Volume 7.21 | Jun 5

Volume 7.21, June 5, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

VitroGro(R) World-First: Culture of Human Embryonic Stem Cells for Therapeutic Use: Brisbane-based biotechnology company Tissue Therapies Limited has potentially overcome a major hurdle in the race to use human embryonic stem cells for medical treatment with the discovery that its VitroGro® technology can be used to replace animal or human serum in the culture of human embryonic stem cells.


Study in Leading Cell Journal Supports Scientific Basis for BrainStorm Cell Therapeutics’ Technology
BrainStorm Cell Therapeutics, Inc. announced today that a new study, published in the April issue of Stem Cells and Development, reports a predisposition of human bone marrow-derived stem cells to differentiate into a variety of nerve cell types. These findings support the prospect of using cell therapies derived from adult bone marrow-derived stem cells to treat devastating neurological diseases such as Parkinson’s disease.

Human Stem Cells Go Into Goat Embryo
A team of Shanghai scientists has reported that it performed the world’s first successful transfer of human stem cells into goat embryos, taking an important step toward using genetic engineering to prevent disease.

Amorcyte, Inc Opens Cell Therapy Trial for Cardiovascular Disease at Emory University
Amorcyte Inc (Amorcyte), a privately funded cell therapy company developing products to treat cardiovascular disease, announced today that its Phase I clinical trial is now open at Emory University School of Medicine, under Arshed A. Quyyumi, M.D., FRCP, FACC, Professor of Medicine, Cardiology, and is expected to open in another center within 90 days.

First Three Patients Treated in Adipose Stem and Regenerative Cell Clinical Safety and Feasibility Study for Breast Reconstruction; Represents First Clinical Use of Cytori’s Regenerative Cell Processing System
Cytori Therapeutics, Inc. has announced the enrollment and treatment of the first three patients in a study using adult adipose (fat) derived stem and regenerative cells for breast reconstruction cancer therapy.

Can Patients’ Stem Cells Fight Heart Disease?
A small group of Twin Cities heart attack victims will receive infusions of their own stem cells as part of a study to prevent congestive heart failure.

Islet Cell Transplantation Significantly Improves Glycemic Control in Diabetes
Patients with type 1 diabetes who receive transplants of insulin-producing islet cells have significantly more stable blood glucose levels and fewer hypoglycemic episodes.

Parents Back Child Gene Therapy
The overwhelming majority of parents whose children have cystic fibrosis want gene therapy trials to go ahead, bypassing normal research guidelines.

Introgen Therapeutics, Inc.’s ADVEXIN p53 Therapy Demonstrates Clinical Benefit In Inherited Cancer
Introgen Therapeutics, Inc. presented important data describing the beneficial effects and key markers of clinical activity in a cancer patient with Li-Fraumeni Syndrome (LFS), a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene.

Two More Professors Suspended in Embryonic Stem Cell Research Scandal
Seoul National University has suspended professors Kang Sung-Keun and Lee Byung-Chun after the nation’s government indicted them on charges of fraud and embezzlement in the misuse of research money.

Hwang Woo-suk Wants to Resume Stem Cell Research
South Korea’s disgraced stem cell researcher Hwang Woo-suk has expressed hope in resuming his research, Hwang’s lawyer said.


Nanotechnology: Assessing the Risks
Andrew Maynard of the Woodrow Wilson International Center for Scholars calls for a strategic approach to research on potential risks to ensure the development of safe, publicly acceptable nanotechnology products.

Moving Human Embryonic Stem Cells from Legislature to Lab: Remaining Legal and Ethical Questions
Research with human embryonic stem cells (hESCs) has been controversial, but in the seven years since their isolation by James Thomson, governments have largely answered, at least for now, the first-level questions about this research. A set of second-level questions, revolving around the donors of cells and embryos used in this research, is also rapidly being answered.


South Korea Aims to be in Top Three in Stem Cell Funding
The Korean government has set up a plan to channel roughly 430 billion won ($454 million) of taxpayers’ money into stem cell research over the next decade.

