Cell Therapy News Volume 6.42 | Oct 17 2005

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    Volume 6.42, October 17, 2005
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Advanced Cell Technology to Announce Alternative Approach for Derivation of Embryonic Stem Cell Lines: Advanced Cell Technology, Inc. (OTCB:ACTC) reported today the generation of embryonic stem cell lines using an alternative approach that does not interfere with the developmental potential of embryos.
    Article

    University Of Minnesota Researchers Use Human Embryonic Stem Cells To Kill Cancer Cells: For the first time, stem cell researchers at the University of Minnesota have coaxed human embryonic stem cells to create cancer-killing cells in the laboratory, paving the way for future treatments for various types of cancers (or tumors). The research will be published in the Oct. 15 issue of the Journal of Immunology.
    Article

    Science

    Stem Cell Heart Cure to Be Tested
    Doctors have launched a trial to test whether heart disease can be treated using a patient’s own stem cells.
    Article

    Stem Cells to Be Supplied to Thai Hospitals
    Chief of the Medical Sciences Department Paijit Warachit said yesterday that stem cells developed by Mahidol University and the National Research Council of Thailand will be channelled via the department to hospitals where they are needed.
    Article

    Amniotic Stem Cells Fix Defective Windpipes
    Using cells from amniotic fluid, researchers at Children’s Hospital Boston were able to reconstruct defective tracheas (windpipes) in fetal lambs.
    Article

    Japanese Researchers Develop Technology to Reproduce Cord Blood Stem Cells
    A health ministry team has developed technology to safely and effectively reproduce stem cells from umbilical cord blood, sources close to the matter said Saturday.
    Article

    Embryonic Cells, No Embryo Needed: Hunting for Ways Out of an Impasse
    If there were no controversy over human embryonic stem cells, Dr. Rudolf Jaenisch of M.I.T. and Dr. George Daley of Harvard Medical School would probably never have started some unusual, and difficult, experiments.
    Article

    Adding Precision to Gene Therapy
    Researchers developed a technique for inserting genes into specific sites on the genome in liver cells.
    Article

    Immune Therapy Could Treat Leukemias, Autoimmune Diseases, Transplant Rejection
    In studies with mice, treatment with a new monoclonal antibody that targets immune system B cells has shown considerable promise for treating leukemias, autoimmune diseases and transplant rejection, according to immunologists at Duke University Medical Center.
    Article

    Researchers Seeking Alternative to Surgery for Brain Cancers
    Kranz’s team will use a bioengineering method called yeast display- created by Kranz and former U. of I. chemical engineer K. Dane Wittrup- to remove and rebuild T-cell receptors for strong binding to tumor cells. Reintroduction into the body would alter T cells so they would bind only to a tumor and destroy it.
    Article

    Surgeons Perform Germany’s First Crossover Kidney Transplantation
    In a crossover transplantation a healthy person in one couple donates his or her kidney to the ill person in another couple, in exchange for a kidney from the recipient’s healthy spouse.
    Article

    ABSTRACT, REVIEWS, & SPECIAL REPORTS

    Embryonic and Extraembryonic Stem Cell Lines Derived from Single Mouse Blastomeres
    Here we report an alternative method of establishing ES cell lines-using a technique of single-cell embryo biopsy similar to that used in pre-implantation genetic diagnosis of genetic defects- that does not interfere with the development potential of embryos.
    Article

    A Model-Based Hematopoietic Stem Cell Tracker
    As an important application of image cytometry, this paper presents a probabilistic model based cell tracking method to locate and associate HSCs in phase contrast microscopic images.
    Abstract

    Adult and Cord Blood T Cells Can Acquire HA-1 Specificity Through HA-1 T-cell Receptor Gene Transfer
    The HA-1 TCR alpha beta transduced T cells show that the HA-1 TCR can be functionally transferred into donor mononuclear cells, which can be exploited in immunotherapeutic settings of SCT and CBT for hematologic malignancies.
    Abstract

    Increasing Donor Age Adversely Impacts Deneficial Effects of Bone Marrow But Not Smooth Muscle Myocardial Cell Therapy
    In conclusion, donor age adversely impacts the efficacy of cellular therapy for myocardial regeneration and is cell-type dependent. SMCs from old donors retain their ability to improve cardiac function after implantation into ischemic myocardium.
    Abstract

    The Human Brain and Its Neural Stem Cells Postmortem: From Dead Brains to Live Therapy
    This article will provide a brief overview about neural stem cells, their prominent features, and prospects for a cellular therapy, and will furthermore illuminate the cells in particular with respect to their newly discovered postmortem provenience, their advantage as a potential cell source, and several unfolding forensic considerations.
    Abstract

