Volume 7.11 | Mar 27

Volume 7.11, March 27, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem Cells Found in Adult Mouse Testes: Researchers in Germany have identified a potential source of reprogrammable cells in adults that could be used for regenerative therapy.

The International Society for Cellular Therapy (ISCT) Announces New Domain for Website: The International Society for Cellular Therapy (ISCT) is pleased to announce that a new website will be launched prior to the annual meeting in Berlin, May 4-7, 2006.


Stem Cells Repair Traumatic Injury in Phase Two Trial
Somatic adult stem cells have been found to fully repair recalcitrant tibial nonunion in 6 months or less, according to preliminary results of an ongoing phase 2 study.

‘Smart Bomb’ Anti-Cancer Therapy Shows Promise
Scientists say they’re closer to perfecting a double-barreled “smart bomb” approach that one day might kill off stubborn cancers without damaging surrounding tissue.

New Lipid Molecule Holds Promise for Gene Therapy
Scientists at the University of California, Santa Barbara have created a new molecule that holds promise in fighting disease via gene therapy.

Cedars-Sinai Researchers Discover Treatment for Deadly Brain Tumors and Infections
Researchers at Board of Governors’ Gene Therapeutics Research Institute at Cedars-Sinai Medical Center have developed a way to overcome immune privilege in the brain to eradicate potentially deadly brain tumors such as glioblastoma multiforme and other types of brain infections.

Cell Therapy Slows Progression of an Inherited Neurological Disease; Improves Motor Skills in Mice
In an important discovery, scientists have demonstrated that the progression of a type of genetic brain disease is slowed and symptoms are improved in mice that received cell transplants.

Infused Spleen Cells Found Not to Impact Islet Recovery and Reversal of Type 1 Diabetes in Mice
Researchers from Joslin Diabetes Center have published in the March 24, 2006, issue of the journal Science a significant study about islet cell recovery and reversal of type 1 diabetes in mice.

Aldagen’s Product Used to Isolate Stem Cells from Cord Blood in Human Clinical Study; Initial Safety Demonstrated
Aldagen, Inc. today announced that clinicians at Duke University Medical School have used its ALDESORT product to isolate stem cells from cord blood and safely infused these cells into patients.

University Research Stretches the Limits to Heal Spinal Cords
Smith and his University of Pennsylvania colleagues have taken clumps of nonessential nerve-cell bodies from rats, stretched them very slowly – a millimeter or two a day, in specially constructed stretching boxes – and successfully implanted them into other rats with injured spinal cords.

Seoul National University Dismisses Hwang
Seoul National University’s disciplinary committee announced on 20 March that it would dismiss disgraced cloner Woo Suk Hwang for his involvement in fabricating data.

Scientists One Step Closer to Cancer Vaccine
Scientists at Karolinska Institutet in Sweden have helped to identify a molecule that can be used as a vaccination agent against growing cancer tumours.


Pluripotency of Spermatogonial Stem Cells from Adult Mouse Testis
Isolation of SSCs (spermatogonial stem cells) from adult mouse testis using genetic selection, with a success rate of 27%.

Synergistic Antitumor Effects of Immune Cell-Viral Biotherapy
Researchers combined an immune effector cell population (cytokine-induced killer (CIK) cells) with an oncolytic viral therapy to achieve directed delivery to, and regression of, tumors in both immunodeficient and immunocompetent mouse models.


Australian Government Faces Decision on Stem Cell Research
Pressure is mounting in Howard Government ranks for a conscience vote on stem cell and cloning legislation.

Abbott to Block Cloning
The Australian Federal Government is facing another divisive debate when laws on controversial stem-cell research go before Parliament.

President Bush’s 2007 Budget Spends $600 Million on Stem Cell Research
Under the 2007 budget, the National Institutes of Health would spend $605 million on stem cell research.


Geron Enters Into Research and Exclusive License Agreements With the University of Oxford for Derivation of Dendritic Cells From Human Embryonic Stem Cells
In a license agreement with Isis Innovation Ltd., the University’s technology transfer company, Geron receives a worldwide exclusive license under patent applications filed by the University for pioneering work by Oxford scientists who derived dendritic cells from hESCs.

VistaGen Therapeutics and Cato BioVentures Sign Strategic Business Development Agreement for CNS Products
VistaGen Therapeutics, Inc., a biopharmaceutical company applying leading embryonic stem cell technology to discover and develop novel treatments for central nervous system disorders, diabetes and cardiovascular disease, and Cato BioVentures, the venture capital affiliate of Cato Research Ltd., a global contract research organization, announced today the signing of a strategic business development agreement.

CytoGenix Enters into a Supply Agreement with GE Healthcare for DNA Production Reagents
GE Healthcare, a unit of General Electric Company, and CytoGenix, Inc. have entered into a supply agreement in which GE Healthcare will provide CytoGenix with DNA production reagents for use in the manufacture of vaccines and therapeutic compounds by CytoGenix.

Norwood Immunology Partners with Australian Stem Cell Centre and Monash University
Norwood Abbey’s subsidiary Norwood Immunology has signed a tripartite research agreement with the Australian Stem Cell Centre and Monash University to form a new technology platform combining immune system research with stem cell know-how.



