Volume 6.29 | Jul 18

Volume 6.29, July 18, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Cancer Researchers Identify ‘Bad’ Stem Cells

Story: Transplanted Neural Stem Cells Serve as Replacement Cells For Tissue Repair and May Also Protect the Brain from Inflammation


Outer Lining of the Umbilical Cord is A Rich Source of Stem Cells
CellResearch Corporation in Singapore and its team of scientists, headed by Chief Scientist, Dr Phan Toan Thang, have recently made a revolutionary discovery: that the outer lining of the umbilical cord is a rich source of stem cells.

Co-Infusion of Peripheral Blood Stem Cells May Improve Umbilical Cord Blood Transplants in Adults
Researchers from Spain have reported that the addition of highly purified CD34+ stem cells from a third party donor improves neutrophil and platelet recovery in adults receiving a single unrelated umbilical cord blood transplant following a reduced intensity but still myeloablative treatment regimen for leukemia.

Gene Injection to Tackle Impotence
‘These studies have shown erectile function can be restored for up to six months,’ says Dr Melman of the Albert Einstein College of Medicine, New York.

Researchers Identify Genes That Foster Blood Cell Development From Stem Cells
Now, University of Minnesota researchers have identified a group of genes that guide the functioning of hematopoietic stem cells, a finding that may help researchers grow enough of the cells in the laboratory to give doctors more options in treating patients.

World’s First Total Marrow Irradiation Using HI-ART System(R) Performed at City of Hope
The world’s first whole marrow irradiation using the TomoTherapy HI-ART System(R) was performed at City of Hope on June 8, 2005.

HIV Therapy Greatly Extends Life of Key T Cells, Scientists Find
Interleukin-2 (IL-2), an immune-boosting drug used experimentally in HIV therapy, greatly increases the lifespan of certain subsets of immune system T cells in some HIV-positive people who respond to this therapy, discovered researchers from the National Institutes of Health (NIH) Clinical Center and the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

Duke Professor to Lead $300 Million NIH Center for HIV Vaccine Research
Duke University Medical Center Professor Barton Haynes, M.D., will lead the Center for HIV/AIDS Vaccine Immunology (CHAVI), a consortium of universities and academic medical centers established today by the National Institute of Allergy and Infectious Diseases (NIAID).

Pakistani Doctors Emerge Pioneer in Applying Autologous Stem Cell Therapy
Pakistani doctors have emerged to be the first to successfully apply autologous stem cell therapy in treating Thalassemia Major, a debilitating blood disorder that affects hundreds of thousands of people and kills several thousand children before they reach the age of ten.


A Bayesian Approach to Jointly Modeling Toxicity and Biomarker Expression in a Phase I/II Dose-Finding Trial

Analysis of Mesenchymal Stem Cells Grown on a Three-dimensional HYAFF 11-based Prototype Ligament Scaffold

Follow the Money—The Politics of Embryonic Stem Cell Research


Spain To Allow Therapeutic Cloning, Minister Says
Spain plans to introduce legislation allowing therapeutic cloning, its Health Minister said on Monday, a decision likely to bring a new clash between the governing Socialists and the Roman Catholic church.

Top Russian Health Official Says Use of Stem Cells in General Practice Prohibited
A senior Russian health official said Monday that the use of stem calls in general Russian medical practice is prohibited, RIA Novosti reported.

US Senate Subcommittee Holds Hearing on Alternative Embryonic Stem Cell Legislation Promoting New, ‘Unproven’ Techniques
The bill -introduced in the House by Rep. Roscoe Bartlett (R-Md.)-would authorize federal funding to be used for animal studies that might eventually allow scientists to create human embryonic stem cells without the use of human embryos (Stolberg, New York Times, 7/13).

Dr. Robert Lanza Of Advanced Cell Technology Testifies Before Senate Subcommittee
Dr. Lanza’s testimony focused on two approaches to creating pluripotent stem cell lines – that of single cell biopsy of embryos and the dedifferentiation of somatic cells back to pluripotency – and strongly encouraged support for the Stem Cell Research Enhancement Act of 2005.

