Volume 10.49 | Dec 14

Cell Therapy News 10.49, December 14, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Researchers Launch Phase II Trial of Stem Cells and Acute Heart Attack: The second phase of a clinical trial testing a new stem cell-based therapy on injured heart muscle has been launched by researchers at The University of Texas Medical School at Houston. [University of Texas Medical School at Houston, Houston]
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Science

UCLA Researchers Demonstrate that Stem Cells can be Engineered to Kill HIV
Researchers from the UCLA AIDS Institute and colleagues have for the first time demonstrated that human blood stem cells can be engineered into cells that can target and kill HIV-infected cells — a process that potentially could be used against a range of chronic viral diseases. [University of California, Los Angeles, Los Angeles]
Article

New Skin Stem Cells Surprisingly Similar to Those Found in Embryos
Scientists have discovered a new type of stem cell in the skin that acts surprisingly like certain stem cells found in embryos: both can generate fat, bone, cartilage, and even nerve cells. [Howard Hughes Medical Institute, Chevy Chase]
Article

VIDEO: Supportive Materials will Help Regenerate Heart Tissue
Bioengineers are developing new regenerative therapies for heart disease that could influence the way in which regenerative therapies for cardiovascular and other diseases are treated in the future. New results identify the use of adult stem cells to regenerate heart tissue in environments that mimic a human post-heart-attack heart. [University of California-San Diego, San Diego]
Article

Stem Cells Battle for Space
Although the manner in which some cells compete for space and dominance is well known to be the survival of the fittest, researchers describe how stem cells win this battle by literally sticking around. [Johns Hopkins School of Medicine, Baltimore]
Article

Stem Cell Research Gives Hope to Stroke Patients
Stroke-damaged brains could be repaired within 5-10 years using adult stem cells from teeth, according to one of Australia’s leading stroke physicians. [Adelaide University’s Centre for Stem Cell Research, Adelaide]
Article

New Stem Cell Technology Leads to Better Treatment for Complicated Bone Fractures
The Hebrew University group has developed a technology called immuno-isolation in which mesenchymal stem cells are sorted out from the other cells residing in a bone marrow sample, using a specific antibody. It was shown that the immuno-isolated cells could be immediately used to form new bone tissue when implanted in laboratory animals, without having to undergo a prolonged incubator growth period. [Hebrew University of Jerusalem, Jerusalem]
Article

Umbilical Stem Cells May Help Recover Lost Vision for Those with Corneal Disease
New research has found that transplanting human umbilical mesenchymal stem cells into mouse models that lack the protein lumican restored the transparency of cloudy and thin corneas. [University of Cincinnati, Cincinnati]
Article

Gene Therapy and Stem Cells Save Limb
Researchers examined if HIF-1 gene therapy treatment, which includes activation of HIF-1 to build new blood vessels, could improve reduced blood flow associated with advanced age. [Johns Hopkins Medicine, Baltimore]
Article

Blood Stem Cell Transplant Regimen Reverses Sickle Cell Disease in Adults
A modified blood adult stem-cell transplant regimen has effectively reversed sickle cell disease in 9 of 10 adults who had been severely affected by the disease. [NIH Clinical Center, Bethesda]
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PUBLICATIONS, REVIEWS AND SPECIAL REPORTS

Signaling Pathways Controlling Pluripotency and Early Cell Fate Decisions of Human Induced Pluripotent Stem Cells
Scientists show that human induced pluripotent stem cells rely on activin/nodal signaling to control Nanog expression and thereby maintain pluripotency, thus revealing their mechanistic similarity to human embryonic stem cells. [Stem Cells]
Article

Complete Genetic Correction of iPS Cells From Duchenne Muscular Dystrophy
Researchers show the complete correction of a genetic deficiency in iPS cells derived from Duchenne muscular dystrophy model mice and a human DMD patient using a human artificial chromosome with a complete genomic dystrophin sequence. [Mol Ther]
Article

Preconditioning Mesenchymal Stem Cells With Transforming Growth Factor-Alpha Improves Mesenchymal Stem Cell-Mediated Cardioprotection
Transplanted cells encounter an inflammatory environment that mitigates their function and survival, so the researchers explored treating the cells with exogenous agents during ex vivo expansion before transplantation as one strategy for overcoming this limitation by enhancing paracrine function. [Shock]
Article

