Volume 7.30 | Aug 7

Volume 7.30, August 7, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

California Stem Cell Institute Set to Solicit Grant Requests: Running with the $150 million loan it just got from Gov. Arnold Schwarzenegger, the board overseeing California’s $3 billion stem-cell institute said Wednesday it will begin soliciting its first research proposals within weeks.


Researchers Use Robotic Surgery To Deliver Cardiac Stem Cell Therapy
Using stem cells and robotic surgical techniques, a team of university researchers has improved the function of pig hearts damaged in a way similar to what happens when a person has a heart attack.

Plans Under Way to Apply Stem Cell Therapy in Thailand
The Prasat Neurological Institute revealed yesterday it is planning to conduct clinical trials of stem-cell therapy to treat three major neural diseases for the first time in the country.

UK Doctors Use Stem Cells to Help Mend Broken Bones
A new way of promoting healing when fractured bones refuse to mend, has been pioneered at a British hospital, saving patients permanent disability or amputation.

Discovery in ‘Bubble Boy’ Disease Gene Therapy
Scientists at St. Jude Children’s Research Hospital have developed a mouse model of a severe disease of the immune system that helps explain why gene therapy used to treat children with this disease at an institution in Europe caused some of them to develop leukemia.

Medical University of South Carolina Researchers Test Possibility of Growing Kidneys for Transplant
Bioengineers from the Medical University of South Carolina and Clemson University believe their research has the potential to save the lives of thousands of patients desperately waiting for a kidney while, at the same time, cutting costs associated with kidney disease.

Malignant Melanoma Cells Secrete Protein Required for Embryo Formation
A Northwestern University research group has discovered that aggressive melanoma cells secrete Nodal, a protein that is critical to proper embryo formation.

Sunnybrook Researchers Identify Which Sets of Molecules are Required to Induce T Cells
Researchers at Sunnybrook Health Sciences Centre have made a critical discovery in T cell development bringing immunologists one step closer to enabling the creation of tailored T cell therapy that could one day be used to treat patients with AIDS or other immune system deficiencies.

Mapping System Tells Skin Cells Whether To Become Scalp, Palm Tissues
Global-positioning system aficionados know that it’s possible to precisely define any location in the world with just three geographic coordinates: latitude, longitude and altitude. Now scientists at the Stanford University School of Medicine have discovered that specialized skin cells use a similar mapping system to identify where they belong in the body and how to act once they arrive.

Biovest International Receives Positive Opinion on Application for Orphan Medicinal Product Designation by European Agency
Biovest International, Inc. has received official notification from the Committee on Orphan Medical Products (COMP) of the European Medicines Agency that a positive opinion was made regarding the application for orphan medicinal product designation for BiovaxID(TM) the company’s autologous immunotherapy for the treatment of follicular lymphoma in the European Union (EU).

Ortec’s FDA Approved Cell Line Plays Pivotal Role in Creation of First Embryonic Stem Cell Lines Fit for Human Clinical Trials
Ortec International, Inc. announced today that their collaboration with ES Cell International Pte, Ltd. (ESI), established in April 2004 in connection with the development of ESI’s human embryonic stem cell (hESC) derived cell therapy products, has yielded its first significant milestone.

Jury is Still Out on Worth of Stem Cell Treatment
Many thoroughbreds are being treated with stem cell treatment, but there is still speculation as to whether it is a wonder cure.


T Lineage Differentiation from Human Embryonic Stem Cells
Using sequential in vitro coculture on murine bone marrow stromal cells, and engraftment into human thymic tissues in immunodeficient mice, the researchers demonstrate that hESC can differentiate through the T lymphoid lineage.

Unique Risk Factors for Insertional Mutagenesis in a Mouse Model of XSCID Gene Therapy
The researchers have developed a model that should be useful for testing safety-modified vectors and for further exploring the risk factors leading to insertional mutagenesis in gene therapy trials.


Americans Dissatisfied with Stem Cell Veto
Many adults in the United States disagree with their president’s decision to reject the Stem Cell Research Enhancement Act of 2005, according to a poll by Gallup released by USA Today. 58 per cent of respondents disapprove of George W. Bush’s decision.

U.K. Seeks Link with California’s Stem Cell Research
Britain is seeking to promote links between stem cell researchers in Britain and California, two leaders in the field, during a visit to the state this week by British Prime Minister Tony Blair.

Hatch Pledges $100 Million State Money for Stem Cell Research
Attorney General Mike Hatch said Sunday that he will propose spending $100 million of state money over 10 years on embryonic stem cell research, if he is elected governor.

