Cell Therapy News Volume 6.12 | Mar 14 2005

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    Volume 6.12, March 14, 2005
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Story: U.N. General Assembly Adopts Nonbinding Statement Urging Governments To Ban All Forms of Human Cloning
    Article

    Story: Tumor-targeted Immune Cells Cure Prostate Cancer in Mice without Causing Systemic Immune Suppression
    Article

    Science

    Stem Cells Regenerate Damaged Heart
    Article

    Umbilical Stem Cells Save Boy with No Immune system
    Article

    Stem Cell Therapy Safety Boosted
    A new way of growing human embryonic stem cells in the laboratory will reduce the risk that their use in therapy could go wrong, say scientists.
    Article 1, Article 2

    Stem Cells Offer Hope to Student
    Quadriplegic hopes surgery in Portugal can cure his paralysis
    Article

    Harvard Institute at Center of Stem Cell Storm
    Article

    Gene Therapy Cures Inherited Liver Disease in Rats
    Article

    Gene Therapy Still Benefits Heart After 2 Years
    People with severe angina given gene therapy to improve the blood supply to the heart continue to benefit 2 years after the treatment was given, investigators report.
    Article

    Genetic Therapy Reverses Nervous System Damage in Animal Model of Inherited Human Disease
    Article

    British Success Heralds Gene Therapy Revolution
    Article

    Gene Therapy Strategy for Alleviating Chronic Pain Associated with Inflammation Described in Human Gene Therapy
    Article

    Early Trial Indicates Prostate Cancer Vaccine Increases Immunity and Reduces Tumor Cells
    A prostate cancer vaccine that trains a patient’s own dendritic cells to attack a protein antigen expressed by tumors can robustly boost a patient’s immune system and clinically reduce the level of tumor cells in the body.
    Article

    How Diabetes Transplants Could Herald the End of the Daily Agony of Insulin Jabs
    Article

    Three Year Phase I Myoblast Cell Transplantation Study Data Presented at American College of Cardiology Scientific Sessions
    Article

    ABSTRACT, REVIEWS, & SPECIAL REPORTS

    Efficient Derivation of New Human Embryonic Stem Cell Lines
    Abstract

    From Bench to Bedside for Gene-directed Enzyme Prodrug Therapy of Cancer
    Abstract

    Outpatient Stem Cell Transplant: Effectiveness and Implications
    Abstract

    Toxin-based Selection of Insulin-producing Cells with Improved Defense Properties for Islet Cell Transplantation
    Abstract

    Policy

    Is the UK Losing Its Way with Stem Cells?
    Scientists believe they are very close to finding a miracle cure for heart disease.
    Article

    UK to Vote Against UN Human Cloning Decision
    Article

    UK Plans to Spend £1bn on Biotech
    The UK government will spend £1bn on biotechnology by 2008.
    Article

    Otago Medical School Experts in New Zealand Hope to Trial Stem Cells
    Article

    Stem Cell Therapy Under Consideration in New Zealand
    Article

    Lawsuits Filed to Invalidate California’s $3 Billion Stem Cell Institute
    Article

    Business

    BUSINESS NEWS

    Bio-Matrix Scientific Group Appoints Dr. Geoffrey O’Neill — Formerly of Cryo-Cell International as New Bio-Matrix President
    Article

    AmCyte Announces First North American Encapsulated Islet Transplant without Long-Term Immune Suppression into a Patient with Type 1 Diabetes
    Article

    Cell Genesys CFO Matthew Pfeffer to Resign; Robert Dow Is Appointed to Medical Affairs Post
    Article

    Geron Announces Publication of Studies Demonstrating That Human Embryonic Stem Cells Can Be Grown with Defined Growth Factors Enabling Scaled Production of Therapeutic Cells
    Article

    Genitope Corporation Appoints Vice President of Research
    Article

    Living Cell Technologies Buys Drug-delivering Technology
    Biotech company Living Cell Technologies Intends to Buy Intellectual & Property Rights to “Tea Bag”-like cell replacement therapy devices from United States companies Theracyte and Baxter.
    Article

    The Immune Response Corporation Announces Encouraging Results from REMUNE Phase II HIV Trials; Results from Clinical Studies in Italy and Spain
    Article

    ThermoGenesis Seeks New Patent Review
    Fresh off a U.S. Patent and Trademark Office ruling that overturned a patent related to the collection and preservation of stem cells, ThermoGenesis Corp. — which makes equipment used to store such cells — has asked the government to consider rejecting the claims made in two more.
    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 March 11, 2005
    Link

    NOTICES

    June Northwest Association for Biomedical Research Regional IACUC Conference
    Link

    Withdrawal from the Independent Scientist Development Award (K02) Program
    Link

    Answers to Frequently Asked Questions: RFA-HL-05-003, Heart Failure Clinical Research Network
    Link

