Volume 8.42 | Oct 29

Volume 8.42, October 29, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT Study of Provenge(R) For Advanced Prostate Cancer: Dendreon Corporation has announced that the Company has completed enrollment of over 500 patients in the Phase 3 IMPACT clinical trial of PROVENGE, the Company’s investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

Osiris Therapeutics Initiates Phase II Clinical Trial Evaluating Prochymal(TM) for Type 1 Diabetes: Through a partnership with the Juvenile Diabetes Research Foundation, the organization has provided $4 million in funding to support the development of Prochymal as a treatment for the preservation of insulin production in patients with newly diagnosed type 1 diabetes mellitus.


Scientists Build a Better Petri Dish
A 3-D petri dish that can grow cells in three dimensions could quickly and cheaply produce more cells for drug development research and tissue transplantation, say the biomedical engineers at Brown University in Providence, R.I., who invented the new dish.

New Source Of Islet Cells For Islet Transplantion For Type 1 Diabetes
The article describes the differentiation of rat pancreatic ductal epithelial cells into insulin-producing cells by the transfection of PDX-1.

Adipose Stem and Regenerative Cells Not Linked to Arrhythmias in Preclinical Study; Important Safety Findings Published in EuroPace Cardiology Journal
Stem and regenerative cells derived from adipose tissue were found not to be linked to arrhythmias following a heart attack in a preclinical study.

Vibration Fends Off Fat in Mice
Short bursts of low intensity vibration can prevent stem cells from turning into fat cells in young mice.

Regulating Embryonic Stem Cell Self-renewal
Dr. Huck-Hui Ng and colleagues at the Genome Institute of Singapore have identified two genes – called Jmjd1a and Jmjd2c – that regulate self-renewal in embryonic stem cells.

New Nerves Grown from Fat Cells
New nerves grown from stem cells taken from a patient’s fat could be available by 2011, researchers have said.

An Eye For An Eye: Using Stem Cells To Treat Damaged Eyes And A Rare Skin Disorder
Doctors and scientists in Italy have shown how stem cells can be used to treat damaged eyes and, in combination with gene therapy, a rare and debilitating skin disease.

Further Positive Preliminary Data on DiabeCell(R) Phase I/IIa Trial
“These early stage results have exceeded our expectations, with one patient no longer dependant on insulin therapy following the smallest dose of DiabeCell(R),” said Professor Bob Elliot, Medical Director of LCT.

Advanced Cell Presents Phase I(b) Data Demonstrating Safety and Optimal Dosage for Myoblast Program at TCT Conference and Exposition
The interim data showed myoblast safety, with no evidence for increased risk of arrhythmia. The safety data presented by Dr. Dib distinguish the ACT Myoblast Program, which in contrast to other clinical programs does not require the use anti-arrhythmia medications and/or an implanted defibrillator device.

New Stem Cell Treatment Reduces Amputations in Critical Limb Ischemia
After the injection of a concentrate of the patients’ own bone marrow stem cells, leg amputation could be avoided in more than half of these patients. This is a major success because under normal circumstances, the amputation rate in CLI is 90-100% in this patient population within a year.

Gene Therapy Trials to Start in UK
Scientists in London are about to hold the world’s first human trials on a new gene therapy technique which they hope will help people suffering from a devastating muscle condition, Duchenne muscular dystrophy.


Adipose-derived Stem Cells Differentiate into a Schwann Cell Phenotype and Promote Neurite Outgrowth in Vitro
These results indicate adipose tissue contains a pool of regenerative stem cells which can be differentiated to a Schwann cell phenotype and may be of benefit for treatment of peripheral nerve injuries.


Cell Therapeutics Supervisor
Philadelphia, PA (AppTec)

Postdoc Fellow
Sweden (Wallenberg Neuro Center Neuronal Survival Unit)

Manager, Manufacturing
Memphis, TN (Cognate Bioservices)


Stem Cell Research Gets Support
New Jersey voters support borrowing $450 million for stem cell research, a poll released Thursday found, as the Catholic church tries to rally voters against supporting the funding.

