Volume 6.00 | Dec 6

Cell Therapy News 6.0, December 6, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Zapped Human Eggs that Divide without Sperm Could Remove Ethical Objections to Embryonic Stem Cells

Story: Umbilical Cord Blood an Acceptable Alternative for Stem Cell Transplantation in Leukemia


Stem Cells of Limited Use for Cardiac Muscle Repair

Stem Cells Rebuild Bladder Control, Curing Incontinence
Article 1, Article 2, Article 3

Stem Cells May Hold Promise as Multiple Sclerosis Cure

Finding Could Improve Safety of Stem Cell Transplants

Boston’s Children’s Hospital Advances Stem Cell Research

Leukemia Patients Survive With Stem Cell Transplant

Stomach Cancer May Start in Bone Marrow

Gene Therapy Shows Promising Results In The Battle Against Incurable ALS Muscle Disease

Jefferson Scientists Use Gene Therapy to Rescue Failing Hearts in Animals

Racial Disparities Noted In Immune System Genes

Stress Causes Immune Cells To Age
Article 1, Article 2

The Cord-Blood-Bank Controversies


The Amy Strelzer Manasevit Research Program For The Study Of Post-Transplant Complications


Washing of Cord Blood Grafts After Thawing: High Cell Recovery Using An Automated and Closed System

Differentiation of Mesenchymal Stem Cells Towards a Nucleus Pulposus-like Phenotype In Vitro: Implications for Cell-Based Transplantation Therapy.

Gene Therapy Progress and Prospects: Episomally Maintained Self-replicating Systems

Intrinsic Ageing of Gut Epithelial Stem Cells

Outcomes After Transplantation of Cord Blood or Bone Marrow from Unrelated Donors in Adults with Leukemia

Transplants of Umbilical-Cord Blood or Bone Marrow from Unrelated Donors in Adults with Acute Leukemia


Swiss Endorse Stem Cell Research



Israel’s Golden Hand Resources Now Brainstorm Cell Therapeutics

Fuji Films Investing $446M in Japanese Research Center for Biotechnology, Nanotechnology, & Optical Technology

Ethics and the Business of Bioscience

French Biotech Venture Capital Fund Launched

Genetic Engineering News’ Top 10 CEOs


Medarex Gets Amgen Milestone Payment

Olympus Develops Highly-sensitive Gene Analysis Technology


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 and to order see:

Cell Therapy Report Summary
Cell Therapy Sample Chapter
Cell Therapy Table of Contents
Cell Therapy Order Form

“Gene Therapy – Technologies, Markets and Companies” is 560 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the gene therapy industry worldwide.
For more information and to order 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 Stategies?
Immunotherapy Strategies Executive Summary
Immunotherapy StrategiesTable of Contents

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

Immunotherapy Reports Order Form


Production Assistance for Cellular Therapy (PACT)
The National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH), is supporting the initiative for an Administrative Center and three facilities for the production and testing of novel somatic (biological) cell therapies. This project is designed to develop novel somatic cellular therapies that will aid investigators by providing production assistance in areas ranging from basic science through animal studies to proof-of-principle and eventually human trials.

Announcing the NIA Aged Non-Human Primate Tissue Bank
(NOT-AG-05-002)National Institute on Aging


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

Exceptions and Alternative Procedures Approved Under
21 CFR 640.120 – Update
Posted: 11/29/2004, Updated through: 11/28/2004

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update
Posted: 11/29/2004, Updated through: 11/28/2004

Draft Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
Posted: 11/29/2004

Compliance Program 7342.002 – Inspection of Source Plasma Establishments – Revision
Posted: 11/30/2004

Oncologic Drugs Advisory Committee; Notice of Meeting



Australian Stem Cell Centre (ASCC) Releases Annual Report



The US Food & Drug Agency:
Home Page
Current Guidances
Dockets Management Homepage
Electronic Freedom of Information 
Investigations Operations Manual 2004
Medical Device GMP Reference Information
Modernization Act of 1997 (FDAMA)

Canada’s Health Products and Food Branch:
Biologics and Genetic Therapies
Biologics and Genetic Therapies Fact Sheet


