Volume 9.32 | Aug 18

Cell Therapy News 9.32, August 18, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Australian Researchers Grow Embryonic Stem Cells in Synthetic Material: Scientists from Queensland University of Technology have successfully grown embryonic stem cells in synthetic material.
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Science

The TriMark Molecular Diagnostics Conference 2008
October 6, 2008  |  New York, New York
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The TriMark Stem Cell Conference 2008
October 20, 2008  |  San Fransisco, California
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Yale Researchers Discover Tiny Cellular Antennae Trigger Neural Stem Cells
Yale University scientists recently reported evidence suggesting that the tiny cilia found on brain cells of mammals, thought to be vestiges of a primeval past, actually play a critical role in relaying molecular signals that spur creation of neurons in an area of the brain involved in mood, learning and memory.
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Lab-Grown Tendons Gradually Fade to Bone
Tissue engineering can produce tendons, cartilage, and even bladders. But only now have researchers managed to make different tissues blend into one another, as they do naturally in the body.
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Mesoblast’s Stem Cells Regrow Knee Cartilage in Severe Post-Menopausal Osteoarthritis
Mesoblast Limited, recently announced successful preclinical trial results which showed that its proprietary adult stem cells regenerated and regrew damaged knee cartilage in post-menopausal osteoarthritis.
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Alnylam and Collaborators Publish New Pre-Clinical Research on RNAi-Mediated Silencing of PCSK9, a Genetically Validated Regulator of LDL Metabolism
The published, peer-reviewed data demonstrate for the first time that a chemically synthesized small interfering RNA (or siRNA, the molecules that mediate RNAi) targeting the gene proprotein convertase subtilisin/kexin type 9 (PCSK9) achieves acute and durable lowering of total cholesterol levels in both mice and rats, and LDL cholesterol levels in non-human primates.
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Pluristem’s PLX-MS Shows Potential Benefit in the Prevention of Multiple Sclerosis
Pluristem Therapeutics Inc. recently announced that the Company’s PLacental eXpanded cells have demonstrated in vivo efficacy in the prevention of Multiple Sclerosis. PLX cells are Pluristem’s placental-derived mesenchymal stromal cells that have been expanded in the Company’s proprietary PluriX(TM) 3-D bioreactor.
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ImmuneRegen(R) BioSciences Confirms Homspera(R) Advances Wound Healing in Topical Application
ImmuneRegen(R) BioSciences, Inc., recently announced that in a controlled study performed on Yorkshire pigs, its wound-healing drug candidate, Homspera(R), has accelerated the healing process of deep, dermal excisions.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Direct Intrabone Transplant of Unrelated Cord-Blood Cells in Acute Leukaemia: a Phase I/II Study
Cord-blood transplants are associated with delayed or failed engraftment in about 20% of adult patients. The aim of this phase I/II study was to establish the safety and efficacy of a new administration route (intrabone) for cord-blood cells, measured by the donor-derived neutrophil and platelet engraftment.
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Regulation of Self-Renewal and Pluripotency by Sox2 in Human Embryonic Stem Cells
To determine the role of Sox2 in maintaining hES cell pluripotency and self-renewal, the researchers used RNA interference to specifically knock down Sox2 gene expression. Reduction of Sox2 expression in hES cells results in loss of the undifferentiated stem cell state, as indicated by a change in cell morphology, altered stem cell marker expression, and increased expression of trophectoderm markers.
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Improved Efficiency and Pace of Generating Induced Pluripotent Stem Cells from Human Adult and Fetal Fibroblasts
The efficiency of generating human induced pluripotent stem cells is low, especially for postnatal human fibroblasts. The researcheres report here that adding SV40 large T antigen to either set of the four reprogramming genes previously used enhanced the efficiency by 23–70-fold from both human adult and fetal fibroblasts.
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Putative Dental Pulp Derived Stem/Stromal Cells Promote Proliferation and Differentiation of Endogenous Neural Cells in the Hippocampus of Mice
Until now, interest in dental pulp stem/stromal cell research has centered on mineralization and tooth repair. Beginning a new paradigm in dental pulp stem/stromal cell research, researchers grafted undifferentiated, untreated dental pulp stem/stromal cells into the hippocampus of immune-suppressed mice.
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Policy

