Volume 7.43 | Nov 6

Volume 7.43, November 6, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

British Scientists Grow Human Liver in a Laboratory: British scientists have grown the world’s first artificial liver from stem cells in a breakthrough that will one day provide entire organs for transplant.

Cytotherapy Report Confirms BioE Stem Cell Is First Human Cord Blood Stem Cell to Differentiate into Lung Cell: BioE(R), Inc. has announced that a report published in the latest issue of the journal Cytotherapy confirms its Multi-Lineage Progenitor Cell™ (MLPC™) is the first human cord blood stem cell to differentiate into a type II alveolar lung cell.


BioLife Solutions Incorporated and Corning Incorporated Announce Increased Cell Performance Through Product Combination
Corning(R) CellBIND(R) surface used with BioLife Solutions’ CryoStor(TM) offers 58-percent increase in 24-hour post-preservation cell survival.

Stem Cells Engage in Dialogue with Cells that Regulate their Future
Dialogue, not a monologue, is the basis of all good communication. Stem cells are no exception. Recent University of Washington (UW) research has found an early indication of two-way cellular communication. This two-way cell-to-cell signaling occurs in the miniscule niches of the body where the futures of stem cells are determined.

Stem Cell Fish Research Shows Heart Regeneration
New information about how the hearts of tiny zebrafish regenerate could help in developing new ways to treat heart damage in humans.

White Blood Cells of Cancer-resistant Mice Overwhelm Natural Defenses of Cancer Cells
The discoverers of the unique mouse line that is resistant to cancer have begun to pin down how the process works and found that white blood cells in these mice overwhelm normal defenses of cancer cells.

A New Form of Gene Therapy Could be Used to Treat Impotence in Diabetic Men
Research in the US has shown that replacing a faulty gene in rats with the equivalent of diabetes can improve their erectile function, suggesting that a similar approach might be useful in diabetic men.

Pluristem Expects to Submit Pre-IND Document to FDA by End of 2006
Pluristem recently presented a Pre-Pre-IND to the Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapies, a department in the Food and Drug Administration (FDA). The Pre-Pre-IND documented the final results of an animal model study using the Company’s innovative adjuvant cell therapy product based on PLacenta eXpanded Mesenchymal cells (PLX-I).

Stem Cell Sciences to Test Neural Stem Cells for Spinal Cord Injury
Stem Cell Sciences PLC said its Neural Stem Cells are to enter pre-clinical testing for spinal cord injury in a collaboration with Regenerative Medicine Institute (REMEDI) at the National University of Ireland, Galway.

INNOVIVE Pharmaceuticals Begins Enrollment in Phase I Study of INNO-305 Peptide Immunotherapy in AML, MDS, Mesothelioma and Non-Small Cell Lung Cancer
INNOVIVE Pharmaceuticals, Inc. has announced that a Phase I clinical trial investigating INNO-305 in acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), mesothelioma and non-small cell lung cancer (NSCLC) has enrolled its first patient.

Northwest Biotherapeutics Discusses Results From Clinical Trials in Brain Cancer at Two Conferences
Northwest Biotherapeutics updated survival and progression data on patients from two clinical trials carried out at The University of California at Los Angeles.

Gamida Cell’s StemEx(R) Registration Study Receives SPA from the FDA
Gamida Cell Ltd. announced it has reached an agreement under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) on the design of the global, pivotal, historical controlled registration study of StemEx(R) for the treatment of hematological malignancies.

Dendreon Presents New Data Correlating Potency of PROVENGE to Survival in Phase 3 Studies
Dendreon Corporation has announced data from an exploratory analysis of Phase 3 Studies (D9901 and D9902A) that showed a significant correlation between cumulative CD54 upregulation and survival for patients treated with Dendreon’s investigational active cellular immunotherapy PROVENGE(R) (sipuleucel-T) in men with advanced androgen-independent (hormone refractory) prostate cancer.

New Biologic Treatment for Tennis Elbow
Specially-prepared platelets taken from the patient which are then re-injected into the tendon of the affected elbow provide more relief than more commonly-used therapies which have failed to yield results, often resulting in surgery.