    REQUESTS FOR APPLICATIONS

    Innovative Grants on Immune Tolerance
    Link

    Pediatric Heart Network
    Link

    PROGRAM ANNOUNCEMENTS

    Cancer Education (R25E) Grants Program
    Link

    NIDDK Mentored Research Scientist Development Award (K01)
    Link

    CBER

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

    Approved Biologics NDA and ANDA Applications – Update
    Link

    Cleared Biologics 510(k) Device Applications – Update
    Link

    Approved Biologics Premarket Approval (PMA) Device Applications
    Link

    Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance
    Link

    Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
    Link

    Licensed Products and Establishments List – Update
    Link

    Regulatory

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

    NEWS & UPDATES

    UNITED STATES

    FDA

    FDA to Provide Guidance on ‘Exploratory’ IND Process
    Link

    Intravenous Immune Globulins in the 21st Century: Progress and Challenges in Efficacy, Safety, and Paths to Licensure; Public Workshop
    Link

    Meetings

    To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit Our Meetings Page

    Journals

    To View a List of Cell Therapy-Related Journals, Please Visit Our Journals Page

    Careers

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

    Acting President
    San Diego, California (California Institute of Regenerative Medicine)

    Cellular Production Lead Technician
    Seattle, WA (Fred Hutchinson Cancer Research Center)

    Director of Biostatistics & Epidemiology 
    Rockville, MD (Center for Biologics Evaluation and Research)

    Director of Cell Therapy
    New York, NY (New York Blood Center)

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

    Faculty Positions in Stem Cell Research 
    Ottawa, Ontario (Ottawa Health Research Institute)

    Lead Quality Assessor 
    Bethesda, MD (AABB)

    Pharmacologist (enter Requisition Code 0412768) NEW!
    Exton, Pennsylvania (Therakos, Inc.)

    Post Doctoral Fellow (enter Requisition Code 0408577)
    Somerville, New Jersey (Ethicon)

    Post Doctoral or Engineer Positions 
    Toronto, Ontario (Centre for Computational Biology Hospital for Sick Children)

    Principal/Senior Scientist (enter Requisition Code 0408581)
    Somerville, New Jersey (Ethicon)

    Product Manager (Immunology)
    Vancouver, BC (StemCell Technologies)

    Project Manager (Research & Development) 
    Vancouver, BC (StemCell Technologies)

    Senior Scientist 
    Brussels, Belgium (Beta-Cell NV)

    Scientist (enter Requisition Code 0408593)
    Somerville, New Jersey (Ethicon)

    Stem Cell Specialist
    Philadelphia, PA (Children’s Hospital of Philadelphia)

    Quality Control Technologist
     Vancouver, BC (StemCell Technologies)

    ISCT

     

    International Society for Cellular Therapy
    www.celltherapy.org

    International Society for Cellular Therapy Facility Sanitization Survey
    The Facility Sanitization Working Group (organized by the ISCT) has created a survey to assess the current cleaning practices from a wide range of cellular therapy practitioners.The results from this survey will help the working group draft guidelines that strike the appropriate balance between regulatory compliance, product safety and relevance to our varied constituents.

    Upcoming Meetings & Conferences:

    2005 Cell Therapy Audioconference Series

    May 3-4, 2005 Current Good Tissue Practice. Vancouver, BC
    Workshop Chairs: Janice Davis-Sproul, MAS, MT (ASCP) SBB (John Hopkins University) & John McMannis, PhD (MD Anderson Cancer Center)
    Email

    May 4-7th, 2005 11th Annual ISCT Meeting. Vancouver, BC
    Program Themes Include: Tissue Engineering, Mesenchymal Stem Cells, Immunotherapy, & Hematopoietic Stem Cells
    Email

    May 4-7th, 2005 Applications of Flow Cytometry in Marrow and Stem Cell Transplantation. Vancouver, BC
    Email

    Profiled Journal

     

    ISCT ACQUIRES NEW JOURNAL TO MERGE WITH CYTOTHERAPY
    Cytotherapy now incorporates Cytokines, Cellular and Molecular Therapy Journal
     

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


    Current Volume
    :Volume 7, Number 1 / March 2005

    Table of Contents

    Two journals merge  
      
    A tribute to David W Golde   
      
    BM stem cells and cardiac repair: where do we stand in 2004?  
       
    Natural killer cell-based immunotherapeutic strategies  

    IL-15: targeting CD8+ T cells for immunotherapy   
      
    Mesenchymal stem cells: progress toward promise 
      
    Cost-effective manufacture of an allogeneic GM-CSF-secreting breast tumor vaccine in an academic cGMP facility  pp. 46 – 56 
      
    Wilms’ tumor 1 (WT1) gene in hematopoiesis: a surrogate marker of cell proliferation as a possible mechanism of action?  pp. 57 – 61 
         
    B-cell expansion in the presence of the novel 293-CD40L-sCD40L cell line allows the generation of large numbers of efficient xenoantigen-free APC 
        
    Implantation of genetically manipulated BM cells for cardiac repair   
     
    Abstracts from the 4th Annual Conference on Mesenchymal and Non-Hematopoietic Stem Cells: Focus on Adult Stem Cells    

    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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