Volume 6.36 | Sep 5

Volume 6.36, September 5, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Embryonic Stem Cells Accrue Genetic Changes: Stem Cell Lines Approved for US Federally-funded Research Have Mutated

Story: Australian Researchers Hail New Cancer-Killing Technique


GABA Halts Stem Cell Production in the Brain
Release of the neurotransmitter GABA by adult neuronal precursor cells that develop into neurons limits stem cell proliferation, according to a study at Yale School of Medicine in the September issue of Nature Neuroscience.

A New Link Between Stem Cells and Tumors
Scientists at the European Molecular Biology Laboratory (EMBL) in Heidelberg and the Institute of Biomedical Research of the Parc Científic de Barcelona (IRB-PCB) have now added key evidence to claims that some types of cancer originate with defects in stem cells.

UCSF Team Advances Probe of Neural Stem Cell-Brain Tumor Link
In the Aug. 25 issue of New England Journal of Medicine, a team of UCSF stem cell scientists and neurosurgeons reports on the increasing evidence from labs around the world that stem cells found in the brain — known as neural stem cells — may be the cause of the most common form of primary brain tumor.

Vitamin C Helps Stem Cells Morph into Heart Cells
In a finding that could aid the development of new heart failure treatments, scientists have observed that vitamin C prompts mouse embryonic stem cells to transform into beating heart muscle cells.

Human Muscle-derived Stem Cells Effective in Animal Models of Incontinence
Human muscle-derived cells, pluripotent stem cells found in muscle, have been used to cure stress urinary incontinence in animal models, a finding which signals that these cells are prime candidates to treat the condition in adults. 

It’s a Miracle: Mice Regrow Hearts
Scientists have created “miracle mice” that can regenerate amputated limbs or damaged vital organs, making them able to recover from injuries that would kill or permanently disable normal animals.

Blood ‘Cleaning’ Aids Transplants
A new technique could allow transplant patients to receive organs from donors with a different blood group.

Clinical Trial Tests New Blood Vessels Growth Through Gene Transfer
Emory Crawford Long Hospital is one of 32 sites participating in a nationwide study of experimental gene transfer designed to stimulate new blood vessel growth in the heart.

First Production Of Human Monoclonal Antibodies In Chicken Eggs Published In Nature Biotechnology
Origen Therapeutics today announced the first published scientific report of fully functional, human sequence monoclonal antibodies (mAbs) produced in chickens.

3rd Complication Case in DICS X Gene Therapy Clinical Trial
In May 2004, the French Health Product Safety Agency (Afssaps) authorised the restart of the gene therapy clinical trial conducted by Prof. Alain Fischer and Marina Cavazzana-Calvo, in Necker-Enfants-Malades hospital in Paris.

Kansas State Establishes New Institute To Study Stem Cells
Scientists at Kansas State University have established the Midwest Institute for Comparative Stem Cell Biology to expand research around stem cells derived from the umbilical cord matrix after birth.


Conditional Expression of a Suicide Gene by the Telomere Reverse Transcriptase Promoter for Potential Post-therapeutic Deletion of Tumorigenesis.

Lessons from the Bone Marrow: How Malignant Glioma Cells Attract Adult Haematopoietic Progenitor Cells

Development of Functional Neurons from Postnatal Stem Cells In Vitro


EU Bones Up on Tissue Research
A research consortium in Europe plans to make tissue engineering that uses stem cells both clinically and commercially viable in the next four years.

California Stem Cell Research Institute Riddled By Lawsuits; Faces Delays
The major challenge the CIRM faces now that site selection is over, are a handful of lawsuits filed against the agency by opponents to Proposition 71.

Thailand Plans Clinical Trials Boost
Thailand is attempting to develop its life sciences sector and promote the country as an attractive location to conduct clinical trials. Global annual expenditure on clinical trials is estimated to be US$15bn.



Affymetrix Microarrays Uncover Genetic Mutations in Embryonic Stem Cells Approved for Federally-Funded Research; Scientists Report That Majority of Cells Develop Mutations Over Time
Affymetrix Inc. announced today that a research group led by scientists at Johns Hopkins School of Medicine and the NIH used Affymetrix GeneChip(R) microarrays to discover that eight of the stem cell lines approved for federally-funded research have mutated, raising concern about the use of the remaining 14 approved cell lines in future research or therapeutic applications.

SEC Issues Formal Order in Investigation of Immuncor Subsidiary
Immucor, which manufactures blood-bank instruments, announced last fall that it was being investigated for improprieties. The SEC started its probe after the company self reported to the agency a violation of the books and records requirements of the Foreign Corrupt Practices Act.

