Cell Therapy News Volume 10.06 | Feb 23 2009

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    Cell Therapy News 10.06, February 23, 2009
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    An Inexhaustible Source of Neural Cells: Scientists in Bonn have now succeeded in deriving brain stem cells of almost unlimited self-renewal capacity and conservation potential from human embryonic stem cells.
    Article

    Science

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    Gene Therapy Shows Promise as Weapon Against HIV
    A new UCLA AIDS Institute study has found that gene therapy can be developed as a safe and active technique to combat HIV.
    Article

    ‘Evolved’ Virus may Improve Gene Therapy for Cystic Fibrosis
    Researchers have turned a relatively benign virus into a highly infectious form that is ideal as a carrier for gene therapy, completely curing human cystic fibrosis lung tissue in culture in its first gene therapy test.
    Article

    Stem Cells’ Deathly Awakening by Interferon
    Interferon-alpha, a messenger substance of the immune system, awakens dormant hematopoietic stem cells in the bone marrow to become active, thus making them vulnerable for the effect of many drugs German researchers have shown.
    Article

    University of Texas Houston Launches Stem Cell Study for Acute Stroke Patients
    Researchers will enroll 10 patients in the phase 1 study, who have just suffered a stroke, and will use the patients’ own stem cells for treatment.
    Article

    Case Report of a Brain and Spinal Tumor Following Human Fetal Stem Cell Therapy
    Researchers recently report the case of a boy with a rare genetic disease, Ataxia Telangiectasia, who underwent human fetal stem cell therapy at a clinic in Moscow and who, four years after the therapy began, was shown to have abnormal growths in his brain and spinal cord.
    Article

    New Therapy with Stem Cells to Treat Crohn’s Disease
    Hospital Clinic, Barcelona is exploring an innovative cellular therapy that uses stem cells to treat Crohn’s disease, a chronic genetic disease that affects 1% of the population in Spain and which has considerable impact on the quality of life of patients.
    Article

    Unrelated and Mismatched Cord Blood Transplantation Can Still Help Children with Deadly Conditions
    An unrelated cord blood transplant, even from a mismatched donor, can be effective in treating children with a host of life-threatening diseases and disorders according to researchers in the Duke Pediatric Blood and Marrow Transplantation Program.
    Article

    Long Term Results of a Successful Phase I Clinical Trial Using Autologous Neural Stem Cells to Treat Parkinson’s Disease
    Scientists announced recently research describing the long term results of the world’s first clinical trial using autologous neural stem cells for the treatment of Parkinson’s Disease.
    Article

    Neuralstem’s ALS Trial on Clinical Hold
    Neuralstem, Inc. announced recently its spinal cord stem cell trial to treat ALS is on clinical hold and that the Federal Drug Administration has provided the Company with specific comments, questions and recommendations for modifications to its protocol.
    Article

    Winners of the Stem Cell Image Contest Announced by the California Institute for Regenerative Medicine
    The twelve winning images from the first California Institute for Regenerative Medicine stem cell image contest range from a whirling galaxy of developing nerve cells to a moonscape of retinal pigment epithelial cells, both derived from human embryonic stem cells.
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    A Multi-instrumental Approach to Identify and Purify Very Small Embryonic-like Stem Cells from Adult Tissues
    In this paper, the researchers employed several complementary cell image analytical methods including ImageStream system (ISS analysis) and molecular approaches to identify and purify from adult murine organs a population of very small embryonic-like stem cells.
    Article

    A Rosette-type, Self-renewing Human ES Cell-derived Neural Stem Cell with Potential for in Vitro Instruction and Synaptic Integration
    Here, the researchers present a pure population of long-term self-renewing rosette-type hESC-derived neural stem cells (lt-hESNSCs), which exhibit extensive self-renewal, clonogenicity, and stable neurogenesis.
    Article

    Immunogenicity of Allogeneic Adipose-derived Stem Cells in a Rat Spinal Fusion Model
    To determine whether adipose-derived stem cells express a non-immunogenic profile in vivo, immune monitoring studies were carried out in conjunction with a rat spinal fusion study.
    Article

    A Multi-center, Randomized, Clinical Study to Compare the Effect and Safety of Autologous Cultured Osteoblast Injection to Treat Fractures
    The researchers performed a multi-center, open, randomized, clinical study of autologous cultured osteoblast injection for long-bone fracture, to evaluate the fracture healing acceleration effect and the safety of autologous cultured osteoblasts.
    Article

