Cell Therapy News Volume 6.38 | Sep 19 2005

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    Volume 6.38, September 19, 2005
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Story: Utah Hospital Begins Injecting Bone Marrow Stem Cells Directly into a Patient’s Hearts During Open-heart Surgery
    Article

    Story: Mice Stem Cells Used To Treat Sheep
    Article

    Science

    Gene Therapy Boosted by Nanoscale Delivery to Cancer Cells
    Cancer Research UK scientists have developed a system for treating hard-to-reach tumours, using nanoparticles to guide a  tumour busting gene to cancer cells.  The results of this study are published today (Thursday) in the journal Cancer Research*.
    Article

    Researchers Discover Key To Human Embryonic Stem-cell Potential
    Now, researchers at Whitehead Institute for Biomedical Research working with human embryonic stem cells have uncovered the process responsible for the single-most tantalizing characteristic of these cells: their ability to become just about any type of cell in the body, a trait known as pluripotency.
    Article

    Novel Strategy for Repairing Lung Damage Proposed in Tissue Engineering Journal
    It may be possible to repair or replace damaged cells that line the inner surface of the lung and are essential for proper lung function by recruiting regenerative cell populations from other sites in the body such as the bone marrow to the damaged lung tissue, according to a paper in the July/August issue  of Tissue Engineering.
    Article

    UCSF Launches Institute for Stem Cell and Tissue Biology
    Capitalizing on the strength of its research and clinical enterprise, UCSF is launching the Institute for Stem Cell and Tissue Biology, providing a framework for close collaboration among investigators from the University’s Schools of Dentistry, Medicine, Nursing and Pharmacy.
    Article

    Childrens Hospital Los Angeles the Only Pediatric Institution in California to Receive a Stand-Alone Stem Cell Training Grant from the California Institute for Regenerative Medicine
    The Saban Research Institute of Childrens Hospital Los Angeles has received an initial three-year, $2.4 million stem cell training grant from the California Institute for Regenerative Medicine (CIRM), according to Donald B. Kohn, M.D., director of the Gene, Immune and Stem Cell Therapy Program at Childrens Hospital Los Angeles, and professor of pediatrics, molecular microbiology and Immunology at the Keck School of Medicine of the University of Southern California.
    Article

    San Francisco’s Gladstone Institutes Assists with Exploratorium Stem Cell Exhibit
    The display, the first-ever exhibit allowing the public to view living embryonic stem cells with an advanced microscope, is open Fridays through Sundays, 10 a.m.-5 p.m. Carlson estimates that more than 20,000 visitors will view the exhibit and its companion media pieces this year.
    Article

    ABSTRACT, REVIEWS, & SPECIAL REPORTS

    Advances in Inner Ear Gene Therapy: Exploring Cochlear Protection and Regeneration
    Abstract

    Cell Transplantation Improves Ventricular Function After a Myocardial Infarction: A Preclinical Study of Human Unrestricted Somatic Stem Cells in a Porcine Model
    Abstract

    Maximizing Ventricular Function with Multimodal Cell-based Gene Therapy
    Abstract

    Strategies to Preserve or Regenerate Spiral Ganglion Neurons
    Abstract

    Policy

    A Proposition for Stem Cells 
    Last fall Robert Klein got Californians to vote for embryonic stem cell work. That was a piece of cake compared with getting the resulting research agency off the ground 
    Article

    Using Chimeric Embryos for Transplants a ‘No-brainer’ – Ethicist
    There is no halachic or ethical barrier to growing chimeric embryos composed of animal and human cells as an endless supply for human organs for transplant, except for brains, said Dr. John D. Loike, director of graduate studies in physiology and faculty member of the Columbia University Center for Bioethics.
    Article

    Business

    BUSINESS NEWS

    Dendreon Announces Plans to Submit Application for FDA Approval of Provenge for the Treatment of Advanced Prostate Cancer
    Dendreon Corporation today announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market Provenge(R), the Company’s investigational immunotherapy for the treatment of advanced prostate cancer. 
    Article

