Cell Therapy News Volume 7.48 | Dec 11 2006

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    Volume 7.48, December 11, 2006
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Transplanted Brain Cells Hold Promise for Parkinson’s Disease: Transplanted neural stem cells hold promise for reducing the destruction of dopaminergic cells that occurs in Parkinson’s disease and for replacing cells lost to the disease.
    Article

    DNA Spray Offers Cystic Fibrosis Hope: British researchers are to trial a new gene therapy for cystic fibrosis in which sufferers simply inhale a spray laden with DNA.
    Article

    Science

    Parkinson’s Approach With Stem Cells A Promising First Step
    Brain cells derived from human embryonic stem cells improved the condition of rats with Parkinson’s-like symptoms dramatically, but the treatment caused a significant problem – the appearance of brain tumors – that scientists are now working to solve.
    Article

    HIV Gene Therapy ‘Ferry’ in Works
    Scientists in New York are working to transform HIV into a gene therapy vector so that corrective DNA can be incorporated into patients’ chromosomes to help treat diseases such as thalassemia and sickle cell disease.
    Article

    Molecular ‘Marker’ on Stem Cells Aids Research, Perhaps Therapies
    A sugar molecule present on embryonic stem cells also has been found on the surface of a type of adult stem cell, a discovery that may help researchers isolate and purify adult stem cells for use in therapies aimed at bone healing, tendon repair and cartilage regeneration, researchers at UT Southwestern Medical Center report.
    Article

    Apollo Life Science’s Human Proteins Lead to Improved Cancer Treatment by Boosting Stem Cell Growth
    Initial studies show human proteins outperform competitor proteins in stimulating faster growth in numbers of blood-producing stem cells
    Article

    siRNAs Can Slow Spread of Prion-based BSE, CJD
    German scientists used special RNAs to halt the production of proteins loosened by prion disease similar to BSE and its human version, Creutzfeldt-Jakob disease, a new study says.
    Article

    ReNeuron Announces Filing IND Application to the FDA for ReN001
    ReNeuron Group plc today announces the filing of its first Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to commence initial clinical studies in the US with ReN001, its stem cell therapy for stroke.
    Article

    Provenge(R), Activated Cellular Immunotherapy, Shows Promise for Treatment of Androgen Independent Prostate Cancer
    Researchers involved in a multicenter trial have reported that Provenge(R) (Sipuleucel-T) may improve the survival of patients with asymptomatic metastatic androgen independent prostate cancer (AIPC) when compared to patients receiving a placebo.
    Article

    Oxford BioMedica’s Trovax(R) Receives Positive Recommendation
    Oxford BioMedica, a leading gene therapy company, has announced that it has received positive opinion from the Committee for Orphan Medicinal Products (COMP) recommending orphan drug designation for TroVax for the treatment of patients with renal cancer in the European Union (EU).
    Article

    Stem Cell Therapy Moves from Theory to Reality
    Despite setbacks and controversy, promising research is underway.
    Article

    Experts Propose New Convention for Human Embryonic Stem Cell Derivation
    Experts have today proposed a new convention for the reporting on the derivation of human embryonic stem cell (hESC) lines.
    Article

    ABSTRACT, REVIEWS AND SPECIAL REPORTS

    Proposal for a Universal Minimum Information Convention for the Reporting on the Derivation of Human Embryonic Stem Cell Lines
    The implementation of novel methodology across the human embryonic stem cell (hESC) field is fraught with difficulties, not least of which is the highly variable reporting of the number and quality of embryos used to derive each new hESC line. In this editorial, the authors highlight the variation in data published and voice suggestions as to how the reporting can become standardized and so facilitate progress in human embryonic stem cell derivation.
    Abstract

    Policy

    Australian Parliament Lifts Cloning Ban
    Lawmakers rejected the moral views of their political leaders Wednesday and lifted a four-year ban on cloning human embryos for stem cell research legislation that could put Australia at the forefront of research into diseases such as diabetes and Alzheimer’s.
    Article

