Volume 10.31 | Aug 10

Cell Therapy News 10.31, August 10, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Researchers Make Stem Cells from Developing Sperm: Scientists have identified key molecular players responsible for how adult cells revert back into a primordial, stem cell state in fruit fly sperm cells. [Johns Hopkins University School of Medicine, Baltimore]
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Science

Webinar: MethoCult(R) Express – A Fast and Simple Hematopoietic Colony-Forming Cell Assay
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Stem Cell Hierarchy Offers Potential for Isolating, Growing Cells
The research from their paper finally provides the experimental proof of the existence of a human MSC at the single cell level, a key step that has previously eluded the scientific community. [University of Toronto Institute of Biomaterials and Biomedical Engineering, Toronto]
Article

Scientists Find Way to Coax Human Stem Cells into Becoming T Cells
Canadian researchers have developed a way to direct unspecified human stem cells into becoming progenitor T cells, which then go to the thymus and give rise to mature T cells, an essential ingredient in immune system reconstitution. [Sunnybrook Health Sciences Centre, Toronto]
Article

Scientists Find Common Trigger in Cancer and Normal Stem Cell Production
Researchers at the School of Medicine have discovered, for the first time, a common molecular pathway that is used by both normal stem cells and cancer stem cells when they reproduce themselves. [Stanford School of Medicine, Stanford]
Article

Mouse Tooth Grown From Stem Cells in Mouth
Researchers have created a “tooth germ” from mouse stem cells, which was implanted the 500-micrometer (0.02-inch) germ inside a mouse’s tooth socket. [Tokyo University of Science, Tokyo]
Article

Non-insulin-producing Alpha Cells in the Pancreas can be Converted to Insulin-producing Beta Cells
In findings that add to the prospects of regenerating insulin-producing cells in people with type 1 diabetes, researchers have shown that insulin-producing beta cells can be derived from non-insulin-producing cells in the pancreas. [Max-Planck Institute for Biophysical Chemistry, Munich]
Article

VIDEO: Researchers Identify Phosphorylated Signaling Proteins in Human Embryonic Stem Cells
Investigators have made the first comparative, large-scale phosphoproteomic analysis of human embryonic stem cells and their differentiated derivatives. [Burnham Institute for Medical Research, Burnham]
Article

Testing Gene Therapy to Improve Brain Function in Alzheimer’s Disease Patients
Researchers are about to launch a Phase 2 clinical trial to test a gene therapy treatment for Alzheimer’s disease called CERE-110, at 12 U.S. sites. [Shiley-Marcos Alzheimer’s Disease Research Center, University of California San Diego, San Diego]
Article

Proprietary Technology in World First Allogenic Stem Cell Trial for Treatment of End-Stage Heart Failure in Patients Supported By Mechanical Heart Assist Devices
Mesoblast Limited recently announced that its United States-based associate company Angioblast Systems Inc. has initiated a Phase 2 clinical trial for its adult stem cell product Revascor(TM) for improving heart muscle function in patients with class IV, end-stage form of heart failure. [Mesoblast Limited, Melbourne]
Article

Aldagen Reaches Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of ALD-301 for Critical Limb Ischemia
The Phase 3 trial will be a double blind, placebo-controlled study designed to assess the ability of ALD-301 to improve clinical outcomes in patients with CLI, including amputation rates, ulcer healing and pain reduction. [Aldagen, Inc., Durham]
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

A Novel Human Gamma-globin Gene Vector for Genetic Correction of Sickle Cell Anemia in a Humanized Sickle Mouse Model: Critical Determinants for Successful Correction
This study shows that lentiviral delivery of human {gamma}-globin gene under {beta]-globin regulatory control elements in hematopoietic stem cells results in sufficient postnatal fetal hemoglobin expression to correct sickle cell anemia in the Berkeley “humanized” sickle mouse. [Blood]
Article

The Ectopic Expression of Pax4 in the Mouse Pancreas Converts Progenitor Cells into {alpha} and Subsequently {beta} Cells
Here, the researchers conditionally and ectopically express Pax4 using different cell-specific promoters and demonstrate that Pax4 forces endocrine precursor cells, as well as mature {alpha} cells, to adopt a {beta} cell destiny. [Cell]
Article

Secreted Frizzled-Related Protein 1 Extrinsically Regulates Cycling Activity and Maintenance of Hematopoietic Stem Cells
This report explores secreted frizzled-related protein 1’s role in maintaining hematopoietic stem cells homeostasis through extrinsic regulation of -catenin. [Cell, Stem Cell]
Article

Engineering the Surface Glycoproteins of Lentiviral Vectors for Targeted Gene Transfer
This article provides an overview of innovative approaches to upgrade lentiviral vectors for tissue targeting. [Cold Spring Harbor Protocols]
Article