European Agency for the Evaluation of Medicinal Products:
Gene Therapy Expert Working Group

The Rules Governing Medicinal Products in the European Union

European Commission:
DG Enterprise: Pharmaceuticals and Cosmetics: Human Tissue Engineering


National Institute for Biological Standards and Control:
Code of Practice for the Production of Human-derived Therapeutic Products


Australian Therapeutic Goods Administration
Australian Research Council
Australian Stem Cell Centre
Biotechnology Australia

Indonesian Ministry of Health

Japan’s Pharmaceuticals and Medical Devices Evaluation Center:

Korean Food and Drug Administration:

New Zealand: 
New Zealand’s Medicines and Medical Devices Safety Authority
New Zealand Bioethics Council

People’s Republic of China:
National Institute for the Control of Pharmaceutical & Biological Products (in Chinese)
State Drug Administration (in Chinese)
Ministry of Health (in Chinese)

Singapore’s Health Sciences Authority
Singapore Bioethics Advisory Committee Homepage

Taiwan’s National Laboratories of Foods and Drugs (in Chinese):


Central Drug Standard Control Organization:


World Health Organization:
Quality Assurance and Safety of Medicines

International Society for Cellular Therapy:
Legal & Regulatory Affairs Online Resources Center

International Society for Life Sciences Professionals:
International Regulatory Information

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH):
Topics and Guidelines

Regulatory Affairs Professionals Society:
Home Page
Combination Products Resource Page

The 21CFRPart11.com
Provides access to information on the rules and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators. 



The Cancer Vaccine Consortium
Accelerating Development of Immunotherapies for Cancer
Through the activities of the Consortium, members whose companies are planning a launch of potential cancer vaccines advance their understanding of ways to achieve licensing and commercialization of this new wave of therapies. The Cancer Vaccine Consortium is focused on the ultimate goal of vaccine development-licensure and commercialization into a medical standard-of-care-and so is looking at advancing products through all phases of the process.


For a more complete listing of conferences, see Malachite Management’s new online, interactive
 Cell Therapy Calendar


Dec. 4-8  American Society for Cell Biology (ASCB) 44th Annual Meeting. Washington, D.C.

Dec.6-10 British Society for Immunology (BSI). Harrogate, United Kingdom

Dec. 8 Cyberspace: e-Tools for Transfusion Medicine. (Part of the Cellular Therapy Audioconference Series)

Dec. 9 Negative Results of Clinical Trials: SEC & FDA Ramifications. Palo Alto, California

Dec. 9-10 EuroConference: Stem cells. Paris, France
Dec. 9-10 DIA/EMEA Workshop on Gene Therapy & Cell Therapy Products.  London, UK. 

Dec. 12-17 Human Leucocyte Differentiation Anitgens (HLDA8) and Australasian Society for Immunology (ASI). Adelaide, South Australia 


 Nov. 29-Dec. 1: Current Good Tissue Practice– Amsterdam, Netherlands

Nov. 30-Dec. 1: Monitoring Clinical Trials – Malvern, Pa. 

cGMP in the Transfusion Service. An online training course. Link

NIH and other stem stem cell training courses – Link

Weekly – UCSFs Human Embryonic Stem Cell Training Program (3-day training course).  Link


Jan. 5 Complete Quality Competency.(Part of the Cellular Therapy Audioconference Series)

Jan. 10-13 CHI’s PepTalk Conference: The Protein Information Week. San Diego, California

Jan. 17-28, BMRC-EMBO Practical Course on Advanced Optical Methods in Cell and Developmental Biology. Biopolis, Singapore 
Application deadline: Nov. 15, 2004 (Selected Participants pay only travel costs)

Jan. 20-22 Stem Cell Transplantation in Children: Current Results and Controversies. Scottsdale, Arizona

Jan. 24-26  Phacilitate Cell & Gene Therapy Forum.  Washington DC

Jan 26 Complications of Blood Donations. (Part of the Cellular Therapy Audioconference Series)

Feb 1-3 FDA and the New Paradigm for Tissue Regulation Conference. Dallas, Texas

Feb. 1-4 International Congress on Anti-Cancer Treatment. Paris, France

Feb. 2 Transfusion Service and Blood Center Cooperation in the Management of Serious Transfusion Reactions. (Part of the Cellular Therapy Audioconference Series) 

Feb.10-15 Molecular Regulation of Stem Cells. Banff, Alberta
Feb. 10-14 Tandem BMT Meetings (Combined ASBMT and IBMTR/ABMTR annual meetings).  Keystone, Colo.

