Volume 7.16 | May 1

Volume 7.16, May 1, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Osiris Completes Enrollment in Stem Cell Trial for Knee Repair: Osiris Therapeutics, Inc. announced today that it has completed enrollment in the first human clinical trial of a stem cell therapy to repair tissue in the knee.


The International Society for Stem Cell Research (ISSCR) Invites You to Attend Their 4th Annual Meeting
Join us at the International Society for Stem Cell Research (ISSCR) 4th Annual Meeting in Toronto June 29 – July 1, 2006.

Trial Set to Test How Stem Cells Heal a Broken Heart
A fresh supply of mitochondria does the trick, say researchers.

Stem Cells with Coronary Artery Bypass Grafting — Heart Failure Patient Shows Astonishing Improvement
Cardiac MRI tests confirm a dramatic 60% increase in patient’s heart function after procedure that combines coronary artery bypass grafting surgery with adult stem cell therapy.

Stem cell Trials Will Use Heart Patients
Timothy O’Brien, director of the Regenerative Medicine Institute in NUI Galway, is preparing tests involving 10 patients suffering from chronic heart conditions. They will have stem cells grafted on to their hearts, to see if this helps to repair the organs.

Stem Cells Used To Help Those With Knee Pain
Some Twin Cities doctors are using stem cells to give relief to people who suffer from chronic pain in their knees.

Experimental Stem Cell Surgery
A 2o-year-old left a quadriplegic after a diving accident is going to Portugal for an experimental surgery using his own stem cells.

Stem Cell Treatment Holds Promise for Kidney Disease
New research out of Beth Israel Deaconess Medical Center in Boston is holding out promise for people suffering from Alport syndrome, an inherited form of kidney disease that usually strikes in childhood.

Novel Stem Cell Technology Leads to Better Spinal Cord Repair
Scientists from the New York State Center of Research Excellence in Spinal Cord Injury showed that rats receiving a transplant of a certain type of immature support cell from the central nervous system (generated from stem cells) had more than 60 percent of their sensory nerve fibers regenerate.

Pluristem Initiates Pre-Clinical Study for PLX-1, an Innovative Stem Cell Solution for Improved Engraftment During Bone Marrow Transplantation
Pluristem Life Systems, Inc., a cell therapy company dedicated to the commercialization of stem cell products, today announced that the Company has started an animal model study of its innovative stem cell therapy product known as PLX-1.

Clues To Breast Cancer Hidden Inside Stem Cells
In the human breast, up to 20 per cent of all tumours are now suspected to originate in stem cells. Now scientists from the Icelandic Cancer Society and the Faculty of Medicine, University of Iceland have grown three-dimensional breast cell cultures to reveal unexpected subtleties about these stem cells that could explain why they spawn malignancies.

Stem Cell Clinic Doctor Hits Out At His Critics
The Cork GP at the centre of a stem cell therapy controversy, believes Ireland is wasting an opportunity for medical and commercial advance by turning its back on the technology.

Trial of Gene Therapy for Peripheral Arterial Disease Under Way at Stanford
A total of about 300 patients at 35 sites in the United States, England and Germany will take part in the study, which is sponsored by the Cambridge-based biotechnology company Genzyme Corp.

Scientists Investigate Gene-Therapy Death
Indirect side effects of therapeutic trials may have led to organ failure.

Safer Gene Therapy
A gene therapy pioneer explains how new delivery mechanisms could help revive the once-promising technology.

X-SCID Gene Therapy Poses Substantial Cancer Risk
New animal studies conducted at the Salk Institute for Biological Studies show that the only human gene therapy treatment to date considered to be largely successful, is, in fact, riskier than realized.

Light-Activated Gene Therapy Possible
A U.S. study has shown for the first time laser light can target gene therapy to the edge of damaged cartilage, while leaving healthy tissue untouched.

