Cell Therapy News Volume 9.02 | Jan 21 2008

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    Cell Therapy News 9.02, January 21, 2008
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Major Advancement Towards Creating Patient-Specific and Disease-Specific Stem Cells For Therapeutic Use: Stemagen has announced it has become the first in the world to create, and meticulously document, a cloned human embryo using somatic cell nuclear transfer (SCNT).
    Article

    Science

    Personalized Medicine through Genomic Analysis and Molecular Diagnostics
    March 31, 2008, Boston, Massachusetts
    Enter “CONNEXON” at checkout and receive 10% off registration.
    Click here to register today.

    Identification Of A Novel Neural Stem Cell Type
    Researchers from the Sloan-Kettering Institute, led by Dr. Lorenz Studer, have discovered a novel type of neural stem cell, which has a broader differentiation potential than previously identified neural stem cells.
    Article

    Stem Cells Modified to Home in Where They’re Needed
    U.S. researchers have found a way to modify the surface of stem cells to direct them to where they’re needed, an advance that may prove useful in many areas of stem cell therapy.
    Article

    Stem Cell Research Aims to Tackle Parkinson’s Disease
    Scientists in Sweden are developing new ways to grow brain cells in the laboratory that could one day be used to treat patients with Parkinson’s disease.
    Article

    Study Gives Insight Into Hair Growth
    Researchers at USC have identified a new mechanism that controls the activation of stem cells during hair regeneration.
    Article

    Researchers Create New Rat Heart in Lab
    The researchers removed all the cells from a dead rat heart, leaving the valves and outer structure as scaffolding for new heart cells injected from newborn rats. Within two weeks, the new cells formed a new beating heart that conducted electrical impulses and pumped a small amount of blood.
    Article

    Gene Therapy Technique: Water Droplets Produced By Electrospray Render Cells Permeable To External DNA
    Japanese researchers have now developed a method which could represent a true alternative to conventional processes. The cells are “bombarded” with water droplets produced and accelerated by electrospray.
    Article

    Pigs Raise Hopes for Blindness Cure
    Pioneering transplants to restore the sight of people affected by the leading cause of blindness in the Western world could start in three years, after successful human cell implants in pigs.
    Article

    Aastrom Announces First Patient Treatment With Autologous Stem Cell Therapy for Heart Failure
    Aastrom Biosciences, Inc. has announced that the first patient has been treated with the Company’s autologous stem cell therapy for dilated cardiomyopathy.
    Article

    StemCells, Inc. Provides Batten’s Clinical Trial Update
    StemCells, Inc. has provided an update on the Company’s Phase I clinical trial of its proprietary HuCNS-SC(R) product candidate.
    Article

    Gene Therapy Implants for Tendons
    Freeze-dried implants loaded with gene therapy solution are being developed which may help repair injured and difficult-to-treat tendons.
    Article

    Gene Therapy Cancers Prompt Design of Safer Virus
    The announcement last month that a fifth child who received gene therapy for an immune system disease has developed leukemia was the latest blow to the field of gene therapy. But there’s new hope: The U.K. team running the trial reports this week that a safer formulation of the treatment can cure the disease in mice and should also work in people.
    Article

    Nucleonics Initiates Hepatitis B Clinical Trial with Expressed Interfering RNA Therapeutic
    Nucleonics, Inc. has announced that the company has begun treating patients in a Phase 1 human safety study of its experimental treatment for chronic Hepatitis B virus infection, NUC B1000.
    Article

    Isolagen Inc. Completes Injections of Isolagen Therapy(TM) in Phase III Wrinkle and Phase II Full Face Studies
    Isolagen(TM), Inc. has announced that injections have been completed in the pivotal Phase III multi-center, double-blind, randomized, placebo-controlled clinical trials evaluating the Isolagen Therapy(TM) for the treatment of nasolabial folds, or wrinkles (Studies IT-A-005 and IT-A-006).
    Article

    Interim Analysis Supports Continuation of Cell Genesys’ VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
    Cell Genesys, Inc. has announced that the Independent Data Monitoring Committee for VITAL-1, the first of two ongoing Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, has completed a pre-planned interim analysis and has recommended that the study continue.
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Human Embryonic Stem Cell-derived Cardiomyocytes Survive and Mature in the Mouse Heart and Transiently Improve Function After Myocardial Infarction
    Researchers show the results of the first long-term (12 weeks) analysis of the fate of HESC-derived cardiomyocytes transplanted intramyocardially into healthy, immunocompromised (NOD-SCID) mice and in NOD-SCID mice that had undergone myocardial infarction.
    Abstract

    Development of a Clinical Model for Ex Vivo Expansion of Multiple Populations of Effector Cells for Adoptive Cellular Therapy
    The goal of these experiments was to develop a good manufacturing practice (GMP) method for expanding clinical-grade activated effector cells that mediate tumor cell killing through various mechanisms that could be infused into patients following high-dose chemotherapy and autologous stem cell transplant.
    Article

    JOB OPPORTUNITIES

    Cell Therapy Business Development Leader
    Portland, OR (Invitrogen)
    Link

    Scientist
    Irvine, CA (Global Biopharmaceutical Company)
    Link

    Biomedical Equipment Technician
    Los Angeles, CA (Cedars-Sinai Medical Center)
    Link

    Quality Manager
    Singapore (Singapore Cord Blood Bank)
    Link

    Policy

    Hybrid Embryo Research Approved
    Stem cell scientist, Dr Lyle Armstrong has been given permission to use animal eggs in research which aims to lead to the development of new therapies for debilitating human conditions such as Parkinson’s Disease and strokes.
    Article