A Better Way to Build a Face
Scientists are poised to perform the first full-face transplant, but a group of Stanford surgeons hopes to eliminate the need for the drastic surgery altogether by learning to regenerate the skin on the face

Targeting Cancer Stem Cells to Stop Brain Tumors
Research on a novel approach to brain cancer – exploring the notion that the source of a brain tumor is a normal stem cell that has gone bad – is moving forward thanks to an award from the James S. McDonnell Foundation to a neurologist at the University of Rochester Medical Center.


Adipose Tissue-Derived Mesenchymal Stem Cells Have In Vivo Immunosuppressive Properties Applicable for the Control of the Graft-Versus-Host Disease
These findings constitute the first experimental proof that Ad-MSCs can efficiently control the GVHD associated with allogeneic hematopoietic transplantation, opening new perspectives for the clinical use of adipose tissue-derived MSCs.


Panel Of Medical Researchers Compare Embryonic Stem Cell Research Practices In U.S., U.K.
A panel of United Kingdom and United States researchers on Wednesday at a Center for American Progress presentation compared human embryonic stem cell research practices in the U.S. and the U.K.

Senate Investigation Recommends Lifting Australian Ban on Stem Cell Cloning
The Senate will next month debate legislation that would relax rules on stem cells research.

Stem Cell Agency Still Waiting for $150M Promised by Governor
A highly publicized $150 million state loan that Governor Arnold Schwarzenegger promised California’s cash-strapped stem cell agency in July has yet to materialize, a delay apparently caused by red tape and election year politics.

New Mexico Governor Proposes $10M Plan for Embryonic Stem Research
New Mexico Governor Bill Richardson has proposed a $10 million, three-year plan to fund embryonic stem cell research in the state, including funds to build a research facility at the University of New Mexico, recruit scientists and create a training program.

New York State Will Provide $10 Million for Stem Cell Blood Bank
The state of New York will provide $10 million to establish a new umbilical cord blood bank that will provide lifesaving stem cells to people with blood diseases.


Merck, Sirna Agree to $1.1B Merger for RNAi Work
Merck plans to buy Sirna Therapeutics to acquire the biotech’s RNA interference technology, the subject of this year’s Nobel Prize in medicine.

Challenges Faced by Stem Cell Therapy Make Venture Capitalists Wary
The enormous market potential for cell-based therapeutic products is matched by considerable challenges facing young biotech companies entering the sector, says Dr Cathy Prescott of Avlar BioVentures.

Mirus Granted European Patent for Gene Therapy
Mirus Bio Corp., a Madison-based biotechnology firm, has won a European patent, its first outside the U.S., that covers a method of treating patients with muscle and other tissue diseases with an injection of genes.

Accentia Biopharmaceuticals Majority-Owned Subsidiary Commercially Launches AutovaxID(TM)
Biovest International, Inc. announced that it has launched its breakthrough AutovaxID automated cell culture device for commercial sale.

Online Embryonic Research Library Created
Two Arizona professors and an international team are working to build an online library of information on controversial issues relating to embryonic research, including stem-cell research, cloning and abortion.

Diseases Put on Notice
The McEwen Centre for Regenerative Medicine, adjacent to Toronto General Hospital, marked its official opening yesterday, bringing together top stem-cell researchers to find new treatments for cancer, heart disease, diabetes, respiratory disease and spinal cord injuries.


New Ethics Rules Causing Many NIH Scientists to Leave 
An agency survey found most NIH scientists believe the rules put in place last year to eliminate conflicts of interest are too severe and will hinder the NIH’s ability to attract medical researchers.

