Volume 7.36 | Sep 18

Volume 7.36, September 18, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Frog Research Team Makes Diabetes Leap
Scottish scientists have made a breakthrough towards developing stem cell treatments for diabetes after carrying out research on an African frog.

Nanotechnology Propels Advances in Regenerative Medicine Research
The promise of regenerative medicine and the nanotechnology catapulting it into the forefront of chemistry are highlighted in two papers presented during the American Chemical Society’s 232nd national meeting.

Austrianova Validates Commercial Potential of its Proprietary Encapsulation Technology
Austrianova Biotechnology has successfully demonstrated the feasibility of encapsulating an insulin-producing cell line in cellulose sulphate on the basis of its proprietary encapsulation technology.

Team Creates Uncanny Cell Replicas for Treatment, Research
The rubbery replicas could be used for all sorts of cell types in laboratory research or medical treatments for repairing nerve damage.

Reconstructive Surgeon Aims For Rejection-free Limb Transplantation
Scientists are conducting research within this relatively unorthodox realm of surgery, investigating therapies that could potentially allow the body to accept donor tissue without the use of immunosuppressive medication.

Embryonic Stem Cell-derived Neuronal Progenitors Transplanted into Ischemic Brain Differentiate
Primate embryonic stem cell-derived neuronal progenitors transplanted into the ischemic mouse brain survive and differentiate.

BrainStorm Cell Therapeutics Enters Letter of Intent to Begin Preclinical Primate Studies of Stem Cell-Based Therapy for Parkinson’s Disease
Testing is to begin by year-end, with human clinical trials to follow as soon as possible.

Stolen Body Parts Sold to NHS
Potentially contaminated body parts allegedly stolen in the US may have been implanted into British patients, a government agency says.

Vet Biotechnology Launches Horse Umbilical Cord Stem Cell Storage Service
Animal health care company Vet Biotechnology reports that they have launched cutting edge technology in Australia with the collection of equine umbilical cord stem cells from the afterbirth of newborn thoroughbred foals.

Access to Science Enhanced by New NIH-ASH(TM) Agreement
The American Society of Hematology and the National Institutes of Health (NIH) have signed an agreement that creates a new option for nonprofit publishers to comply with the NIH’s Public Access Policy

MaxCyte to Present Poster at the 9th International Conference Dendritic Cells
MaxCyte, Inc., a clinical stage therapeutic company and pioneer in commercial scale, non-viral cell loading systems will present a poster abstract at the 9th International Conference Dendritic Cells in Edinburgh, UK.


Regenerative Medicine and the Developing World
As the field of regenerative medicine regroups after recent scandal, it is important that recent events do not overshadow the potential benefits of the field. These benefits include the opportunity to improve health care for the more than two-thirds of the world’s population who live in developing countries.


Australian Stem Cell Bill Introduced to Parliament
Proposed laws that would expand stem cell research in Australia have been introduced to federal parliament.

Australian Chief Scientist Backs Animal Egg Ban
The nation’s chief scientist says researchers should not be allowed to inject human genetic material into animal eggs – a process attacked by critics as leading to the creation of hybrid humans.

New Battle Lines Are Drawn Over Egg Donation
The issue of whether to pay women to be stem cell research donors has split feminists, causing some to align with Christian conservatives.

Missouri Science Centers to Launch Stem Cell Exhibits
The exhibits are meant to increase public understanding of an initiative that will be on Missouri’s November ballot. The exhibits will answer the question of what stem cells are, their sources, their use in research and their potential to provide lifesaving cures.

Controversy Over California Stem Cell Committee
There continues to be enormous controversy over the committee that oversees how all that money will be spent on the state’s stem-cell program, and who gets to sit on that committee.


Cobra to Support Novel Gene Therapy Trials
UK based Cobra Biomanufacturing Plc announced an agreement with the Italian Telethon Foundation to manufacture plasmids for two innovative gene therapy trials.

Stem Cell Innovations Signs Material Transfer Agreement to Supply PluriCells(TM) to Stanford University Researchers
Under the agreement, investigators at Stanford may receive the cells for use in their laboratories.

WiCell Research Institute and Advanced Cell Technology Offer to Distribute New Stem Cell Lines to U.S. Researchers
The stem cell lines would be produced using a recently announced technique in the peer-reviewed journal Nature, provided that the United States federal government recognizes these new lines and funds research utilizing them.

Healtheuniverse Signs Clinical Research and Marketing Agreement With The California Institute of Cosmetic and Reconstructive Surgery for Fat Based Stem Cell Technology and Products
The agreement provides for CICRS to conduct clinical trials in the United States for fat based stem cell applications in the areas of cosmetic, plastic, and reconstructive surgery. CICRS grants Healtheuniverse patent, technology, IP, and licensing rights to market and sell products developed by these clinical trials, if they are approved for marketing.

Medistem Laboratories Files Patent Application for Cardiac Valve Therapy
Medistem’s patent application says the novel invention relates to using modified stem cells, to substantially ameliorate, and in some cases induce a therapeutic benefit, to a patient suffering from a dysfunction of the mitral, aortic, tricuspid, or pulmonary valve.

WARF Expects Review of Stem Cell Patents
While a decision by the United States Patent and Trademark Office might not come for another month, the Wisconsin Alumni Research Foundation expects the office to review its controversial stem cell patents.


NIH Offers $35,000 in Annual Student Loan Repayment
The five Loan Repayment Programs (LRPs) offered by the NIH include the Clinical Research LRP, Clinical Research LRP for Individuals from Disadvantaged Backgrounds, Contraception and Infertility Research LRP, Health Disparities Research LRP, and Pediatric Research LRP.

OLAW Guidance on PHS Policy on Humane Care and Use of Laboratory Animals Provided in Frequently Asked Questions (NOT-OD-06-101)

Clarification of a Change in eSubmission Instructions for R21/R33 Phased Innovation Applications in Response to RFA-CA-07-019 and RFA-CA-07-024 (NOT-CA-06-038)

NIH/AHRQ Now Using Version 2 of SF424 (R&R) and Agency-Specific Electronic Forms For SBIR/STTR, Conferences/Scientific Meetings, and Other Specific Funding Opportunities (NOT-OD-06-103)


2006 Biological Approvals 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 Issues Guidance to Tissue Establishments
The Food and Drug Administration (FDA) is reminding companies that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) that they must comply with FDA regulations. 

Red Cross Fined $4.2 Million Over Blood Safety
The U.S. government fined the American Red Cross $4.2 million for failing to ask blood donors proper screening questions and skipping other steps meant to keep the blood supply safe.

Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Direct Final Rule; Withdrawal


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
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T 604-484-2851
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