Volume 6.01 | Dec 13

Cell Therapy News 6.1, December 13, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: New Marrow Transplant Method Developed at Stanford May Eliminate Graft-versus-Host Disease

Story: NIH Stops Sickle Cell Anemia Transfusion Study Because of Strokes


Stem Cell Implant Effective in Treating Cerebral Infarction

Mammary Gland Cells Formed During Maternity Have Stem Cell Properties

Stem-cell ‘Miracle’ Thriving

New Research Shows Stomach (Gastric) Cancer Originates From Bone Marrow Derived Stem Cells

Key HIV-fighting Genes Identified

Gene Therapy Reduces Skin Cancer to Sunburn in Mouse Model

Neural Crest Stem Cells in Skin Could Provide Alternative to Embryonic Stem Cell Use

A New Concept in Immunology: Natural Killer Cells Present Foreign Antigens to T cells

High Protein Levels Associated with Remission and Survival in Patients with Blood-borne Cancers

U of MN Researchers Set New Standard of Care for Adult Cord Blood Transplant Patients

Cord Blood Studies Hold Hope for Cancers

Investigating The Role of T cells in Rheumatoid Arthritis

Scientists Reverse Paralysis In Dogs

Important Genetic Risk Factor for Amyotrophic Lateral Sclerosis

Gene Therapy Curbs Fibroids, in Mice

Genetic Target Found For Pediatric Leukemia

Leukemia Vaccine Shows Early Promise

Novel Drugs Help Solve Gleevec Resistance

Nancy And Ron Reagan Presented Award For Their Support Of Stem Cell Research

University of Miami Medical School Receives $100 Million Donation for Biomedical Research


Transplanted Hematopoietic Stem Cells Demonstrate Impaired Sarcoglycan Expression After Engraftment into Cardiac and Skeletal Muscle

Evolution of Hematopoietic Stem Cell Transplantation in Eastern and Western Europe from 1990 to 2003. A Report from the EBMT Activity Survey

Allogenic Transplantation of Human Mesenchymal Stem Cells for Tissue Engineering Purposes: An In Vitro Study

Embryonic Stem Cells Generte Airway Epithelial Tissue

Fatalities Following Allergen Immunotherapy

Gene-mediated Restoration of Cartilage Matrix by Combination Insulin-like Growth Factor-I/interleukin-1 Receptor Antagonist Therapy

RNA interference:A Potential Novel Therapeutic Combating HIV-1 in the Central Nervous System

Lymphotoxin-Mediated Regulation of Gamma Delta Cell Differentiation by Alpha Beta T Cell Progenitors


India’s National Policy Dialogue on the Transplantation of Human Organs Act



Dendreon Corporation Further Strengthens Management Team

Neural Cell Therapy Programs Reviewed by NeuroInvestment

AnorMED receives FDA response to Special Protocol Assessment and Initiates Pivotal Phase III Program for New Stem Cell Transplant Drug Candidate

Chromos Announces Publication of a Landmark Article Describing Its Artificial Chromosome Engineering System (ACE System) in Nucleic Acids Research

Australia’s Mesoblast Gains $21 Million from Initial Public Offering

FDA Grants Fast Track Designation for Amgen’s AMG 531 and AMG 706 Experimental Therapies to Potentially Treat Life-Threatening Conditions

Gamida-Cell Reports Complete Safety and Efficacy Results of Phase I/II Study of StemEx for the Treatment of Leukemia

GPC Biotech Announces Clearance from Swiss Regulatory Authority to Initiate Human Clinical Trials with 1D09C3 Anticancer Monoclonal Antibody

Introgen Breast Cancer Drug Shows Promise in Trial

Invitrogen Signs Agreement to Acquire China-Based Bio Asia


HepaLife Announces the addition of Dr. Jorge Alberto Ortiz to the Company’s Scientific Advisory Board

Point Therapeutics Reports Results of Phase 1 Study of Talabostat in Non-Hodgkin’s Lymphoma at the Meeting of the American Society of Hematology

Proneuron’s Phase II Experimental ProCord Procedure for Complete Spinal Cord Injury Now Available at The Mount Sinai Medical Center in NY & University Hospital in collaboration with Kessler Institute for Rehabilitation in NJ

Xcyte Therapies, Inc. Presents Results of Phase I/II Clinical Trial of Xcellerated T Cells in Chronic Lymphocytic Leukemia at American Society of Hematology Meeting


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 Strategies Table of Contents

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

Immunotherapy Reports Order Form



NIH National Stem Cell Bank: RFP Announcement

RFP-NIH-NHLBI-RR-05-19(NOT-RR-05-002) National Center for Research Resources

NHLBI Stops Study Testing How Long Children with Sickle Cell Anemia Should Have Blood Transfusions to Prevent Stroke

The Stem Cell Genome Anatomy Project (SCGAP) Web Portal
This portal provides access to results from studies on stem and progenitors cells for organ systems like blood, liver, bone, prostate, bladder, kidney and gut.

NIH Provides $32.8 Million to Enhance Biomedical Informatics Research Network

National Cancer Institute Announces Awards to Accelerate Cancer Biomarker Discovery

International HapMap Consortium Widens Data Access
Mapping of Human Genetic Variation Will Speed Search for Disease Genes

Requests for Applications

Innovative Technologies for Molecular Analysis of Cancer(RFA-CA-06-002)
National Cancer Institute
Application Receipt Date(s): February 17, 2005; June 17, 2005; October 18, 2005

Application of Emerging Technologies for Cancer Research (RFA-CA-06-003)
National Cancer Institute
Application Receipt Date(s): February 17, 2005; June 17, 2005; October 18, 2005

Innovations in Cancer Sample Preparation (RFA-CA-06-004)
National Cancer Institute
Application Receipt Date(s): February 17, 2005; June 17, 2005; October 18, 2005

Heart Failure Clinical Research Network(RFA-HL-05-003)
National Heart, Lung, and Blood Institute
Application Receipt Date(s): August 16, 2005

Assay Development for High Throughput Molecular Screening (RFA-RM-05-011)
NIH Roadmap Initiatives
Application Receipt Date(s): February 14, 2005


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

Compliance Program – Inspection of Biological Drug Products
– 7345.848
Posted: 12/8/2004



FDA Request for Nominations for a Nonvoting Member Representing Industry Interests on the Cellular Tissue & Gene Therapies Advisory Committee

 Link 2

FDA Releases New Guide “Combination Products: How to Develop the Optimal Strategic Path for Approval”



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. 



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


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


 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)

Jan 27-28 Cytokines & Inflammation. San Francisco, California

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. 11-12 Stem Cells Research & Therapeutics. San Diego, California

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. 


For information on posting an opportunity email: tiffany


Buyer / Purchaser NEW!
Vancouver, BC (StemCell Technologies)

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)

Director of Oncology/Hematology Medical Communications NEW!
New Jersey (Confidential)

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)


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

Interested in Advertising in Cytotherapy?
For more information and advertising rates, Click here

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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