Volume 7.15 | Apr 24

Volume 7.15, April 24, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

ISCT Announces 6th Annual Somatic Cell Therapy Symposium: The annual Somatic Cell Therapy Symposium is a forum provided to engage FDA and industry in an ongoing dialogue regarding the regulatory issues pertaining to somatic and other cell therapies.


How Embryonic Stem Cells Maintain Their Identity
Two studies in the April 2006 Cell report new details of the “genetic program” that affords embryonic stem cells the flexibility to give rise to any cell type in the body.

Cytori Therapeutics Demonstrates Adipose Stem and Regenerative Cells Reduce Incidence of Arrhythmia after Heart Attacks in Preclinical Study
Cytori Therapeutics, Inc. announced preclinical data demonstrating that adipose stem and regenerative cell-based therapy following a heart attack in pigs is not associated with an increased risk of irregular heart rhythms.

Thailand to Begin Stemcell Heart Study
Thai scientists are set to begin the country’s first official study into the effects of stem cell technology in curing heart disease.

Cell Discovery on Breast Cancer
Australian researchers have discovered how pre-cancerous cells evade early detection and develop unhindered into breast cancer tumours — a finding that could lead to a new treatment for the disease.

Primitive Adult Stem Cells Found in Peripheral Blood
Moraga Biotechnology Corporation, an adult stem cell company based in Los Angeles, California, announces the discovery of its proprietary Blastomere-Like Stem Cells (BLSCs) circulating in the peripheral blood of mammals.

Stem Cell Study for Patients with Heart Attack Damage Seeks to Regenerate Heart Muscle
Rush cardiologists are hoping that transplanted stem cells can regenerate damaged heart muscle in those who experience a first heart attack.

Gene Therapy May Help Child With Rare Disease
A 2-year-old boy in Colorado battling a Canavan’s Disease may get help from artificial gene therapy.

Clinical Safety and Feasibility Study Initiated Using Adipose Stem and Regenerative Cells in Breast Reconstruction Procedures
Cytori Therapeutics, Inc. announced today approval to begin an investigator-initiated safety and feasibility study in Japan using adult adipose (fat) derived stem and regenerative cells for breast reconstruction.

Disgraced South Korean Stem Cell Scientist Appeals Dismissal from University
South Korea’s disgraced cloning scientist Hwang Woo-suk has appealed to the Education Ministry to overturn his dismissal from a top university over fraudulent stem cell research.

China’s First Face Transplant Carried Out On A Man
A spokesman at the Xijing Military Hospital, Xian, China, announced that it has carried out the country’s first face transplant on a man whose face had been disfigured by a bear attack.


Control of Developmental Regulators by Polycomb in Human Embryonic Stem Cells
The results indicate that PRC2 occupies a special set of developmental genes in ES cells that must be repressed to maintain pluripotency and that are poised for activation during ES cell differentiation.

A Bivalent Chromatin Structure Marks Key Developmental Genes in Embryonic Stem Cells
The results highlight the importance of DNA sequence in defining the initial epigenetic landscape and suggest a novel chromatin-based mechanism for maintaining pluripotency.


Push for Stem Cell Funds Stalling on Capitol Hill
Eight months after Congress seemed on the verge of extending federal support to more types of stem cell research over the objections of President Bush, the bill’s prospects are growing dim, with a crowded calendar and a changing political landscape threatening to push the issue off of the agenda until after this fall’s congressional elections.

Embryo Cloning Dispute Heats Up
Bureaucrats are attempting to overturn cabinet opposition to cloning for therapeutic purposes despite a desire among senior ministers to retain a ban on the practice.

Judge Says California Stem Cell Agency Legal
California’s novel, $3 billion stem cell research institute is a legitimate state agency, and two lawsuits challenging its constitutionality have no merit, a state judge ruled Friday.

Should We Put Human Cells in Animal Embryos?
Many people may be repulsed by the idea of scientists creating chimeras, or human-animal hybrids, but a better understanding of the research could lead to greater acceptance.


Chemicon International and Australian Stem Cell Centre Announce Exclusive Agreement to Commercialize Stem Cell Products
Serologicals Corporation and the Australian Stem Cell Centre (ASCC) announced today that they have signed an agreement whereby Chemicon International, Inc., Serologicals’ wholly-owned subsidiary, has obtained exclusive rights to commercialize, market and distribute stem cell reagents developed at the ASCC to scientists all over the world.

Ortec Completes Merger With Hapto Biotech
Ortec International, Inc., a company focused on development and commercialization of tissue-engineered therapeutic products, today announced that all the requirements necessary to effectuate the merger of Hapto Biotech, Inc. with Ortec and allow for the release of the proceeds of its recently completed $6.1 million financing from escrow have been completed.

ReNeuron and Chemicon Enter Into Agreement for Exclusive Sale and Marketing of ReNcell Neural Stem Cell Lines
ReNeuron Group announced that it has signed an agreement with Chemicon International, Inc., a subsidiary of Serologicals Corporation, whereby Chemicon will exclusively manufacture and distribute two of ReNeuron’s patented ReNcell neural stem cell lines worldwide for research purposes.

ReNeuron Enters into Cell Supply Agreement with StemCells, Inc.
ReNeuron Group today announces that it has entered into a further agreement with StemCells, Inc., a leading US, NASDAQ-quoted adult stem cell development company.

Advanced Cell Technology Announces Completion of Its First GMP Laboratory
Advanced Cell Technology, Inc. announced that it is in the final phase of validating its first Good Manufacturing Practices (“GMP”) laboratory in its facility in Worcester, Massachusetts.

Nature to Publish ASGT Molecular Therapy
The American Society of Gene Therapy and Nature Publishing Group announce a new publishing partnership



NIH Clinical Trial Planning Grant Program (R34)


Guidance for Industry: Providing Regulatory Submissions in Electronic Format–Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications


Food and Drug Administration (United States of America)

MicroArray Quality Control Project on the Evaluation of Analysis Protocols for Deoxyribonucleic Acid Microarray Data


ISCT2006. May 4-7. Berlin, Germany.
Visit http://www.celltherapysociety.org.

AABB-ISCT Cellular Therapy Audioconference Series

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