Gene Therapy and Bone Marrow Stem Cell Transfer to Treat Autoimmune Disease
Gene therapy combined with bone marrow stem cells has successfully introduced genes lacking in immunodeficiences. [Trends in Molecular Medicine]
Article

Doubts Over Stem Cell Images Prompt New Inquiry
The University of Minnesota in Minneapolis has launched yet another inquiry into research at its Stem Cell Institute after New Scientist raised further concerns about papers that seem to contain duplicated and manipulated images. [University of Minnesota in Minneapolis, Minneapolis]
Article

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Policy

US House Panel Backs Exclusivity for Biologic Drugs
A U.S. House committee approved an amendment that would give brand-name makers of biologic drugs 12 years of exclusivity, dealing a setback to efforts by President Barack Obama and consumer groups to open the market to generic drug makers sooner.
Article

Two Lines Account for Most Human Embryonic Stem Cell Research
For the past eight years, scientists who wanted to use federal funds for research on human embryonic stem cells had to restrict their studies to 21 cell lines approved by the National Institutes of Health. But an analysis by a researcher at the Stanford University School of Medicine suggests that only two of those lines have been used routinely. [Stanford School of Medicine, Stanford]
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.
Article

University Hospitals Case Medical Center Selects STEMSOFT Software for Entire BMT Program
STEMSOFT Software Inc, the leading provider of software solutions for cell therapy transplant programs, is pleased to announce the licensing of STEMSOFT’s complete suite of applications to the University Hospitals Case Medical Center. [STEMSOFT, Vancouver]
Article

Opexa Announces Stem Cell Agreement with Novartis
Opexa Therapeutics, Inc recently announced that it has entered into an exclusive agreement with Novartis for the further development of Opexa’s novel stem cell technology. [Opexa Therapeutics, Inc, The Woodlands]
Article

DARA BioSciences, Inc. and America Stem Cell, Inc. Collaborate On Stem Cell Research
DARA BioSciences, Inc. announced recently that the Company is collaborating with America Stem Cell to expand on observations from recent preclinical studies showing that dipeptidylpeptidase inhibitors improve the efficiency of hematopoietic stem cell transplants. [DARA BioSciences, Raleigh]
Article

Athersys Looking for Commercial Partners to Advance Stem Cell, Drug Therapies
Biopharmaceutical company Athersys Inc. is looking for commercial partners to help it develop and test its stem cell and drug therapies aimed at treating a variety of health problems. [Athersys Inc., Cleveland]
Article

Millipore Licenses Novel Stem Cell Technology from Boston University
Boston University and Millipore Corporation recently announced a licensing agreement for a highly efficient method for creating induced Pluripotent Stem cells derived from mouse fibroblasts by using a single virus vector instead of multiple viruses in the reprogramming process. [Millipore, Billerica]
Article

Alnylam and Tekmira Participate in New Research Collaboration
Alnylam Pharmaceuticals, Inc. and Tekmira Pharmaceuticals Corporation announced recently that they will jointly participate in a new research collaboration focused on the discovery of novel cationic lipids and lipid nanoparticles for the systemic delivery of RNAi therapeutics. [Alnylam Pharmaceuticals, Inc., Cambridge]
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Pluristem’s Award from the Israeli Office of the Chief Scientist Increased to $2.3 Million
Pluristem Therapeutics Inc. will receive a total of $2.3 million in funding for its stem cell programs from the Ministry of Industry, Trade and Labor of Israel; an increase from the previously announced amount of $1.9 million. [Pluristem, Haifa]
Article

BMTbase(TM) 4 Beta Version Released
Completely redesigned from the ground up using .NET technology, version 4 is a browser-based application allowing for easier user access, deployment and more robust database management and security. (STEMSOFT, Vancouver)
Article

NIH

Reminder of NIH Requirements for Submission of Financial, Administrative, and Scientific Closeout Reports in a Timely and Accurate Fashion (NOT-OD-09-128)
Link

Initiative to Maximize Research Education in Genomics (R25) (PAR-09-245)
Link

CBER

Bone Marrow Collection/Transfusion Kit; Approved Products – Fenwal Inc.
Link

2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
Link

Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

FDA, European Medicines Agency Launch Good Clinical Practices Initiative
The U.S. Food and Drug Administration and the European Medicines Agency recently announced an agreement to launch a bilateral Good Clinical Practices Initiative, designed to ensure that clinical trials are conducted uniformly, appropriately and ethically.
Article

ROZDRAVNADZOR (Russia)

Lilly to Train Russian FDA
Eli Lilly is among the organizations partnering to provide training for the Rozdravnadzor, Russia’s equivalent of the FDA, which is seeking to improve its knowledge of manufacturing standards.
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