California Institute for Regenerative Medicine New Faculty Grants Awarded to University of California San Diego Researchers
Adding $11.5 million to the more than $20 million in funding that researchers at the University of California, San Diego have received to date from the California Institute for Regenerative Medicine, five University of California San Diego researchers and physicians have been awarded New Faculty grants.
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Stanford Professor Given $3.1 Million Stem Cell Research Grant
Assistant Professor of Medicine Ching-Pin Chang was awarded a five year, $3.1 million grant by the California Institute of Regenerative Medicine for stemcell research.
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Court to Hear Stem Cell Arguments in October
A Missouri state judge will decide in October on a lawsuit seeking to block $21 million from going to the Life Sciences Research Board.
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Stem Cell Advocates Doubt McCain Support
McCain’s efforts to win the backing of abortion rights opponents and religious conservatives has caused fears that the Arizona senator will reverse his position on stem cell research.
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Bulgaria Minister Resigns in Stem Cell Row
Last week the Health Minster, Evgeni Zhelev, dismissed the management and head of St Ivan Rilski hospital in Sofia over allegations that it illegally conducted transplantations of stem cells.
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Business

Genentech Special Committee of Independent Directors Responds to Roche Proposal
The special committee of the Board of Directors of Genentech, Inc. announced that, after careful consideration, it has unanimously concluded that Roche’s proposal to acquire the shares of Genentech not owned by Roche for $89.00 per share substantially undervalues the company.
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Geron and Exeter Life Sciences Merge Start Licensing and Viagen To Form Combined Licensing and Operating Company for Animal Cloning Technologies
The merger of Start and ViaGen, combines the full breadth of intellectual property rights to nuclear transfer cloning technology, including that developed at the Roslin Institute for cloning Dolly the sheep, with in-house state-of-the-art breeding services and expertise in advanced reproductive technologies, particularly in cloning, to provide a one-stop licensing and operating company.
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Talecris Enters into Definitive Merger Agreement with CSL Limited
Talecris Biotherapeutics, Inc. recently announced that it has signed a definitive merger agreement with CSL under which CSL has agreed to acquire Talecris for $3.1 billion in cash.
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Tekmira Pharmaceuticals Announces RNAi Research Collaboration with Bristol-Myers Squibb
Tekmira Pharmaceuticals Corporation announced recently a research collaboration with Bristol-Myers Squibb using Tekmira’s SNALP technology to deliver small interfering RNAs to specific organs and tissues outside of the liver. 
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Cytori to Raise $17 Million in Private Placement with Olympus and Institutional Investors
Cytori Therapeutics is to raise approximately $17 million from a private placement financing led by Olympus Corporation with participation from select institutional investors. Net proceeds are expected to be approximately $16.4 million after offering-related fees and expenses.
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Opexa Therapeutics Completes $3 Million Financing
Opexa Therapeutics, Inc. recently announced the completion of a private placement financing with total gross proceeds of approximately $3.0 million.
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Introgen Appoints James E. Rothman, Ph.D., to Board of Directors
Introgen Therapeutics, Inc. recently announced the appointment of James E. Rothman, Ph.D., to the Company’s board of directors.
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StemCells, Inc. Appoints Stewart Craig, Ph.D., Senior Vice President, Development and Operations
StemCells, Inc. recently announced that Stewart Craig, Ph.D., an acknowledged expert in the development of cell-based therapeutics, will be joining the Company as Senior Vice President, Development and Operations, effective September 15, 2008.
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Genitope Corporation Announces Receipt of Nasdaq Delisting Notice
Genitope Corporation recently announced that, on August 7, 2008, it received a staff determination letter from The Nasdaq Stock Market formally notifying Genitope that it has not regained compliance with the minimum $1.00 per share bid price requirement for continued inclusion on the Nasdaq Global Market and that, unless appealed, trading in Genitope’s common stock will be suspended. Genitope does not currently intend to appeal this determination.
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NIH

Notice of Non-Participation in PA-08-191 Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers
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Request for Information (RFI): AHRQ Requests Input to Develop an Innovations Research Portfolio
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CBER

Substantially Equivalent 510(k) Device Information – LifeSouth Community Blood Centers Inc
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Product Approval Information – Blood Grouping Reagent Anti-S (Monoclonal)
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Product Approval Information – Blood Grouping Reagent Anti-s (Monoclonal)
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Product Approval Information – Blood Grouping Reagent Anti-Fya (Monoclonal)
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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Current Licensed Establishments and Products
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Blood Products Advisory Committee
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