Stem Cell Lab Takes First Step
New Jersey Governor Jon Corzine, joined by relatives of Christopher Reeve, the late “Superman” actor, broke ground yesterday at the site of what is hoped will be a trailblazing center for stem cell science.

Michigan Fights for Stem Cell Cash
Michigan is losing businesses, jobs and some of its best scientists because of restrictive embryonic stem cell research laws, according to scientists and others seeking to change the research climate.

Stem Cell Bank Gets $7.6M
The Massachusetts Life Sciences Center yesterday authorized funds for the University of Massachusetts Medical School to open an embryonic stem cell bank and registry for storage, study and distribution of stem cell lines to researchers from around the world.


Stem Cell Sciences to Develop Novel Muscle Stem Cells for Drug Discovery and Toxicology
Stem Cell Sciences plc has announced the signing of an exclusive agreement with San Raffaele Scientific Institute covering assay validation and future commercialisation of novel human muscle stem cells for drug discovery and toxicology applications.

National Stem Cell Holding in Final Stage Negotiations for Exclusive Licensing of its Recently Discovered Biomaterial for Anti-Aging Applications
National Stem Cell Holding, Inc. has announced that it is currently in final stage negotiations to exclusively license one of its recently discovered biomaterials which holds promise as an effective anti-aging agent and treatment.

Progenitor Cell Therapy Adds Development and Manufacturing Expertise
Marta Schilling joins Progenitor Cell Therapy as Director of its West Coast Manufacturing Operations.

BioTime Names Robert W. Peabody Senior Vice President and Chief Operating Officer
BioTime, Inc. has announced that Robert W. Peabody, CPA, has joined BioTime as Senior Vice President and Chief Operating Officer. Mr. Peabody will head BioTime’s efforts to obtain research funding grants from private and public sources, including the California Institute for Regenerative Medicine (“CIRM”), to help finance BioTime’s entry into the field of regenerative medicine and stem cell research.

Millipore Corporation Launches State-of-the-Art Website
Powered by a fast, robust search engine, the new millipore.com provides visitors with quick and easy access to product or other information, by application, product type, pathway diagrams, and research topic.


NIH Director’s Council of Public Representatives Welcomes Six New Members to the Next Meeting, October 26, 2007 in Bethesda, MD.
The National Institutes of Health has selected six individuals to serve as members of the Director’s Council of Public Representatives (COPR), the advisory committee to the NIH Director on issues important to the public.

NIAID Funds $51 Million Contract to Create Comprehensive Model of Immune Responses
A team of scientists is expanding efforts to develop a detailed picture of immune system function with a new $51 million, five-year contract from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

Mandate For Public Access To NIH-funded Research Poised To Become Law
The U.S. Senate has approved the FY2008 Labor, HHS, and Education Appropriations Bill (S.1710), including a provision that directs the National Institutes of Health to strengthen its Public Access Policy by requiring rather than requesting participation by researchers.

Delays in Grant Application Submission Due to Fires in California (NOT-OD-08-009)

Pilot Compliance Program–Financial Conflict of Interest Requirements for All NIH-Supported Institutions (NOT-OD-08-010)


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

Biological Product Deviation Reporting (BPDR) – Product Deviation Codes – Update

Biological Product Deviation Reporting (BPDR) – Non-Blood Product Codes – Update

Draft Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; CGMP for Blood and Blood Components;  Notification of Consignees and Transfusion Recipients Receiving Blood  and Blood Components at Increased Risk of Transmitting HCV Infection (“Lookback”)

Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2008 Medical Device User Fee Small Business Qualification and Certification

November 2007 Vaccines and Related Biological Products Advisory Committee Meeting

Challenges in Biologics Compliance: 2nd Annual FDA Inspections Summit – Slide Presentation



Vaccines and Related Biological Products Advisory Committee; Notice of Meeting


Export of Human Blood/Tissue and Related Materials (Updated)



In response to increasing calls for smaller, more regionalized meetings, ISCT is pleased to announce the launch of its first Regional Meeting.

Date: November 2-4, 2007
Location: Texas Children’s Hospital  The Feigin Center  Houston, TX
Target Audience: Laboratory practitioners and technicians working in cellular therapy laboratories
Learning Objectives:
To provide an overview of the biology of cellular therapy 
To provide education on cell processing laboratory procedures and issues

Click here for more information, including program, speakers, accommodation and registration. 

