Volume 7.24 | Jun 26

Volume 7.24, June 26, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Paralyzed Mice Move Again With Stem-Cell Therapy: For the first time, researchers have enticed transplants of embryonic stem cell-derived motor neurons in the spinal cord to connect with muscles and partially restore function in paralyzed animals.


StemCell Technologies’ Contract Assay Services is Providing a Free, Educational Webinar on Human Bone Marrow Toxicity Testing on July 13, 2006.
“Toxicity Testing: What Bone Marrow Can Tell Us” will discuss: benefits of using primary (human bone marrow) cells in drug development; correlation of assays with clinical outcome; and advantages of conducting specific human or mouse bone marrow studies.

Successful Transplantation from Pig Embryos to Mice
Insulin-producing pancreas tissues from animals could potentially provide a nearly unlimited supply for transplantation. New research by Professor Yair Reisner of the Weizmann Institute’s Immunology Department has brought the possibility of transplants from pig embryos one step closer.

Engineered Tissue Cells Could Replace Pacemakers in Children
Researchers report early success in implanting biotech-altered tissues -rather than a pacemaker- in animals in order to maintain a beating heart. The research team at Children’s Hospital Boston said it had engineered skeletal muscles capable of doing the work of implanted pacemakers.

Ortec Initiates Pre-Clinical Animal Model Study to Evaluate Fibrin Microbead Technology for Stem Cell Regeneration of Non-Union Bone Defects
Ortec International, Inc., a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, has announced that it has begun a pre-clinical study in rabbits to evaluate the capabilities of the Fibrin Microbead system to accomplish the full cycle of steps required to use a patient’s own stem cells therapeutically to regenerate large gaps in long bone tissue.

The Molecular Mechanism of a Diabetes Vaccine Revealed
A team of researchers led by Professor Irun Cohen of the Weizmann Institute of Science Immunology Department has revealed the molecular mechanism of a vaccine for Type 1 diabetes.

Brighton Firm Pioneers Use of UV Laser, Gene to Repair Cartilage
A study conducted by Edward Schwarz and his colleagues at the University of Rochester Medical Center revealed that using ultraviolet light and a tissue-restoring gene to target an area of damaged cartilage can safely help restore the cartilage without damaging surrounding tissue.

Teasing Out Tissue From Blood
Pharmafrontiers claims to have refined a way to produce stem cells from white blood cells called monocytes and develop them into many different tissue types including, crucially, insulin-producing cells.

The Key To Blood Renewal Lies In Bones
Researchers at the Weizmann Institute of Science have discovered a crucial association between the bones and the blood renewal system in the body.

New Stem Cell Findings Can Help the Body to Cure Itself
Researchers at Karolinska Institutet have identified an important mechanism that regulates how many new cells are produced by each intestinal stem cell.

Stanford Doctors Advance in Bid to Turn Mice Stem Cells into Blood Vessels
Researchers at the Stanford University School of Medicine have taken a first step toward growing blood vessels from stem cells that could eventually be transplanted into living organisms.

Can You Hear Me Now? Scientists Find Previously Unknown Receptors On Adult Stem Cells
Scientists at the Oklahoma Medical Research Foundation have discovered that marrow stem cells possess receptors that recognize bacteria and viruses.

Doctors to Consider First Full Face Transplant
Doctors will seek approval for the world’s first full face transplant from a hospital’s ethics panel this week, a spokesman for the research team said on Monday.

Egg Donation for Stem Cell Research – Balancing the Risks and Benefits
In the wake of the scandal involving fraudulent cloning research, concerns about the welfare of women donating eggs for research purposes have arisen.

“Designer Babies” Proposed in U.K. to Avoid Autism
A team of U.K. doctors is seeking clearance to create “designer babies” for couples with family histories of autism in order to avoid the disease in newborns.


Embryonic Pig Pancreatic Tissue Transplantation for the Treatment of Diabetes
In this study, the researchers examined the growth potential, functionality, and immunogenicity of pig embryonic pancreatic tissue harvested at different gestational ages.

Nature Publishing Group Special Web Focus – 25 Years of Embryonic Stem Cells
Nature is featuring papers that show the progression of ES cell research.


Japan to Lift Ban on Research on Cloned Human Embryos
Japan is expected to lift next year or later a ban on research on cloned human embryos for regenerative medicine after restricting the acquisition of human eggs that are the sources of the embryos.

Stem Cell Debate in Australia Gets Green Light
Prime Minister John Howard has caved in to his party room and will allow coalition members to debate whether to expand stem cell research.