Feb. 16 Basic Antibody Identification. (Part of the Cellular Therapy Audioconference Series)

Feb. 23-25: The Clinical Trials Congress – Philadelphia

Feb. 23 Process Validation/Qualification for Cell Therapy Procedures. ( Part of the Cellular Therapy Audioconference).

Mar. 2 Introducing the 23rd Edition of Standards for Blood Banks and Transfusion Services. ( Part of the Cellular Therapy Audioconference).

Mar 3-4 Commercialisation of Stem Cells: Are Stem Cells Commercially Viable? London, UK

Mar. 4-5 Stem Cell 2005: Progress to Therapy? EICC, Edinburgh, Scotland 

Mar. 16 Advanced Transfusion Reactions. ( Part of the Cellular Therapy Audioconference).

Mar. 17-18 3rd International Symposium on Cellular Therapy. Regensburg, Germany

Mar. 16-20  American Society of Transplantation (AST) and Canadian Society of Transplantation (CST) Annual Winter Symposium. Banff, Canada.

Mar. 20–23  European Group for Blood & Marrow Transplantion Annual Mtg.  Prague, Czech Republic.

Mar. 30 Cord Blood Banking and Transplantation: Decision Making for Selection of Cord Blood Units.( Part of the Cellular Therapy Audioconference).

Apr. 6 Team Approach to Red Blood Cell Exchange.( Part of the Cellular Therapy Audioconference).

Apr. 11-13 R&D Leaders’ Forum Spring 2005. The Biltmore Hotel, Coral Gables, FL

Apr. 13 Reimbursement Guide for Blood Products and Services. ( Part of the Cellular Therapy Audioconference).

Apr. 20 Biology of Stem Cell Mobilization. ( Part of the Cellular Therapy Audioconference).

Apr. 27-30 American Society for Apheresis 26th Annual Meeting Chicago, IL.  

May 3-4, Current Good Tissue Practice. Vancouver, BC
Workshop Chairs: Janice Davis-Sproul, MAS, MT (ASCP) SBB (John Hopkins Univeristy) & John McMannis, PhD (MD Anderson Cancer Center)

May 3-7.  11th Annual Meeting and Scientific Conference of the International Society for Cellular Therapy (ISCT) Vancouver, Canada.  (combined with Good Tissue Practices Workshop & Flow Cytometry for HSC Transplantation Workshop)

May 4 West Nile Virus and SARS: Challenges to Transfusion Safety, Then and Now. ( Part of the Cellular Therapy Audioconference).

May 4-7th, Applications of Flow Cytometry in Marrow and Stem Cell Transplantation. Vancouver, BC

May 11 Increasing Collections: Three Successful Case Studies ( Part of the Cellular Therapy Audioconference).

May 11-14 International Symposium on Technological Innovations in Laboratory Hematology (ISLH). San Francisco, California, USA

May 12-16 5th Annual Conference of the Federation of Clinical Immunology Societies (FOCIS). Boston, Massachusetts

May 14-16 American Society of Pediatric Hematology/Oncology (ASPH/O) 18th Annual Meeting. Washington, D.C.

May 14-17 American Society of Clinical Oncology (ASCO). Orlando, FL, USA

May 18 Leadership and Self-Deception ( Part of the Cellular Therapy Audioconference).

May 18-20  2nd World Congress on Regenerative Medicine.  Leipzig, Germany. 

May 20-25 American Society of Transplantation (AST) American Transplant Congress. Seattle, Washington

May 23-25 Phacilitate Vaccine Forum Spring 2005.Amsterdam

June 1 Facility Requirements for a Cell Therapy Laboratory ( Part of the Cellular Therapy Audioconference).

June 1-5  American Society of Gene Therapy Annual Meeting.  Saint Louis, MO. 