    Policy

    California Institute for Regenerative Medicine: Research Institutions, Hospitals, Universities, Patient Advocacy Organizations File Amicus Brief in Support of CIRM and a Swift Resolution of Lawsuit
    Today some of the most notable institutions and patient advocacy organizations from throughout the state and the country filed an amicus brief to support the California Institute for Regenerative Medicine’s motion advocating a quick dismissal of a lawsuit which is obstructing the agency from funding its research.
    Article

    Public Attitudes on Embryonic Stem Cell Research – Values in Conflict, New Survey Data, USA
    The Genetics and Public Policy Center, supported by The Pew Charitable Trusts in partnership with the Phoebe R. Berman Bioethics Institute at Johns Hopkins University, surveyed 2,212 Americans from September 9-19, 2005 to probe respondents’ knowledge, awareness and attitudes toward embryonic stem cell research and their policy preferences for that research.
    Article

    Business

    New Stem Cell Treatment Being Evaluated for Critically Ill Bone Marrow Transplant Patients; Osiris Launches a Phase II Clinical Trial for Severe Graft vs Host Disease
    Osiris Therapeutics, Inc. announced today that it has received clearance from the United States Food and Drug Administration (FDA) to conduct a Phase II trial to evaluate the safety and effectiveness of its lead investigational stem cell drug, Prochymal, for the rescue of patients with the most severe form of acute graft vs. host disease (GVHD).
    Article

    Renal Cell Carcinoma, Trovax Phase II Results Encouraging
    The data show that TroVax is safe and well tolerated in this patient group and that the product induces a strong anti-tumour immune response against the 5T4 tumour antigen.
    Article

    GE Healthcare and ThermoGenesis Announce Worldwide Distribution Agreement and R&D Collaboration
    The companies will jointly present the AXP AutoXpress Platform, a closed and automated system for harvesting mononuclear cells (MNC) from cord blood, at the AABB Annual Meeting in Seattle, Washington on October 17th and 18th.
    Article

    Cryo-Cell Affiliate Awarded Grants for Cell Therapy Research: Saneron CCEL to Evaluate Cord Blood Cells for Cardiac Therapy
    Cryo-Cell International, Inc. (OTC Bulletin Board: CCEL – News; the “Company”) announced today that its affiliate, Saneron CCEL Therapeutics, Inc. (“Saneron CCEL”), has been awarded two grants to study the effects of cord blood stem cells for the treatment of myocardial infarction, commonly known as heart attack.
    Article

    Targeted Genetics Initiates Next Clinical Trial of tgAAC94 in Inflammatory Arthritis
    tgAAC94 utilizes Targeted Genetics’ Adeno-Associated Viral (AAV) vector technology to deliver a DNA sequence encoding an inhibitor of TNF-alpha, a potent proinflammatory cytokine that plays a major role in inflammatory arthritis.
    Article

    Inovio Study Results of Gene-Based Therapies for HIV and Vascular Disease Published in Scientific Journals; Articles Published in Collaboration with Boehringer Ingelheim and Chiron Corporation
    Inovio Biomedical Corporation (AMEX:INO), a late stage developer of oncology and other therapies using electroporation to deliver drugs and nucleic acids, announced today that two articles presenting study results relating to gene-based therapies for HIV and vascular disease were published in peer-reviewed scientific journals in September 2005.
    Article

    Invitrogen Wins Appeals Court Decision against Stratagene; Stratagene’s Competent Cell Products Found to Infringe Invitrogen’s Patent
    On appeal from a decision by the U.S. District Court for the Western District of Texas, the U.S. Court of Appeals for the Federal Circuit found that substantially all of the chemically competent cell products sold by Stratagene infringed Invitrogen’s patent. In the decision, the Court of Appeals remanded the case to the district court for further proceedings.
    Article

    VIRxSYS Completes $30 Million Financing
    VIRxSYS Corporation, a privately held company developing genetic therapies for HIV and cancer, announced the final closing of their latest financing round.
    Article

    Cognate Therapeutics, Inc. Announces Appointment Of Brandon J. Price As Chief Executive Officer
    Cognate Therapeutics, Inc. today announced the appointment of Brandon J. Price as Chief Executive Officer and member of the Board of Directors, effective September 12, 2005.
    Article