    Neuronal Guidance Protein Netrin-1 Induces Differentiation in Human Embryonal Carcinoma Cells
    This study suggests that Netrin-1 can induce neuroectodermal-like differentiation of human EC cells by affecting c-src signaling via SHP-2 activation and regulation of Nanog, Oct4, and Cripto-1 expressions.
    Article

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    Policy

    Obama to Lift Ban on Stem Cell Research Soon: Aide
    U.S. President Barack Obama will soon issue an executive order lifting an eight-year ban embryonic stem cell research imposed by his predecessor, President George W. Bush, a senior adviser said on Sunday.
    Article

    Cash Boost Coming for Stagnant U.S. Medical Research
    After years of stagnant funding, medical research in the United States is set for a big cash infusion that experts expect will boost work on a range of ailments as well studies involving human embryonic stem cells.
    Article

    Industry Could Lose Battle over Language for Comparative Effectiveness Research
    A House-Senate conference committee last night settled on a provision of the stimulus package that could be critical to the biotech and pharmaceutical industry in the coming years, nailing down the details of a $1.1 billion fund for comparative effectiveness research.
    Article

    Maryland Stem Cell Research Commission’s Focus to Change
    Maryland Stem Cell Research Commission members hashed out plans for the group’s future Tuesday, as they discussed a new bill that would reorganize the commission to include biotechnology and change the purpose of the fund.
    Article

    Business

    ParkwayHealth and Mesoblast to Provide Cutting Edge Treatment Using Proprietary Adult Stem Cells
    Parkway Group Healthcare Pte Ltd and Mesoblast Limited recently announced a collaborative program to facilitate commercialization of Mesoblast’s proprietary “off-the-shelf” stem cell products within the extensive ParkwayHealth hospital network in Asia.
    Article

    BioBusiness.TV and the Cell Therapy Group Team Up to Cover the Phacilitate Cell and Gene Therapy Forum 2009
    Recently BioBusiness.TV has published video coverage highlighting the some of the presentation and thoughts of panelists and guests of the Phacilitate Cell and Gene Therapy Forum 2009.
    Article

    California Institute for Regenerative Medicine to Seek $400M in Private Bond Placement
    California’s stem cell funding agency will seek $200 million in a private bond placement this year and $200 million next year to ease a cash-flow crunch.
    Article

    Texan Governor Announced Emerging Technology Fund Investment in Stem Cell Research at Texas A and M Health Science Center
    Governor Rick Perry announced a $5 million investment through the Texas Emerging Technology Fund to recruit leading scientists focused on regenerative medicine technologies to the Texas A and M Health Science Center College of Medicine Institute for Regenerative Medicine at Scott and White.
    Article

    University of Texas San Antonio Wins $500K to Develop Biomed Doctorate
    The University of Texas at San Antonio announced recently it will receive $500,000 from The University of Texas System over the next five years to develop a unique Graduate Program Initiative emphasizing biosensors and regenerative medicine.
    Article

    Oklahoma Funding for Adult Stem Cell Research Approved
    Legislation that could provide nearly $2 million for adult stem cell research in Oklahoma received committee approval last week.
    Article

    Senate Votes to Authorize Stem Cell Research
    A bill authorizing embryonic stem cell research in New Mexico has been approved by the Senate recently.
    Article

    Geron’s Push to Europe Thwarted
    Some of Geron’s glow faded on Friday when the company realized that its worldwide license for its stem-cell technology is not valid in Europe.
    Article

    NIH

    Findings of Scientific Misconduct (NOT-OD-09-052)
    Link

    Initiative for Maximizing Student Development (IMSD) (R25) (PAR-09-104)
    Link

    CBER

    License Applications: Resolution of Differences in Scientific Judgment in the Review Process
    Link

    2009 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals – Update
    Link

    2009 Biological Device Application Approvals – Update
    Link

    2009 Biological License Application Supplement Noteworthy Approvals – Update
    Link

    2009 Biological License Application Approvals – Update
    Link

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States)

    Healthy Competition for the Top FDA Post
    The Obama administration, though a tad slow on nominations this month has winnowed a fairly large field down to two finalists.
    Article

    MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

    Biologicals and Vaccines Expert Advisory Group Summary Minutes – 10 December 2008
    Link


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