Differential Destruction of Stem Cells: Implications for Targeted Cancer Stem Cell Therapy
This study presents a mathematical model to predict how selective a therapy must be to ensure that enough hematopoietic stem cells survive when leukemic stem cells have been eradicated. [Cancer Res]
Article

iPS Cells: Mapping the Policy Issues
Given the explosion of research on induced pluripotent stem cells, it is timely to consider the various ethical, legal, and social issues engaged by this fast-moving field. Here, issues associated with the procurement, basic research, and clinical translation of iPS cells are reviewed. [Cell]
Article

Policy

Clinical Trials Involving Animal to Human Transplantation
The Australian National Health and Medical Research Council recently announced that clinical trials involving animal to human transplantation (xenotransplantation) would be allowed to proceed, when stringent regulatory and surveillance frameworks have been put in place.
Article

CIRM Provides $11 Million Boost in Funding to Train Stem Cell Scientists
Two critical programs funded by the California Institute for Regenerative Medicine (CIRM), the state stem cell agency, got an $11 million increase today when the agency’s 29-member Governing Board voted to approve funding for two additional grants in the Training II program and five additional grants in the Bridges program.
Article

Business

BioLife Solutions Announces Custom cGMP Manufacturing & License Agreement
BioLife Solutions, Inc. recently announced that it has executed a license and custom cGMP manufacturing agreement with Centocor Research & Development, Inc. The agreement includes the production of a custom variant of BioLife’s proprietary serum-free and protein-free CryoStor biopreservation media product.
Article

ThermoGenesis Announces Agreement for Adipose Tissue Clinical Program
ThermoGenesis Corp. announced recently that it has entered into a material transfer agreement with the GID Group for the processing of adipose, or fatty, tissue – a rich source of adult stem cells.
Article

Financial Backing from the University of California Spurs Construction of Stem Cell Center
Construction has begun on San Diego’s stem cell center, the Sanford Consortium for Regenerative Medicine, now that financing is in place.
Article

Cleveland Clinic Receives $2.75 Million Grant to Study Stem Cell Use in Treating Multiple Sclerosis
The four-year grant from the Department of Defense will fund a 24-patient study to be done by the Center for Stem Cell and Regenerative Medicine.  In the study, patients with relapsing multiple sclerosis who are still able to walk, even though they have moderate to severe disability, will have bone marrow removed from their hips.
Article

Cedars-Sinai to Supply Stem Cells to Scientists Developing Treatments for Huntington’s Disease
As part of the $3.7 million grant from the National Institutes of Health, the Cedars-Sinai Regenerative Medicine Institute, directed by Clive Svendsen, Ph.D., will supply scientists at five leading laboratories, including Cedars-Sinai, with all the adult stem cells used in the study.
Article

Genzyme Names Leaders in Key Areas
Genzyme Corp. announced recently that it has tapped senior executives from major pharmaceutical and biotechnology companies to strengthen its leadership ranks in regulatory and clinical affairs and other areas.
Article

Australian Stem Cell Centre Publishes Patient Handbook
In response to increasing concerns surrounding unregulated and unproven stem cell therapies offered to patients overseas, the Australian Stem Cell Centre has recently published its Patient Handbook.
Article

NASDAQ Hearings Panel Grants Exception Period to Aastrom Based on Request to Remain Listed on the NASDAQ Stock Market
Aastrom Biosciences, Inc. announced recently that the NASDAQ Hearings Panel has granted the Company’s request to remain listed on the NASDAQ Stock Market until March 31, 2010, subject to certain conditions.
Article

NIH

Delays in Grant Application Submission due to Winter Storm December 2009 (NOT-OD-10-028)
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Development of Multifunctional Drug and Gene Delivery Systems (R01) (PAR-10-048)
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CBER

User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the Public Health Service Act
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

December 15, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents
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THERAPEUTIC GOODS ADMINISTRATION (Australia)

Draft Australian Code of Good Manufacturing Practice: Human Blood and Blood Components, Human Tissues and Human Cellular Therapies
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