Volume 7.28 | Jul 24

Volume 7.28, July 24, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Bush Vetoes Stem Cell Bill: The House failed to muster enough votes to override President Bush’s veto of a bill to expand federally funded embryonic stem cell research.


Breast Stem Cells Have Features Similar To ‘Basal’ Tumours
Scientists have discovered that breast stem cells do not express receptors for the female hormones oestrogen or progesterone. These and other features of the stem cell resemble the aggressive ‘basal’ subtype of breast cancer.

Scientists Isolate Leukemia Stem Cells in a Model of Human Leukemia
The leukemia stem cells isolated proved to be surprisingly different from normal blood stem cells, a finding that may be good news for developing a drug that selectively targets them.

Probable Cause of Deadly Brain Cancers Established
New evidence adds weight to the theory that one of the most deadly forms of brain cancer, called malignant glioma, is caused when stem cells deep within the brain begin to proliferate abnormally.

Massachusetts General Hospital Study Finds Potential Ovarian Cancer Stem Cells
These cells may underlie tumor recurrence and resistance and suggest new treatment approaches.

Cytori Therapeutics Reports Safety and Efficacy of its Celution System (TM) in a Preclinical Study of Coronary Artery Disease
Cytori Therapeutics, Inc. reported top-line preliminary results demonstrating that adipose-derived stem and regenerative cells from its proprietary Celution (TM) System were safe and improved heart function in a chronic ischemia model, representing a severe form of coronary artery disease.

Study Establishes Safety of Spinal Cord Stem Cell Transplantation
Transplanting human embryonic stem cells does not cause harm and can be used as a therapeutic strategy for the treatment of acute spinal cord injury

Gene Therapy Overcomes Muscular Dystrophy
Focusing on the muscleblind protein, scientists eliminated muscle hyperexcitability in a mouse model of the most common form of muscular dystrophy.

Research Finds Antibodies Seem to Stop Alzheimer’s in its Tracks
Treatment with antibodies naturally produced in the body appears to halt the memory-robbing progression of Alzheimer’s disease.

Cell Genesys, Inc. Launches Expanded Multiple-Dose Phase 1 Trial Of CG0070 In Recurrent Bladder Cancer
The expanded trial was prompted by encouraging interim safety and efficacy data recently reported for single-dose administration of CG0070 and will include up to 45 additional patients.

Facial Rejuvenation Product Successfully Completes Phase I Study
Intercytex, the cell therapy company developing products for the advanced woundcare and aesthetic medicine markets, today announces the successful completion of a Phase I study of ICX-RHY, its novel cell therapy product for facial rejuvenation.

Biovest International Gains Key Regulatory Approval for Clinical Trial Sites in Russia
Biovest International, Inc. has received regulatory approval for its ongoing Phase 3 clinical trial of BiovaxID(TM) for the treatment of indolent follicular non-Hodgkin’s lymphoma (NHL).

FDA Grants Intracel Special Protocol Assessment (SPA) for Confirmatory, Pivotal Phase III Study of OncoVAX(R) Colon Cancer Vaccine
The OncoVAX(R) vaccine is designed to prevent recurrence in Stage II colon cancer patients following surgical tumor resection.

Stem Cell Process to Aid Kidney Transplant Sans Drugs
The Kidney Hospital in Ahmedabad has announced a major breakthrough by which embryonic stem cell-aided transplant will enable a kidney patient to accept a donor organ with minimal dose of drugs.

Human Stem Cells Can Contribute to a Developing Mouse Embryo, Despite Evolutionary Differences
Using a newly derived line of human embryonic stem cells, Rockefeller University researchers have coaxed human cells to grow in mouse tissue.


Stem Cells: The Real Culprits in Cancer?
A dark side of stem cells – their potential to turn malignant – is at the root of a handful of cancers and may be the cause of many more. Eliminating the disease could depend on tracking down and destroying these elusive killer cells


Schwarzenegger Gives $150 million Loan to Stem Cell Agency
A day after President Bush vetoed expanded federal funding of embryonic stem cell research, Governor Arnold Schwarzenegger authorized a $150 million loan to fund California’s stem cell institute.

California Panel Against Forcing Biotechs to Share Stem Cell Research
The intellectual property task force of the California stem cell agency board recommended against requiring the biotech industry to share its state-supported stem cell research with research institutions in the state.

Germany Seeks EU Ban on Stem Cell Research Funding
Germany urged its fellow European Union members to impose a ban on supporting embryonic stem cell research with EU science program funds.


DomaniCell Launches Hospital-based Cord Blood Banking Business
The program involves hospitals partnering with DomaniCell to develop their own cord blood stem cell banking program that is built on DomaniCell infrastructure and technology.

Millipore Completes Acquisition of Serologicals
Acquisition will transform Millipore into a $1.4 billion life science leader with leading positions in rapidly growing markets.