Cloned Dog Celebrates First Birthday in South Korea
The world’s first and only cloned dog celebrated its first birthday on Monday, as the leader of the South Korean team that produced the Afghan hound faced a criminal investigation for possible fraud and ethics violations.

HepaLife’s Artificial Liver Research Passes Critical Human Plasma Milestone
HepaLife Technologies, Inc., today announces that the Company’s PICM-19H liver cells have demonstrated the capability to fully survive and remain intact following exposure to human plasma, an important finding in the future integration of these cells into an artificial liver device for human use.

Brain Tumor Vaccine Shows Promise
A new vaccine could help extend survival for people stricken with a deadly brain tumor called glioblastoma multiforme (GBM).


Gene Therapy: Therapeutic Gene Causing Lymphoma
Gene-therapy trials for X-SCID, which have been based on the assumption that IL2RG is minimally oncogenic, may pose some risk to patients.

Astrocytes Derived from Glial-Restricted Precursors Promote Spinal Cord Repair
Pre-differentiation of glial precursors into GDAs before transplantation into spinal cord injuries leads to significantly improved outcomes over precursor cell transplantation, providing both a novel strategy and a highly effective new cell type for repairing CNS injuries.


Stem-Cell Debate Ends, For Now
The mere mention of embryonic stem-cell research was voted off a biomedical research bill Thursday, effectively ending the debate over the controversial issue this session.

Senate Panel Approves Paying for Embryonic Stem Cell Research
Several top Senate Republicans joined Democrats in voting Tuesday for a measure to provide state money for embryonic stem cell research, opening the door for continued debate on the controversial but potentially promising type of medical research.

Canadian Stem Cell Project Put On Hold
The $532,000 project, to be led by researchers in Toronto, Vancouver and London, Ont., was forwarded to the stem cell oversight committee for review last fall and the researchers had hoped it would be under way by now.


Operators of Fake Embryonic Stem Cell Research Company Arrested
Three men who ran a bogus embryonic stem cell research company in Utah that defrauded people around the world of millions of dollars have been arrested.

Living Cell Technologies awarded NZ$2.7m investment through the Foundation for Research, Science and Technology
Living Cell Technologies Limited today announced that it has been awarded investment of NZ$2.73 million (approx. A$2.32m) from the Foundation for Research, Science and Technology to further build the company’s cell production capability to meet clinical trial and market demands.

International Support For Swedish Stem Cell Research
Scientists at Swedish universities will be receiving international support for their research on stem cells. Seven research projects will be sharing SEK 36 million over three years.

Illinois Grant Supports Stem Cell Research at University of Illinois at Chicago
Researchers at the University of Illinois at Chicago have been awarded $2 million by the Illinois Regenerative Medicine Institute (IRMI) of the State of Illinois to establish a Center for the Development of Stem Cell Therapies for Human Diseases.

Advanced Cell Technology Announces Collaboration with Xgene Corporation to Assess Its Dermal Cell Technologies in Human Skin Models
In the collaboration, Advanced Cell Technology will provide the human embryonic stem cell-derived skin cells, and Xgene will provide its technology for reconstituting skin from cultured cells, to achieve the mutually beneficial development of advanced in vitro human skin models.

Korea Revamps Stem Cell Hub, Tries to Put Hwang Saga Behind
South Korea has built a gene therapy clinic at “ground zero” of the country’s once-celebrated World Stem Cell Hub inside Seoul National University Hospital.

Geron announces issuance of U.S. Patent for Production of Insulin Secreting Cells from Human Embryonic Stem Cells
Geron Corporation announced that it has been granted U.S. Patent No. 7,033,831, covering the production of insulin secreting cells from human embryonic stem cells (hESCs).

Stem Cell Innovations Files Patents Relating to Production of Human Motor Neurons and Progenitors
Cells May Be Useful in Therapies for ALS, Parkinson’s, Multiple Sclerosis and Other Neurodegenerative Diseases.



