Volume 7.29 | Jul 31

Volume 7.29, July 31, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Clinical Use Embryonic Stem Cells Made in Singapore: Four ‘safe’ embryonic stem-cell lines, which have been made from scratch specifically for clinical use, made their debut this week.


University of California, Los Angeles Researchers Transform Stem Cells Found in Human Fat Into Smooth Muscle Cells
The study is one of the first to show that stem cells derived from adipose tissue can be changed to acquire the physical and biochemical characteristics, as well as the functionality, of smooth muscle cells.

Duke Scientists Discover Key to Growing New Stem Cells
Scientists at Duke University Medical Center have demonstrated they can grow human stem cells in the laboratory by blocking an enzyme that naturally triggers stem cells to mature and differentiate into specialized cells.

New Human Stem Cells Set To Speed Up Drug Discovery
Stem Cell Sciences have announced the in-licencing of a novel human stem cell, called the human multi-potent adipocyte-derived stem (hMADS) cell. Discovered in fat tissue and easily grown, hMADS show great promise as biologically relevant cells to improve drug discovery.

University of Florida Scientists Test Improved Gene Therapy Method for Hereditary Heart Conditions
A new way of delivering corrective genes with a single injection into a vein holds promise for long-lasting treatments of hereditary diseases of the heart.

TissueGene Initiates Phase I Clinical Trial with TG-C
The study aims to assess safety and pharmacokinetics of TG-C for the treatment of degenerative joint diseases such as osteoarthritis.

ViaCell Announces Completion Of CB001 Phase I Clinical Trial
The Phase I clinical trial is a safety study of CB001 using stem cells that have been isolated from umbilical cord blood and expanded using ViaCell’s proprietary expansion technology.

German Biopharmaceutical Company, co.don(R) AG Enhances its Product Portfolio
For the first time worldwide, a hip cartilage defect was successfully treated by using autologous 3-dimensional cultured chondrocytes (co.don chondrosphere(R)).

Genitope Hammered on Study Setback
A data safety monitoring board recommends continuation of MyVax(R) Personalized Immunotherapy Phase 3 trial after second interim analysis.

Disgraced Scientist Says He Tried to Clone Mammoth
Disgraced scientist Hwang Woo-suk denied Tuesday that he had spent research funds for personal use and said part of the money was used in failed attempts to clone mammoths, extinct relatives of today’s elephants.

Equine Science Sells Longevity
An experimental therapy developed at the Royal Veterinary College in London allows for the “regrowth” of tendons.


Embryonic Pig Pancreatic Tissue Transplantation for the Treatment of Diabetes
In this study, researchers examined the growth potential, functionality, and immunogenicity of pig embryonic pancreatic tissue harvested at different gestational ages.


Britain Allows Lab to Recruit Stem Cell Egg Donors
A British research institute will be allowed to recruit women having fertility treatment to donate eggs for stem cell research and therapeutic cloning.

European Union Extends Stem Cell Research Funding with Limitations
The European Union will continue to fund human embryonic stem cell research that does not involve human cloning or destroying embryos.


BioLife Solutions Expands Executive Team
BioLife Solutions Inc., a developer, manufacturer, and marketer of proprietary cryopreservation solutions for cells and tissue storage and preservation at low temperatures, announced it has named veteran medical technology executive Michael Rice as its president and chief executive officer and a member of the board of directors.

Biotech Heads Skeptical After Meeting with California Stem Cell Institute
Some area biotech executives who met with California’s stem cell research institute in San Francisco acknowledge they are nervous about getting involved with the $3 billion program. The institute faces two constitutionality lawsuits that have delayed issuance of bonds needed to finance the program, and some executives say a possible requirement to share profits might discourage companies from participating.

New Survey Shows Golden State is Magnet for Stem Cell Researchers
One of the promises made by proponents of Proposition 71 was that it would turn California into a Mecca for stem-cell research. According to a new study from Princeton University, this promise is starting to come true.

Stem Cell Bank Opens
The world’s largest family newborn stem cell bank was launched by the Cord Blood Registry.

CalbaTech, Inc. Announces Launch Date For Stem Cell Microbank(TM)
CalbaTech, Inc., an emerging life sciences company concentrating on banking adult stem cells for possible future therapeutic uses and providing products and platforms to the biotech, pharmaceutical research market and to academic institutions, has announced that its wholly owned subsidiary, LifeStem, Inc. will begin operations of its Adult Stem Cell Microbank(TM) collection service on August 15th 2006.