Netcare Buys Stake in Stem Cell Firm
South African healthcare group Netcare acquired a 75 percent stake in stem cell storage company Biocells Ltd, which markets and collects umbilical cord blood.

Cord Blood America Announces it is Nearing Collection of Adipose Tissue Stem Cells for Future Medical Use
The Company is moving forward in developing one of the nation’s first private storage companies to collect adult stem cells from adipose tissue for future medical use.

US Patent Office Upholds Neuralstem Patent
Neuralstem, Inc. has announced the issuance of a certificate of reexamination from the USPTO confirming the validity of one of its core patents covering both process and composition of matter claims for it’s proprietary human neural stem cells.

Request to Re-Examine WARF Stem Cell Patents Escalates War of Words
The Public Patent Foundation, on behalf of the California-based Foundation for Taxpayer and Consumer Rights, filed a formal request with the United States Patent and Trademark Office to re-examine three patents held by WARF.


Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research (PA-06-481)


The Australia New Zealand Therapeutic Products Authority Project (Australia and New Zealand)

The Australia New Zealand Therapeutic Products Authority Project July Newsletter

Medsafe (New Zealand)

Regulatory Consultants

GMP Certified Contract Testing Laboratories

Medicines and Healthcare Products Regulatory Agency (United Kingdom)

Implementation of the Good Clinical Practice Directive


AABB-ISCT Cellular Therapy Audioconference Series

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

European branch of the International Society for Cellular Therapy (ISCT-Europe) and German Society for Transfusion Medicine and Immunohematology (DGTI) Joint meeting “Regulatory Framework for Advanced Medicinal Products in Europe”

Profiled Journal

Current Issue: Volume 15, No. 4


Original Contribution

Neural Transplantation in Huntington’s Disease: The NEST-UK Donor Tissue Microbiological Screening Program and Review of the Literature
M. Farrington, T. G. Wreghitt, A. M. L. Lever, S. B. Dunnett, A. E. Rosser, and R. A. Barker


Chemokines and Their Receptors in Islet Allograft Rejection and as Targets for Tolerance Induction
Shaheed Merani, Wayne Truong, Wayne W. Hancock, Colin C. Anderson, and A. M. James Shapiro

Original Contributions

Porcine Islet Graft Function Is Affected by Pretreatment With a Caspase-3 Inhibitor
Daniel Brandhorst, Vidya Kumarasamy, Adel Maatoui, Alexandra Alt, Reinhard G. Bretzel, and Heide Brandhorst

Survival and Function of Transplanted Islet Cells on an In Vivo, Vascularized Tissue Engineering Platform in the Rat: A Pilot Study
David L. Brown, Peter J. Meagher, Kenneth R. Knight, Effie Keramidaris, Rosalind Romeo-Meeuw, Anthony J. Penington, and Wayne A. Morrison

Maintenance of Mouse, Rat, and Pig Pancreatic Islet Functions by Coculture With Human Islet-Derived Fibroblasts
Atsushi Miki, Michiki Narushima, Teru Okitsu, Yuichi Takeno, Alejandro Soto-Gutierrez, Jorge David Rivas-Carrillo, Nalú Navarro-Alvarez, Yong Chen, Kimiaki Tanaka, Hirofumi Noguchi, Shinichi Matsumoto, Michinori Kohara, Jonathan R. T. Lakey, Eiji Kobayashi, Noriaki Tanaka, and Naoya Kobayashi

Differentiation of Human Embryonic Stem Cells to Hepatocytes Using Deleted Variant of HGF and Poly-amino-urethane-Coated Nonwoven Polytetrafluoroethylene Fabric
Alejandro Soto-Gutierrez, Nalú Navarro-Alvarez, Jorge David Rivas-Carrillo, Yong Chen, Tomoki Yamatsuji, Noriaki Tanaka, and Naoya Kobayashi

The Development and Characterization of an HEK293-Derived Cell Line for Use in an Intratumoral Cytokine Delivery System
M. J. Hamilton, Q. X. Huang, C. L. Li, and K. A. O. Ellem

Short-Term Heart Retention and Distribution of Intramyocardial Delivered Mesenchymal Cells Within Necrotic or Intact Myocardium
Nguyen Tran, Yan Li, Fatiha Maskali, Laurent Antunes, Pablo Maureira, Marie-Helene Laurens, Pierre-Yves Marie, Gilles Karcher, Frederique Groubatch, Jean-François Stoltz, and Jean-Pierre Villemot

Brief Communication

Survival of Microencapsulated Islets at 400 Days Posttransplantation in the Omental Pouch of NOD Mice
Tsunehiro Kobayashi, Yukio Aomatsu, Hiroo Iwata, Tatsuya Kin, Hiromichi Kanehiro, Michiyoshi Hisanga, Saiho Ko, Mitsuo Nagao, George Harb, and Yoshiyuki Nakajima

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.