Volume 8.09 | Mar 12

Volume 8.09, March 12, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Type of Stem Cell Found to Reside in Transplanted Lungs: A new study involving a type of stem cells from the lungs of transplant patients demonstrates for the first time that these progenitor cells reside in adult organs and are not derived from bone marrow, which leads to the possibility that the cells may be able to help with the rejection of donated organs and with various kinds of lung disease.

Scientists Plan China, Hong Kong, Taiwan Stem Cell Trial: Scientists are preparing for a large clinical trial in 2008 which aims to use stem cells to help 400 patients with spinal cord injuries in Hong Kong, mainland China and Taiwan grow new cells and nerve fibres.


Researchers Discover New Mechanism That Regulates Stem Cell Division
Errors in stem cell division can give rise to tumours. By studying stem cells in the fruit fly, scientists at the Institute for Research in Biomedicine have identified one of the mechanisms that govern how these cells divide.

Scientists Seek Alternative Stem Cell Research
South Korean researchers are going all out to find alternative ways to extract human stem cells without killing embryos.

Cannibalistic Signals Help Mammalian Embryos Develop Normally
A cannibalistic process called autophagy spurs dying embryonic stem cells to send “eat me” and “come get me” signals to have their corpses purged, a last gasp that paves the way for normal mammalian development

Enabling Nerve Regeneration Means Evicting The Cleanup Crew
Macrophages are the immune cells that engulf and destroy the debris of damaged tissue to enable the healing process to begin. Their presence at the scene of damage is critical, but once their task is complete, it is just as critical that macrophages exit rapidly, ending the inflammatory process and making way for regrowth. In fact, the continued presence of macrophages could damage tissue, compromising repair.

Treating Male Infertility With Stem Cells
New research has examined the usefulness of bone marrow stem cells for treating male infertility, with promising results.

Clinical Trial of Diabetes Regenerative Therapy Shows Positive Results
Transition Therapeutics, Inc recently announced interim data from an exploratory Phase IIa clinical trial of a diabetes regenerative product, E1-INT, a therapeutic combination product that may be effective at regenerating the insulin producing beta cells that are lost when people develop type 1 diabetes.  

Healing Bone with Stem Cells
New techniques to boost survival of adult stem cells could improve surgeries for severe fractures.

Seven Arrested in Puerto Rico Cancer Scam
A U.S. federal grand jury indicted seven people in a case where terminally ill cancer patients were allegedly injected with a bogus cure made from the patients’ own blood.

Two Accused of Trading in Cadaver Parts
The former director of the cadaver donor program at the University of California, Los Angeles, and an associate have been charged with conspiracy and grand theft, accused of illegally trading body parts that had been donated for medical research.


Allogeneic Hemopoietic Stem Cell Transplants for Patients with Relapsed Acute Leukemia: Long-term Outcome
This study confirms that a fraction of relapsed leukemias is cured with an allogeneic transplant: selection of patients with a blast count <30%, identification of young, human leukocyte antigen-matched donors and the use of total body radiation may significantly improve the outcome.

Evidence for Tissue-resident Mesenchymal Stem Cells in Human Adult Lung from Studies of Transplanted Allografts
These studies of cells derived from human lung allografts demonstrate the presence of a multipotent mesenchymal cell population, which is locally resident in the human adult lung and has extended life span in vivo.


Irish Public Asked About Stem Cell Research
The Irish public is being asked to give its opinions on stem cell research. The Irish Council for Bioethics is launching a consultation forum on Monday to get as many views as possible on whether this research should be allowed in this country.

Will Korea Allow Full-Fledged Stem Cell Research?
The National Bioethics Committee will convene soon to discuss such contentious issues as human egg donation, which is important in experiments with cloned embryos.


Selling the Stem Cell Promise
The potential of stem cells’ curative powers has spawned the creation of private tissue banks.  But marketing is outpacing the medicine.

New Company is Only in U.S. That Stores Frozen Immune Cells Giving Clients Options for Future Medical Treatments
BioBancUSA(TM) launches the nation’s first revolutionary immune cell preservation center dedicated to providing ‘bioinsurance’ against disease. Several of the world’s foremost physicians have developed the advanced technology to collect and store an individual’s immune cells as insurance against future disease.

Hospital Offers Option for Storing Stem Cells from Cord, Placenta
Officials at St. Barnabas Medical Center said yesterday they have established the program with LifebankUSA of Cedar Knolls, a division of Celgene, a Summit biotechnology company.

Cord Blood America Completes CorCell, Inc. Acquisition
With this announcement, Cord Blood America completes the acquisition of the CorCell Sample, fully acquiring approximately 12,000 customers.

