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.


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.

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.

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.

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.

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.

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.

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.


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.


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.


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.

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.

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.

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.

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.

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.


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.

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


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

Fast Track Designation Request Performance

Approved Biological NDA and ANDA Applications – Update

Cleared Biological 510(k) Device Applications – Update

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

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)

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


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

AABB-ISCT Cellular Therapy Audioconference Series

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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