Italian Minister in Storm Over Stem Cell Research
A move by the new center-left government suggesting it might break with the conservative past by favoring embryonic stem cell research has caused a political storm in Italy.


Bioheart and PharmaCell Open GMP Lab Facility in Europe to Support Adult Stem Cell Research
This new lab is an advanced research facility that also has GMP cell production capabilities to support research related to Bioheart’s adult muscle stem cell technology.

Novocell, Juvenile Diabetes Research Foundation Announce Partnership to Clinically Test Encapsulated Human Islets
The Juvenile Diabetes Research Foundation announced today that it has established a partnership with Novocell, Inc., an Irvine, California-based, biotechnology company, to support an on-going proof of principle Phase I/II human clinical trial for Novocell’s polyethylene glycol encapsulation of insulin-producing islets.

BioE and University of Newcastle Form Research Partnership to Advance Near-Term Therapeutic Application of Cord Blood Stem Cells
BioE(R), Inc., a biomedical company providing human cord blood stem cells as enabling, high-quality cellular tools for drug discovery and therapeutic research, and the University of Newcastle upon Tyne in England have announced that the two parties have formed a research partnership to advance the near-term therapeutic application of cells derived from human umbilical cord blood, including stem cells.

Medistem Advances Negotiations to License New Stem Cell Laboratories and Clinics in Europe, Asia and North America
Medistem Laboratories, Inc., committed to the ethical development of next-generation medical therapies from non-controversial adult stem cell sources, has announced continued progress in its strategic goal to establish a series of international laboratory and clinical facilities to conduct research and fee-for-service treatments employing the Company’s proprietary stem cell-based therapeutic technologies.

Stem Cell Innovations Officially Opened its European R&D Facility in Leiden, The Netherlands Stem Cell Innovations, Inc. has announced that the Company has opened a new R&D facility to commercialise their proprietary platform of human pluripotent stem cells (PCs(TM)) in Europe.

Bristol-Myers Squibb To Build New Biologics Facility In Massachusetts
Bristol-Myers Squibb Company has announced that the company intends to build a new large-scale multi-product bulk biologics manufacturing facility in Devens, Massachusetts, subject to final agreement between the company and the state.

Healtheuniverse Announces Corporate Update; Pursuing New Lab Facilities and Major Pre-Clinical Stem Cell Trials
Healtheuniverse Inc., a diversified biotechnology development firm specializing in the development and commercialization of patented biopharmaceutical and biomedical products is pleased to report that progress is being made towards the acquisition of new expanded lab facilities in preparation for a major pre-clinical trial utilizing its proprietary non-embryonic stem cell technology.

ViaCell, Inc. And Children’s Hospital Oakland Research Institute (CHORI) Expand Sibling Cord Blood Donor Program
The combined program brings together CHORI’s nation-wide program and transplant experience with the high quality processing and customer service offered by ViaCord(R), ViaCell’s product offering for the preservation and storage of cord blood for related use.

ViaCell Announces New Office Actions Rejecting PharmaStem Patent Claims
ViaCell, Inc. has announced that, following a re-examination, the United States Patent and Trademark Office (PTO) issued two new office actions rejecting all of the claims of PharmaStem Therapeutics Inc.’s U.S. Patent No. 5,192,553 and U.S. Patent No. 6,569,427 as being unpatentable over prior art.

Oncolytics Biotech Inc. Announces Issuance of 17th U.S. Patent
Oncolytics Biotech Inc. has been granted U.S. Patent 7,052,832 entitled “Methods for the Treatment of Cellular Proliferative Disorders.” The claims describe methods of identifying the susceptibility of cells to reovirus infection.

Ortec International Inc. Obtains First U.S. Patent Allowance On Haptide(TM) Cell Attachment Technology
Haptides(TM), developed at Hapto Biotech, Israel, Ortec’s wholly owned subsidiary, by Drs. Gerard Marx and Raphael Gorodetsky, comprise proprietary synthetic peptides that mimic the mechanism by which cells attach to the blood clot protein, fibrinogen, and can improve the activity of a variety of biomaterials by accelerating the attachment of cells.