    California Stem Cell Board Approves Terms for Grants to For-profit Research Entities
    The groundbreaking policy guarantees that the State of California will realize a tiered-return on CIRM stem cell research grants to for-profit entities whenever a commercial, CIRM-funded project generates $500,000 in revenue.
    Article

    California Stem Cell Grants Could Focus on Single Disease
    An assessment two years after California’s $3 billion initiative for embryonic stem cell research was approved by voters shows none of the expected breakthroughs in sight. A draft of an agenda for the state research institute created by the initiative sets as its top goal to establish that a therapy developed from human embryonic stem cells can “restore function for at least one disease” within the initiative’s 10-year life span.
    Article

    Chief of California Stem Cell Venture Resigns
    The president of the California Institute for Regenerative Medicine resigned his post today, citing “almost entirely personal reasons” for leaving the controversial $3-billion stem-cell research venture created in 2004 by the passage of Proposition 71.
    Article

    New Jersey Lawmakers Agree on Stem Cell Funding Plan
    New Jersey lawmakers said they have reached agreement on a $500 million plan to finance stem-cell studies, almost three years after the state became the second in the U.S. to legalize the research.
    Article

    Business

    Mesoblast Television Coverage
    Australian adult stem cell company, Mesoblast Limited, has confirmed that a recent news item broadcast focused on its adult stem cell platform technology.
    Article

    Stem Cell Firm on Growth Fast-track
    Stem cell specialist NovaThera is pursuing a strategy of ‘organic growth,’ with plans to double its Cambridge workforce, build a new manufacturing plant and raise a sizable venture capital round.
    Article

    Immunicon Launches EasyCount(TM) System for Automated Cell Counting
    Immunicon Corporation today announced the availability of the EasyCount(TM) System, a fluorescent microscopy-based imaging system that accurately counts dead and live nucleated cells and automatically calculates cell viability, in a single test.
    Article

    StemCells, Inc. Announces Key Executive Appointments
    Dr. Stephen Huhn joins StemCells Inc. as head of neural program; Ann Tsukamoto, Ph.D., is appointed Chief Operating Officer; and Maria Millan and Rodney Young are promoted.
    Article

    NIH

    NIH Policy on Late Submission of Grant Applications – Clarification for Multiple PI Applications and New Submission/Receipt Dates
    Link

    Shared Instrumentation Grant Program (S10)
    Link

    CBER

    Public Hearing: Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management
    Link

    Approved Biological NDA and ANDA Applications
    Link

    Current Licensed Establishments and Products – Update
    Link

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

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States of America)

    Senate Confirms Von Eschenbach as Chief of FDA
    Andrew von Eschenbach gained the overwhelming support of the Senate in his long-delayed bid to become chief of the FDA. Senators supported his nomination by a vote of 80 to 11.
    Article

    ISCT

    Call for Abstracts
    On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the ISCT Website. 
    Submission deadline: February 16, 2007
    Link

    ISCT Membership
    Renew your ISCT Membership for 2007 now!
    Not a member?  Visit the ISCT website to learn about the benefits of membership.
    Link

    AABB-ISCT Cellular Therapy Audioconference Series
    Link

    Profiled Journal

    Editor-in-Chief:
    Robert Weinstein, MD
    Chief, Division of Transfusion Medicine, UMass Memorial Medical Center, Worcester, MA.

    The Journal of Clinical Apheresis provides the world’s premier source of current information in the field of apheresis. The Journal presents work in all aspects of basic and clinical research, practical applications, emerging technologies and regulation in apheresis and related fields including hematology, nephrology, neurology, rheumatology, transplantation, cellular therapies, blood banking, transfusion medicine, and others.

    A subscription to the journal is a key benefit of ASFA membership, which ranges from $120-145 annually. To become a member please contact:

    ASFA Head Office
    375 West 5th Ave, Suite 201
    Vancouver, BC V5Y IJ6, Canada
    T 604-484-2851
    F 604-874-4378
    E asfa@apheresis.org
    www.apheresis.org

    Please visit the website for all you need to know about publishing in or subscribing to the Journal of Clinical Apheresis:
    http://www.interscience.wiley.com/journal/jca


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