Volume 7.34 | Sep 4

Volume 7.34, September 4, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Gene Therapy Found Effective Against Terminal Cancer: Scientists for the first time have genetically modified tumor-fighting immune cells, allowing patients to rid themselves of an aggressive form of cancer.


Embryonic War
Scientists and ethicists put the latest stem-cell ‘breakthrough’ under the microscope.

Backtracking On Stem Cell Advance
The California biotech company that grabbed headlines last week for sparing human embryos while creating stem cells in fact destroyed all 16 embryos used in the experiments.

Adult Stem Cells Are Touchy-Feely, Need Environmental Clues for Change
Researchers have discovered that mesenchymal stem cells, which regularly reside in the bone marrow as part of the bodys natural regenerative mechanism, depend on physical clues from their local environment in order to transform into different types of tissue.

Decision-Making Circuitry of Blood Stem Cells Mapped
Experimental work has led to the first mathematical model of a regulatory circuit that blood-forming stem cells use to decide what kind of white blood cell they will become. The model explains the puzzling behavior of differentiating stem cells, in which they simultaneously assume genetic signatures of different cell types before committing to one identity.

Rats Born to Mice in Bizarre Lab Work
Scientists have generated rats from mice that developed rat sperm.

A Switch Between Life and Death
Researchers have discovered how a signal tells cells whether to grow or die. This is important as growth needs to be controlled or the result may be defects in embryonic development or cancer in adults.

Northwest Biotherapeutics Updates Brain Cancer Clinical Data
63% of patients are still alive after more than two years, compared with 26% receiving standard treatments.

Players Storing Children’s Stem Cells as “Repair Kit”
Some leading English soccer players are storing stem cells from their newborn babies as a potential future treatment for their own career-threatening sports injuries.

Stem Cell Treatment Warning
A company operating out of South Africa is charging tens of thousands of pounds for stem cell treatments, using cells that should not be injected into people, putting the lives of their vulnerable and chronically ill patients at risk.

Study Finds How Organs Monitor Themselves During Early Development
A discovery involving a feedback loop governing ovarian development could lead to treatments of many disorders and could show how the power of stem cells could be harnessed for organ regeneration.


Cancer Regression in Patients After Transfer of Genetically Engineered Lymphocytes
Using a retrovirus encoding a T cell receptor, the researchers here report the ability to specifically confer tumor recognition by autologous lymphocytes from peripheral blood.


Internal Divisions Deepen Over Stem Cell Report
Divisions are deepening within the Australian Federal Government ranks over the issue of stem cell research after the release of a report which found the argument for therapeutic cloning has not advanced since 2002.

Massachusetts Rearchers Say New Stem Cell Rules May Thwart Scientists
The rules passed this week by the Public Health Council included language that critics said goes against the intent of a stem cell law passed last year whose goal was to create a more hospitable environment in Massachusetts for research on human embryonic stem cells.


Wiley Partners With The International Society For Stem Cell Research
Global publisher John Wiley & Sons, Inc., and the International Society for Stem Cell Research (ISSCR) today announced they have signed a multi-year agreement to develop and publish Current Protocols in Stem Cell Biology.

Cook Biotech Resolves to Pursue Life Sciences Patent Infringement Case Against ACell Inc.
The U.S. Court of Appeals for the Federal Circuit recently overturned the verdict reached by a jury in the Federal Court for the Northern District of Indiana concerning biomaterials derived from bladder tissue for use as medical products.

Stem Cell Institute Reinstates Key Research Provision After Compromise
A California stem cell institute committee has reinstated regulations allowing a scientist at a university or non-profit institution to experiment with patented inventions and preventing universities from using patents to impede vital research.

AnorMED Rejects Unsolicited Approach from Genzyme
AnorMed considers the Genzyme proposal undervalued.

StemCells, Inc. Grants License to Stem Cell Therapeutics
StemCells, Inc. has announced that it has entered into a license agreement with Stem Cell Therapeutics Corp., a Canadian biotechnology company engaged in treating certain central nervous system (CNS) disorders by stimulating endogenous neural stem cells.

Cellartis and NovaThera Collaborate to Develop Stem Cell Applications
Cellartis AB and NovaThera announce today further progress in developing platform technologies for regenerative medicine by forming a research partnership, utilizing the proprietary stem cell technology from Cellartis AB.

Olympus Increases Investment in Cytori Therapeutics
Expanded Partnership Leading to Accelerated Development of Regenerative Medicine Business Based on Adipose-Derived Stem and Regenerative Cells

ImmunoGen, Inc. Announces that sanofi-aventis has Extended the Term of its Research Collaboration with the Company
ImmunoGen now will receive committed research support funding from sanofi-aventis through August 31, 2008.

Stem Cell Sciences to Take Part in EU Funded Stem Cell Research Programme
Stem Cell Sciences is one of three commercial partners taking part in this Framework Programme (FP) VI initiative which is being led by the University of Sheffield.

University Nets £240,000 Boost for Stem Cell Work
Researchers at Edinburgh University have been awarded almost £240,000 to further their work in stem cell research.


Announcing 2007 NIH Regional Seminars in Program Funding and Grants Administration (NOT-OD-06-097)

Delays in Grant Application Submission due to Hurricane Ernesto (NOT-OD-06-098)

Cancer Education Grants Program (R25) (PAR-06-540)


FDA Forms Task Force on Human Tissue Safety
The Food and Drug Administration (FDA) today announced the formation of a multidisciplinary FDA task force on human cell and tissue safety.

Compliance Program Guidance Manual: 7342.001 – Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors

Compliance Program Guidance Manual: 7342.002 – Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors

FDA Public Health Notification: Donor Referral Services

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Proposed Rule

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update

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


Food and Drug Administration (United States of America)

FDA Re-evaluates Rules Allowing Research Without Patient Consent
U.S. health officials said on Tuesday they were re-evaluating rules that allow the testing of unapproved emergency treatments without patient consent, a practice that came under fire in recent studies of potential blood substitutes.

Annual Guidance Agenda

Medsafe (New Zealand)

Regulatory Consultants Update

Progress on Trans-Tasman Therapeutics Agency


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

AABB-ISCT Cellular Therapy Audioconference Series

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”

Profiled Journal

Robert Weinstein, MD
Chief, Hematology and Transfusion Medicine, Caritas St. Elizabeth’s Medical Center, Tufts University School of Medicine, Boston, MA

The Journal of Clinical Apheresis provides the world’s premier source of current information in the field of apheresis. The Journal presents work in all aspects of basic and clinical research, practical applications, emerging technologies and regulation in apheresis and related fields including hematology, nephrology, neurology, rheumatology, transplantation, cellular therapies, blood banking, transfusion medicine, and others.

A subscription to the journal is a key benefit of ASFA membership, which ranges from $120-145 annually. To become a member please contact:

ASFA Head Office
570 West 7th Ave, Suite 402
Vancouver, BC V5Z IB3, Canada
T 604-484-2851
F 604-874-4378
E [email protected]

Please visit the website for all you need to know about publishing in or subscribing to the Journal of Clinical Apheresis:

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