Does the Wisconsin Alumni Research Foundation’s European Stem Cell Patent Application Have a Realistic Chance for Approval?
Wisconsin Alumni Research Foundation’s application seeks patent protection for a purified preparation of primate and human embryonic stem cells. The European Patent Office’s Examining Division rejected the application in 2004; however, WARF has appealed this ruling.

Patent Experts Criticize Streamlining Proposal
Increasing backlogs at the U.S. Patent Office are a longstanding frustration for biotech executives. But they said a new set of proposals meant to reduce the waiting time will not provide much relief.

Dr. Gabor Rubanyi Of Berlex Biosciences Joins Cardium Therapeutics, Inc. As Chief Scientific Officer
Cardium Therapeutics, Inc. announced today the appointment of Gabor M. Rubanyi, M.D., Ph.D. as Chief Scientific Officer.

China the “Land of Opportunity” for Stem Cell Research
China could be the first country to conduct human stem cell trials and presents a significant opportunity for Western companies who are brave enough to use this risky destination as a place to pursue this potentially lucrative sector of the biotech industry.


Approved Biological NDA and ANDA Applications – Update

Clinical Investigator Inspection List – Updated


Food and Drug Administration (United States of America)

Acting Head of FDA to Quit as NCI Director
The acting head of the FDA has decided to give up his other job as director of the National Cancer Institute, effective June 10.

Guidance for Industry on Chemistry, Manufacturing, and Controls Information; Withdrawal and Revision of Seven Guidances

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New Drug Regulations

Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

International Conference on Harmonisation; Guidance on Q9 Quality Risk Management; Availability

Center for Disease Control and Prevention (United States of America)

Morbidity and Mortality Weekly Report: Investigation into Recalled Human Tissue for Transplantation

European Medicines Agency (Europe)

European Medicines Agency Introduces New, Faster Scientific Advice Procedure
The European Medicines Agency has finalised its ‘New Framework for Scientific Advice & Protocol Assistance’, which introduces significant changes to the way the Agency provides scientific advice on the research and development of new medicines.

Profiled Journal

Current Volume: Volume 15, No. 3



Original Contributions

Repairing the Nervous System: A Special Issue Based on the 12th Annual
American Society for Neural Therapy and Repair (ASNTR) Meeting
Kathy Steece-Collier

Timing of Cord Blood Treatment After Experimental Stroke Determines Therapeutic Efficacy
Jennifer D. Newcomb, Craig T. Ajmo, Jr., Cyndy D. Sanberg, Paul R. Sanberg, Keith R. Pennypacker, and Alison E. Willing

Genetically Engineered Human Mesenchymal Stem Cells Produce Met-Enkephalin at Augmented Higher Levels In Vitro
Ikuko Sugaya, Tingyu Qu, Kiminobu Sugaya, and George D. Pappas

Behavioral and Histological Characterization of Intrahippocampal Grafts of Human Bone Marrow-Derived Multipotent Progenitor Cells in Neonatal Rats With Hypoxic-Ischemic Injury
Takao Yasuhara, Noriyuki Matsukawa, Guolong Yu, Lin Xu, Robert W. Mays, Jim Kovach, Robert J. Deans, David C. Hess, James E. Carroll, and Cesar V. Borlongan


Progressive Dopamine Neuron Loss in Parkinson’s Disease: The Multiple Hit Hypothesis
Paul M. Carvey, Ashok Punati, and Mary B. Newman

Neural Repair Strategies for Parkinson’s Disease: Insights From Primate Models
Katherine Soderstrom, Jennifer O’Malley, Kathy Steece-Collier, and Jeffrey H. Kordower

CNS Gene Therapy and a Nexus of Complexity: Systems and Biology at a Crossroads
Carolyn M. Tyler and Howard J. Federoff


Additional Abstracts for the 13th Annual Meeting of the American Society for Neural Therapy and Repair

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.