    UK House of Lords Rejects Ban on Hybrid-Embryo Research
    The vote came after an amendment to the Human Fertilisation and Embryology Bill was put forward in the House of Lords. But the motion was defeated by 268 votes to 96. When the legislation comes into force, scientists will be able to keep hybrid embryos alive for 14 days, but not implant them into a womb.
    Article

    South Australian Ministers of Parliament are Being Lobbied to Reject Legislation Allowing Cloning of Human Embryos for Medical Research
    The South Australian Parliament will be the first in the world to vote on the issue since the discovery, announced in November, of the creation of embryonic stem cells without using human eggs or embryos.
    Article

    Lawmakers to Again consider Money for Stem Cell Research
    Lawmakers will push to spend state money on embryonic stem cell research again this year now that a citizens initiative on the issue appears unlikely to get on the November ballot.
    Article

    Stem Cell Agency to Offer $41M in Awards
    An independent oversight committee with the state’s stem cell agency approved a measure Jan. 17 that will provide additional grant money to 14 young scientists pursuing stem cell research.
    Article

    Business

    Plasticell Acquires Rights to Six Human Embryonic Stem Cell Lines
    Plasticell has entered into an agreement with Axordia Ltd to exploit and market a panel of six human embryonic stem cell lines.
    Article

    Regenetech Signs cellXpansion(TM) License with Korea Stem Cell Bank
    Regenetech(R), Inc. is pleased to announce that it has signed a license covering the Republic of Korea for its proprietary stem cell expansion technology, cellXpansion(TM), with Korea Stem Cell Bank Co., Ltd.
    Article

    Forticell in Stem Cell Collaboration with Korea’s CJ Corporation
    Forticell Bioscience Inc. has signed a material transfer and technology evaluation agreement with South Korea’s CJ Corporation, which will use the company’s Fibrin MicroBeads technology for the extraction and expansion of mesenchymal-type stem cells from human umbilical cord blood.
    Article

    International Stem Cell Corporation to Provide Corneal Epithelial Cells Differentiated from Its Parthenogenetic Stem Cells for Use in Photorefractive Keratectomy FDA Clinical Trials
    International Stem Cell has announced that it will be providing corneal epithelial cells, derived from its Parthenogenetic stem cells and human keratinocytes, for use in Federal Drug Administration clinical trials aimed at creating a tissue transplant technology to improve photorefractive keratectomy.
    Article

    PharmaCell Receives Official Licence as Registered Tissue Establishment
    On December 11th, 2007 PharmaCell received news from the Dutch Health Care Authorities that it is now recognised as Registered Tissue Establishment.
    Article

    LifeCell Gets AABB Accreditation News 
    LifeCell has become the first and only cord blood stem cell bank in India to have AABB accreditation.
    Article

    Dendreon Receives European Patent Covering PROVENGE(R) and Company’s ACI Platform Technology
    Dendreon Corporation has announced that the company has been granted a broad European patent covering the company’s lead product candidate PROVENGE(R).
    Article

    CryoLife Faces a $110M Suit, Pledges Vigorous Defense
    CryoLife Inc. is once again being sued for allegedly providing contaminated cadaver tissue for a knee surgery.
    Article

    Arteriocyte Receives $509,000 Grant from Cleveland Clinic’s Global Cardiovascular Innovation Center
    The funding, received as part of a $60 million Third Frontier award to the Cleveland Clinic-led Global Cardiovascular Innovation Center initiative, will allow Arteriocyte to initiate Phase II clinical evaluation of its lead stem cell product to be used in chronic coronary ischemia.
    Article

    Lifecell Plans for an IPO by July 2008
    Lifecell is planning for an initial public offering within the next six months to expand its operations in the areas of stem cell therapy research and cord blood banking.
    Article

    NIH

    NIH Administrative Revisions for Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources (NOT-NS-08-013)
    Link

    Salary Limitation on Grants, Cooperative Agreements, and Contracts (NOT-OD-08-035)
    Link

    Request for Information (RFI): Notice of Request for Information on Cancer and Normal Tissue Acquisition and Processing Variables (NOT-CA-08-002)
    Link

    Alzheimer’s Disease Research Centers (P50) (RFA-AG-09-001)
    Link

    CBER

    Human Cells, Tissues, and Cellular and Tissue-Based Products – CFR Correction
    Link

    Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices; Proposed Rule
    Link

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States)

    FDA Aims To Establish Overseas Staff Posts, Starting In China
    FDA is considering posting staff overseas to perform inspections and foster relationships with foreign government counterparts and industry.
    Article

    Food and Drug Administration’s Transition to the Federal Dockets Management System
    Link

    Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
    Link

    Advisory Committees; Tentative Schedule of Meetings for 2008
    Link

    Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices
    Link

    MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

    Closer Ties On Medicines Safety Between European And Canadian Regulatory Authorities
    The regulatory experts from the European Union and Canada will from now on be able to exchange confidential information about the authorisation and safety of medicines.
    Article

    Committee Document – Biologicals & Vaccines Expert Advisory Group Summary Minutes (December 3, 2007)
    Link

    ISCT

    14th ISCT Annual Meeting

    May 17-20, 2008
    Downtown Miami, Florida

    Abstract Submission and Early Registration Deadline: January 31, 2008

    Full details at: http://www.celltherapysociety.org


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