Cell Therapy News Volume 7.02 | Jan 23 2006

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    Volume 7.02, January 23, 2006
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Powerful Technique for Multiplying Adult Stem Cells May Aid Therapies: Now, researchers in the lab of Whitehead Institute Member and MIT professor of biology Harvey Lodish have discovered a way to multiply an adult stem cell 30-fold, an expansion that offers tremendous promise for treatments such as bone marrow transplants and perhaps even gene therapy.
    Article

    Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products; Final Rule: The Food and Drug Administration (FDA) is amending its regulations governing the content and format of labeling for human prescription drug products (including biological products that are regulated as drugs).
    Article

    Science

    Cell Therapy News Introduces New Section for Cell Therapy-related Scientific Journals
    Cell Therapy News, the online resource for the cell therapy community, is pleased to announce a new section in its e-newsletter.
    Article

    Cloned Stem Cells Prove Identical To Fertilized Stem Cells
    Scientists generally agree that all cloned animals are biologically flawed. But they don’t agree about what that means for stem cells derived from cloned embryos, the basis for therapeutic cloning.
    Article

    Science Creates a Living Bandage for Broken Hearts
    Merging artificially engineered products with a patient’s own heart to stop or reverse cardiac damage could be the wave of the future, researchers say.
    Article

    Human Cells Applied as Patch Improve Cardiac Function After Heart Attack, According to a Report in Tissue Engineering
    A three-dimensional scaffold populated with human fibroblast cells and applied as a patch to heart muscle damaged by a heart attack improved heart function and stimulated the formation of new blood vessels that supply oxygen and essential nutrients to the heart, according to a report published in the November/December issue (Volume 11, Number 11-12) of Tissue Engineering.
    Article

    Study Reports Efficacy of Umbilical Cord Blood to Treat Thalassemia Patients
    StemCyte discussed a new study which, it says, confirms prior research suggesting that unrelated Umbilical Cord Blood (UCB) transplants may be a promising approach for curative therapy of thalassemia.
    Article

    Turning Stem Cells into Tissues
    Scientists are now integrating genomics, proteomics, and other technologies in an effort to understand the two unique properties of stem cells: their ability to divide indefinitely to create more stem cells, and their ability to differentiate into any number of cell types.
    Article

    Clinical Trial on Gene Therapy for Macular Degeneration Published in Human Gene Therapy
    An adenoviral-based vector containing the gene for human pigment epithelium-derived factor (PEDF) showed evidence of being able to stop disease progression when injected directly into the eyes of patients with neovascular age-related macular degeneration, according to the results of a phase I clinical trial.
    Article

    Gene Therapy ‘Turns Off’ Mutation Linked to Parkinson’s
    A group of Northwestern University researchers is developing a novel gene therapy aimed at selectively turning off one of the genes involved in the development of Parkinson’s disease.
    Article

    University of Rochester Tests Whether Stem Cells Can Heal Hearts
    For the first time, the University of Rochester is testing adult stem cells in patients to see whether the cells can actually repair an organ.
    Article

    Study Links Alzheimer’s Disease to Abnormal Cell Division
    A new study in mice suggests that Alzheimer’s disease (AD) may be triggered when adult neurons try to divide.
    Article

    Mouse Model Reveals That Oncoprotein Induces Abnormal Preleukemic Blood Cell Progenitors
    Scientists have developed a novel mouse model for leukemia that reveals critical information about the mechanisms involved in leukemia progression and provides a model system for evaluation of new drugs for treatment of leukemia.
    Article

    Immunotherapy May Prevent Neuroblastoma Relapse
    A combined cellular and humoral immunotherapy regimen has increased survival rates in a murine model of human disseminated neuroblastoma.
    Article

    Taiwan Issues Glowing Report on Pigs
    Scientific team says that even the internal organs of the fluorescent swine are green
    Article

    ABSTRACT, REVIEWS, & SPECIAL REPORTS

    Cardiac Patch Constructed from Human Fibroblasts Attenuates Reduction in Cardiac Function after Acute Infarct
    The results shos that the 3DFC as a cardiac patch functioned to attenuate further loss of LV function accompanying acute myocardial infarct and that this may be related in part to myocardial revascularization.
    Abstract

    Activation of NK Cells by an Endocytosed Receptor for Soluble HLA-G
    This unique stimulation of resting NK cells by soluble HLA-G, which is endocytosed by KIR2DL4, implies that NK cells may provide useful functions at sites of HLA-G expression, such as promotion of vascularization in maternal decidua during early pregnancy.
    Abstract

    Identification of Pip4k2ß as a Mechanical Stimulus Responsive Gene and Its Expression During Musculoskeletal Tissue Healing
    We suggest that the expression of Pip4k2ß can be used as a marker for cells receiving a suitable mechanical stimulus.
    Abstract

