsu, Hiroo Iwata, Tatsuya Kin, Hiromichi Kanehiro, Michiyoshi Hisanga, Saiho Ko, Mitsuo Nagao, George Harb, and Yoshiyuki Nakajima

    Cell Transplantation publishes original, peer-reviewed research and review articles on the subject of cell transplantation and its application to human diseases. To ensure high-quality contributions from all areas of transplantation, separate section editors and editorial boards have been established. Articles deal with a wide range of topics including physiological, medical, preclinical, tissue engineering, and device-oriented aspects of transplantation of nervous system, endocrine, growth factor-secreting, bone marrow, epithelial, endothelial, and genetically engineered cells, among others. Basic clinical studies and immunological research papers are also featured. To provide complete coverage of this revolutionary field, Cell Transplantation will report on relevant technological advances, and ethical and regulatory considerations of cell transplants.