    BioE Appoints Vice President of Corporate Development; Dr. Sarah Haecker Brings Significant Bench-to-Business Life Sciences Experience and Strong Leadership, Management Skills to BioE
    BioE(R), Inc., a biomedical company providing enabling non-embryonic, human stem cells, announced today it appointed Sarah Haecker, Ph.D. vice president of corporate development.
    Article

    Leading US Neuroscientist appointed Chief Scientific Officer of LCT BioPharma
    LCT announced that Dwaine F. Emerich has been appointed Chief Scientific Officer of LCT BioPharma Inc.
    Article

    Innate Pharma Completes Its Management Team with the Recruitment of Dr. Patrick Squiban as Chief Medical Officer
    Innate Pharma, a French biotechnology company focused on cancer immunotherapy through the manipulation of the innate immune system, announced today the appointment of Patrick Squiban M.D. as Chief Medical Officer.
    Article

    BioE Selected as a 2005 Tekne Award Finalist; Annual Award Program Honors Companies and Individuals Who Have Shown Superior Technology Innovation and Leadership in Minnesota
    BioE(R), Inc., a biomedical company providing enabling non-embryonic, human stem cells, announced today the Minnesota High Tech Association (MHTA) and Minnesota Technology, Inc. (MTI), in partnership with Medical Alley/MNBio, selected it as a 2005 Tekne Award finalist in the emerging biotechnology company category.
    Article

    Iasis Software Releases Donor and Collections Management Module
    Iasis Software this week released I-Collect, our comprehensive solution for managing the collections process and donor information.
    Article

    NIH

    NIH/NHLBI-funded PACT Group Announces Session at AABB
    The Production Assistance for Cellular Therapies (PACT) Group announces its participation in a session at the Annual AABB Meeting at Washington State Convention and Trade Center in Seattle, WA.
    Link

    NIH Launches Major Program to Transform Clinical and Translational Science
    National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., today announced a new program designed to spur the transformation of clinical and translational research in the United States, so that new treatments can be developed more efficiently and delivered more quickly to patients.
    Link

    NIBIB Launches New Web Site
    A completely redesigned and enhanced web site was launched today by the National Institute of Biomedical Imaging and Bioengineering (NIBIB).
    Link

    Amendments and Corrections to RFA-DA-06-009 “Development and Improvement of Inbred ES Cell Lines for Use in Generation of Mouse Mutants”
    Link

    Institutional Clinical and Translational Science Award (RFA-RM-06-002)
    Link

    Planning Grants for Institutional Clinical and Translational Science Awards (RFA-RM-06-001)
    Link

    CBER

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

    Substantially Equivalent 510(k) Device – Pall Acrodose PL System, Platelet Pool and Store Set with eBDS – Medsep Corp
    Link

    Follow-on Biologics Workshop: Scientific Issues in Assessing the Similarity of Follow-on Protein Products
    Workshop Date: 12/12-14/2005
    Link

    Biological Product Deviation Reporting – Product Deviation Codes – Update
    Link

    Recall of Human Tissue Products – LifeCell Corp
    Link

    Recall of Plasma Protein Fraction, Plasmanate
    Link

    Licensed Products and Establishments List – Update
    Link

    Approved Biological Premarket Approval (PMA) Device Applications – Update
    Link

    CBER Fast Track Designation Request Performance Report – Update
    Link

    Regulatory

    Food & Drug Administration (USA)

    Blood Products Advisory Committee; Notice of Meeting
    Link

    ISCT

    2005 Cell Therapy Audioconference Series
    Link

    Profiled Journal

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

    Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”.

    Cytotherapy/Telegraft Advertising Offer
    Cytotherapy- the official journal of the International Society for Cellular Therapy (6x annually) – and Telegraft –ISCT’s global cell therapy newsletter (4 x annually) – are offering an integrated advertisement rates package enabling even more effective coverage of your products, services and recruitment vacancies to the industry at large. The combined reach is impressive, comprising as it does your target audience core.

    Here’s how the deal works:

    Display advertising / print: book an advertisement, any size, in both publications and we will apply a full 30% discount off the combined ratecard price. Plus, we’ll allow any earned volume discount too!

    Recruitment advertising / online: postings on the ISCT website are $1,000 for 2 months. But we’ll reduce that by 50% to $500 only if the posting is taken in addition to a print advertisement in Telegraft or Cytotherapy. ISCT web site receives over 125,000 hits per months, guaranteeing your posting industry wide exposure.

    All we ask is that you make your first insertion before the end of 2005 but we’ll be pleased to extend this deal with full rate protection into 2006 on anything booked before December 31st 2005. For more information and advertising rates, click here.

    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.
    http://journalsonline.tandf.co.uk/link.asp?id=107693


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