Volume 7.42 | Oct 30

Volume 7.42, October 30, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem Cell Injections Could Produce Brain Tumors: A study by U.S. researchers suggests injecting embryonic stem cells into the brains of Parkinson’s disease patients could cause tumors. The scientists said their research with rats showed such injections clearly reduced the symptoms, but some of the cells began growing in a way that could lead to tumors.
Article

Science

Stretching Bone Marrow Stem Cells Pushes Them Towards Becoming Blood Vessels
When stretched, a type of adult stem cell taken from bone marrow can be nudged towards becoming the type of tissue found in blood vessels.
Article

Human Virus Turns Fat Stem Cells Into Pre-fat Cells and Onto Fatter Fat Cells
Key scientific findings recently released show a human virus targets fat stem cells to cause formation of more, fatter, fat cells. This finding may lead to new insights into the study of obesity.
Article

Alzheimer’s Jab Trial Resurrected
Research into a vaccine for Alzheimer’s disease, which was stopped early on safety grounds, is to be resurrected.
Article

Bone Marrow Stem Cells Treat Recent Heart Attack Patients
Patients who recently have suffered an acute heart attack are being recruited for a new Emory University School of Medicine clinical study using stem cells generated within the bone marrow to grow new blood vessels to improve circulation around the heart and enhance its function.
Article

Stem Cells Injected Into Heart To Treat Coronary Artery Disease
A study has found that injecting patient’s own stem cells into the heart to treat severe coronary artery disease is well tolerated.
Article

Dendreon Announces New Data Analyses Presented at Prostate Cancer Foundation Scientific Retreat
Dendreon Corporation has announced that Eric J. Small, M.D. presented new exploratory analyses of the Phase 3 Study (D9901) that further support the results observed with the Company’s investigational active cellular immunotherapy PROVENGE(R) in men with advanced androgen-independent prostate cancer.
Article

Anormed Completes Enrollment in Phase III Trial For Mozobil on Schedule
AnorMED Inc. has announced that it has completed enrollment in the second pivotal Phase III clinical trial evaluating its proprietary product MOZOBIL in cancer patients, and that the Company is on track to meet its schedule of releasing top-line data from both Phase III trials in the first half of 2007.
Article

Stem Cells from Fat Tissue Demonstrate Early Success in Reconstructive Surgery
Stem cells derived from human fat tissue were reported to demonstrate early success in reconstructive surgeries in over 30 patients in Japan that underwent facial and breast procedures.
Article

Stem Cell Treatment Proven to Reduce Parkinson’s Symptoms
Tiantan Puhua Neurosurgical Hospital has announced the first known successful stem cell therapy treatment in China, and one of the first in the world, of an American citizen inflicted with the debilitating Parkinson’s disease.
Article

Biologists Want to Drop the Word ‘Cloning’
Don’t say cloning, say somatic cell nuclear transfer. That at least is the view of biologists who want the term to be used instead of "therapeutic cloning" to describe the technique that produces cloned embryos from which stem cells can then be isolated.
Article

Hwang Woo-suk Claims He Can Prove He Cloned Stem Cells
The disgraced South Korean cloning expert on trial for fraud and fake research insisted in court he could still prove he created the first cloned human stem cells.
Article

UK Surgeons Get Go-ahead for Full Face Transplant
British surgeons have been given the final go-ahead to perform the world’s first full face transplant, a radical procedure that has raised concerns about its physical and psychological risks.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Recent Advances on the Significance of Stem Cells in Tissue Regeneration and Cancer Therapies
In this study, the reviewers report on recent advances on the functions of embryonic, fetal, and adult stem cell progenitors for tissue regeneration and cancer therapies.
Abstract

Policy

Solution Possible in Stem Cell Impasse
Senator Johnny Isakson and a University of Georgia professor think they’ve found a solution to the national impasse over embryonic stem cell research. It lies with the thousands of malformed but fertilized eggs routinely sent to biomedical trash heaps.
Article

Missouri Stem Cell Issue a Factor in Senate Race
A Missouri political battle over an initiative supporting embryonic stem cell research has spilled into the state’s U.S. Senate campaign. Musician and cancer survivor Sheryl Crow and actor Michael J. Fox, who has Parkinson’s disease, taped ads for the initiative, supported by the Democratic candidate, while sports stars are among the celebrities in ads opposing the initiative, a stance supported by the Republican incumbent.
Article

Business

Cambrex Sells Divisions to Lonza for $460M
Cambrex has agreed to sell its bioproducts and biopharma business to Switzerland’s Lonza Group for $460 million.
Article

Millipore and Stem Cell Sciences Announce Agreement To Provide Human Embryonic Stem Cell Media
Millipore Corporation and Stem Cell Sciences today announced an exclusive license for Millipore to develop and market SCS’ serum free media for the growth of human embryonic stem cells (hESCs).
Article

New Human Stem Cell Center at Johns Hopkins Expected to Speed Research and Keep it Safe
In a novel effort to simplify and speed up safe human stem cell research, Johns Hopkins has set up a “one-stop shop” to preserve, create, supply and test high-quality cell lines for its own researchers now and the greater scientific community later.
Article

BioEDEN Tooth Stem Cell Banking Service Now Available in Canada
BioEDEN – the first fully operational processing laboratory and storage bank for primary tooth stem cells in the world – is now able to offer their services to Canada
Article

Collecting Stem Cells for Profit
The industry eyes a new model for gathering umbilical cord blood.
Article

ThermoGenesis Corp. Granted Broad Patent Protection From European Patent Office for Its BioArchive (R) Cryopreservation and Storage System
ThermoGenesis Corp. announced today that the European patent office has granted a new patent entitled "Method & Apparatus for Cryogenic Storage of Thermolabile Products" which contains broad claims covering the technology used in the BioArchive System.
Article

Top Stem Cell Researcher Lured Back from U.S.
Gordon Keller, one of the world’s leading stem cell scientists, is returning to Canada.
Article

NIH

Research Demonstration and Dissemination Grants (R18)(PA-07-017)
Link

CBER

Substantially Equivalent 510(k) Device Information – GenesisCS Component Concentrating System – Perfusion Partners & Associates, Inc
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Donor Screening Tests for Testing HCT/P Donors – Updates
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2006 Biological Approvals – Update
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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)

Biological Product Deviation Reporting (BPDR) – Update
Link

Biological Product Deviation Reporting Product Deviation Codes – Update
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Biological Product Deviation Reporting Non-Blood Product Codes – Update
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Workshop on Molecular Methods in Immunohematology – Transcripts
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Workshop on Molecular Methods in Immunohematology – Slide Presentations
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ISCT 6th Annual Somatic Cell Therapy Symposium – Slide Presentations
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Australia New Zealand Therapeutic Products Authority (Australia and New Zealand)

Questions & answers from the Phase 1 Stakeholder Consultation Sessions
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Australia New Zealand Therapeutic Products Authority Project Newsletters
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ISCT

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

AABB-ISCT Cellular Therapy Audioconference Series
Link

Profiled Journal

Join ISCT and receive the journal as a benefit of membership.

Current Volume: Volume 8 Number 5 / November 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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