Cell Therapy News Volume 7.38 | Oct 2 2006

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    Volume 7.38, October 2, 2006
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Clinical Trial Shows Islet Transplantation is a Promising Procedure For Certain Patients with Severe Type 1 Diabetes: The first international, multicenter trial of the Edmonton Protocol — a standardized approach to the transplantation of insulin-producing islets — demonstrates that this may be an appropriate therapy that can dramatically benefit certain patients with severe complications of Type 1 diabetes mellitus.
    Article

    Science

    Stem Cell Researchers to Devise Treatments for Faster Bone Healing
    Stem cell researchers in Singapore have linked up with a New Zealand company to devise treatments for faster healing of damaged bones, skin and organs.
    Article

    Gene Transfer Using Mutant Form of Good Cholesterol Cuts Vascular Plaque and Inflammation
    Transfer of a gene that produces a mutant form of good cholesterol provides significantly better anti-plaque and anti-inflammation benefits than therapy using the “normal” HDL gene.
    Article

    Breast Cancer Vaccine Enters Clinical Development
    Pevion Biotech announced the start of phase I clinical testing of its virosome-based breast cancer vaccine. The multivalent vaccine will be tested for its safety and immunogenicity in patients overexpressing the HER-2/neu oncoprotein.
    Article

    Gene Therapy Study Takes Aim at Prostate Cancer
    Researchers at Baylor College of Medicine are hoping a new gene therapy that takes a gene called RTVP-1 directly into the prostate tumor will prove effective in preventing recurrence of the disease.
    Article

    FDA Issues Approvable Letter To Ortec International Inc. For Use Of Cryopreserved OrCel(R) In Epidermolysis Bullosa Patients’ Hand Reconstructions And Donor Sites
    Ortec International, Inc. , a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, has been notified by the Food and Drug Administration (FDA) that its HDE Supplement is approvable subject to an inspection by the FDA of its commercial manufacturing facility
    Article

    Chinese Cancer Therapy Drawing Foreign Patients
    A revolutionary anti-tumour drug in China is attracting terminally ill cancer patients from around the world, including Canada.
    Article

    Jumping Gene Could Provide Non-viral Alternative for Gene Therapy
    A jumping gene first identified in a cabbage-eating moth may one day provide a safer, target-specific alternative to viruses for gene therapy, researchers say.
    Article

    ABSTRACTS, REVIEWS & SPECIAL REPORTS

    Bit Player or Powerhouse? China and Stem-Cell Research
    It seems China’s position in stem-cell science is similar to its position in other spheres. It is an up-and-coming player — a player with global ambitions, a burgeoning pool of talent, and specific assets that derive from its sheer size.
    Article

    Scientific and Ethical Roadblocks to Human Embryonic Stem Cell Therapy
    This review discusses roadblocks on the way to using embryonic stem cells for treating human disease and injury.
    Article

     

    Policy

    Australian Bill Would Allow Therapeutic Cloning Before 2007
    A ban on therapeutic cloning could be overturned before the end of the year after a Government backbencher introduced legislation paving the way for a conscience vote on the issue.
    Article

    Governor Signs Ortiz-Runner Bill to Protect Women Who Donate Eggs for Stem Cell Research
    Legislation by Senator Deborah Ortiz (D-Sacramento) and Senator George Runner (R-Antelope Valley) to protect women who donate eggs for stem cell research was signed yesterday by the governor.
    Article

    Business

    Progenitor Cell Therapy Hosts UK Trade Mission
    UK Department of Trade and Industry visits Progenitor Cell Therapy in tour of leading U.S. cell and tissue therapy companies.
    Article

    Wisconsin to Offer Access to Embryonic Stem Cell Lines
    Access to Wisconsin’s bank of embryonic stem cell lines will be offered for free on a nonexclusive license basis to companies that carry out their research at state nonprofit and academic institutions.
    Article

    Asklepios Biopharmaceutical and GlaxoSmithKline Ink Gene Therapy Agreement
    Asklepios Biopharmaceutical entered into a cross license agreement with GlaxoSmithKline to develop and commercialize gene therapy-based treatments.
    Article

    Cancer Stem Cell Research Program Launched By Rochester
    The promise of cancer stem cell research has reached a critical point and the University of Rochester Medical Center is establishing itself as a leader in the field by creating a Cancer Stem Cell Research Program.
    Article

    £2m Centre to Boost Stem Cell Research
    A £2m project – hailed as the first in Europe – has been launched in Scotland to help find treatments for diseases like diabetes and leukaemia.
    Article

    Stem Cell Research Facility Plan Advances
    The University of Connecticut Board of Trustees Tuesday authorized the UConn Health Center’s finance committee to enter into negotiations to purchase a facility to use for stem cell research.
    Article

    Geneva Joins Race for Stem Cell Breakthrough
    Scientists in Geneva are aiming to produce the world’s first “clean” line of stem cells for use in the treatment of degenerative diseases such as Parkinson’s.
    Article

    CBER

    Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
    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)bvbvbvbn

    Food and Drug Administration-Regulated Products Containing Nanotechnology Materials; Public Meeting
    Link

    Guidances on Providing Regulatory Submissions in Electronic Format; Withdrawal of Guidances
    Link

    Quality Systems Approach to Pharmaceutical CGMP Regulations
    Link

    ISCT

    International Society for Cellular Therapy – http://www.celltherapysociety.org

    AABB-ISCT Cellular Therapy Audioconference Series
    Link

    Profiled Journal

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

    Current Volume: Volume 8 Number 4 / August 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.


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