Cell Therapy News Volume 7.13 | Apr 10 2006

    0
    25
    Volume 7.13, April 10, 2006
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
    Cell Therapy News on Facebook  Cell Therapy News on Twitter

    Top Stories

    Gene Therapy Fights Immune Disorder: Two men, diagnosed with a genetic immune disorder, were able to overcome life-threatening fungal infections after receiving gene therapy, according to the study in Nature Medicine, a biomedical research journal.
    Article

    Science

    Michigan Team Singles Out Cancer Stem Cells for Attack
    Close on the heels of the discovery that cancer has its own rejuvenating stem cells, a University of Michigan research team has found a way to distinguish these bad-actors from the normal stem cells that they so closely resemble, and to kill the cancer stem cells without harming the normal stem cells in the same tissue.
    Article

    Lab Grows Bladders From Cells of Patients
    It is the first time a complex human organ like the bladder has been mostly replaced with tissue grown from a patient’s own cells.
    Article

    Broken Bone Treatment First
    A Melbourne hospital is using cultured adult stem cells to heal broken bones in a clinical trial.
    Article

    Bone Loss Seen in Children After Stem Cell Therapy
    A type of stem cell therapy called hematopoietic cell transplantation (HCT) often leads to a reduction in bone formation in children, according to Minneapolis-based researchers.
    Article

    New Applications for Cord Lining Stem Cells – Diabetes and Wound Healing
    Cord Lining Stem Cells discovered by CellResearch Corporation makes headway in areas with exciting potential therapeutic applications
    Article

    Gene Therapy Helps Blind Mice See the Light
    A protein normally found in green algae can make retinal cells in blind mice sensitive to light, researchers report, adding that advances with the technique could one day help restore sight in people with inherited eye problems.
    Article 1 Article 2

    Umbilical Cord Blood: The Future of Stem Cell Research?
    Researchers at the University of Minnesota recently announced that they were able to largely reverse the effects of stroke in lab rats using stem cells found in human umbilical cord blood.
    Article

    Results In For First Gene Therapy For Alzheimer’s Disease
    Researchers say they see promising results from the first gene therapy trial for Alzheimer’s disease. And one of the trial’s patients believes the experimental treatment slowed down her disease.
    Article

    Researchers Explore New Technique to Treat High Blood Pressure, Kidney Damage
    Using a corrective gene, scientists were able to block a protein in the kidneys that triggers high blood pressure and kidney damage.
    Article

    Stem Cell Transplants Improve Recovery In Animal Models For Stroke, Cerebral Palsy
    A single dose of adult donor stem cells given to animals that have neurological damage similar to that experienced by adults with a stroke or newborns with cerebral palsy can significantly enhance recovery from these types of injuries, researchers say.
    Article

    Factor Stimulates Cartilage Growth from Stem Cells
    A novel growth factor significantly improves the ability of specialized stem cells derived from human fat to be transformed into cartilage cells, according to Duke University Medical Center and Pratt School of Engineering researchers.
    Article

    Israeli Researchers Regenerate Torn Ligaments and Tendons with Adult Stem Cells
    In studies conducted on rats, the researchers at the Skeletal Biotechnology Laboratory at the university’s Faculty of Dental Medicine have successfully used adult stem cells to form new tendon or ligament tissue.
    Article

    Virginia Commonwealth University’s Medical CenterTeam Implants Total Artificial Heart
    The cardiac surgery team at Virginia Commonwealth University’s Pauley Heart Center has performed the first artificial heart implant on the East Coast.
    Article

    AVEO Presents a Novel System for the Generation of Fully Human Breast Tumors in Mice
    AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel cancer medicines, announced today that is has developed the first system which allows for the generation of fully human breast tumors in mice.
    Article

    Mutation in Blood Stem Cells Provides Clues to Cancer Development
    A mutation in blood stem cells occurs in patients with a blood disorder called polycythemia vera (PV), scientists at the Moores Cancer Center at the University of California, San Diego (UCSD) and the Institute for Stem Cell Biology and Regenerative Medicine and Comprehensive Cancer Center at Stanford University School of Medicine have confirmed.
    Article

    The Immune Response Corporation’s MS vaccine Spurs T-cell Response
    The Immune Response Corporation announced that its T-cell receptor peptide vaccine candidate, NeuroVax(TM), induces increased FOXP3 expression resulting in re-establishment of normal levels of the FOXP3+ regulatory T-cells believed to be important in controlling the development of multiple sclerosis (MS).
    Article

    Co-Researcher of Hwang Faked Stem Cells Alone
    Prosecutors have tentatively concluded that Kim Sun-jong, co-researcher of disgraced cloning expert Hwang Woo-suk, fabricated samples of stem cell lines without Hwang’s knowledge.
    Article