    MultiCell Technologies Awarded Pilot Grant for Study of Type 1 Diabetes Therapeutic
    MultiCell Technologies, Inc., a leading adult stem cell company and a supplier of immortalized non-tumorigenic human hepatocytes for drug discovery applications, announced today that it has been awarded a pilot grant for an A Pilot Study for type 1 diabetes using its properitary Immunoglobulin Therapeutic.
    Article

    Cytori Therapeutics Demonstrates Adipose-Derived Adult Stem and Regenerative Cells Enhance Cardiac Function in Preclinical Study
    Cytori Therapeutics, Inc. (Frankfurt: XMP), today announced preclinical results that support therapeutic opportunities for adult stem and regenerative cells derived from adipose, also known as fat tissue, in the treatment of cardiac injury following acute myocardial infarction (heart attack).
    Article

    Phase I ProCord Study Results Published in the Journal of Neurosurgery: Spine, September 2005 Issue ProCord Phase I Study Results Suggest Evidence of Safety
    The FDA-sanctioned study was an uncontrolled, Phase I clinical trial designed to assess the safety and tolerability of ProCord (autologous incubated macrophages), an experimental immune cell therapy.
    Article

    Introgen’s INGN 225 Cancer Vaccine Shows Promising Safety and Efficacy Results in Phase 2 Lung Cancer Trial
    Introgen Therapeutics, Inc. presented updated interim results from an ongoing Phase 2 trial of its investigational cancer vaccine, INGN 225, in patients with advanced small cell lung cancer.
    Article

    MedImmune to Acquire Cellective Therapeutics, Inc.
    MedImmune, Inc. announced today that it has expanded its pipeline of potential drug candidates by signing a definitive agreement to acquire privately held Cellective Therapeutics, Inc.
    Article

    Protein Design Labs, Inc. Announces Successful Closing Of Global Alliance With Biogen Idec To Develop And Commercialize Three Phase II Antibody Products
    Protein Design Labs, Inc. today announced the successful closing of its previously-announced collaboration with Biogen Idec following the satisfaction of all closing conditions, including expiration of the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
    Article

    Galapagos, Amsterdam Molecular Therapeutics, Netherlands Institute for Brain Research and Vrije Universiteit Amsterdam Announce Collaboration to Develop Innovative Treatments for Traumatic Spinal Cord and Peripheral Nerve Injuries
    The project will focus on developing innovative therapeutics to promote nerve regeneration and to diminish the effect of neural scarring, one of the main causes for the failure of the traumatically injured spinal cord and peripheral nerve to regenerate.
    Article

    Sangamo BioSciences, Inc. Announces Second Expansion Of Research Collaboration With LifeScan, Inc. Focused On Novel Diabetes Treatments
    Sangamo BioSciences, Inc. announced today the second expansion of its research collaboration with LifeScan, Inc. to use Sangamo’s proprietary zinc finger DNA binding proteins (ZFPs) to develop therapeutic cell lines as a treatment for diabetes.
    Article

    Stem Cell Therapy International Corp. is Acquired by Altadyne
    Stem Cell Therapy International Corp., a company devoted to the sale and distribution of biological solutions containing stem cell products, today announced it has been acquired by Altadyne, Inc., a Nevada corporation.
    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 HEALTHDevelopment and Improvement of Inbred ES Cell Lines for Use in Generation of Mouse Mutants (RFA-DA-06-009)
    Link

    CBER

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

    Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002
    Link

    Exemptions and Alternative Procedures Under 21 CFR Part 1271.155
    Link

    10th Annual GMP by the Sea Conference (Slides)
    Link

    2005 Biological Approvals – Update
    Link

    Substantially Equivalent 510(k) Device – COBE Angel Whole Blood Separation System – COBE BCT
    Link

    Regulatory

    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

    Gene & Cell Therapy
    December 1-2
    Paris, France
    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

    Cell Processing Tech I NEW!
    Houston, Texas (Baylor College of Medicine Center for Cell & Gene Therapy)

    Hospital Scientist 

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

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

    Clinical Consultant  
    Deerfield, Illinois (Baxter Healthcare)

    Cord Blood Director 
    Minneapolis Minnesota (The National Marrow Donor Programâ„¢)

    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/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 4 / September 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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