Volume 7.14 | Apr 17

Volume 7.14, April 17, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Malachite Management Inc. Announces Pro Tem Co-Executive Directors for the International Society for Cellular Therapy: Malachite Management Inc. is pleased to announce Martha Davis and Ashka Wirk as Pro Tem Co-Executive Directors of the International Society for Cellular Therapy (ISCT).


Aldagen IND for Stem Cell Clinical Trial to Treat Critical Limb Ischemia Is Cleared By FDA
Aldagen, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to conduct a clinical trial using Aldagen’s ALDESORT product to isolate a unique stem cell population for therapy for critical limb ischemia patients.

First Clinical Trial of Stem Cell Therapy to Treat Peripheral Artery Disease Underway in Thailand
TheraVitae Ltd. announced that the first clinical trial using its autologous adult stem cells from peripheral blood to treat patients suffering from severe Peripheral Artery Disease (PAD) of the lower limbs has commenced at Siriraj Hospital in Bangkok, Thailand.

Techniques Push Stem Cells to Repair Damaged Nerves
Two new studies suggest that use of cells derived from bone marrow, as well as a seaweed-derived product called hydrogel, may prompt stem cells to repair nerve damage caused by stroke or spinal cord injury.

Nano-Patterns Guide Stem Cell Development
Stem cells can be prompted to develop into bone, instead of muscle or cartilage tissue, if they are grown on a substrate etched with nanoscopic patterns – and no added chemicals – researchers have found.

Stem Cells – An Alternative to Skin Grafting?
A Singapore company has used stem cells to help victims of serious burns and other wounds grow fresh skin.

MicroIslet Announces Encouraging Data From Islet Transplantation Studies in Primates
The data shows that minimally-invasive transplantation of encapsulated porcine islets into diabetic primates resulted in significant and prolonged (greater than 30 days) improvement of blood sugar, with reduced insulin use, in the primate subjects.

Scientists in U.S. to Attempt Human Cloning South Koreans Faked
American scientists plan to create stem cells that have a genetic makeup identical to that of living human adults, a feat that Korean scientists falsely claimed they accomplished last year.

Cell Division Rewind Button Found
Scientists have found a way to reverse the process of cell division, previously thought to be unstoppable.

Gene Therapy Can Battle Blood Pressure Problems
Using a corrective gene, scientists at the University of Florida have been successful in blocking a protein in the kidneys that triggers high blood pressure and kidney damage.

The Notch Effect Steers Stem Cells into Cells of the Nervous System
Stem cell scientists at the University of Edinburgh have discovered that Notch, a protein first discovered more than 80 years ago in the fruit fly, directs unspecialized embryonic stem cells to become cells of the nervous system.

Print Me a Heart and a Set of Arteries
Sitting in a culture dish, a layer of chicken heart cells beats in synchrony. But this muscle layer was not sliced from an intact heart, nor even grown laboriously in the lab. Instead, it was “printed”, using a technology that could be the future of tissue engineering.


Notch Promotes Neural Lineage Entry by Pluripotent Embryonic Stem Cells
In this study we report that Notch receptors and ligands are expressed in ES cells where they play a previously unsuspected role in the promotion of primary neural fate.

The Reversibility of Mitotic Exit in Vertebrate Cells
These findings demonstrate that proteasome-dependent degradation of cyclin B provides directionality for the M phase to G1 transition.

Monocytes/Macrophages Cooperate with Progenitor Cells during Neovascularization and Tissue Repair
Long-term implantation of Matrigel plugs qualifies as a novel experimental model of tissue regeneration, in which neovascularization intimately couples with fibrosis and organogenesis and in which cells of MC/Mph phenotype play a key structural role.


California Awards First Grants from Stem Cell Initiative
In all, sixteen non-profit institutions in California received $12.1 million to train the next generation of stem cell researchers in the first grants awarded by the California stem cell agency.

Drive to Cut Fraudulent Research
The UK Research Integrity Office will develop a code of practice for staff working in the NHS, universities and the health industry.


Australian, U.S. Institutes to Collaborate on Stem Cell Research
Scientists from Monash University and the Australian Stem Cell Centre will work with a leading Californian university to create a powerful new international collaboration in stem cell research.

Stem Cell Innovations Makes Their Human Embryonic Germ Cell Platform Commercially Available in Europe
Stem Cell Innovations, Inc. announced that the Company will commercialize their proprietary platform of human pluripotent stem cells in Europe through their newly established European R & D facility in Leiden, the Netherlands.

Burnham Institute Considers Expanding in Florida
The Burnham Institute, one of San Diego County’s leading centers for research on stem cells, neuroscience, cancer, aging and other medical fields, might build a campus in Florida.

Invitrogen Corporation Taps Renowned Stem Cell Expert Mahendra Rao, MD, Ph.D. to Lead New Research Area; Company Transforms Group of Highly-Utilized Products into Stem Cell Platform
Invitrogen Corporation (Nasdaq:IVGN) today announced it has named former NIH stem cell section chief Mahendra Rao, MD, Ph.D. Vice President, Research, Stem Cells and Regenerative Medicine.

Marie DeVito Leads Progenitor Cell Therapy’s Quality Assurance and Quality Control Program
Progenitor Cell Therapy, LLC (PCT), a leading full service cell therapy development and contract manufacturing company, is pleased to announce Marie DeVito as Senior Director of Quality Assurance and Quality Control.

StemCells, Inc. Names Elizabeth Leininger Vice President, Regulatory Affairs and Quality Assurance
Dr. Leininger will direct and manage the Company’s global regulatory affairs strategy and help guide the development of new stem cell therapies from the preclinical stage to clinical testing.



Top Government Scientist Quits
The leader of the stem-cell unit at the National Institute on Aging, part of the National Institutes of Health, announced he will leave the NIH to join the private sector at a biotech company called Invitrogen in Carlsbad, California.

Memory T Lymphocytes in Cancer Immunology (R21)

Memory T Lymphocytes in Cancer Immunology (R01)


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

2006 Biological Approvals Update

Center for Biologics and Evaluation Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier; Withdrawal of Guidance

Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing; Withdrawal of Guidance


Food and Drug Administration (United States of America)

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Blood Establishment Registration and Product Listing

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export Certificates for Food and Drug Administration-Regulated Products

Regulatory Site Visit Training Program

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

Medicines and Healthcare Regulatory Agency (United Kingdom)

The MHRA Electronic Portal is Now Available

Future of the European Medicines Regulatory Network – Public Consultation


ISCT2006. May 4-7. Berlin, Germany.
Visit http://www.celltherapysociety.org.

AABB-ISCT Cellular Therapy Audioconference Series

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

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Current Volume: Volume 8 Number 1/February 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.