Cell Therapy News Volume 6.37 | Sep 12 2005

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    Volume 6.37, September 12, 2005
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Story: Review of the First Commercially Approved Gene Therapy Product Presented in Human Gene Therapy
    Article

    Story: Stem Cells That Can Repair Cardiac Muscle Found In Human Heart
    Article

    Science

    ‘Virgin Conception’ First for UK
    Human embryos created using a so-called “virgin conception” technique have been made in the UK for the first time.
    Article

    Concern Over Three-parent Embryo
    Critics have expressed horror about research to create a human embryo with genetic material from three parents.
    Article

    New Drug May Help Cancer Patients Who Need Stem Cell Transplants, Trial
    A new drug may help cancer patients mobilize the cells necessary to restore their blood-forming system after high-dose chemotherapy, according to results from a clinical trial at the Kimmel Cancer Center at Thomas Jefferson University Hospital in Philadelphia and at other centers across the nation.
    Article

    Key to Stem Cell Transplant Success is Tricking Immune System
    Tricking the bodys immune system into ignoring stem cells will be the key to successful stem cell transplants, according to Professor Maggie Dallman , Imperial College London, speaking today at the BA Festival of Science.
    Article

    Adult Stem Cells from Adipose Tissue Could Save Lives
    National and international scientists, including those from the University of Virginia Health System, will announce findings from a significant number of studies showing that adult stem cells from adipose tissue (fat) could eventually be used to treat injured or damaged tissues.
    Article

    Nanotechnology Used to Develop Artificial Kidneys
    Animal studies for artificial-kidney prototypes should begin one or two years from now, and clinical trials would follow a year or two afterward, reported scientists at Biophiltre in Burlingame, Calif., the medical-device company developing the artificial-kidney technology.
    Article

    Transplanting Animal Organs Could Soon Be a Reality
    Dr Anthony Warrens, from Imperial College London and Hammersmith Hospital, says: “Although the idea of xenotransplantation is far from new, it is only in recent years that many of the potential immunological problems, such as transplant rejection, have been solved, meaning the process of transplanting organs from one species into another, could soon be a reality.”
    Article

    Severe Hypoglycemia is Rare After Islet Transplantation
    Episodes of dangerously low blood glucose, or hypoglycemia, were greatly reduced in people who received an islet transplant for poorly controlled type 1 diabetes, according to an analysis of outcomes in 138 patients who had the procedure at 19 medical centers in the United States and Canada.
    Article

    New DFG Research Centre for Regenerative Medicine Established in Dresden, Germany
    The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) will establish a DFG Research Centre on “Regenerative Therapy” at the Dresden University of Technology.
    Article

    Liverpool Leads New European Tissue Engineering Project
    Scientists at the University of Liverpool are leading a major European clinical engineering project that should see human tissue grown from stem cells available for transplant in the next four years.
    Article

    Gene Therapy Scientist Won’t Face Trial
    A renowned geneticist accused of molesting a girl in California will not face trial on charges that he abused a Maryland boy.
    Article

    Californian Heart Disease Patient Shows Improvement After Stem Cell Therapy
    Improvement of California woman stuns her cardiologist one month after receiving stem cell treatment in Bangkok, Thailand.
    Article

    ABSTRACT, REVIEWS, & SPECIAL REPORTS

    Bone Marrow Transplantation and Approaches to Avoid Graft-versus-host Disease (GVHD)
    Abstract

    CD4(+) Regulatory Cells as a Potential Immunotherapy
    Abstract

    Current Status of Gendicine in China: Recombinant Human Ad-p53 Agent for Treatment of Cancers
    Abstract

    Gene Therapy, Cell Transplantation and Stroke
    Abstract

    Nuclear Reprogramming by Human Embryonic Stem Cells
    Abstract

    Policy

    California Institute for Regenerative Medicine Press Release: Zach Hall Appointed Permanent President of the CIRM
    The Independent Citizens Oversight Committee (ICOC) for the California Institute for Regenerative Medicine (CIRM) announced today that it has appointed Zach Hall, Ph.D. as permanent President of the CIRM, following an extensive search.
    Article

    Stem Cell Law Review Hearings Continue in Sydney
    Leading Australian stem cell researchers and the outspoken Sydney Anglican and Catholic dioceses are today having their say about the future of Australia’s ban on human embryo cloning.
    Article

    India Plans Clinical Trials Body Styled on US FDA
    Amid plans to streamline its healthcare regulation, India could create a new agency to monitor clinical trials, with standards modelled along US FDA lines.
    Article

    Business

    BUSINESS NEWS

    Cord Blood America Launches Revolutionary Pricing Plan to Provide Affordable Umbilical Cord Blood Stem Cell Preservation
    The plan is simple: No money down and no payment until six months after the child is born.
    Article

    Progenitor Cell Therapy Inks Manufacturing Deal with Cellerant Therapeutics to Bring Stem Cell Treatment to Market
    Progenitor Cell Therapy, LLC (PCT), a leading cell engineering and cell therapy services company,  announced today that its cGMP facility in Mountain View, California  will serve as the manufacturing site for Cellerant Therapeutics, Inc.’s (Cellerant) premier product.
    Article

