Cell Therapy News Volume 8.41 | Oct 22 2007

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    Volume 8.41, October 22, 2007
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Osiris Therapeutics Receives FDA Clearance to Initiate Phase III Pivotal Trial for Prochymal(TM) as a First Line Treatment for Acute Graft vs. Host Disease: Strong data from a Phase II trial supports remission and survival endpoints in life threatening condition.
    Article

    Science

    Quantum Dot Imaging Could Benefit Embryonic Stem Cell Therapy
    have now used QDs for in vivo imaging of embryonic stem cells in mice.
    Article

    The Inkjet Approach to Building Life
    If you print over and over on a single piece of paper, the ink layers will eventually build up a three-dimensional structure. What if, scientists are asking, you use that same inkjet technology to print layers of cells on a tissue matrix? Can you eventually build up a living structure like a heart or a kidney?
    Article

    Herpes Virus Can Be Used As Nanomachines For Cancer Treatment
    Researchers at the LSU School of Veterinary Medicine are using the virus to potentially fight breast cancer.
    Article

    Gene Therapy Breakthrough at Penn
    Ina Dobrinski, associate professor and the director of the Center for Animal Transgenesis and Germ Cell Research, led the study, which used a harmless gene therapy process to transfer a genetic modification to male reproductive cells of mice and goats. The virus then was passed on naturally to offspring.
    Article

    Biotech Patch Offers No-risk Birth Control
    The fresh approach to contraception will use a revolutionary technique for switching off genes to disable eggs without affecting future fertility or any other body systems.
    Article

    Independent Study by Fraunhofer Institute in Germany, Using Pluristem’s PLX Cells, Shows Promise in the Treatment of Ischemic Stroke
    Fraunhofer Institute’s scientists systemically injected PLX cells into spontaneously hypertensive rats that had undergone middle cerebral artery occlusion, a commonly accepted ischemic stroke model. At the current stage, this animal trial shows a significant advantage in functional recovery over a control group that did not receive PLX cells.
    Article

    Stem Cell Growth ‘May Help Hip Replacements’
    British scientists are to test a promising way to harvest a patient’s stem cells in the hope it can boost the success rate of “revision hip replacements”.
    Article

    Alnylam and Collaborators Publish New Pre-clinical Results on RNAi Therapeutics for the Treatment of Huntington’s Disease
    New findings demonstrate potent and durable therapeutic silencing of the gene responsible for Huntington’s Disease.
    Article

    Muscular Dystrophy Trial to Start
    A gene therapy trial for the fatal disorder Duchenne muscular dystrophy is about to begin in London.
    Article

    Aastrom Stem Cell Therapy Demonstrates Positive Results in Severe Long Bone Non-Union Fracture Trial
    Phase I/II study results presented at the Orthopaedic Trauma Association Annual Meeting show a healing rate of 91 percent in patients with non-union tibia, humerus or femur fractures who failed to heal after one or more medical procedures.
    Article

    OMRIX Biopharmaceuticals Announces Positive Phase I Results with Fibrin Patch
    OMRIX Biopharmaceuticals, Inc. has announced the results of its prospective, open label, Phase I study of its novel Fibrin Patch. The results show that the Fibrin Patch appears to be safe as an adjunct to hemostasis.
    Article

    Stem Cell Therapy Gives Dogs a New Leash on Life
    Man’s best friend is benefiting from stem-cell therapy. Procedures that began experimentally with horses four years ago were expanded to dogs and cats in May.
    Article

    Swarthmore College Students Use Mice Stem Cells in New Biology Class Course Believed to Be Only One of Its Kind in Country
    In a new biology class at Swarthmore College this fall, students are able to conduct research using embryonic stem cells from mice. Taught by Visiting Assistant Professor of Biology William Anderson, “Stem Cells and Cloning” is believed to be the first and only course of its kind in the country.
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Preparing Clinical Grade Ag-specific T Cells for Adoptive Immunotherapy Trials
    In this review we address salient issues related to the technical, immunologic, practical and regulatory aspects of manufacturing these advanced T-cell products for clinical use.
    Abstract

    Has Stem Cell Transplantation Come of Age in the Treatment of Sickle Cell Disease?
    Currently, hematopoietic SCT is the only intervention that can restore normal hematopoiesis to provide a ‘cure’ in sickle cell disease. Yet, this treatment modality is used sparsely.
    Abstract

