Volume 7.27 | Jul 17

Volume 7.27, July 17, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

New Source of Multipotent Adult Stem Cells Discovered in Human Hair Follicles: Researchers at the University of Pennsylvania School of Medicine have isolated a new source of adult stem cells that appear to have the potential to differentiate into several cell types.
Article

World First Stem Cell Research Could Aid Male Infertility: Scientists have shown for the first time that sperm grown from embryonic stem cells can be used to produce offspring.
Article

Science

Cardinals to Hear About Breakthrough in Umbilical Cord Research
A Northern Ireland-born professor will tell a Vatican-sponsored conference in September that it is possible to use stem cells from the umbilical cords of living babies to produce insulin in diabetics and to grow blocks of human tissue for use in drug tests.
Article

Tumor Wizardry Wards Off Attacks from the Immune System
Researchers at Washington University School of Medicine in St. Louis have found that pancreatic tumors hide from the body’s immune surveillance by surrounding themselves with cells that make it hard for the immune system to detect them.
Article



Donor T Cells Change the Fate of Stem Cells in Transplantation
In laboratory and animal models, researchers showed that alloreactive T cells change the fate of blood stem cells and may themselves stimulate a strong immune response.
Article

Magnets Enlisted in Gene Therapy Research
A Swiss scientist says magnets may one day drag genes around the body in a novel form of gene therapy.
Article

Scientists Engineer Human Tissue with Electricity
A technique, which uses electric fields to build up layers of cells to form a tissue, is being used to create Hematons – aggregates of blood producing cells essential in the function of healthy bone marrow.
Article

Ortec Issues Update on Its Three Technology Platforms for Regenerative Medicine and Stem Cells
The update details the business strategy for developing and commercializing their newly acquired Haptides(TM) and Fibrin Microbeads biomaterial technologies
Article

Cardiac Stem Cell Therapy Boosts Blood Vessel Growth And Injury Repair
A study provides evidence that the transplantation of bone marrow-derived c-kit+ cells can lead to improvement in cardiac function in mice after acute myocardial infarction that is independent of the differentiation of these cells into cardiac muscle cells, but rather is associated with the release of molecules known as cytokines that stimulate the growth of new blood vessels to the area of injury, promoting healing.
Article

Penn Researchers Enlist Proteins To ‘Switch On’ Heart Tissue Repair System In Animal Models
By triggering the cell-cycle signal, researchers can manipulate cells in animal models to regenerate damaged heart tissue.
Article

Favrille Publishes Data From Phase 2 Clinical Trial Demonstrating Biologic Activity Of Lead Product Candidate FavId In Indolent Non-Hodgkin’s Lymphom
FavId(R) as a single agent is active and well tolerated in previously treated and relapsed patients with indolent B-cell non-Hodgkin’s lymphoma (NHL).
Article

AnorMED Completes Enrollment In Phase III Trial For MOZOBIL In Stem Cell Transplant In Multiple Myeloma
The two Phase III trials are evaluating MOZOBIL in a standard stem cell mobilization regimen.
Article

Seoul University Scientists Clone Two Female Puppies
A team of Seoul National University scientists has confirmed it has cloned two female puppies to be mates for the male dog, Snuppy, which the team cloned last year.
Article

ABSTRACTS, REVIEWS & SPECIAL REPORTS

Isolation of a Novel Population of Multipotent Adult Stem Cells from Human Hair Follicles
The researchers isolated a novel population of multipotent adult stem cells from human hair follicles, showing that human follicles may provide an accessible, autologous source of adult stem cells for therapeutic application.
Article

Policy

White House Aide Confirms Threatened Veto of American Stem Cell Bill
White House aide Karl Rove confirmed President George W. Bush intends to issue his first veto if Congress passes a bill expanding federal funding of embryonic stem cell research.
Article

China to Tackle Misuse of Science Funding
Amid rising claims of misuse of Chinese research funding, the country’s science ministry is planning to set up a centre to assess how the money it disburses is spent.
Article

Australian Medical Association Urges Australian States to go it Alone on Stem Cell Research
There are calls for Queensland and Victoria to proceed with plans to legislate in favour of using human embryos for stem cell research after the recent Council of Australian Governments (COAG) meeting.
Article

Italian Stem Cell Researchers Look to Government
Italian scientists specialising in embryonic stem cell research recently gathered in Rome to launch an appeal for government support .
Article

Business

Stem Cell Innovator TheraVitae Establishes Subsidiary in North America
TheraVitae Inc. will develop and commercialize TheraVitae’s adult stem cell technologies in North America under exclusive license.
Article

Takeda and Galaxy Biotech Sign License Agreement for Galaxy’s Investigational Antibodies for the Treatment of Cancer
Takeda Pharmaceutical Company Limited and Galaxy Biotech, LLC announced that both parties have entered into an agreement for the development and marketing of HuL2G7, a humanized anti-Hepatocyte Growth Factor (HGF) monoclonal antibody created by Galaxy.
Article

BrainStorm Advances Its International Patent Application (PCT) for Stem Cell Procedure with Potential for Treating Parkinson’s and Other Neurodegenerative Diseases
BrainStorm Cell Therapeutics announced today that it has advanced its patent application from a provisional to an international patent application for a new procedure to derive “neuronal-supporting cells” from adult bone marrow with the US Patent and Trademark Office.
Article

Stem Cell Authority Ltd.(TM) Open For Public Trading
NASDAQ authorized Stem Cell Authority Ltd., the company which possesses the exclusive rights for the collection and storage of human umbilical cord matrix stem cells, to be publicly traded.
Article

NIH

NIH Offers Commercialization Assistance Program to SBIR Phase II Awardees (NOT-OD-06-081)
Link

NIH Announces the Opportunity for Funded Extensions and/or One-Time Administrative Supplements to Grants Located in New Orleans Affected by Hurricane Katrina (NOT-OD-06-083)
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NIH/AHRQ Reminder to Use Updated SF424 (R&R) and Agency-Specific Electronic Forms in Reposted FOAs (NOT-OD-06-085)
Link

Assay Development for High Throughput Molecular Screening (R21) (RFA-RM-07-001)
Link

Nanoscience and Nanotechnology in Biology and Medicine(R21) (PAR-06-475)
Link

CBER

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

Failure to Register Notice
The FDA has noticed that many Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) establishments have failed to register.
Article

Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format
Link

Fast Track Designation Request Performance
Link

Regulatory

Food and Drug Administration (United States of America)

FDA Supporting New Approach to Clinical Trials
The FDA is backing new guidelines for clinical trials that will allow studies to be altered while in progress based on early results.
Article

Contaminated Product Release
At a recent FDA liaison meeting for stakeholders in cellular therapy, FDA confirmed requirements for reporting deviations relating to products that have been infused and found to have positive microbial culture results and for the testing of HCT/Ps that were tested in mini-pools by NAT.
Article

ISCT

AABB-ISCT Cellular Therapy Audioconference Series
Link

For more information on the Somatic Cell Therapy Symposium, see www.celltherapysociety.org.

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”
Link

Profiled Journal

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Current Volume: Volume 8 Number 3 / May 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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