Notice of Intent to Reissue a R01 Request for Applications for Minority Organ and Tissue Donation (RFA-DK-02-019) (NOT-DK-06-019)

Minority Organ and Tissue Donation (R01) (RFA-DK-06-016)

Notice of the NHLBI Program for Ancillary Studies in Clinical Trials (NOT-HL-06-136)


Notice: FDA Form 3356 Annual Tissue Establishment Registration – December 2006

American Association of Blood Banks Annual Meeting – Slide Presentations

CBER Organizational Information – Update

Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) – Alphabetical List of Registered Establishments – Update

Biological Product Deviation Reporting Product Deviation Codes – Update

Substantially Equivalent 510(k) Device Information – BloodTrack 4.1 – Neoteric Technology Ltd


International Cellular Therapy Coding and Labeling Advisory Group (International)

International Cellular Therapy Coding and Labeling Advisory Group Progress Report

Food and Drug Administration (United States of America)

Guidance for Industry on Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Availability

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Public Meeting; Extension of Comment Period

Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

Medicines and Healthcare Products Regulatory Agency (United Kingdom)

Clinical Trials For Medicines: Memorandum of understanding between MHRA, COREC (Central Office for Research Ethics Committees) and GTAC (Gene Therapy Advisory Committee)

Field Safety Notice – IVDS, Haematology: Software – Beckman Coulter (Beckman Instruments (UK) Ltd) – Software – Cytomics FC 500 MPL Flow Cytometry System with MXP Software

Therapeutic Goods Administration (Australia)

Latest Consolidation of the Therapeutic Goods Act

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

Continued Consultation on the Proposed Trans-Tasman Regulatory Scheme for Therapeutic Products

Second Phase of ANZTPA Consultation Documents Released


International Society for Cellular Therapy – http://www.celltherapysociety.org

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal


Current Issue: Volume 15, No 7



Bone Marrow Stromal Cells for Repair of the Spinal Cord: Towards Clinical Application
Rishi D. S. Nandoe, Andres Hurtado, Allan D. O. Levi, Andre Grotenhuis, and Martin Oudega

Original Contributions

Transplanted Human Neural Precursor Cells Migrate Widely But Show no Lesion-Specific Tropism in the 6-Hydroxydopamine Rat Model of Parkinson’s Disease
M. Jain, R. J. E. Armstrong, S. Elneil, and R. A. Barker

In Vitro Culture Duration Does Not Impact the Ability of Encapsulated Choroid Plexus Transplants to Prevent Neurological Deficits in an Excitotoxin-Lesioned Rat Model of Huntington’s Disease
Dwaine F. Emerich and Christopher G. Thanos

Retinal Progentior Cell Xenografts to the Pig Retina: Immunological Reactions
Karin Warfvinge, Jens F. Kiilgaard, Henry Klassen, Parisa Zamiri, Erik Scherfig, Wayne Streilein,
Jan U. Prause, and Michael J. Young

Resolution of Neurotoxicity and ?-Cell Toxicity in an Islet Transplant Recipient Following Substitution of Tacrolimus With MMF
Tatiana Froud, David A. Baidal, Gaston Ponte, Jacqueline V. Ferreira, Camillo Ricordi, and Rodolfo Alejandro

Tetracycline-Regulated Expression of VEGF-A in Beta Cells Induces Angiogenesis: Improvement of Engraftment Following Transplantation
Zoltan Mathe, Philippe Dupraz, Chris Rinsch, Bernard Thorens, Domenico Bosco, Marie Zbinden, Philippe Morel, Thierry Berney, and Michael S. Pepper

Transplantation of Murine Bone Marrow Stromal Cells Under the Kidney Capsule to Secrete Coagulation Factor VIII
Taekeun Oh, Alexandra Peister, Kazuo Ohashi, and Frank Park

Human Umbilical Cord Blood Progenitor Cells Are Attracted to Infarcted Myocardium and Significantly Reduce Myocardial Infarction Size
Robert J. Henning, Jose D. Burgos, Leo Ondrovic, Paul Sanberg, John Balis, and Michael B. Morgan

Brief Communication

Use of Repeating Dispensers to Increase the Efficiency of the Intramuscular Myogenic Cell Injection Procedure
Daniel Skuk, Marlyne Goulet, and Jacques P. Tremblay


Cell Transplantation: Toward Cell Therapy
Agneta SanMartin and Cesar V. Borlongan

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.

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