Stage Set for World-Leading Stem Cell Research Centre
The Wellcome Trust has announced funding of £10 million to establish an international centre of excellence in fundamental stem cell research at the University of Cambridge.

Ottawa Stem Cell Researchers Benefit from $7-Million Donation
An Ottawa-born investor has made a $7-million donation to stem cell researchers at the Ottawa Hospital.


Selection of Funding Opportunities Related to Exfoliated Cells and Circulating DNA in Cancer Detection and Diagnosis (NOT-CA-06-034)


Food and Drug Administration (United States of America)

Blood Products Advisory Committee Charter – Updated

Cellular, Tissue and Gene Therapies Advisory Committee Charter – Updated

Vaccines and Related Biological Products Advisory Committee Charter – Updated

CBER FY 2005 Annual Report

Agency Information Collection Activities; Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products

FDA Announces Plan to Strengthen Advisory Committee Processes

Warning Letter – Oklahoma Blood Institute Institutional Review Board

Ministry of Health (China)

China Regulates Stem Cell Collection, Transplantation
China’s Ministry of Health has outlined new requirements concerning stem cell collection and transplants, banning profits from illegal stem cell transplantation.


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

AABB-ISCT Cellular Therapy Audioconference Series

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

Volume 15, Supplement 1



Bruno Gridelli

End-Stage Organ Failure: Will Regenerative Medicine Keep Its Promise?
Fabio Triolo and Bruno Gridelli

Tissue Engineering and the Challenges Within
Sara L. Wargo, Thangappan Ravi Kumar, and Alan J. Russell

Development of Composite Porous Scaffolds Based on Collagen and Biodegradable Poly(ester urethane)urea
Jianjun Guan, John J. Stankus, and William R. Wagner

The Use of Extracellular Matrix as an Inductive Scaffold for the Partial Replacement of Functional Myocardium
Stephen F. Badylak, Paul V. Kochupura, Ira S. Cohen, Sergey V. Doronin, Adam E. Saltman, Thomas W. Gilbert, Damon J. Kelly, Ronald A. Ignotz, and Glenn R. Gaudette

Growth Factor Enhancement of Cardiac Regeneration
Nadia Rosenthal, Maria Paola Santini, and Antonio Musarò

Stem Cell Therapy for Ischemic Heart Disease: Beginning or End of the Road?
Christof Stamm, Andreas Liebold, Gustav Steinhoff, and Dirk Strunk

Wound Healing in the Biliary Tree of Liver Allografts
A. J. Demetris, Paulo Fontes, John G. Lunz, III, Susan Specht, Noriko Murase, and Amadeo Marcos

Flexible Lineage Specifications of Adult Hepatic Cells, Associated Molecular Pathways, and Their Relationship to Liver Cancer
George K. Michalopoulos

Towards the Development of a Pediatric Ventricular Assist Device
Harvey S. Borovetz, Stephen Badylak, J. Robert Boston, Carl Johnson, Robert Kormos, Marina
V. Kameneva, Marwan Simaan, Trevor A. Snyder, Hiro Tsukui, William R. Wagner, Joshua Woolley, James Antaki, Chenguang Diao, Stijn Vandenberghe, Bradley Keller, Victor Morell, Peter Wearden, Steven Webber, Jeff Gardiner, Chung M. Li, Dave Paden, Bradley Paden, Shaun Snyder, Jingchun Wu, Gill Bearnson, John A. Hawkins, Gordon Jacobs, John Kirk, Pratap Khanwilkar, Peter C. Kouretas, James Long, and R. E. Shaddy

Is Facilitating Pancreatic Beta Cell Regeneration a Valid Option for Clinical Therapy?
Massimo Trucco

Protein Transduction: A Novel Approach to Induce In Vitro Pancreatic Differentiation
Juan Domínguez-Bendala, Ricardo L. Pastori, Camillo Ricordi, and Luca Inverardi

Bioreactors for Extracorporeal Liver Support
Jörg C. Gerlach

Hepatocyte Transplantation: Clinical Experience and Potential for Future Use
Stephen C. Strom, Paolo Bruzzone, Hongbo Cai, Ewa Ellis, Thomas Lehmann, Keitaro Mitamura, and Toshio Miki

The Regenerative Potential of Stem Cells in Acute Renal Failure
Marina Morigi, Ariela Benigni, Giuseppe Remuzzi, and Barbara Imberti

Vascular Tissue Engineering
Chiara Arrigoni, Davide Camozzi, and Andrea Remuzzi


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.