Cell Therapy News Volume 7.17 | May 8 2006

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    Volume 7.17, May 8, 2006
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Advanced Cell Therapeutics to Treat U.K. Patients Offshore to Avoid Ban: A company offering controversial “stem cell” injections to hundreds of people from the UK with multiple sclerosis and other neurological diseases is planning to get around a ban on treatment in Ireland by carrying it out in international waters on an overnight ferry.
    Article

    Science

    Retinitis Pigmentosa(RP) Patient Gets Stem Cell Implant
    On Apri1 29, 2006, a Nevada physician performed on a patient with RP, a procedure that might be a first of its kind.
    Article

    Spray-On Treatment for Damaged Skin Developed
    A Korean venture start-up looks to market a new drug created via stem cell technologies to heal damaged skin, such as from burns, in a couple of months.
    Article

    New Zealand Brain Disease Breakthrough
    Neuroscientists at Auckland University, working on rats, have for the first time successfully transplanted a viable number of adult stem cells, enabling brain cells destroyed by Huntington’s to be replaced.
    Article

    New Findings Support Using Stem Cells to Treat Neurodegenerative Diseases
    Scientists from three institutes in Israel have shown that human stem cells derived from bone marrow are predisposed to develop into a variety of nerve cell types.
    Article

    Tohoku University Verifies That Mouse Embryonic Stem Cells Can Generate Neural Cell Species
    Tohoku University’s Biomedical Engineering Research Organization, in collaboration with the University of Cambridge and Cardiff University, has verified that neural cell species can be derived from mouse embryonic stem cells.
    Article

    More Stem Cells Are Better – Expanding Hematopoietic Stem Cells With HOXB4
    The research team showed that HOXB4 over-expression in populations of cells enriched for stem cells (i.e. those that are used for transplantation) for 6-9 days prior to transplantation greatly improved their subsequent engraftment in monkeys whose hematopoietic system had been destroyed through radiation.
    Article

    Experts Confirm Seoul National University Analysis: Hwang’s Embryonic Stem Cell Research Faked
    A group of experts has confirmed the findings of Seoul National University, which said in January that all of the embryonic stem cell research conducted by disgraced scientist Hwang Woo-suk and his research team was falsified.
    Article

    Targeted Virus Compels Cancer Cells to Eat Themselves
    An engineered virus tracks down and infects the most common and deadly form of brain cancer and then kills tumor cells by forcing them to devour themselves, researchers at The University of Texas M. D. Anderson Cancer Center report this week in the Journal of the National Cancer Institute.
    Article

    A New Technique Devised by MIT Engineers May One Day Help Physicians Detect Cancerous Tumors During Early Stages of Growth
    The technique allows nanoparticles to group together inside cancerous tumors, creating masses with enough of a magnetic signal to be detectable by a magnetic resonance imaging (MRI) machine.
    Article

    United Kingdom OKs Designer Baby for Sibling Stem Cell Transplant
    A couple from Leicester have been given permission by the fertility watchdog to have a “saviour sibling” in a bid to help their sick 20-month-old daughter.
    Article

    Transplant Patient Feels New Face
    The French woman who received the world’s first partial face transplant has complete feeling in the new tissue five months after the operation.
    Article

    ABSTRACTS, REVIEWS & SPECIAL REPORTS

    Human Mesenchymal Stem Cells Express Neural Genes, Suggesting a Neural Predisposition
    The results suggest that, as opposed to cells that do not express neural genes, human MSCs are predisposed to differentiate to neuronal and glial lineages, given the proper conditions. The results also further promote the possibility that adult human MSCs are promising candidates for cell-based therapy of neurodegenerative diseases.
    Article

    Differential Effects of HOXB4 on Nonhuman Primate Short- and Long-Term Repopulating Cells
    These data demonstrate that HOXB4 overexpression in CD34+ cells has a dramatic effect on expansion and engraftment of short-term repopulating cells and a significant, but less pronounced, effect on long-term repopulating cells.
    Abstract

    Policy

    Democrats Push for Stem Cell Vote in Senate
    Senate Democrats sought on Thursday to jump-start a long-awaited debate on legislation to allow federal funding of embryonic stem cell research by considering it while it debates other health measures this month.
    Article

    Senator Talent Announces Opposition To Proposed Embryonic Stem Cell Research Ballot Initiative, Supporters Submit Signatures
    U.S. Senator Jim Talent announced his opposition to a ballot proposal that would amend the Missouri Constitution to ensure that embryonic stem cell research permitted under federal law is protected in the state.
    Article

    Australian Government Under Pressure to Respond to Stem Cell Report
    The Australian government is being put under pressure to respond to a review it commissioned about stem cell research.
    Article

    Business

    Stem Cell Research Centre to be Opened
    The Australian federal government is pumping $22 million into a research facility for adult stem cells as parliament prepares for a likely conscience vote on therapeutic cloning.
    Article