Announcing availability of pre-registration for the NIH Regional Seminar on Program Funding and Grants Administration, to be held in Riverside, California

Extension of the Submission Date for PAR-03-068: NEI Institutional Clinical Scientist Development Program (K12)

Computational Modeling for Heart, Lung, Blood, and Sleep Biologists: Introductory Courses (T15)

Collaborative Studies on Lung Stem Cell Biology and Cell Based Therapy (R01)


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

Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT)

Frequently Asked Questions Bar Code Label Requirements for Blood and Blood Components


Food and Drug Administration (United States of America)

Regulatory Site Visit Training Program; Correction

Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop; Correction

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable; Availability


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

AABB-ISCT Cellular Therapy Audioconference Series

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

Current Volume: Volume 15, No. 2



Pig-to-Nonhuman Primate Islet Xenotransplantation: A Review of Current Problems
P. P. M. Rood, L. H. Buhler, R. Bottino, M. Turcco, and D. K. C. Cooper

Coinhibitory T-Cell Signaling in Islet Allograft Rejection and Tolerance
Wayne Truong, Wayne W. Hancock, Colin C. Anderson, Shaheed Merani, and A. M. James Shapiro

Original Contributions:

Viability and Functionality of Bovine Chromaffin Cells Encapsulated Into Alginate-PLL Microcapsules With a Liquefied Inner Core
T. Moustafa, S. Girod, F. Tortosa, R. Li, J.C. Sol, F. Rodriguez, R. Bastide, Y. Lazorthes, and B. Sallerin

One-Step Induction of Neurons From Mouse Embryonic Stem Cells in Serum-Free Media Containing Vitamin B12 and Heparin
Hironori Yamazoe, Masato Kobori, Yoshinobu Murakami, Keiichi Yano, Mitsuo Satoh, Kenji Mizuseki, Yoshiki Sasai, and Hiroo Iwata

Engrafted Neural Progenitor Cells Express a Tissue-Restricted Reporter Gene-Associated With Differentiated Retinal Photoreceptor Cells
Thien N. Sam, Jing Xiao, Heidi Roehrich, Walter C. Low, and Dale S. Gregerson

Subnormothermic Preservation Maintains Viability and Function in a Porcine Hepatocyte Culture Model Simulating Bioreactor Transport
M.-P. van de Kerkhove, R. Hoekstra, F. C. van Nooijen, F. O. B. Spoelstra, B. M. Doorschodt, A. C. W. A. van Wijk, P. P. C. Poyck, R. A. F. M. Chamuleau, and T. M. van Gulik

Quantitative Assay for Quality Assurance of Human Cells for Clinical Transplantation
Steven T. Boyce, Benjamin A. Anderson, and Horacio L. Rodriguez-Rilo

Comparison of Cooling Systems During Islet Purification
Sue Swift, Tatsuya Kin, Mohammadreza Mirbolooki, Richard Wilson, and Jonathan R. T. Lakey

Estimation of Pancreas Weight From Donor Variables
Tatsuya Kin, Travis B. Murdoch, A. M. James Shapiro, and Jonathan R. T. Lakey

Ameliorating Injury During Preservation and Isolation of Human Islets Using the Two-Layer Method With Perfluorocarbon and UW Solution
Payam Salehi, Mohammadreza Mirbolooki, Tatsuya Kin, Toshiaki Tsujimura, A. M. James Shapiro, Thomas A. Churchill, and Jonathan R. T. Lakey

Functional MR Microimaging of Pancreatic b-Cell Activation
Barjor Gimi, Lara Leoni, Jose Oberholzer, Mark Braun, Jose Avila, Yong Wang, Tejal Desai, Louis H. Philipson, Richard L. Magin, and Brian B. Roman

Brief Communication:

Size-Dependent Revascularization of Transplanted Pancreatic Islets
Caroline Kampf, Göran Mattsson, and Per-Ola Carlsson

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.