SEC Files Civil Complaint Against Former CEO of Transkaryotic Therapies
The former chief executive of Transkaryotic Therapies Inc. is charged in a civil complaint with reassuring investors about failed drug trials to artificially inflate the stock price, then selling off his own shares.

TransGenic Wins Aid For Gene Knockout Mice Research From Hyogo Prefecture
In collaboration with the National Institute of Radiological Sciences (NIRS), TransGenic will analyze gene expressions in embryonic stem (ES) cells of gene knockout mice.

Geron Announces Publication of Studies Demonstrating Engraftment of Human Embryonic Stem Cell-Derived Cardiomyocytes in the Rodent Heart
The results provide proof of concept that transplanted hESC-derived cardiomyocytes survive and retain properties of cardiomyocytes, important for their use in the treatment of heart failure and myocardial infarction.

ViaCell Announces Publication of Preclinical Study Demonstrating That Umbilical Cord Stem Cells Improve Heart Function
ViaCell, Inc. announced today the publication of results of a preclinical study demonstrating that administration of stem cells sourced from umbilical cord blood and using ViaCell’s proprietary process significantly improved heart function in an in vivo model of myocardial infarction (heart attack).

ViaCell Announces Expansion of Amgen Collaboration and License Agreement and New Technology License from Johns Hopkins
ViaCell, Inc. today announced that the Company has licensed from Amgen rights related to the use of recombinant human Granulocyte Colony Stimulating Factor (r- metHuG-CSF) for the development of a cellular therapy product to treat hematological malignancies and genetic diseases.

ImmunoGen, Inc. Announces Sanofi-Aventis Group Extends Research Collaboration; Providing $18.2 Million In Research Support
ImmunoGen, Inc.  today announced that Aventis Pharmaceuticals Inc. of the Sanofi-aventis Group has exercised its right to extend the term of its research collaboration with the Company and committed to fund ImmunoGen $18.2 million in research support over the twelve months beginning September 1, 2006.

Immunicon Corporation To Lay Off Workers, Take Charge
Immunicon Corporation , a development-stage company developing and commercializing proprietary cell- and molecular-based human diagnostic and life-science research products with an initial focus on cancer, announced today actions to align staff levels and other expenses with its current commercialization strategy and expectations for near-term revenue growth.

MicroIslet Inc. And The Scripps Research Institute Extend Collaboration In Islet Cell Transplantation Therapies For Treatment Of Insulin Dependent Diabetes
Under the terms of the agreement, MicroIslet and TSRI will continue preclinical studies utilizing MicroIslet’s proprietary technologies.

Mesoblast Commences Bone Regeneration Trials at Colorado State University
Australian adult stem cell company, Mesoblast has commenced preclinical trials at Colorado State University in support of its investigational new drug submissions to the FDA.

Osteotech Introduces New Bio-Implant Product
Osteotech, a provider of human bone and bone connective tissue for transplantation as well as a developer and marketer of biomaterial and implant products for musculoskeletal surgery based in Eatontown, N.J. – has announced the release of its Graftech Lordotic Cervical Spacer.

StemCells, Inc. Receives Manufacturing License for Cell Processing Facility in California
StemCells, Inc. today announced that it has received a manufacturing license for its cell processing facility from the State of California Department of Health Services, Food and Drug Branch. This enables the Company to use its proprietary neural cell therapy product, HuCNS-SC, which is made at its licensed facility, in clinical trials.

Invitrogen Promotes David Onions, Ph.D. to Chief Medical Officer; Scientific Leader to Help Company Transition toward Patient-Centric Support Technologies
In this new role, Dr. Onions will be responsible for guiding the company’s scientific efforts as it moves into areas more closely associated with medical research and closer to patients, such as stem cell technologies, diagnostics support and other clinical studies.


Malachite Management has joined forces with established and reputable authors and publishers to bring you the following market reports outlining the very latest in Cell Therapy, Gene Therapy, and Immunotherapeutic approaches to Cancer. 

“Cell Therapy – Technologies, Markets, and Companies” is over 400 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the cell therapy industry worldwide.
For more information, including order forms, please see:

Cell Therapy Report Summary
Cell Therapy Sample Chapter
Cell Therapy Table of Contents Vol. 1  Vol. 2
Cell Therapy Order Form

“Gene Therapy – Technologies, Markets, and Companies” is over 500 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the gene therapy industry worldwide.
For more information, including order forms, please see:

Gene Therapy Report Summary
Gene Therapy Table of Contents Vol. 1 Vol. 2
Gene Therapy Order Form

The Immunotherapy Reports cover the most recent developments in the immunotherapeutic approaches to cancer.