June 2-5  European Hematology Association Meeting. Stockholm, Sweden

June 3-4 3rd Annual International Umbilical Cord Blood Transplant Symposium.Los Angeles, California

June 5 Serological Case Studies: They Didn’t Tell Me about This in School.( Part of the Cellular Therapy Audioconference).

June 22 Two Sides of the Same Coin: Getting the Most from External Assessments.( Part of the Cellular Therapy Audioconference).

June 23-25  3rd Annual Meeting of the International Society for Stem Cell Research. San Francisco, CA. 

July 13 Unrelated Donor Hematopoietic Cell Transplantation: The Effect of Hematopoietic Cell Source, Cell Dose and Conditioning Regimen on Recipient Outcome. ( Part of the Cellular Therapy Audioconference).

July 20 Therapeutic Apheresis in Practice: What’s New? ( Part of the Cellular Therapy Audioconference).

July 27 My Ideal Donor Center. ( Part of the Cellular Therapy Audioconference).

Jul.30- Aug 2 International Society for Experimental Hematology Tradition Meets Innovation 34th Annual Scientific Meeting.Glasgow, Scotland 

Aug. 10 Creative Training Techniques: Stepping Out of the Training Box.( Part of the Cellular Therapy Audioconference).

Sept. 14 Hematopoietic Progenitor Cell Transplantation: Transfusion Requirements and Immunohematologic Complications. ( Part of the Cellular Therapy Audioconference).

Sept. 21 Changes in the New AABB Technical Manual. ( Part of the Cellular Therapy Audioconference).

Sept. 21-25  International Society of Pediatric Oncology Conference.  Vancouver, Canada. 

Sept/Oct  Second International Epithelial Mesenchymal Transfer Conference.  Vancouver, Canada. 



Cell Therapy Laboratory Positions
Houston, Texas (MD Anderson Cancer Center)

Cellular Therapy Laboratory Manager
Seattle, Washington (Seattle Cancer Alliance Center)

Chief Medical Scientist
Dublin, Ireland (St. James Hospital)

Clinical Laboratory Scientist- Cellular Therapies Laboratory
Cinncinatti, Ohio (Hoxworth Blood Center)

Director of Cellular Therapies
Baltimore, Maryland (AABB)

Manager, Regulatory Affairs- Transplant Production Facility
Omaha, Nebraska (The Nebraska Medical Center)

Medical Technologist- Stem Cell Lab
Salt Lake City, Utah (University of Utah)

Quality Manager
Dublin Ireland (St. James Hospital)

Section Chief Technologists-Stem Cell
Amman, Jordan (King Hussein Cancer Center)
Senior Scientist, Process Development: TVAX Product
Menlo Park, California (Geron)

Technical Writer
Vancouver, BC (StemCell Technologies)


International Society for Cellular Therapy 

ISCT’s Quality Assurance Group launches online discussion board to discuss Quality Management issues via open, honest discussion by experienced, interested parties.

Advertise in the Telegraft!

The Telegraft is the Society’s newsletter. It provides the membership with current information on new developments, items of interest, regulatory updates, and contact information. Special issues are also published as required to cover developments of particular importance or interest to the membership
For more information including advertising rates, Click here

Upcoming Meetings & Conferences:

2003-4 Cell Therapy Audioconference Series

May 3-4, 2005 Current Good Tissue Practice. Vancouver, BC
Workshop Chairs: Janice Davis-Sproul, MAS, MT (ASCP) SBB (John Hopkins Univeristy) & John McMannis, PhD (MD Anderson Cancer Center)

May 4-7th, 2005 11th Annual ISCT Meeting. Vancouver, BC
Program Themes Include: Tissue Engineering, Mesenchymal Stem Cells, Immunotherapy, & Hematopoietic Stem Cells

May 4-7th, 2005 Applications of Flow Cytometry in Marrow and Stem Cell Transplantation. Vancouver, BC

Profiled Journal

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Read Cytotherapy in 2005!  Join ISCT ($130) and receive the journal as a benefit of membership

The Current Issue is: Volume 6, Number 5 / October 2004

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 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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