Volume 7.39 | Oct 9

Volume 7.39, October 9, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Cloning Without Stem Cells Works: New research dismisses the notion that adult stem cells are necessary for successful animal cloning, proving instead that cells that have completely evolved to a specific type not only can be used for cloning purposes, but they may be a better and more efficient starting point.
Article

Science

Researchers Identify a Key Regulator for Skin Stem Cells
By turning on a single gene, researchers can prevent skin stem cells from maturing into the three types of adult skin cells — epidermal, sebaceous and hair cells.
Article

Researchers Find Breast Cancer Stem Cells in Marrow
Discovery of breast cancer stem cells in bone marrow may mean greater risk for cancer patients than previously thought.
Article

Stem Cell Technique To Arrest Urinary Incontinence
The University Hospital of Navarra is to carry out clinical trials for urinary incontinence using the intraurethral injection of myoblasts.
Article

Stem Cell-Coated Stent Could Extend Lives
A pioneering stem cell treatment being developed in Yorkshire could see a massive increase in the number of heart patients living longer.
Article

Cytori Therapeutics Achieves 510(k) Clearance for the Celution(TM) System
Cytori Therapeutics, Inc. was awarded 510(k) clearance from the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) for the Celution(TM) Cell Concentration System as a cell saver device.
Article

Generex Biotechnology Publishes Studies Demonstrating Anti-Tumor Potential of Immunotherapeutic Vaccine
Generex Biotechnology Corporation announced publication of studies demonstrating specific anti-tumor activity of its novel Ii-Key/HER-2/neu immunotherapeutic vaccine.
Article

Prima Biomed Prepares for Next CVac(TM) Ovarian Cancer Clinical Trial with Cell Manufacturing Scale-up
Prima in collaboration with its contract manufacturer, Cell Therapies Pty Ltd, has completed a Process Development study that improves and scales-up CVac(TM) manufacturing.
Article

ABSTRACTS, REVIEWS & SPECIAL REPORTS

Differentiated Cells Are More Efficient than Adult Stem Cells for Cloning by Somatic Cell Nuclear Transfer
The researchers tested whether SCNT-derived animal clones could be derived from truly differentiated somatic cells and found that cloning efficiency increases over the differentiation hierarchy, and terminally differentiated postmitotic granulocytes yield cloned pups with the greatest cloning efficiency.
Article

Policy

California Unveils $3 Billion Stem Cell Research Plan
California’s proposed plan for spending $3 billion on stem cell research includes creating a state-wide stem cell bank and other facilities that scientists can share, as well as funding the study of human egg and embryo development, tissue engineering and inter-disciplinary teams of scientists.
Article

Business

Medical College to Build $6M Transplant Database
The Center for International Blood and Marrow Transplant Research at the Medical College of Wisconsin has won a contract worth $6,180,029 to collect and analyze standardized data on the outcomes of blood stem cell transplants that use cells from bone marrow or cord blood.
Article

Oxford Biomedica Expands Its Ocular Programme Through Collaboration and Investment Led by the Foundation Fighting Blindness
Oxford BioMedica and The Foundation Fighting Blindness (FFB) through its translational research arm National Neurovision Research Institute (NNRI) announced that they have signed a research and collaboration agreement to develop a portfolio of gene therapy products for the treatment of eye diseases.
Article

Stem Cell Innovations and Twente University to Evaluate Bone Forming Capacity of PluriCells(TM)
Under the material transfer agreement, the University of Twente will get access to Stem Cell Innovations (SCI) proprietary human pluripotent stem cell technology and know-how. In return SCI will receive a nonexclusive license to intellectual property generated with the PluriCells.
Article

Epeius Biotechnologies Corporation Gains Federal Support For Landmark Clinical Trials Of Tumor-Targeted Gene Therapy Using Rexin-G(TM) For Metastatic Cancer
Epeius Biotechnologies Corporation announced that it received a prestigious R01 grant from the United States Food and Drug Administration (U.S. FDA) to assist in the evaluation of a Phase I/II clinical trial using Rexin-G(TM) for advanced or metastatic pancreatic cancer.
Article

Federal Agency to Re-examine U.S. Stem Cell Patents
The U.S. Patent and Trademark Office will re-examine patents covering embryonic stem cell discoveries made by University of Wisconsin researchers.
Article

BioLife Solutions Forms Scientific Advisory Board
BioLife Solutions Inc. announced it has formed a Scientific Advisory Board to be comprised of leading researchers, scientists and consultants to help guide and counsel the Company as it develops products for its core markets including biotechnology, cellular therapy, tissue engineering, and organ transplantation.
Article

NIH

NIH Launches National Consortium to Transform Clinical Research
The National Institutes of Health (NIH) Director has announced the launch of a national consortium that will transform how clinical and translational research is conducted, ultimately enabling researchers to provide new treatments more efficiently and quickly to patients.
Article

Non-Competing Grant Awards Under the Current Continuing Resolution (NOT-OD-07-004)
Link

CBER

Guidance for Industry: Bar Code Label Requirements – Questions and Answers
Link

Fast Track Designation Request Performance
Link

Approved Biological NDA and ANDA Applications – Update
Link

Cleared Biological 510(k) Device Applications – Update
Link

FDA/NCI Workshop: Bringing Therapeutic Cancer Vaccines and Immunotherapies Through Development to Licensure
Link

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

Regulatory

Food and Drug Administration (United States of America)

Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; Availability
Link

ISCT

International Society for Cellular Therapy – http://www.celltherapysociety.org

AABB-ISCT Cellular Therapy Audioconference Series
Link

Profiled Journal

Editor-in-Chief:
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]
www.apheresis.org

Please visit the website for all you need to know about publishing in or subscribing to the Journal of Clinical Apheresis:
http://www.interscience.wiley.com/journal/jca



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