Volume 8.48 | Dec 10

Volume 8.48, December 10, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Reprogrammed Adult Cells Treat Sickle-cell Anemia in Mice: Mice with a human sickle-cell anemia disease trait have been treated successfully in a process that begins by directly reprogramming their own cells to an embryonic-stem-cell-like state, without the use of eggs.


Personalized Medicine through Genomic Analysis and Molecular Diagnostics
March 31, 2008  |  Boston, Massachusetts
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Germinal Cells Can Become Embryonic Stem Cells
Primordial germinal cells, which are precursors to spermatozoids, apparently have the capacity of turning into embryonic stem cells.

Mechanism by which Signaling Pathways Regulate Growth and Differentiation of Adult Muscle Stem Cells is Revealed
A group of scientists at the Burnham Institute for Medical Research in La Jolla, CA, analyzed the mechanism by which certain cellular signaling cues cause epigenetic modifications when released within the regenerative microenvironment, thus controlling the expression of genes that regulate growth and differentiation of muscle stem cells that repair injured muscle.

Stem Cells Show Power to Predict Disease, Drug Toxicity
For the first time, scientists have used human embryonic stem cells to predict the toxic effects of drugs and provide chemical clues to diagnosing disease.

PET and Bioluminescent Imaging Aid Evaluation of Stem Cells’ Potential for New Ways to Treat Disease
Using positron emission tomography imaging with bioluminescence—the light produced by a chemical reaction within an organism—researchers are starting to understand the behavior of transplanted or implanted stem cells that may one day be used to develop new treatments for disease.

Australian Stem Cell Scientist on Target to Prevent Age-related Loss of Brain Function
Stem cell scientists are developing a novel approach to slow or possibly prevent the cognitive decline that typically occurs with advancing age.

Human Embryonic Stem Cell Derived Bone Tissue Closes Massive Skull Injury
There are mice in Baltimore whose skulls were made whole again by bone tissue grown from human embryonic stem cells.

Replacing The Cells Lost In Parkinson Disease
Researchers at the Karolinska Institue, Sweden, have identified a new source for dopamine (DA) cells that provided marked benefit when transplanted into mice with a parkinson disease (PD)-like disease.

Bone Marrow Cell Transplants Help Nerve Regeneration
A study carried out by researchers at the Kyoto University School of Medicine has shown that when transplanted bone marrow cells containing adult stem cells are protected by a 15mm silicon tube and nourished with bio-engineered materials, they successfully help regenerate damaged nerves. The research may provide an important step in developing artificial nerves.

Cell Transplants Hold Promise for Heart Attack Survivors
Working with mice, scientists strengthened the heart’s electrical system to prevent it from going haywire.

ViRexx Announces Pivotal OvaRex(R) MAb Trial Results Fail to Achieve Statistical Significance
ViRexx Medical Corp. has announced that preliminary analysis of results from the two Phase III clinical trials of OvaRex(R) MAb for the treatment of advanced ovarian cancer showed that the studies failed to reach statistical significance.

Patients Who Undergo a ‘Mini Transplant’ Have Similar Outcomes Regardless of Whether Stem Cell Donor is Related or Unrelated
People who undergo nonmyeloablative stem-cell transplants, or “mini transplants,” for leukemia, lymphoma and other blood cancers have comparable outcomes regardless of whether they receive tissue-matched stem cells from a related or unrelated donor, according to new findings by researchers at Fred Hutchinson Cancer Research Center.


Generation of Induced Pluripotent Stem Cells Without Myc From Mouse and Human Fibroblasts
The researchers describe a modified protocol for the generation of iPS cells that does not require the Myc retrovirus.

Adipose-derived Stem Cells and Chondrogenesis
This review discusses the application of Adipose-derived stem cell to cartilage formation.


Biomedical Equipment Technician
Los Angeles, CA (Cedars-Sinai Medical Center)

Quality Manager
Singapore (Singapore Cord Blood Bank)

Clinical Development Research Associate
Poway, California (VetStem)

Islet Cell Associate Research Director
Irvine, CA (University of California, Irvine)


United States House Moving to Facilitate Paired Organ Donations
The House was expected to pass legislation Tuesday to ease the way for organ donations by unrelated living donors.

California Stem Cell Agency to Fund Non-Embryonic Alternatives
California’s stem cell agency plans to spend up to $13 million on research in 2008 to investigate techniques that do not destroy human embryos. It’s a shift from the institute’s original goal of funding mostly embryonic stem cell research.

California Plans for a $750 Million Biotech Bank
A new source of $750 million in funding could soon become available for the perennially cash-starved biotech industry, particularly stem cell firms.


Advanced Cell Technology Seeking International Partners for Its Therapeutic Programs
Advanced Cell Technology, Inc. has announced that it is seeking international partners for each of its three lead therapeutic programs, including its Myoblast program for treating heart failure, its Retinal Pigment Epithelium program for treating degenerative retinal disease, and the Hemangioblast program for the treatment of blood and cardiovascular indications.

Avid Bioservices to Manufacture Lead Cancer Stem Cell Antibody for ARIUS
Avid Bioservices, Inc. has announced it has signed a manufacturing supply and technology transfer agreement with ARIUS Research, Inc. The agreement covers ARIUS’ lead cancer stem cell antibody, which targets a novel epitope of CD44 found in breast, colon and prostate cancers.

Neurologix Receives Grant from the Epilepsy Research Foundation for Gene Transfer Research
The grant will help fund a Phase I human clinical study of Neurologix’s proprietary gene transfer approach to the treatment of epilepsy. The Company expects to initiate this study by early 2008, subject to final authorization from the United States Food and Drug Administration.

StemCor Systems Announces Acquisition of Intellectual Property to Enhance Bone Marrow Aspiration Platform
StemCor Systems, Inc. has announced that it has acquired U.S. Patent 6,849,051, “Devices And Methods For Extraction of Bone Marrow”, and associated know-how from USPure Sciences, LLC.

BrainStorm Cell Therapeutics’ New Vivarium Set to Enhance Company Research
BrainStorm Cell Therapeutics Inc. announces the constructing of its new vivarium, an animal research facility, located at BrainStorm’s headquarters in Petach-Tikva, Israel.


Notice Regarding Authentication of Cultured Cell Lines (NOT-OD-08-017)

Delays in Grant Application Submission due to Winter Storms – December 2007 (NOT-OD-08-019)


Substantially Equivalent 510(k) Device – Galileo Automated Blood Bank System – Add the Reverse ABO Group Assay – Immucor, Inc

Approved Biological NDA and ANDA Applications – Update



Committee Document: Biologicals & Vaccines Expert Advisory Group Summary Minutes – 9 July 2007

Committee Document: Clinical Trials Expert Advisory Group Summary Minutes – 9 October 2007


14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Abstract Submission and Early Registration Deadline: January 31, 2008

Full details at: http://www.celltherapysociety.org

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