Volume 7.33 | Aug 28

Volume 7.33, August 28, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Make Stem Cells Without Harming Embryos: By using single cells plucked from human embryos, scientists have grown human embryonic stem cells, which can turn into any other kind of cell in the body, while leaving the original embryo intact.


Researchers Enhance Safety And Effectiveness Of Therapeutic Virus That Fights Cancer
Mayo Clinic researchers working with colleagues in Germany have devised a much-needed multilevel safety feature for viruses used to treat cancer.

Gene Silencer Helps Shut Down Ovarian Cancer
Tiny fatty spheres (liposomes) loaded with genetic material called “short interfering RNA” (siRNA) were able to penetrate deeply into ovarian tumor cells and silence a targeted protein (FAK).

Mouse Mimics Chronic Leukemia, Will Aid Drug Development
A study by cancer researchers here reveals that a new strain of mice offers the first real animal model for an incurable form of chronic leukemia and should greatly aid the development of new drugs for the disease.

UC Davis Researchers Move Biotechnology Closer to Replacing Electronic Pacemakers
UC Davis researchers have successfully used a custom designed protein and gene delivery system to restore normal heart rhythms in pigs with electronic pacemakers, reducing their dependence on implanted devices.

Living Cell Technologies Lodges Application for Clinical Trial of its Type 1 Diabetes Treatment
Living Cell Technologies Ltd has announced that it has lodged an application with the  New Zealand regulator MedSafe to conduct a Phase I/IIa clinical trial of its type 1 diabetes cell therapy product DiabeCell(R).

Doctors Test Ways to Grow Knee Cartilage
Doctors are testing new ways to spur cartilage to regrow in damaged knees, from implanted “cartilage plugs” to injections of bone-marrow stem cells.

Further Positive Phase II Results of Trinam Gene Therapy
Ark Therapeutics Group plc has announced further positive results from a Phase II trial of Trinam(R), its novel gene therapy to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery.

Dendreon Submits Clinical and Non-Clinical Sections of Rolling BLA to FDA for PROVENGE to Treat Advanced Prostate Cancer Patients
Dendreon Corporation has announced that the Company has submitted the clinical and non-clinical sections of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for PROVENGE® (sipuleucel-T) for the treatment of asymptomatic patients with metastatic, androgen-independent prostate cancer.

Human Tissue Products Recalled in U.S.
The tissue products, which were retrieved from corpses, were supplied by Donor Referral Services, a body parts broker in Raleigh, N.C., which launched the recall.


Human Embryonic Stem Cell Lines Derived from Single Blastomeres
In this study, the researchers report a series of ten separate experiments demonstrating that hES cells can be derived from single blastomeres.


California Stem Cell Bill Put on Hold
The bill would have created a ballot measure asking voters to require more grant-makers to disclose their financial interests before awarding stem cell research funding.

Stem Cell Group Asks for First Grant Proposals
The California Institute for Regenerative Medicine asked Tuesday for proposals under two new research grant programs.

Australian Cloning Bill Bid Hits ‘Yuk Factor’
A push to legalise therapeutic cloning hit a hurdle last night as parliamentarians disagreed about the details of a planned private member’s bill.

Stem Cell Scientists in Iran Less Restricted Than Those in U.S.
In the cutting-edge field of human embryonic stem-cell research, the scientists work with a freedom that US researchers can only dream of: broad government approval, including government funding, to work on the potent cells from early-stage embryos that researchers believe hold the promise to cure many diseases.


ACell, Inc. Wins Court Battle Initiated By Cook Biotech and Purdue
The victory frees ACell to broadly promote the development, licensing and commercialization of its remarkable tissue graft biotechnology.

ThermoGenesis Signs Product Development and Supply Assurance Agreement With Cord Blood Registry(TM)
ThermoGenesis Corp. notes that GE Healthcare (GEHC) and Cord Blood Registry (CBR) have announced a multi-year contract to supply CBR with ThermoGenesis’ AutoXpress(TM) cord blood processing system and disposables.

PrimeCell(TM) Therapeutics Partners with Regeneration Technologies, Inc. to Co-Develop Stem Cell Product for Orthopedic Applications
PrimeCell(TM) Therapeutics LLC has announced an agreement with Regeneration Technologies, Inc. (RTI), the Florida-based processor of orthopedic, cardiovascular and other biologic implants, to pursue orthopedic applications using PrimeCell(TM) Therapeutics’ germ cell reprogramming technology.

Pluristem Receives Grant To Develop Stem Cell Product
Pluristem Life Systems, Inc. announces that its fully owned subsidiary Pluristem Ltd received a $470,000 grant from Israel’s Chief Scientist Office (CSO).

Southern Illinois University Carbondale to Set Up Stem Cell Research Facility
Seven state public universities, including Southern Illinois University Carbondale’s School of Medicine, will share $5 million to begin or continue stem cell research.

University of Colorado Lands $6 Million Gift for Stem Cell Research
A $6 million gift from the Gates family will pay for a new stem cell research program at the University of Colorado School of Medicine in Denver.


Clarification Of Eligibility For Mid-Career Investigator Award In Patient-Oriented Research (K24) (NOT-OD-06-095)

NIH Announces Requirement for Detailed (Non-Modular) Budget Submissions for All Competing Grant Applications from Foreign (Non-U.S.) Institutions (NOT-OD-06-096)

Institutional Clinical and Translational Science Award (U54) (RFA-RM-07-002)

Innovations in Biomedical Computational Science and Technology Initiative (STTR [R41/R42]) (PAR-06-534)

Innovations in Biomedical Computational Science and Technology Initiative (SBIR [R43/R44]) (PAR-06-535)


2006 Biological Approvals – Update

FDA Orders Human Tissue Firm to Shut Down

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)

Notice of Public Workshop: Molecular Methods in Immunohematology


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

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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