Penn Bioethicst Challenges Scientists To Lead The Public In Discussions About Their Work
In the first-ever article on bioethics to appear in Cell, one of the nation’s leading bioethicists challenges scientists to proactively engage the public in discussions about the value and significance of their research protocols – to maintain an ethical base, at all times, in the conduct of their own research – and to help advance scientific knowledge among the public and their colleagues by freely sharing new and relevant information.

Wisconsin and California Could Spar Over Stem Cells
The Wisconsin Alumni Research Foundation is discussing concerns over use of its stem cells by a California institute hoping to disburse three billion dollars in stem cell research grants.

Cell-Mixing Draws Critics, Controversy
Researchers defend experiments as beneficial to medicine, science


Progenitor Cell Therapy Continues Expansion
Progenitor Cell Therapy, LLC (PCT), a leading full service provider for the contract development of cell therapies, announced today that it has completed construction of additional Class 10,000 clean room space at its manufacturing facility in Mountain View, California.

Geron Announces Collaboration to Develop Synthetic Surfaces for Growth of Embryonic Stem Cells
Geron Corporation announced today that they have entered into a collaboration and license agreement with Corning Incorporated for the development and commercialization of synthetic surface matrices for the growth of human embryonic stem cells (hESCs).

Child Dentistry Provides Life-Saving Medicine
Discarded Primary teeth have been found to be an excellent source for adult stem cells, which could potentially be used to treat a growing number of severe illnesses and injuries, including cancer and heart disease. A new company has been founded to provide preservation service for these cells.

Biovest International’s National Cell Culture Center to Open Their Doors to Non-Academic Researchers
Biovest International, Inc. and its research partner the National Cell Culture Center have agreed to extend to the general research market access to their research resource facility, as well as Biovest’s hollow fiber instruments.

Ortec to Be Granted European Patent on Its Fibrin Microbead Enabling Technology for Stem Cell Isolation and Therapy
The Fibrin Microbead technology developed at Hapto Biotech, Israel, Ortec’s wholly owned subsidiary, is a proprietary matrix for the isolation, expansion and differentiation of matrix-dependent cells including Mesenchymal- type adult stems cells and their potential reimplantation into the patient.

Transgene To Collaborate In A Novel Melanoma Treatment Under A Cooperative Research And Development Agreement Letter Of Intent
Transgene S.A. announces that it has executed a Cooperative Research and Development Agreement Letter of Intent with the National Cancer Institute (NCI) for the development of novel melanoma treatments with Steven A. Rosenberg, M.D., Ph.D., Chief, Surgery Branch.

Epeius Biotechnologies Corporation Receives $400,000 Grant to Support Gene Therapy Trials for Pancreatic Cancer
Epeius Biotechnologies Corporation announced today that the Company has been awarded a $400,000 grant by the Lazarex Cancer Foundation to expand and support ongoing cancer gene therapy clinical trials for advanced and metastatic pancreatic cancer.

Stowerses Up Investment in Massachusetts Institute
The founders of the Stowers Institute for Medical Research will invest another $4.75 million in embryonic stem cell research at an institute in Cambridge, Massachusetts.

Stem Cells(R), the Journal, and Invitrogen Join to Create Stem Cells(R) Young Investigator Award; First Awardee to Be Named at International Society for Stem Cell Research Meeting
This award will be given to a scientist age 40 or younger who is the principal author of the qualifying stem cells paper from the past year judged to be most important. The award carries a $10,000 prize.

Stem Cell Discoveries Likely to Take Years to Generate Revenue
Paralyzed rat treatment points up stem cell break-through, but sales remain elusive.


Streamlined Review Process to be used for Ruth L. Kirschstein National Research Service Awards (NRSA) Postdoctoral Fellowship Applications (F32) (NOT-OD-06-077)

Bioengineering Research Partnership NHLBI Focus Areas: PAR-06-459: Bioengineering Research Partnerships (BRP) [R01] (NOT-HL-06-131)

Announcement of a Limited Competition for the Continuation of the Transfusion Medicine/Hemostasis Clinical Trials Network (TMH CTN) [U01] (RFA-HL-06-108)


Food and Drug Administration (United States of America)

Draft Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability

Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

European Agency for the Evaluation of Medicinal Products (Europe)

European Agency for the Evaluation of Medicinal Products Management Board Moves For Greater Transparency
The Board agreed in principle to publish its meeting agendas and minutes, together with all non-confidential documents it adopts.


AABB-ISCT Cellular Therapy Audioconference Series

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

Profiled Journal

Robert Weinstein, MD
Chief, Hematology and Transfusion Medicine, Caritas St. Elizabeth’s Medical Center, Tufts University School of Medicine, Boston, 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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