A Shift in Cancer Immunotherapy Strategies?
Immunotherapy Strategies Executive Summary
Immunotherapy Strategies Table of Contents

Future Perspectives in Cancer Immunotherapy
Future Perspectives Executive Summary
Future Perspectives Table of Contents

Immunotherapy Reports Order Form



NIH Guide for Grants and Contracts – Week Of September 2, 2005

NIH Offers $35,000 in Annual Student Loan Repayment
Starting Thursday, September 1, 2005, the National Institutes of Health (NIH) will begin accepting applications to its five Loan Repayment Programs (LRPs). Deadline for applications is December 1, 2005.

Delays in Grant Application Submission due to Hurricane Katrina (NOT-OD-05-072)

NIH Grantees Affected by Hurricane Katrina (NOT-OD-05-073)


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

Recall of Albumin (Human) 25%, Albuminar – ZLB Behring LLC




Educational Workshops on Current Good Manufacturing Practices; Public Workshops

The Food and Drug Administration (FDA) is announcing a series of educational workshops on current good manufacturing practice (CGMP). The workshops, which will be held in collaboration with Peking University (Beijing, China) and the International Society for Pharmaceutical Engineering (ISPE), are intended to educate participants on current methods for compliance with good manufacturing practices (GMP).

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
September 22, 2005 (1:30 p.m. to 5 p.m.)

Blood Products Advisory Committee; Notice of Meeting
September 29, 2005 (8 a.m. to 5 p.m.)

For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More, Please Visit The Regulatory Page On The Cell Therapy News Website 



Research Review Subcommittee of the Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
September 29, 2005

Stem Cells & Regenerative Medicine. Pittsburgh, PA
October 17- 18, 2005

Stem-Cell Research and Cell-Line Banking Regulation: What Sponsors, Researchers, Hospitals and IRBs Need to Know
An audioconference with Mark Barnes
September 16, 2005 (11:00 a.m. – 12:30 p.m. EDT)


Emerging Cardiac Cellular Therapies: Incorporating cGMP Federal Regulations into Clinical Trials. Bethesda, MD
Co-sponsored by AABB and ISCT
September 15 – 16, 2005
This year, a Cardiac Cell Therapy Workshop has been created to precede the annual Somatic Cell Therapy Symposium. This workshop was designed to address questions related to the various cell types being used in the context of cardiac repair.

Fifth Annual Somatic Cell Therapy Symposium. Bethesda, MD
Co-sponsored by AABB, ISCT and FDA
September 16 – 18, 2005
The annual Somatic Cell Therapy Symposium is a forum provided to engage FDA and industry in an ongoing dialogue regarding the regulatory issues pertaining to somatic and other cell therapies.

To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit The Meetings Page  On The Cell Therapy News Website


To View a List of Cell Therapy-Related Journals, Please Visit The Journals Page On The Cell Therapy News Website


For information on posting an opportunity email: [email protected]

Hospital Scientist  NEW!
Sydney, Australia (Bone Marrow Stem Cell Laboratory of St. Vincent’s Hospital)

Scientist/Immunologist (Research and Development
Gaithersburg, Maryland (Maxcyte)

Acting President

San Diego, California (California Institute of Regenerative Medicine)

Clinical Consultant  
Deerfield, Illinois (Baxter Healthcare)

Cord Blood Director 
Minneapolis Minnesota (The National Marrow Donor Program™)

Cytotherapy Technologist Stem Cell 
New York, New York (Memorial Sloan-Kettering Cancer Center)

Director of Research Programs 
Toronto, Ontario (Ontario Genomics Institute) 

Laboratory Supervisor (Stem Cell Lab)
Charlottesville, Virginia (University of Virginia Health System)

Scientific Review & Program Officers 
San Diego, California (California Institute of Regenerative Medicine)

Scientific Sales Representative
Vancouver, British Columbia (StemCell Technologies)

Scientific/Technical Officer,Stem Cell Transplant Laboratory/Haematology 
Sydney, Australia (SWAPS, Liverpool Hospital)

Senior Officer for Medical & Ethical Standards 
San Diego, California (California Institute of Regenerative Medicine)

Vice President of Manufacturing Operations 
Dallas, Texas (ODC Therapy Inc.)


Upcoming Meetings & Conferences:

2005 Cell Therapy Audioconference Series

5th Annual Somatic Cell Therapy Symposium. Bethesda, Maryland
Sept. 15-18, 2005

Profiled Journal

Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”

Join ISCT ($130) and receive the journal as a benefit of membership

Current Volume: Volume 7, Number 3/ July 2005

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells , immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes
contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.

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