Volume 7.38 | Oct 2

Volume 7.38, October 2, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Clinical Trial Shows Islet Transplantation is a Promising Procedure For Certain Patients with Severe Type 1 Diabetes: The first international, multicenter trial of the Edmonton Protocol — a standardized approach to the transplantation of insulin-producing islets — demonstrates that this may be an appropriate therapy that can dramatically benefit certain patients with severe complications of Type 1 diabetes mellitus.


Stem Cell Researchers to Devise Treatments for Faster Bone Healing
Stem cell researchers in Singapore have linked up with a New Zealand company to devise treatments for faster healing of damaged bones, skin and organs.

Gene Transfer Using Mutant Form of Good Cholesterol Cuts Vascular Plaque and Inflammation
Transfer of a gene that produces a mutant form of good cholesterol provides significantly better anti-plaque and anti-inflammation benefits than therapy using the “normal” HDL gene.

Breast Cancer Vaccine Enters Clinical Development
Pevion Biotech announced the start of phase I clinical testing of its virosome-based breast cancer vaccine. The multivalent vaccine will be tested for its safety and immunogenicity in patients overexpressing the HER-2/neu oncoprotein.

Gene Therapy Study Takes Aim at Prostate Cancer
Researchers at Baylor College of Medicine are hoping a new gene therapy that takes a gene called RTVP-1 directly into the prostate tumor will prove effective in preventing recurrence of the disease.

FDA Issues Approvable Letter To Ortec International Inc. For Use Of Cryopreserved OrCel(R) In Epidermolysis Bullosa Patients’ Hand Reconstructions And Donor Sites
Ortec International, Inc. , a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, has been notified by the Food and Drug Administration (FDA) that its HDE Supplement is approvable subject to an inspection by the FDA of its commercial manufacturing facility

Chinese Cancer Therapy Drawing Foreign Patients
A revolutionary anti-tumour drug in China is attracting terminally ill cancer patients from around the world, including Canada.

Jumping Gene Could Provide Non-viral Alternative for Gene Therapy
A jumping gene first identified in a cabbage-eating moth may one day provide a safer, target-specific alternative to viruses for gene therapy, researchers say.


Bit Player or Powerhouse? China and Stem-Cell Research
It seems China’s position in stem-cell science is similar to its position in other spheres. It is an up-and-coming player — a player with global ambitions, a burgeoning pool of talent, and specific assets that derive from its sheer size.

Scientific and Ethical Roadblocks to Human Embryonic Stem Cell Therapy
This review discusses roadblocks on the way to using embryonic stem cells for treating human disease and injury.



Australian Bill Would Allow Therapeutic Cloning Before 2007
A ban on therapeutic cloning could be overturned before the end of the year after a Government backbencher introduced legislation paving the way for a conscience vote on the issue.

Governor Signs Ortiz-Runner Bill to Protect Women Who Donate Eggs for Stem Cell Research
Legislation by Senator Deborah Ortiz (D-Sacramento) and Senator George Runner (R-Antelope Valley) to protect women who donate eggs for stem cell research was signed yesterday by the governor.


Progenitor Cell Therapy Hosts UK Trade Mission
UK Department of Trade and Industry visits Progenitor Cell Therapy in tour of leading U.S. cell and tissue therapy companies.

Wisconsin to Offer Access to Embryonic Stem Cell Lines
Access to Wisconsin’s bank of embryonic stem cell lines will be offered for free on a nonexclusive license basis to companies that carry out their research at state nonprofit and academic institutions.

Asklepios Biopharmaceutical and GlaxoSmithKline Ink Gene Therapy Agreement
Asklepios Biopharmaceutical entered into a cross license agreement with GlaxoSmithKline to develop and commercialize gene therapy-based treatments.

Cancer Stem Cell Research Program Launched By Rochester
The promise of cancer stem cell research has reached a critical point and the University of Rochester Medical Center is establishing itself as a leader in the field by creating a Cancer Stem Cell Research Program.

£2m Centre to Boost Stem Cell Research
A £2m project – hailed as the first in Europe – has been launched in Scotland to help find treatments for diseases like diabetes and leukaemia.

Stem Cell Research Facility Plan Advances
The University of Connecticut Board of Trustees Tuesday authorized the UConn Health Center’s finance committee to enter into negotiations to purchase a facility to use for stem cell research.

Geneva Joins Race for Stem Cell Breakthrough
Scientists in Geneva are aiming to produce the world’s first “clean” line of stem cells for use in the treatment of degenerative diseases such as Parkinson’s.


Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

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)bvbvbvbn

Food and Drug Administration-Regulated Products Containing Nanotechnology Materials; Public Meeting

Guidances on Providing Regulatory Submissions in Electronic Format; Withdrawal of Guidances

Quality Systems Approach to Pharmaceutical CGMP Regulations


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

AABB-ISCT Cellular Therapy Audioconference Series

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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