    Pair Indicted For Fake Stem Cell Therapy
    A federal grand jury in Atlanta has returned an 51-count indictment against Laura Brown, 35, of Miami Beach, Florida, and Stephen Van Rooyen, 44, of Cape Town, South Africa, on charges of wire fraud and distributing unapproved and misbranded drugs relating to fraudulent claims of stem cell treatment and therapy.
    Article

    ABSTRACTS, REVIEWS & SPECIAL REPORTS

    The Long Journey from Stem Cells to Medical Product
    There is much interest in developing stem cells and the cells derived from them as therapies for treating human disease and injury, but many biological, technological and regulatory hurdles have to be overcome before these cell therapies can be brought to commercial fruition.
    Abstract

    Correction of X-linked Chronic Granulomatous Disease by Gene Therapy, Augmented by Insertional Activation of MDS1-EVI1, PRDM16 or SETBP1
    The results suggest that gene therapy in combination with bone marrow conditioning can be successfully used to treat inherited diseases affecting the myeloid compartment such as Chronic Granulomatous Disease.
    Abstract

    Pten Dependence Distinguishes Haematopoietic Stem Cells from Leukaemia-Initiating Cells
    Mechanistic differences between normal stem cells and cancer stem cells can be targeted to deplete cancer stem cells without damaging normal stem cells.
    Abstract

    Policy

    Health and Technology Leaders Release the Connecting for Health Common Framework for Initiating Private and Secure Health Information Sharing
    The Common Framework provides the initial elements of a comprehensive approach for secure, authorized, and private health information sharing, so that patients and their authorized providers can have access to vital clinical data when and where they are needed.
    Article

    U.S. Trails Other Countries in Publishing Embryonic Stem Cell Studies, Stanford Researcher Finds
    A study by a researcher at the Stanford University School of Medicine for the first time documents that stem cell researchers in other countries are out-publishing U.S. scientists.
    Article

    Business

    ReNeuron Announces Initial Pre-clinical Data with its ReN003 Retinal Stem Cell Programme and Signs Collaboration Agreement with Schepens Eye Research Institute
    ReNeuron Group today announces initial survival efficacy data with its ReN003 stem cell therapy programme for diseases of the retina.
    Article

    Advanced Cell Technology Announces Exclusive License of Key Intellectual Property Portfolio on Somatic Cell Reprogramming Technology
    Advanced Cell Technology, Inc. announced today that it has exclusively licensed a key intellectual property portfolio in regard to somatic cell reprogramming from TranXenoGen, Inc., Shrewsbury, Massachusetts.
    Article

    California Stem Cell Agency to be Loaned $14M
    Six philanthropic organizations have agreed to loan California’s stem cell agency $14 million until it can raise money on its own, state Treasurer Phil Angelides said Tuesday.
    Article

    ProBioGen Signed Agreement on Testing of Neuronal Cell Lines with Serono
    ProBioGen announced today that Serono, Switzerland has signed an Agreement to evaluate ProBioGen’s novel human neuronal cell line for the production of recombinant proteins.
    Article

    Osiris Completes Enrollment in Stem Cell Trial to Treat Cardiac Disease
    Osiris Therapeutics, Inc. announced today that it has completed enrollment in a human clinical trial designed to evaluate the safety and preliminary effectiveness of its universal adult stem cell drug candidate Provacel(TM), being developed to treat patients suffering from heart attacks.
    Article

    Brain Power Combined to Form New $125M Institute
    In an effort to discover better treatments for brain disorders and create one of the world’s top 10 neuroscience research institutes, the Howard Florey Institute, Brain Research Institute and the National Stroke Research Institute will amalgamate to form a new neuroscience institute in Melbourne.
    Article

    Cordis Corporation To Develop Global Cardiac And Vascular Institute
    Cordis Corporation announced today plans to develop a world-class global cardiac and vascular institute that will provide physicians and other health care providers with educational and clinical resources designed to help advance the understanding and treatment of a broad range of cardiac and vascular conditions, including coronary artery disease and stroke.
    Article

    Amgen Slates Major Growth for Seattle Research Campus
    Amgen plans a major expansion of its Helix research campus on Elliott Bay, a company spokeswoman said today.
    Article

    Amgen Cuts 98 Fremont Workers
    Abgenix employed about 440 workers companywide, and 98 workers were given notices, according to the Alameda County Workforce Investment Board. Klem said the company retained all the employees at its other site in Burnaby, British Columbia.
    Article

    Nabi Biopharmaceuticals Acquires Exclusive North American Commercialization Rights To Phase III Antibody Product For Prevention And Treatment Of Rejection Following Organ Transplantation
    Nabi Biopharmaceuticals today announced that it has signed an agreement with Fresenius Biotech to advance the development of ATG-Fresenius S in the U.S. and Canada.
    Article