California Institute for Regenerative Medicine Press Release: Independent Citizens’ Oversight Committee Approves Policy Enhancements; Staff to Present Final Refinements to ICOC in August
The Independent Citizens’ Oversight Committee (ICOC) of the California Institute for Regenerative Medicine (CIRM) this morning approved policies designed to establish model standards — in partnership with the Legislature and the public — for the CIRM and stem cell research.

$10 Million Grant to Focus on Stem Cell Research
Illinois Gov. Rod Blagojevich ordered $10 million in state tax money to be used for stem cell researh.

Ethical Guidelines Suggested for Research that Would Put Human Stem Cells in Primates; Stanford Law Professor Says Recommendations Could ‘Minimize Ethical Risks’
Before conducting research that involves putting human stem cells into the brains of nonhuman primates such as monkeys or apes, scientists and oversight committees should consider a series of ethical criteria, according to a policy paper released in the July 15 issue of Science.

World’s Oldest, Largest Organization of Cancer Scientists Favors “Full Spectrum of Stem Cell Biology”
Stem cell research – including research involving human embryonic stem cells – is essential to the advancement of cancer research, according to a position statement adopted by the Board of Directors of the American Association for Cancer Research.

DFG Approves Three Clinical Research Units, Germany
One of the three new research projects will be working on adult stem cells. This means that the DFG will now be funding three research projects on adult stem cells.



Geron Corporation Enters Into A Collaboration And License Agreement With Merck & Co., Inc. For Cancer Vaccines Targeting Telomerase; Geron Stocks Rise
Geron Corp. shares surged 28 percent in Monday morning trading, after the biopharmaceutical company said it will team with Merck & Co. to develop a cancer vaccine against telomerase.

Bio-Matrix Files Stem Cell Device Patent Applications 
Bio-Matrix Scientific Group has filed two new patents on its stem cell instruments and devices.

BioSurface Engineering Technologies Announces Agreement With Biomet, Inc. Subsidiary EBI, LP
Under the terms of the agreement, BioSET will work with EBI to facilitate the evaluation by EBI of one of BioSET’s synthetic growth factor peptides in pre-clinical models. The agreement provides for the evaluation and development of tissue healing and regenerative applications across multiple orthopedic fields of use.

Clinical Trial For Pancreatic Cancer Opens At Mayo Clinic Using Tumor-Targeted Gene Therapy Vector
Epeius Biotechnologies Corporation, announced today that a Phase I clinical trial has opened at Mayo Clinic Cancer Center, Rochester, Minnesota to test the safety of Rexin-G(TM), the first tumor-targeted gene therapy vector to gain Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

Crucell, DSM to License PER.C6 Cell Line Technology to Denmark’s Symphogen
The license agreement allows Symphogen to use PER.C6 for the production of its proprietary recombinant polyclonal antibodies, known as symphobodies.

Endocyte Names Head of Clinical Program
Endocyte Inc. has appointed Richard Messmann, M.D., M.H.S, M.Sc., to the position of vice president clinical affairs.

Maharashtra to Have Stem Cell-based Treatment Soon
US-based Histostem has inked a deal with the Maharashtra government for setting up national (umbilical) cord banking (NCB) centre in Mumbai.  Three more centres would be set up in Delhi, Chennai and Kolkata. 

Participants in the Gene Therapy Market Discover New Ways to Improve Clinical Efficiency and Generate Revenue
Research involving novel designs for vectors, methods of introducing ‘naked’ deoxyribonucleic acid (DNA), and the use of electroporation to improve DNA uptake into cells have been successful in pre- clinical studies.

StemCell Pharma Acquires Exclusive Rights to New Stem Cells/Placenta Products
StemCell Pharma announces that it has acquired exclusive rights on two types of products containing placenta-derived stem cells, namely: 1. A line of anti-aging/aging control products in oral form and 2. Cosmetics from face creams to hair products.

Celladon Names Dr. Stephen Grant Chief Medical Officer
Celladon Corporation, a La Jolla-based biotech company focused on the development and commercialization of new molecular therapies for heart failure, today announced that Dr. Stephen Grant has joined the company as Chief Medical Officer.