    Policy

    Korea Tightens Rules on Stem Cell Therapy
    The Korean government is moving to make it more difficult to launch clinical tests with stem cells here as problems arise from the fast-track processing of requests to conduct experimental cell therapy.
    Article

    Virginia House Of Delegates Committee Passes Legislation Establishing Cord Blood Bank, USA
    The Virginia House of Delegates’ Health, Welfare and Institutions Committee on Tuesday by voice vote passed a bill (HB 413) that would establish a statewide umbilical cord blood bank system
    Article

    California Institute for Regenerative Medicine Official on Hot Seat
    The Oakland-based Center for Genetics and Society said in a report that the new state agency overseeing $3 billion in taxpayer funds over the next 10 years for basic science is not accountable to the public and is going back on campaign promises of affordable cures.
    Article

    Business

    Dendreon Announces Strategic Realignment to Focus on PROVENGE BLA and Commercialization
    Dendreon Corporation (Nasdaq: DNDN) announced today the Company has realigned its resources to focus on advancing PROVENGE(R) (sipuleucel-T), its lead investigational active cellular immunotherapy for the treatment of prostate cancer, toward the market as expeditiously as possible.
    Article

    MicroIslet Inc. (MII) Appoints Dr. James R. Gavin III Interim President And CEO
    MicroIslet, Inc. today announced that it has appointed James R. Gavin III, M.D., Ph.D., as its interim President and CEO, effective January 20, 2006. Dr. Gavin has been a member of MicroIslet’s Board of Directors since March 2001.
    Article

    Vitro and PhosphoSolutions Collaborate to Study Stem Cell Proteomics
    Vitro Diagnostics, Inc. (OTC BB: VODG), dba Vitro Biopharma, announced establishment of research collaboration with PhosphoSolutions, LLC (Aurora Colorado) to characterize intracellular signaling mechanisms involved with regulation of stem cell growth and differentiation.
    Article

    Aniara Corporation Growth Driven by Global Presence and Extensive Product Offering for Medical Exploration and Discovery
    Aniara Corporation, a multi-national distributor of diagnostic and research agents, as well as screening tools, has strengthened its commitment to meeting today’s highest standards for porduct quality and cost-efficient delivery.
    Article

    NIH


    NATIONAL INSTITUTES OF HEALTH

    Directed Stem Cell Differentiation for Cell Based Therapies for Heart, Lung, Blood, and Aging Diseases (SBIR [R43/R44]) (PA-06-124)
    Link

    Directed Stem Cell Differentiation for Cell Based Therapies for Heart, Lung, Blood, and Aging Diseases (STTR [R41/R42]) (PA-06-125)
    Link

    Specialized Cooperative Centers Program in Reproduction and Infertility Research (U54)
    Link

    Sarcoidosis: Research into the Cause of Multi-organ Disease and Clinical Strategies for Therapy (R01) (PA-06-123)
    Link

    CBER

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

    Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
    Link

    Current Good Manufacturing Practice Regulation and Investigational New Drugs; Direct Final Rule
    The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational “Phase 1” drugs from complying with the requirements in FDA’s regulations.
    Link

    Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products; Final Rule
    Link

    Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
    Link

    Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
    Link

    Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products – Content and Format
    Link

    Draft Guidance for Industry: Labeling for Human Prescription Drug and Biological Products – Implementing the New Content and Format Requirements
    Link

    Draft Guidance for Industry: INDs – Approaches to Complying with CGMP During Phase 1
    Link

    Biological Product Deviation Reporting – Codes for Human Tissues and Cellular & Tissue-Based Products – Update
    Link

    2005 Biological Approvals – Update
    Link

    Approved Biological NDA and ANDA Applications – Update
    Link

    Cleared Biological 510(k) Device Applications – Update
    Link

    Approved Biological Premarket Approval (PMA) Device Applications – Update
    Link

    Licensed Products and Establishments List – Update
    Link

    Regulatory SOPP 8407 – Compliance Status Checks
    Link

    Approval Information – Immune Globulin Subcutaneous (Human) (Vivaglobin) – ZLB Behring, L.L.C
    Link

    Regulatory

    TGA- Therapeutic Goods Administration (Australia)

    Therapeutic Goods Order No. 74 Standards for Blood Components
    Link

    ISCT

    ISCT2006. May 4-7. Berlin.
    Click here for the Call for Abstracts and preliminary program or registration information.

