Cell Therapy News Volume 10.30 | Aug 3 2009

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    Cell Therapy News 10.30, August 3, 2009
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    United States FDA Clears the REGEN Trial to Test Bioheart’s Combination Gene and Stem Cell Therapy in Heart Failure Patients: The REGEN trial will enroll 15 patients in a multicenter, randomized, dose escalation study to assess the safety and cardiovascular effects of the implantation of MyoCell SDF-1 in congestive heart failure patients post myocardial infarction(s). [Bioheart, Inc., Sunrise]
    Article

    Science

    New: Mammary Epithelial Cell Colony Interactive Tutorial

    – Zoom-in and zoom out of bi-potent colonies to view details
    – Highlight luminal and basal structures in 3D morphogenesis structures

    Try the tutorial now

    Scientists Closer to Making Implantable Bone Material
    Scientists from Imperial College London have compared the ‘bone-like’ material grown from three different commonly used clinically relevant cell types and have discovered significant differences between the quality of bone-like material that these can form. [Imperial College London, London]
    Article

    Researchers Rapidly Turn Bacteria into Biotech Factories
    Using a novel cell programming method that retools evolution to generate genetic diversity at an unprecedented rate, a research team turned self-serving bacteria into efficient factories for making a variety of compounds. [Harvard Medical School, Boston]
    Article

    Male Germ Cells Can Be Directly Converted Into Other Cell Types
    Researchers have found a way to directly convert spermatogonial stem cells, the precursors of sperm cells, into tissues of the prostate, skin and uterus. [University of Illinois at Urbana-Champaign, Champaign]
    Article

    Injection Reverses Heart Attack Damage
    Injured heart tissue normally can’t regrow, but researchers at Children’s Hospital Boston have now laid the groundwork for regenerating heart tissue after a heart attack, in patients with heart failure, or in children with congenital heart defects. [Children’s Hospital Boston, Boston]
    Article

    Reprogramming Human Cells Without Inserting Genes
    A research team has discovered a novel way to turn on stem cell genes in human fibroblasts (skin cells) without the risks associated with inserting extra genes or using viruses. [Worcester Polytechnic Institute, Worcester]
    Article

    Placenta-derived Stem Cells May Help Sufferers of Lung Diseases
    According to Italian researchers cells delivered via intra-peritoneal transplant, regardless of the cells being allogenic or xenogenic resulted in a significant anti-fibrotic effect on the lab animals. [Centro di Ricerca E. Menni, Brescia]
    Article

    Scientists Program Blood Stem Cells To Become Vision Cells
    University of Florida researchers were able to program bone marrow stem cells to repair damaged retinas in mice, suggesting a potential treatment for one of the most common causes of vision loss in older people. [University of Florida, Gainesville]
    Article

    United States FDA Clears the REGEN Trial to Test Bioheart’s Combination Gene and Stem Cell Therapy in Heart Failure Patients
    The REGEN trial will enroll 15 patients in a multicenter, randomized, dose escalation study to assess the safety and cardiovascular effects of the implantation of MyoCell SDF-1 in congestive heart failure patients post myocardial infarction(s). [Bioheart, Inc., Sunrise]
    Article

    ReNeuron Receives UK Ethics Committee Favorable Opinion for Stroke Clinical Trial
    ReNeuron Group plc recently announced that the UK Gene Therapy Advisory Committee has issued a Favorable Opinion subject to conditions in respect of ReNeuron’s proposed Phase I clinical trial with its ReN001 stem cell therapy for stroke. [ReNeuron, Guildford]
    Article

    Osiris Achieves Milestone Payment for Progress Developing Stem Cell Therapy for Type 1 Diabetes
    Osiris Therapeutics, Inc. recently announced that it has achieved a $750,000 milestone payment from the Juvenile Diabetes Research Foundation (JDRF) for progress made on a Phase II clinical trial evaluating Prochymal, as a treatment for patients recently diagnosed with type 1 diabetes. [Osiris Therapeutics, Inc., Columbia]
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Study on Sperm Made From Stem Cells Retracted for Plagiarism
    A scientific journal has retracted a paper that reported researchers had created human sperm from stem cells because a section of the article was plagiarized, the editor of the journal, Stem Cells and Development, said recently.
    Article