    Saneron CCEL Therapeutics, Inc. And University of Minnesota Sign An Exclusive License For An Umbilical Cord Blood Stem Cell Line
    According to the agreement, Saneron CCEL will provide research funding and make milestone payments in return for worldwide exclusive development, marketing, and manufacturing rights to the cell line developed.
    Article

    CryoLife Announces First Human Implants of BioDisc(TM) Spinal Disc Repair System
    CryoLife, Inc., a biomaterials and biosurgical device company, announced today that BioDisc(TM) Spinal Disc Repair System, a nucleus pulposus repair device, was successfullyimplanted in two patients.
    Article

    Bystander Effect of Introgen’s INGN 241 Increases Cancer-Killing Activity in Breast Cancer Cells 
    Researchers at Introgen Therapeutics, Inc. and their collaborators at The University ofTexas M. D. Anderson Cancer Center today reported that MDA-7 protein released from cells treated with INGN 241 can kill nearby, untreated breast cancer cells resulting in additional therapeutic effect.
    Article

    Knock-out US Deal Means Mice Could Roar for Stem Cell
    Stem Cell Sciences is to receive £650,000 and “a large number” of genetically-engineered “knock-out” mice as part of a new licensing deal with the US’s Deltagen, the company announced yesterday.
    Article

    MedImmune, Inc. And VasGene Therapeutics Inc. Announce Collaboration To Develop Monoclonal Antibodies Targeting Cancer
    MedImmune, Inc. and VasGene Therapeutics, Inc. announced today that they have entered into a collaborative agreement to develop cancer- focused monoclonal antibodies (MAbs) targeting a novel member of a subfamily of receptor tyrosine kinases, EphB4, as well as its ligand, EphrinB2.
    Article

    Microbix Biosystems Inc. Announces Update On Vaccine Technology; Ends Talks With Vaccine Manufacturer
    Microbix Biosystems Inc announced today that the Company has ceased negotiations with the previously announced vaccine manufacturer currently evaluating Microbix’ yield enhancement technology.
    Article

    MultiCell Technologies Inc. Forms New Company To Develop Novel Therapies For Diabetes And Other Autoimmune Diseases
    Alliance Pharmaceutical Corp. (“Alliance”) and its wholly owned subsidiary, Astral, Inc. (“Astral”) today announced that they have transferred substantially all of the assets of Astral and the business of Astral to Astral Therapeutics, Inc., a newly created entity formed solely for this purpose, and to be re-named MultiCell Immunotherapeutics, Inc. (“MCTI”), as set forth below.
    Article

    Progenics Reports Positive Results from Phase 1 Clinical Trial of PRO 140, a Novel Monoclonal Antibody That Blocks HIV Entry; Single Dose Coats Immune Cells for Two Months, Potential Long-Acting HIV Therapy
    Article

    Oxxon Therapeutics Presents Positive Data Evaluating DNA/MVA PrimeBoost Immunotherapy in Metastatic Melanoma Patients
    Oxxon’s PrimeBoost immunotherapy delivers multiple melanoma specific epitopes in a priming and boosting regimen.
    Article

    MARKET REPORTS

    Malachite Management has joined forces with established and reputable authors and publishers to bring you the following market reports outlining the very latest in Cell Therapy, Gene Therapy, and Immunotherapeutic approaches to Cancer. 

    “Cell Therapy – Technologies, Markets, and Companies” is over 400 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the cell therapy industry worldwide.
    For more information, including order forms, please see:

    Cell Therapy Report Summary
    Cell Therapy Sample Chapter
    Cell Therapy Table of Contents Vol. 1  Vol. 2
    Cell Therapy Order Form

    “Gene Therapy – Technologies, Markets, and Companies” is over 500 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the gene therapy industry worldwide.
    For more information, including order forms, please see:

    Gene Therapy Report Summary
    Gene Therapy Table of Contents Vol. 1 Vol. 2
    Gene Therapy Order Form

    The Immunotherapy Reports cover the most recent developments in the immunotherapeutic approaches to cancer.

    A Shift in Cancer Immunotherapy Strategies?
    Immunotherapy Strategies Executive Summary
    Immunotherapy Strategies Table of Contents

    Future Perspectives in Cancer Immunotherapy
    Future Perspectives Executive Summary
    Future Perspectives Table of Contents

    Immunotherapy Reports Order Form

    NIH

    NATIONAL INSTITUTES OF HEALTH

    NIH Guide for Grants and Contracts – Week Of September 9, 2005
    Link

    NIH Announces A Grants Query Report To Identify NIH Contact Information For Grantees Affected By Hurricane Katrina
    Link

    Delayed Receipt Dates for Principal Investigators who Assist in Recovery Efforts for Hurricane  Katrina
    Link