Space is limited! Register now!

Profiled Journal

Cell Transplantation
Current Issue: Volume 16, No 6


Original Contributions
Autologous Transplantation of Muscle-Derived CD133+ Stem Cells in Duchenne Muscle Patients
Y. Torrente, M. Belicchi, C. Marchesi, G. D’Antona, F. Cogiamanian, F. Pisati, M. Gavina, R. Giordano, R. Tonlorenzi, G. Fagiolari, C. Lamperti, L. Porretti, R. Lopa, M. Sampaolesi, L. Vicentini, N. Grimoldi, F. Tiberio, V. Songa, P. Baratta, A. Prelle, L. Forzenigo, M. Guglieri, O. Pansarasa, C. Rinaldi, V. Mouly, G. S. Butler-Browne, G. P. Comi, P. Biondetti, M. Moggio, S. M. Gaini, N. Stocchetti, A. Priori, M. G. D’Angelo, A. Turconi, R. Bottinelli, G. Cossu, P. Rebulla, and N. Bresolin

Ex Vivo Expansion and Transplantation of Hematopoietic Stem/Progenitor Cells Supported by Mesenchymal Stem Cells From Human Umbilical Cord Blood
Guo-Ping Huang, Zhi-Jun Pan, Bing-Bing Jia, Qiang Zheng, Chun-Gang Xie, Jiang-Hong Gu, Ian K. McNiece, and Jin-Fu Wang

A Closed System for Islet Isolation and Purification Using the COBE2991 Cell Processor May Reduce the Need of Clean Room Facilities
R. A. Klaffschenkel, A. Biesemeier, M. Waidmann, H. Northoff, W. Steurer, A. Königsrainer, and N. Lembert

Toward Maximizing the Success Rates of Human Islet Isolation: Influence of Donor and Isolation Factors
Gaston M. Ponte, Antonello Pileggi, Shari Messinger, Angel Alejandro, Hirohito Ichii, David A. Baidal, Aisha Khan, Camillo Ricordi, John A. Goss, and Rodolfo Alejandro

Encapsulation of Porcine Islets Permits Extended Culture Time and Insulin Independence in Spontaneously Diabetic BB Rats
Lawrence S. Gazda, Horatiu V. Vinerean, Melissa A. Laramore, Carolyn H. Diehl, Richard D. Hall, Albert L. Rubin, and Barry H. Smith

Distribution of Intraportally Implanted Microspheres and Fluorescent Islets in Mice
Erik von Seth, Daniel Nyqvist, Arne Andersson, Per-Ola Carlsson, Martin Köhler, Göran Mattsson, Astrid Nordin, Per-Olof Berggren, and Leif Jansson

Hepatocyte Transplantation for Glycogen Storage Disease Type Ib
Kwang-Woong Lee, Ji-Hyun Lee, Sung Wook Shin, Sung Joo Kim, Jae Won Joh, Doo-Hoon Lee, Jong-Won Kim, Hwa-Young Park, Soo-Youn Lee, Hwan Hyo Lee, Jin Wan Park, Shi-Yeon Kim, Hee-Hoon Yoon, Doo-Hee Jung, Yon Ho Choe, and Suk-Koo Lee

Cryopreservation-Induced Nonattachment of Human Hepatocytes: Role of Adhesion Molecules
Claire Terry, Robin D. Hughes, Ragai R. Mitry, Sharon C. Lehec, and Anil Dhawan

Culture of Keratinocytes for Transplantation Without the Need of Feeder Layer Cells
Neeltje A. Coolen, Michelle Verkerk, Linda Reijnen, Marcel Vlig, Antoon J. van den Bogaerdt, Melanie Breetveld, Susan Gibbs, Esther Middelkoop, and Magda M. W. Ulrich

Inhibition of Apoptosis by Expression of Antiapoptotic Proteins in Recombinant Human Keratinocytes
Claudia Y. U. Choi, Kerstin Reimers, Christina Allmeling, Susanne Kall, Yeong-Hoon Choi, and Peter M. Vogt

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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