    AABB-ISCT Cellular Therapy Audioconference Series
    Link

    Profiled Journal

    Current Volume: VOLUME 14, NUMBER 9, 2005

    CONTENTS

    REVIEW

    A Role of the Choroid Plexus in Transplantation Therapy
    Dwaine F. Emerich, Stephen J. M. Skinner, Cesario V. Borlongan, and Christopher G. Thanos

    ORIGINAL CONTRIBUTIONS

    Minimal Focal Steatosis of Liver After Islet Transplantation in Humans: A Long-Term Study
    Paola Maffi, Enzo Angeli, Federico Bertuzzi, Carlo Paties, Carlo Socci, Carlo Fedeli, Francesca De Taddeo, Rita Nano, Valerio Di Carlo, Alessandro Del Maschio, and Antonio Secchi

    Generation of Islet-Like Hormone-Producing Cells In Vitro From Adult Human Pancreas
    Fouad Atouf, Yong Choi, Michael J. Fowler, Greg Poffenberger, Jan Vobecky, Malancha Ta, George B. Chapman, Alvin C. Powers, and Nadya L. Lumelsky

    AN69 Hollow Fiber Membrane Will Reduce But Not Abolish the Risk of Transmission of Porcine Endogenous Retroviruses
    Oleg Pakhomov, Lionel Martignat, Jiri Honiger, Béatrice Clémenceau, Pierre Saï, and Sylviane Darquy

    Effective Islet Isolation Method With Extremely High Islet Yields From Adult Pigs
    Yukihide Yonekawa, Shinichi Matsumoto, Teru Okitsu, Takashi Arata, Yasuhiro Iwanaga, Hirofumi Noguchi, Hideo Nagata, John J. O’Neil, and Koichi Tanaka

    The Effects of Bone Marrow-Derived Mesenchymal Stem Cells and Fascia Wrap Application to Anterior Cruciate Ligament Tissue Engineering
    Zigang Ge, James Cho Hong Goh, and Eng Hin Lee

    Analysis of Allogeneic and Syngeneic Bone Marrow Stromal Cell Graft Survival in the Spinal Cord
    Sharon A. Swanger, Birgit Neuhuber, B. Timothy Himes, Ajay Bakshi, and Itzhak Fischer

    Purified Human Bone Marrow Multipotent Mesenchymal Stem Cells Regenerate Infarcted Myocardium in Experimental Rats
    Shaoheng Zhang, Zhuqing Jia, Junbo Ge, Lizhong Gong, Yanling Ma, Tao Li, Jingxuan Guo, Ping Chen, Qikuan Hu, Ping Zhang, Yonggang Liu, Zhaoping Li, Kangtao Ma, Linsong Li, and Chunyan Zhou

    Protection of Photoreceptor Cells From Phototoxicity by Transplanted Retinal Pigment Epithelial Cells Expressing Different Neurotrophic Factors
    Toshiaki Abe, Yoko Saigo, Masayoshi Hojo, Tetsuya Kano, Ryosuke Wakusawa, Yumi Tokita, and Makoto Tamai

    Synergistic Effect of Keratinocyte Transplantation and Epidermal Growth Factor Delivery on Epidermal Regeneration
    So-Jung Gwak, Sang-Soo Kim, Kyungeun Sung, Joungho Han, Cha Yong Choi, and Byung-Soo Kim

    Differentiation Effects by the Combination of Spheroid Formation and Sodium Butyrate Treatment in Human Hepatoblastoma Cell Line (Hep G2): A Possible Cell Source for Hybrid Artificial Liver
    J. Fukuda, K. Okamura, K. Ishihara, H. Mizumoto, K. Nakazawa, H. Ijima, T. Kajiwara, and K. Funatsu

    The Effect of Simulated Microgravity by Three-Dimensional Clinostat on Bone Tissue Engineering
    Masataka Nishikawa, Hajime Ohgushi, Noriyuki Tamai, Koichi Osuga, Masaru Uemura, Hideki Yoshikawa, and Akira Myoui

    Influence of Preservation Solution on the Isolation and Culture of Human Hepatocytes From Liver Grafts
    Alfonso Serralta, Maria Teresa Donato, Amparo Martinez, Eugenia Pareja, Francisco Orbis, Jose Vincente Castell, Jose Mir, and Maria Jose Gómez-Lechón

    Large-Scale Isolation of Human Hepatocytes for Therapeutic Application
    Krassimira Alexandrova, Carsten Griesel, Marc Barthold, Hans-Gert Heuft, Michael Ott, Michael Winkler, Harald Schrem, Michael P. Manns, Timm Bredehorn, Marc Net, Martí Manyalich I Vidal, Sabine Kafert-Kasting, and Lubomir Arseniev

    COMMENTARY

    Stem Cells and Development Publishes Neural Stem Cells Compendium
    Paul R. Sanberg and Cathryn R. Greene-Zavertnik

    BOOK REVIEW

    A Manual for Primary Human Cell Culture (Jan-Thorsten Schantz and Kee Woei Ng)
    Gary R. Hellermann

    ERRATUM

    Effects of Copper and Cross-Linking on the Extracellular Matrix of Tissue-Engineered Arteries
    Shannon L. M. Dahl, Robert B. Rucker, and Laura E. Niklason

    Cell Transplantation publishes original, peer-reviewed research and review articles on the subject of cell transplantation and its application to human diseases.