Volume 7.35 | Sep 11

Volume 7.35, September 11, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Clarification Issued on Stem Cell Work: The scientific journal Nature has corrected a press release and is considering whether to add further information to an article published last week reporting that human embryonic stem cells could be generated without destroying an embryo.
Article

Science

Scientists Identify Compounds That Stimulate Stem Cell Growth In The Brain
Scientists at Harvard University have identified key compounds that stimulate stem cell growth in the brain, which may one day lead to restored function for people affected by Parkinson’s disease, strokes, multiple sclerosis, and a wide range of neurological disorders.
Article

Who Gives Stem Cells Their Marching Orders?
Researchers from the Swiss Institute for Experimental Cancer Research (ISREC) have shown that a single gene involved in embryonic development is responsible for two seemingly contradictory activities – maintaining stem cells after the embryo has implanted in the mother’s uterus, and later providing cues to direct their differentiation in a coordinated fashion when the time is ripe.
Article

Genes Unique to the Human Egg Identified
The identification opens the way to understanding these genes’ functions, which may lead to solving problems from infertility to degenerative diseases.
Article

Switching Off Aging in Stem Cells
A single molecular switch plays a central role in inducing stem cells in the brain, pancreas, and blood to lose function as they age, researchers have found.
Article

Bio-Matrix Scientific Group Inc. to Unveil Stem Cell Extraction Devices
Bio-Matrix Scientific Group Inc. announced that it will unveil its new stem cell extraction kits at the American Association of Tissue Banks.
Article

Lost in the Labyrinth
Recent research decodes the instructions that tell cells how to become blood.
Article

Italians In Stem Cell Advances 
Two teams of Italian scientists have made important advances in stem cell research that could pave the way for new treatments for kidney and liver disease.
Article

Stem Cell and Myoblast Cotransplantation Improves Ventricular Function in Chagas Disease
Cellular transplantation is emerging as a promising strategy for the treatment of postinfarction ventricular dysfunction.
Article

Introgen Therapeutics and Gendux AB Announce Orphan Designation for ADVEXIN Therapy in European Union
Gendux was notified by the European Medicines Agency (EMEA) Committee for Orphan Medicinal Products that ADVEXIN(R) p53 therapy has received Orphan Medicinal Product Designation in Europe for the treatment of Li-Fraumeni Syndrome (LFS).
Article

Immunotherapy Shows Promise in Mild Heart Failure
Immune modulation therapy could benefit patients with mild heart failure, according to results of a large randomized, controlled trial.
Article

Regulatory Clearance for Start of Patient Recruitment in 120-patient Phase II Trial of TroVax in Patients With Late-Stage Breast Cancer
Oxford BioMedica announces that the Southwest Oncology Group has received regulatory clearance to commence a Phase II trial of Oxford BioMedica’s cancer immunotherapy, TroVax, in patients with late-stage breast cancer.
Article

Success of Gene Drug Trials Boosts Ark
Ark Therapeutics, maker of Cerepro has announced that it has successfully manufactured a batch of the medicine to commercial standards and its facilities have met European regulatory standards.
Article

Vet First Out of Gate in Canada to Use Stem Cells in Treating Horses
An Alberta veterinarian is pushing the boundaries of medicine, becoming the first doctor in Canada to use emerging stem-cell technology to treat five injured horses.
Article

Stem Cells Improve Child Brain Cancer Outcomes
A highly targeted treatment that relies on the patient’s own stem cells improves outcomes for children with brain tumors called medulloblastomas.
Article

Mother and Toddler Caught in Stem Cell Scam
A Sydney mother determined to find treatment for her brain-damaged son has become the unwitting victim of an apparent international stem cell scam.
Article

Stem Cell Firm Suspends Treatments
Advanced Cell Therapeutics has decided to temporarily suspend commercial treatments.
Article

Stem Cells Could be Next Generation of Sports Doping
For athletes, stem cells have much more than the potential to cure disease and save lives — they may be able to heal injuries, boost strength and endurance, and provide a lasting edge over the competition.
Article

 

ABSTRACTS, REVIEWS & SPECIAL REPORTS

Adipose-Derived Stem and Progenitor Cells as Fillers in Plastic and Reconstructive Surgery
Regenerative cell-based strategies such as those encompassing the use of stem cells hold tremendous promise for augmentation of the soft-tissue space. Preclinical studies and early clinical series show that adipose-derived stem cells offer the possibility of finally fulfilling the key principle of replacing like with like as an aesthetic filler, without the drawbacks of current technology.
Abstract

Policy

Australian Government Denies ‘Buying’ Stem Cell Report
John Howard has denied he released a controversial report on stem cell research to influence debate on the issue, as fresh criticism surfaced over the report’s independence.
Article

Business

AnorMED Board Recommends Shareholders Reject Hostile Genzyme Corporation (GENZ) Offer And Not Tender Shares
AnorMED Inc. announced that its Board of Directors, based on the recommendation of its Strategic Initiatives Committee, unanimously recommends that AnorMED shareholders reject and not tender their shares to the unsolicited offer by Genzyme Corporation to acquire all of the outstanding shares of AnorMED.
Article

Advanced Cell Technology, Geron Settle Flap Over Cloning Patents
The dispute involved certain nuclear transfer cloning patents and patent applications.
Article

International Accord Gives U.S. Firm Rights To Stem Cell Liver Cure
Stem Cell RegenCo and an international stem cell research group have entered into an exclusive joint venture giving liver damage patients a crucial alternative to a dangerous and uncertain liver transplant.
Article

Lentigen Corporation Announces Second Collaborative Research Agreement With The University of Pennsylvania
Under the terms of this agreement, Lentigen will be working with Carl H. June M.D., Professor, Department of Pathology and Laboratory Medicine of the University of Pennsylvania School of Medicine, to develop Lentigen’s lentiviral vector for clinical gene therapy research.
Article

Maisonneuve-Rosemont Hospital to Build Stem Cell Centre
Maisonneuve-Rosemont Hospital is continuing to expand its facilities, announcing it will build a $9.2-million stem-cell research and therapy centre by the fall of 2008.
Article

Tasco Holdings International Changes Name to Bio-Matrix Scientific Group Inc.
Tasco Holdings International Inc. has announced that effective Tuesday, September 5, 2006 the company will be known as Bio-Matrix Scientific Group Inc.
Article

CBER

FDA Fines American Red Cross $4.2 Million for Failure to Meet Established Blood Safety Laws
Link

Clinical Investigator Inspection List – Updated
Link

Licensed Products and Establishments List – Update
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Approved Biological NDA and ANDA Applications – Update
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Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research
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Annual Guidance Agenda
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Workshop – CGMP By the Sea – Slide Presentations
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All new CBER information can be reached from the What’s New page at WHAT’S New Page

Regulatory

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Identifiable
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Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements
Link

ISCT

For more information on the Somatic Cell Therapy Symposium, see www.celltherapysociety.org.

AABB-ISCT Cellular Therapy Audioconference Series
Link

European branch of the International Society for Cellular Therapy (ISCT-Europe) and German Society for Transfusion Medicine and Immunohematology (DGTI) Joint meeting “Regulatory Framework for Advanced Medicinal Products in Europe”
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Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Current Volume: Volume 8 Number 4 / August 2006

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.



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