    JOB OPPORTUNITIES

    Cell Therapeutics Supervisor
    Philadelphia, PA (AppTec)
    Link

    Postdoc Fellow
    Sweden (Wallenberg Neuro Center Neuronal Survival Unit)
    Link

    Manager, Manufacturing
    Memphis, TN (Cognate Bioservices)
    Link

    Policy

    Going Against Bush, NIH Director Urges Expanded Stem Cell Research
    National Institutes of Health Director Elias A. Zerhouni suggests that embryonic stem cell research should be expanded.
    Article

    Senate Democrats Drop Plan to Challenge Stem Cell Restrictions
    Senate Democrats, yielding to a veto threat, have dropped provisions from a spending bill that would have loosened President George W. Bush’s restrictions on embryonic stem-cell research.
    Article

    Planned Stem Cell Referendum Up in Air
    A proposed November 6 public referendum on a $450 million stem-cell research program could be in jeopardy after a state appeals court agreed to hear a lawsuit challenging it.
    Article

    New Head of Stem Cell Agency Not Affected by Tainted Research
    A Melbourne laboratory headed by Alan Trounson, the acclaimed researcher tapped to run California’s $3 billion stem cell agency, is embroiled in an investigation of alleged irregularities in a government-funded experiment, according to news accounts in Australia.
    Article

    China to Continue Actively Developing Stem Cell Research, GM Crops
    China will pay close attention to ethical issues as it continues to support stem cell research and the development of GM crops, a senior official from the Ministry of Science and Technology said.
    Article

    Business

    NeoStem Announces Multi-Territory Development Agreement With Stem Cell Collect, LLC to Accelerate Growth of Nationwide Collection Center Network
    Stem Cell Collect has purchased the right to open six adult stem cell collection facilities with an option to develop significantly more territories. According to the agreement, Stem Cell Collect is entitled to begin by expanding the NeoStem network throughout most of California and to launch the Colorado market.
    Article

    NeoStem Announces Agreement with ProHEALTH to Open Adult Stem Cell Collection Center in the New York Metropolitan Area
    ProHEALTH, one of the largest and most prominent multi specialty practices in the New York metropolitan area, has over 100 providers in its network and provides care for over 250,000 patients in one of the most populous and affluent markets in the nation.
    Article

    Merck & Co., Inc. Licenses SNALP Technology from Protiva
    Under the terms of the broader agreement Protiva will receive a one-time payment from Merck with the potential for milestone and royalty payments based upon the developmental progress of future RNAi-based product candidates.
    Article

    Immunomedics’ Cancer Therapy Gets Patent
    Immunomedics Inc. said Tuesday the biopharmaceutical company received a patent for its product candidate hPAM4 to treat pancreatic cancer, sending its stock sharply higher.
    Article

    National Stem Cell Holding Announces Patent Application for Newly Discovered Cellular Derived Biomaterials for Anti-Aging Applications
    National Stem Cell Holding, Inc. today announced the filing of a provisional patent application for a newly discovered group of biomaterials, derived from the company’s stem cell and progenitor cell lines, that may stimulate a variety of naturally occurring physiological mechanisms that are involved with the skins ability to preserve and repair itself .
    Article

    IVF ‘Cell Bank’ Plan Criticised 
    A US firm’s controversial proposition to store stem cells from spare IVF embryos has angered UK scientists. 
    Article

    NIH

    New Features in eRA Commons (NOT-OD-08-007)
    Link

    Continued Development and Maintenance of Software (R01) (PAR-08-010)
    Link

    CBER

    Applications for Food and Drug Administration Application Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements; Final Rule
    Link

    ISCT 7th Annual Somatic Cell Therapy Symposium – Slide Presentation
    Link

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States of America)

    Training Program for Regulatory Project Managers; Information Available to Industry
    Link

    Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Special Protocol Assessment
    Link

    Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank
    Link

    MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

    Good Clinical Practice (GCP) in Today’s Changing Environment
    Link

    ISCT

    ISCT REGIONAL MEETING – HOUSTON, TEXAS

    In response to increasing calls for smaller, more regionalized meetings, ISCT is pleased to announce the launch of its first Regional Meeting.

    Date: November 2-4, 2007
    Location: Texas Children’s Hospital  The Feigin Center  Houston, TX
    Target Audience: Laboratory practitioners and technicians working in cellular therapy laboratories
    Learning Objectives:
    To provide an overview of the biology of cellular therapy 
    To provide education on cell processing laboratory procedures and issues

    Click here for more information, including program, speakers, accommodation and registration. 

    Space is limited! Register now!


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