Guidance on Use of Telecommunications for IACUC Meetings under the PHS Policy on Humane Care and Use of Laboratory Animals (NOT-OD-06-052)

Program Projects for Basic Research on Human Embryonic Stem Cells (P01)(RFA-GM-07-002)

New Approaches to Non-Viral Systems for Gene Transfer Applications for Heart, Lung, and Blood Diseases (R21/R33) (PA-06-243)

Pancreatic Development and Regeneration: Toward Cellular Therapies for Diabetes (R01) (PA-06-271)

Pancreatic Development and Regeneration: Toward Cellular Therapies for Diabetes (R21) (PA-06-272)

Collaborative Research in Stem Cell Biology (R21) (PAS-06-264)

Axonal Damage in Multiple Sclerosis: Strategies for Protection and Repair (R21) (PAS-06-266)


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

Substantially Equivalent 510(k) Device – BD Vacutainer SST II Advance Tubes; BD Vacutainer Plus K2EDTA Tubes; BD Vacutainer Plus Serum Tubes; BD Vacutainer SST Glass Tubes; BD Vacutainer SST Plus Tubes – Becton, Dickinson & Co

Workshop on Behavior-Based Donor Deferrals in the Era of Nucleic Acid Testing – Slide Presentations


Food and Drug Administration (United States of America)

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction


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

AABB-ISCT Cellular Therapy Audioconference Series

The organizing committee for the 6th Annual Somatic Cell Therapy Symposium is asking for your assistance with the program of this year’s meeting. The original survey that was posted experienced technical difficulties and did not capture all of the responses. Therefore, we are requesting you take a few moments to visit this link to take the survey again even if you have previously responded.

Please respond by March 29, 2006.

Here is a link to the survey:

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

Profiled Journal

Current Volume: Volume 15, No. 1


Original Contributions

Genetic Modification of Hepatocytes Towards Hepatocyte Transplantation and Liver Tissue Engineering
Hiroyuki Kuge, Kazuo Ohashi, Takashi Yokoyama, Hiromichi Kanehiro, Michiyoshi Hisanaga, Fumikazu Koyama, Ginny L. Bumgardner, Ken-Ichiro Kosai, and Yoshiyuki Nakajima

Hepatocyte Transplantation in the Long Evans Cinnamon Rat Model of Wilson’s Disease
Seon Mee Park, Kim Vo, Michel Lallier, Alexis-Simon Cloutier, Pierre Brochu, Fernando Alvarez, and Steven R. Martin

Cryopreserved Fetal Liver Cell Transplants Support the Chronic Failing Liver in Rats With CCl4-Induced Cirrhosis
Olga V. Ochenashko, Nataliya A. Volkova, Svetlana P. Mazur, Alexander Yu. Somov, Barry J. Fuller, and Alexander Yu. Petrenko

Analysis of the Effects of Cryopreservation on Rat Hepatocytes Using SELDI-TOF Mass Spectrometry
Claire Terry, Matthew Bailey, Ragai R. Mitry, Sharon C. Lehec, Anil Dhawan, and Robin D. Hughes

Sertoli Cells Induce Systemic Donor-Specific Tolerance in Xenogenic Transplantation Model
R. Shamekh, N. S. El-Badri, S. Saporta, C. Pascual, P. R. Sanberg, and D. F. Cameron

Effects of Simulated Microgravity on the Morphology and Function of Neonatal Porcine Cell Clusters Cultured With and Without Sertoli Cells
G. Luca, M. Calvitti, C. Nastruzzi, G. Macchiarulo, E. Becchetti, L. M. Neri, S. Capitani, G. Basta, P. Brunetti, R. Calafiore, and D. F. Cameron

Engineered Cell Therapy for Sustained Local Myocardial Delivery of Nonsecreted Proteins
Jing Bian, Matt Kiedrowski, Niladri Mal, Farhad Forudi, and Marc S. Penn

Molecular Imaging Reveals Skeletal Engraftment Sites of Transplanted Bone Marrow Cells
Philipp Mayer-Kuckuk, Mikhail Doubrovin, Luc Bidaut, Tulin Budak-Alpdogan, Shangde Cai, Vanessa Hubbard, Onder Alpdogan, Marcel van den Brink, Joseph R. Bertino, Ronald G. Blasberg, Debabrata Banerjee, and Juri Gelovani

Book Reviews

Bone Morphogenetic Protein and Collagen (Glyn O. Phillips, editor)
Deana Hussamy and John T. Sinnott

Epidermal Cells: Methods and Protocols (Kursad Turksen, editor)
Deepak Agrawal

Stem Cells in Endocrinology (Linda B. Lester, editor)
Niketa A. Patel

Cell Transplantation publishes original, peer-reviewed research and review articles on the subject of cell transplantation and its application to human diseases. To ensure high-quality contributions from all areas of transplantation, separate section editors and editorial boards have been established. Articles deal with a wide range of topics including physiological, medical, preclinical, tissue engineering, and device-oriented aspects of transplantation of nervous system, endocrine, growth factor-secreting, bone marrow, epithelial, endothelial, and genetically engineered cells, among others. Basic clinical studies and immunological research papers are also featured. To provide complete coverage of this revolutionary field, Cell Transplantation will report on relevant technological advances, and ethical and regulatory considerations of cell transplants.