Maryland Board Discusses Funding Strategies
The newly formed Maryland Stem Cell Research Commission, which will allocate state funds for public and private projects, held its first meeting recently and agreed to stay away from political debate on the merits of embryonic versus adult stem cells.

Stem Cell Debate Hushed
Senior stem cell researchers fear Prime Minister John Howard has given in to conservative sentiment and will sideline debate on the nation’s embryo research and cloning legislation.

Group Wants Vote on Stem Cells
A coalition of patients and researchers have joined a Liberal backbencher’s call for the Government to trigger a conscience vote on the future of therapeutic cloning in Australia.

Doctors Paid up to $5,000 to Recruit Human Guinea Pigs
If your doctor suggests you’re the perfect candidate for some clinical trial, you might ask how much he’s getting paid to recruit you.


DomaniCell Opens First Hospital-based Family Cord Blood Banking Program
Hackensack University Medical Center launches DomaniCell cord blood banking program.

Invitrogen Licenses Geron IP for Development of Research Tools
Invitrogen Corporation and Geron Corporation announced that Invitrogen has licensed Geron intellectual property (IP) related to the growth of human embryonic stem cells (hESCs).

Dendreon Completes Construction of New Jersey Manufacturing Facility
This state-of-the art facility has the capacity to support clinical processes and future anticipated commercial needs for PROVENGE(R) (sipuleucel-T), the Company’s investigational active cellular immunotherapy for advanced prostate cancer.

Tasco’s Bio-Matrix Scientific Unit Installs New, Cutting-Edge Stem Cell Technology in Preparation for Anticipated September 2006 Grand Opening of Its Stem Cell Cryogenic Banking and Processing Facility
Tasco Holdings International’s wholly-owned subsidiary Bio-Matrix Scientific Group, Inc. has announced that it has received and installed a CBS Isothermal liquid nitrogen vapor storage tank and a K Series cryo-storage tank for stem cell storage.

New Stem Cell Research Grants Announced
The Tri-Institutional Stem Cell Initiative, comprised of three leading New York City biomedical research institutions — Memorial Sloan-Kettering Cancer Center, The Rockefeller University, and Weill Medical College of Cornell University — has announced the first wave of stem cell research projects to be funded through a $50 million gift from The Starr Foundation.

Grant Support for Cancer Immunotherapy Programmes
Oxford BioMedica had been awarded a grant of more than £900,000 to support its immunotherapy programme

Gary L. Mossman, Executive Vice President & Chief Operating Officer of Cambrex Corporation, Announces Retirement
Cambrex Corporation announces that Gary L. Mossman, Executive Vice President, Chief Operating Officer and President Cambrex Pharma, will retire effective August 31, 2006.

Foundation’s Stem Cell Patents Impede Research, Scientists Say
The University of Wisconsin Alumni Research Foundation, generally known as WARF, holds three broad patents that essentially give it control of embryonic stem cells used in the United States.


Request for Information (RFI): Proposed Change in Grant Appendix Materials (NOT-OD-06-088)

Notice of New NIH Policy for Funding of Tuition, Fees, and Health Insurance on Ruth L. Kirschstein National Research Service Awards (NOT-OD-06-090)

Muscular Dystrophy: Pathogenesis and Therapies (R21) (PA-06-508)

Enabling Technologies for Tissue Engineering and Regenerative Medicine (R01) (PAR-06-504)

Specialized Programs of Research Excellence (SPOREs) in Human Cancer for the Year 2007 (P50) (PAR-06-505)

National Cancer Institute (NCI) Cancer Education and Career Development Program (R25) (PAR-06-511)


Licensed Products and Establishments List – Update

Approved Biological NDA and ANDA Applications – Update

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update


Food and Drug Administration (United States of America)

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment

FDA Revamps its Approach to Clinical Trials Monitoring
The US Food and Drug Administration (FDA) has announced a series of new policy and regulatory developments to modernise the way it monitors clinical trials and bioresearch.

Medsafe (New Zealand)

Introducing a Streamlined Process for Evaluating New Zealand Products that are Identical to Those Approved in Australia

Australia New Zealand Therapeutic Products Authority (Australia and New Zealand)

Consultation on the Proposed Joint Regulatory Scheme Under the Australia New Zealand Therapeutic Products Authority (ANZTPA)
Submissions are being welcomed on the proposed regulatory scheme or “draft Rules” for medicines and medical devices; a description of the proposed Grouping Order for medicines; draft guidelines on transition provisions for product licensing; the key components of the draft Administration Rule; and the consultation document on the proposed fees and charges.


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.

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