    California Stem Cell Research Committee Ready to Distribute Money
    The California committee charged with distributing billions in taxpayer funds for embryonic stem cell research and human cloning is ready to get going with the first $300 million in grants after winning the first stage of a lawsuit filed against it.
    Article

    Maryland Stem Cell Research Company Moving to California Despite Tax Funds
    Rockville-based NeuralStem, which is looking for millions of dollars to develop products from stem cell research, said in a recent SEC filing that it plans to move to California.
    Article

    Researchers Organize to Realize Ottawa Region’s Potential
    The front-end investment needed by biotechnology startups often scares investors away, but one venture capitalist says Ottawa’s brain power regarding regenerative medicine has revolutionary potential.
    Article

    Novocell, a Stem Cell Engineering Company, Hired Alan Lewis, Ph.D., as President and CEO
    Novocell, Inc. hired Alan Lewis, Ph.D., as president and CEO to accelerate the company’s mission of creating, delivering and commercializing stem cell therapies and drugs for diabetes and other chronic diseases.
    Article

    U.S. Patent Office Issues Office Actions Rejecting All Claims In Two PharmaStem Umbilical Cord Blood Patents
    ViaCell, Inc. today announced that, following a re-examination, the United States Patent and Trademark Office (PTO) has issued office actions rejecting all of the claims of PharmaStem Therapeutics Inc.’s U.S. Patent Nos. 6,461,645 and 5,004,681. These patents relate to certain aspects of the collection, cryopreservation and storage of hematopoietic stem cells from umbilical cord blood and were asserted against ViaCell and several other defendants by PharmaStem in pending patent infringement cases.
    Article

    Bioheart, Inc. and Tricardia, LLC Sign Patent Licensing Agreement
    Bioheart, Inc., a leader in developing cell therapies for heart repair, announced today the signing of a patent licensing agreement with Tricardia, LLC of Eden Prairie, Minnesota for patents covering an improved injection needle.
    Article

    New Life Scientific and Biorigen Srl Announce Strategic Alliance Agreement
    New Life Scientific, Inc. announced that it has entered into a strategic alliance with Biorigen Srl, a Biotech Company with certain intellectual properties and Centro Biotecnologie Avanzate to pursue development of a series of research projects, the first one being the project of “Bone Repair by Tissue Engineering” that is using novel biotechnology.
    Article

    ImmunoGen, Inc. To Develop Commercial-Scale Manufacturing Process For Trastuzumab-DM1 For Genentech, Inc.
    ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics using its Tumor-Activated Prodrug (TAP) technology, today announced that the Company has entered into an agreement to collaborate with Genentech to create a commercial manufacturing process for Genentech’s trastuzumab-DM1 TAP compound.
    Article

    NIH

    NATIONAL INSTITUTES OF HEALTH

    NIH Lanches Clinical Studies Nationwide to Investigate Rare Diseases
    More than 20 studies are expected to open in the next few months at about 50 sites across the United States and in several other countries including the United Kingdom, Japan, and Brazil.
    Article

    Extension of Expiration Date for Mentored Clinical Scientist Development Award (K08) and Independent Scientist Award (K02) Funding Opportunity Announcements (NOT-OD-06-063)
    Link

    NIH Announces Plans to Eliminate Mailing of Paper Assignment and Change of Assignment Letters (NOT-OD-06-066)
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    Reminder: All R03, R21, R21/R33, R33 and R34 Grant Applications Must Use SF424 (R&R) and Grants.gov for the June 1, 2006, Submission Date and Beyond (NOT-OD-06-068)
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    Innovative Technologies for Molecular Analysis of Cancer (R21) (RFA-CA-07-015)
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    Innovative Technologies for Molecular Analysis of Cancer (R33) (RFA-CA-07-016)
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    Application of Emerging Technologies for Cancer Research (R21) (RFA-CA-07-017)
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    Application of Emerging Technologies for Cancer Research (R33) (RFA-CA-07-018)
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    Application of Emerging Technologies for Cancer Research (R21/R33) (RFA-CA-07-019)
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    CBER

    All new CBER information can be reached from the What’s New page at What’s New Page

    Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P)
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    Blood Products Advisory Committee Roster – Update
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    Approved NDA and ANDA Applications
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    CBER’s Vision and Mission
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    Regulatory

    Food and Drug Administration (United States of America)

    Current Good Manufacturing Practice Regulation and Investigational New Drugs; Withdrawal
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    Industry Exchange Workshop to Celebrate Food and Drug Administration Centennial
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    Research Review Subcommittee of the Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
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    Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
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    Guidance for Industry on Using Electronic Means to Distribute Certain Product Information; Availability
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    ISCT

    AABB-ISCT Cellular Therapy Audioconference Series
    Link

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

    Profiled Journal

    Join ISCT($130) and receive the journal as a benefit of membership.

    Current Volume: Volume 8 Number 2 / May 2006

    Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.
    http://journalsonline.tandf.co.uk/link.asp?id=107693