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



NIH Guide for Grants and Contracts – Week Of July 15, 2005

Notice of the Cardiovascular Cell Therapy Research Network (NOT-HL-05-126)

Neuroimmune Mechanisms and Chronic Fatigue Syndrome (RFA-OD-06-002)

Testing Stem Cell Therapy in Mouse Models of Premature Aging (PA-05-136)


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

Substantially Equivalent 510(k) Device – Donor Information System (DIS) 3.1 – BioLife Plasma Services LP

2005 Biological Approvals – Update

Recall of Hemoflow Model 300 – Applied Science, Inc

Licensed Products and Establishments List – Update

Workshop on Biological Therapeutics for Rare Plasma Protein Disorders – Slides

CBER Organizational Information

Urgent Product Correction: Six-Part BarCode Labels for Sarstedt Tubes – Roche Diagnostics Corp, Inc

Tissue Action Plan – Investigators Product List – Update




Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

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 


These meetings were added to the calendar this week:

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]

Acting President
San Diego, California (California Institute of Regenerative Medicine)

Assistant Supervisor (Human Cellular Therapy) 
Rochester, Minnesota (Mayo Clinic)

Cell Processing Medical Technologists 
Oldsmar, Florida (Cryo-Cell International Inc.)

Cell Therapy Scientist 
Philadelphia, Pennsylvania (RheoGene, Inc.)

Cell Therapy Specialist 
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Cell Therapy Supervisor 
New York, New York (New York Blood Center)

Cell Therapy Technologist 
New York, New York (New York Blood Center)

Cellular Production Lead Technician
Seattle, Washington (Fred Hutchinson Cancer Research Center)

Clinical Laboratory Scientist
Los Angeles, California (Cedars-Sinai Medical Center)

Clinical Consultant  
Deerfield, Illinois (Baxter Healthcare)

Clinical Trials Coordinator 
Vancouver, British Columbia (Malachite Management)

Consultant– (AABB)

Director of Cell Therapy
New York, New York (New York Blood Center)

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

Faculty Positions 
Singapore (John Hopkins Singapore)

Instrumentation Engineer II 
Gaithersburg, Maryland (Maxcyte)
Laboratory Manager 
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

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

Manager, Device Engineering
Gaithersburg, Maryland (Maxcyte)

Manager, Quality Assurance 
Gaithersburg, Maryland (Maxcyte)

Marketing Manager 
Denver, Colorado (Gambro BCT)

Medical Laboratory Technologist (Stem Cell)
Roswell Park Cancer Institute (Buffalo, New York)

Post Doctoral Fellowship 
Memphis, Tennessee (St. Jude Children’s Research Hospital)

Program Leader: Cell Biology (Professor/Associate Professor) 
Melbourne, Australia (Peter MacCallum Cancer Centre)

Quality Assurance Associate
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Quality Control Technologist 
Vancouver, British Columbia (StemCell Technologies)

Research Associate II 
Gaithersburg, Maryland (Maxcyte)

Scientific Director 
Boston, Massachusetts (CBR Insitute for Biomedical Research CHCT)
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)

Scientist, Bacteriology
Potters Bar, Hertfordshire, England (National Institute for Biological Standards and Control)

Senior Hospital Scientist 
Sydney, Australia (Australian Stem Cell Facility Sydney Children’s Hospital)

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

Stem Cell Lab Lead Technologist
Boston, Massachusetts (Beth Israel Deaconess Medical Center)

Stem Cell Specialist
Philadelphia, PennsylvaniaA (Children’s Hospital of Philadelphia)

Supervising Medical Laboratory Technologist (Quality Assurance)
Buffalo, New York (Roswell Park Cancer Institute)

Supervising Medical Laboratory Technologist (HLA, Stem Cell, Therapeutic Apheresis) 
Buffalo, New York (Roswell Park Cancer Institute)

Therapy Scientist
(Therapeutic Aphaeresis and Cell Therapy)
Denver, Colorado (Gambro BCT)


International Society for Cellular Therapy

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 2 / May 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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