Stemagen and UPenn Partner to Advance the Therapeutic Use of New and Unique Type of Human Embryonic Stem Cell
Stemagen Corporation announced today it has acquired the exclusive rights to a patent for a groundbreaking technique that allows the development of embryonic stem cells appearing to have a markedly enhanced potential for therapeutic use – uniparental embryonic stem cells.

Biotech Firm Gel-Del is Just Beginning to Jell Well
A St. Paul company is a year away from bringing its first product to market, but a California firm still signed a $15 million licensing deal to distribute it.

Mesoblast’s Road to United States Product Registration
Australia’s adult stem cell company, Mesoblast Limited, has provided investors with a timetable and update of proposed clinical programs leading to product registration in the United States, the world’s largest health care market.

EU Supports Cell Therapy Project, Fosters Dialogue with Patient Groups
The EU has given the green light to a new project that focuses on the most common and debilitating form of muscular dystrophy, known as Duchenne Muscular Dystrophy (DMD). The project has identified a gap in the current body of knowledge concerning stem cell therapies for DMD, and aims to pool existing studies into a single knowledge base that can be used as a synthesised resource in a final preparatory stage leading to clinical studies.

University of Massachusetts Considers Stem Cell Research Center
The University of Massachusetts could position itself as a contender in the stem cell research arena by developing a new system-wide institute to advance life sciences through human and animal research, according to a report to the university’s board of trustees.

Stem Cell Innovations Names Ian Lyons, Ph.D., U.S. Chief Scientific Officer
Stem Cell Innovations, Inc. has announced Ian Lyons, Ph.D., has been appointed Chief Scientific Officer, U.S. Dr. Lyons joins Helmuth van Es, Ph.D., Chief Scientific Officer, Europe, as co-leader of Stem Cell Innovation’s scientific programs. Dr. Lyons helped develop and characterize several of the human embryonic stem cell lines that are on the list approved for federally funded research in the U.S.

t2cure Appoints Dr. Manfred Ruediger as CEO
t2cure, a biopharmaceutical company engaged in the field of stem cell-based regenerative medicine, has announced that it has appointed Dr. Manfred Ruediger as CEO.


NIH Director Launches Program for Innovative New Investigators
NIH Director Elias A. Zerhouni, M.D., has announced a special program to fund new investigators who propose highly innovative research projects that could have an exceptionally great impact on biomedical or behavioral science. The NIH Director’s New Innovator Award offers grants of up to $1.5 million in direct costs over five years.

Reiteration of the Commitment of NIH to Protect Sensitive Data and Information Used in Research (NOT-OD-07-054)

Notice of Limited Competition for Competitive Continuation of Centers of Biomedical Research Excellence (COBRE) (NOT-RR-07-007)

Change in Scientific Contact for Requests for Applications (RFAs) under the Innovative Technologies for Molecular Analysis of Cancer (IMAT) Program (NOT-CA-07-011)

2007 NIH Director’s New Innovator Award Program (DP2) (RFA-RM-07-009)

Competitive Continuation of Centers of Biomedical Research Excellence (COBRE)[P20] (RFA-RR-07-001)

National Gene Vector Biorepository and Coordinating Center (P40) (RFA-RR-07-002)

Avon-NCI “Progress for Patients” (PFP) Awards for Early Phase Clinical Interventions and Biomarkers in Breast Cancer (Limited Competitive Supplements [Revisions] for P30 Cancer Center Support Grants) (PAR-07-244)

Avon-NCI “Progress for Patients” (PFP) Awards for Early Phase Clinical Interventions and Biomarkers in Breast Cancer (Limited Competitive Supplements [Revisions] for P50 SPORE Grants) (PAR-07-245)

Technologies and Software to Support Integrative Cancer Biology Research (SBIR) [R43/R44] (PAS-07-242)


2007 Biological Approvals – Update

Approved Biological NDA and ANDA Applications – Update

Licensed Products and Establishments List – Update

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


FOOD AND DRUG ADMINISTRATION (Untited States of America)

Cellular, Tissue and Gene Therapies Advisory Committee Meeting


Health Canada Proposes Progressive Drug Licensing
Health Canada is considering changing its system of licensing prescription drugs, moving to one in which the safety and effectiveness of medicines would be more closely monitored after products are approved for sale.


ISCT 2007-Register Now!
13th ISCT Annual Meeting
June 24-27, 2007
Sydney, Australia

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ISCT Membership
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Profiled Journal

Robert Weinstein, MD
Chief, Division of Transfusion Medicine, UMass Memorial Medical Center, Worcester, 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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