    Sartorius and ProMetic Announce Two Agreements
    Sartorius AG and ProMetic Life Sciences Inc. announced today the signing of a collaboration agreement utilizing bioseparation systems to recover proteins from human blood plasma, between Sartorius and ProMetic’s subsidiary ProMetic BioTherapeutics, Inc.
    Article

    GE Healthcare Unveils New Life Sciences Business
    GE Healthcare has today announced the creation of GE Healthcare Life Sciences – a new business, involving the combination of two existing businesses – Protein Separations and Discovery Systems and is effective immediately.
    Article

    CancerVax Announces FDA Approval of IND for Novel Anti-Angiogenic Antibody D93
    CancerVax Corporation, a biotechnology company focused on the research, development and commercialization of biological products for the treatment of cancer, announced today that the United States Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for D93, an investigational, humanized, monoclonal antibody with a novel anti-angiogenic and tumor inhibitory mechanism of action.
    Article

    NIH

    NATIONAL INSTITUTES OF HEALTH

    NIH Announces Change in Business Process: Replacing Principal Investigator Signature on Grant Applications, Progress Reports, and Prior Approval Requests with an Institutional Compliance Requirement
    Link

    NIH/AHRQ Announce Change in Business Process Concerning eRA Commons Verifications of Electronically Submitted Applications
    Link

    NIH Announces Interim Changes to the PHS398 Application and Instructions
    Link

    NIH Announces Changes to the SF424 (R&R) Instructions
    Link

    NIH Announces Interim Changes to the PHS2590 Noncompeting Progress Report Forms and Instructions
    Link

    Findings Of Scientific Misconduct
    Link

    Notice of Availability of Administrative Supplements for Training in Techniques in the Establishment and Manipulation of Organotypic Model Systems
    Link

    Extension of Expiration Date for PAR-02-076 –Mentored Clinical Scientists Development Award (K12)
    Link

    Reduction in Percent Effort for NHLBI Mentored Career Development K Awards
    Link

    Clinical Trial Methods In Neurology
    Link

    CBER

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

    Frequently Asked Questions – Bar Code Label Requirements for Blood and Blood Components
    Link

    FDLI 49th Annual Conference CBER Update 2006 – Slide Presentation
    Link

    Licensed Products and Establishments List – Update
    Link

    Import Alert #57-19 “Importation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”
    Link

    Approved Biological NDA and ANDA Applications – Update
    Link

    Regulatory

    Food and Drug Administration (United States of America)

    Acting U.S. FDA Head Says He’s Giving up Cancer Job
    Andrew von Eschenbach, the director of the National Cancer Institute, who last week took on the added duties of acting Food and Drug Administration commissioner after the abrupt resignation of Commissioner Lester M. Crawford, said yesterday that he will temporarily step down from his day-to-day leadership of the cancer institute.
    Article

    Cooperative Agreement to Support a Single-Source Application–The Critical Path Institute: Collaborative Cardiovascular Drug Safety and Biomarker Research Program
    Link

    Australia New Zealand Therapeutic Products Authority (Australia and New Zealand)

    Second meeting of the Joint Interim Expert Advisory Committee on Standards
    Link

    Medsafe (New Zealand)

    Details of the consultation process being undertaken as part of the establishment of the joint Australia New Zealand Therapeutics Products Authority
    Link

    ISCT

    ISCT2006. May 4-7. Berlin, Germany.
    Visit http://www.celltherapysociety.org.

    AABB-ISCT Cellular Therapy Audioconference Series
    Link

    For more information on the Somatic Cell Therapy Symposium, see www.celltherapysociety.org.

    Profiled Journal

    Editor-in-Chief:
    Robert Weinstein, MD
    Chief, Hematology and Transfusion Medicine, Caritas St. Elizabeth’s Medical Center, Tufts University School of Medicine, Boston, MA

    The Journal of Clinical Apheresis provides the world’s premier source of current information in the field of apheresis. The Journal presents work in all aspects of basic and clinical research, practical applications, emerging technologies and regulation in apheresis and related fields including hematology, nephrology, neurology, rheumatology, transplantation, cellular therapies, blood banking, transfusion medicine, and others.

    A subscription to the journal is a key benefit of ASFA membership, which ranges from $120-145 annually. To become a member please contact:

    ASFA Head Office
    570 West 7th Ave, Suite 402
    Vancouver, BC V5Z IB3, Canada
    T 604-484-2851
    F 604-874-4378
    E asfa@apheresis.org
    www.apheresis.org

    Please visit the website for all you need to know about publishing in or subscribing to the Journal of Clinical Apheresis:
    http://www.interscience.wiley.com/journal/jca


     Learn more about Cell Therapy News:  Archives  |  Events  |  Update Profile  |  Contact Us