    NIH Grantees Affected by Hurricane Katrina
    Link

    NIH Announces Plans to Eliminate Mailing of Paper Notifications: Summary Statements & Peer Review  Outcome Letters
    Link

    Announcing the NIA Aged Non-Human Primate Tissue Bank
    Link

    Completion of a Comprehensive Mouse Knockout Resource (RFA-HG-05-007)
    Link

    A Data Coordination Center for the Knockout Mouse Project (KOMP)(RFA-HG-05-008)
    Link

    Centers of Excellence in Genomic Science (CEGS) (PAR-05-163)
    Link

    CBER

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

    Blood Products Advisory Committee Meeting
    Link

    Vaccines and Related Biological Products Advisory Committee Meeting
    Link

    Recall of Level 1 H-31B Air Detector / Clamping Devices and Level 1 H-1200 Fast Flow Fluid Warmers – Smiths Medical ASD, Inc
    Link

    Licensed Products and Establishments List – Update
    Link

    Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update
    Link

    Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update
    Link

    Regulatory

    UNITED STATES

    FDA

    Cellular, Tissue and Gene Therapies Advisory Committee – Research Review Subcommittee
    The program is intended to provide dynamic, responsive, cutting edge research to contribute to OCTGT’s regulatory mission and facilitate development of safe and effective biological products.
    Link

    For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More, Please Visit The Regulatory Page On The Cell Therapy News Website 

    Meetings

    NEW THIS WEEK

    The 2005 International Cytokine Society Conference: Cytokines, Immunity, Immunotherapy and Vaccine”
    October 27-31
    Seoul, Korea
    Link

    5TH Meeting of the Cancer Vaccine Consortium: “Future Opportunities & Challenges for Cancer Vaccines”
    November 13-14
    Alexandria, Virginia
    Link

    27th Annual Meeting of The American Society for Apheresis (ASFA)
    May 23-26
    Las Vegas, Nevada
    Link

    4th ISSCR Annual Meeting
    June 29-July 1, 2006
    Toronto, Ontario
    Link

    FEATURED MEETINGS

    Emerging Cardiac Cellular Therapies: Incorporating cGMP Federal Regulations into Clinical Trials. Bethesda, MD
    Co-sponsored by AABB and ISCT
    September 15 – 16, 2005
    This year, a Cardiac Cell Therapy Workshop has been created to precede the annual Somatic Cell Therapy Symposium. This workshop was designed to address questions related to the various cell types being used in the context of cardiac repair.
    Link

    Fifth Annual Somatic Cell Therapy Symposium. Bethesda, MD
    Co-sponsored by AABB, ISCT and FDA
    September 16 – 18, 2005
    The annual Somatic Cell Therapy Symposium is a forum provided to engage FDA and industry in an ongoing dialogue regarding the regulatory issues pertaining to somatic and other cell therapies.
    Link

    To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit The Meetings Page  On The Cell Therapy News Website

    Journals

    To View a List of Cell Therapy-Related Journals, Please Visit The Journals Page On The Cell Therapy News Website

    Careers

    JOB POSTINGS IN CELL THERAPY NEWS ARE FREE!
    For information on posting an opportunity email: info@connexoncreative.com

    Hospital Scientist 
    Sydney, Australia (Bone Marrow Stem Cell Laboratory of St. Vincent’s Hospital)

    Scientist/Immunologist (Research and Development
     
    Gaithersburg, Maryland (Maxcyte)

    Acting President

    San Diego, California (California Institute of Regenerative Medicine)

    Clinical Consultant  
    Deerfield, Illinois (Baxter Healthcare)

    Cord Blood Director 
    Minneapolis Minnesota (The National Marrow Donor Program™)

    Cytotherapy Technologist Stem Cell 
    New York, New York (Memorial Sloan-Kettering Cancer Center)

    Director of Research Programs 
    Toronto, Ontario (Ontario Genomics Institute) 

    Laboratory Supervisor (Stem Cell Lab)
    Charlottesville, Virginia (University of Virginia Health System)

    Scientific Review & Program Officers 
    San Diego, California (California Institute of Regenerative Medicine)

    Scientific Sales Representative
    Vancouver, British Columbia (StemCell Technologies)

    Scientific/Technical Officer,Stem Cell Transplant Laboratory/Haematology 
    Sydney, Australia (SWAPS, Liverpool Hospital)

    Senior Officer for Medical & Ethical Standards 
    San Diego, California (California Institute of Regenerative Medicine)

    Vice President of Manufacturing Operations 
    Dallas, Texas (ODC Therapy Inc.)

    ISCT

    Upcoming Meetings & Conferences:

    2005 Cell Therapy Audioconference Series

    5th Annual Somatic Cell Therapy Symposium. Bethesda, Maryland
    Sept. 15-18, 2005
    Link

    Profiled Journal

    Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”

    Join ISCT ($130) and receive the journal as a benefit of membership
    http://www.celltherapy.org/mem_app.htm

    Current Volume: Volume 7, Number 3/ July 2005

    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.
    www.cytotherapy.com


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