    In Vitro Derivation of Human Sperm from Embryonic Stem Cells
    The researchers in this stud developed an in vitro strategy for establishing of male GSCs from human embryonic stem cells. [Stem Cells and Development]
    Article

    Protein Kinase C{gamma} Mediates Regulation of Proliferation by the Serotonin 5-Hydroxytryptamine Receptor 2B
    Activation of the 5-hydroxytryptamine receptor 2B (5-HT2B), a Gq/11 protein-coupled receptor, results in proliferation of various cell types. [Journal of Biological Chemistry]
    Article

    Cultivated Human Conjunctival Epithelial Transplantation for Total Limbal Stem Cell Deficiency
    The purpose of this study was to determine the feasibility of cultivated conjunctiva as a viable epithelial sheet for transplantation and corneal resurfacing in eyes with limbal stem cell deficiency. [Investigative Ophthalmology and Visual Science]
    Article

    Characterization in Vitro and Engraftment Potential in Vivo of Human Progenitor T Cells Generated from Hematopoietic Stem Cells
    Human umbilical cord blood hematopoietic stem cells were induced to differentiate to the T lineage in OP9-DL1 co-cultures to elucidate molecular and cellular events occurring at early stages of human T-cell development. [Blood]
    Article

    Muscle Stem Cell Behavior is Modified by MicroRNA-27 Regulation of Pax3 Expression
    The researchers identified microRNA-27b (miR-27b), which directly targets the 3′-UTR of Pax3 mRNA, as a regulator of skeletal muscle stem cells are regulation. [Proceedings of the National Academy of Sciences]
    Article

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    Policy

    Obama Enacts New U.S. Stem Cell Research Rules
    U.S. President Barack Obama directed federal agencies on Thursday to enact new rules governing federally funded research on human embryonic stem cells.
    Article

    Germany Tightens Law on Stem Cell Treatments
    Treatments in Germany involving adult stem cells will be more closely regulated after revision of Germany’s medical products law received final approval by the Bundesrat, the upper house of parliament.
    Article

    Business

    Connexon Creative Launches Cord Blood News
    Cord Blood News is a weekly e-newsletter that keeps members of the cord blood community informed by providing the latest news from all areas of the field, including its science, research, policy, and business.
    Link

    Developing Gene Therapy to Fight Blindness
    An international team of scientists and clinicians from the United States and Saudi Arabia are working to develop gene therapy for treating a rare, hereditary retinal disease. [University of California, San Diego School’s Shiley Eye Center, San Diego]
    Article

    North Carolina Mayors to Talk Biotech
    North Carolina Mayors agreed to pursue priorities in several areas, including support for funding of innovation, educating citizens about biotech job opportunities and benchmarking best practices from communities around the state, according to an announcement that followed the closed-door session.
    Article

    Living Cell Technologies Raises A$4.2m from a Placement of Shares to Fund Clinical Trials of DIABECELL(R)
    Living Cell Technologies Limited announced that it has closed a private placement of share capital raising A$4.2m. [Living Cell Technology, Sydney]
    Article

    Pennsylvania Researchers Win Fight Over Stem Cell Patent
    Two University of Pittsburgh researchers won a patent ruling over their discovery that stem cells gleaned from liposuctioned fat could be used to produce bone, cartilage and muscle. [University of Pittsburgh, Pittsburgh]
    Article

    NIH

    Recovery Act of 2009: Information on Quarterly Reporting Requirements for NIH Award Recipients (NOT-OD-09-129)
    Link

    Corrections to the Instructions in SF424 (R&R) Individual Fellowship Application Guide for NIH and AHRQ (NOT-OD-09-131)
    Link

    CBER

    Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products
    Link

    Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
    Link

    Regulatory

    FOOD AND DRUG ADMINISTRATION (United States)

    Wisconsin Law Professor Tapped for FDA Job
    A University of Wisconsin-Madison law professor, Alta Charo, will work as a senior adviser in the Office of the Commissioner starting Aug. 30.
    Article

    Science Board to the Food and Drug Administration; Notice of Meeting, August 17, 2009
    Link

    Agency Information Collection Activities; Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
    Link

    Agency Information Collection Activities; Request for Samples and Protocols
    Link


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