Volume 6.02 | Dec 20

Cell Therapy News 6.2, December 20, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: First Case of Adipose Derived Stem Cells for Repairing Human Skull Defects Reported

Story: Gene Therapy Cures Boys of Severe Combined Immunodeficiency


MIT Researchers Grow Heart Tissue from Rats’ Cells

How Human Blood Stem Cells Transform Themselves to Repair Injured Animal Hearts

Stem Cells ‘To Treat Liver Harm’

Stem Cell Transplants Help Mice See

New Stem-cell Sources May End Ethics Debate

BBC Rekindles Adult vs. Embryo Stem Cell Cloning Debate

Ethicists Wary of New Stem Cell Proposals

“Nano-needle” Operates on Cell: Could Be Used to Manipulate Embryonic Stem Cells Intended For Use In Medical Treatment

“Nano-scissors” Laser Shows Precise Surgical Capability

Eph Affects T Cell Function

Injectable Gel That Holds Cartilage-Producing Cells in Place Could Speed Repair of Torn Cartilage

New Model of Rare Childhood Blindness Holds Promise for Testing Preventive Gene Therapies

Novel p53 Gene-Based Therapy Boosts Immune System and Reduces Tumor Size

Gene Vaccine For Alzheimer’s Disease Shows Promising Results

Small Variations in Genes Can Determine Risk of Developing Breast Cancer

Study IDs Key Aspect Of Immune Response Against HIV

Israeli-developed Leukemia Treatment Passes Clinical Hurdle

TRALI Consensus Recommendations Published in AABB’s Transfusion Journal

Canadian Blood Services Launches transfusionmedicine.ca


Comparison of High-capacity and First-generation Adenoviral Vector Gene Delivery to Murine Muscle In Utero

Isolation of Cancer Stem Cells from Adult Glioblastoma Multiforme

Life-threatening Neurological Complications After Bone Marrow Transplantation in Children

Sonic Hedgehog Gene-enhanced Tissue Engineering for Bone Regeneration


Schwarzenegger Nominates Stem Cell Research Chief

Illinois Stem cell Tax Vote Expected in Spring

Minnesota Funding Proposed for Stem Cell Research

Stem Cell Committee at 22; Five More to Go



StemCell Technologies to Distribute AllCells’ Product Line Worldwide

Chromos Enters into Agreement with Pfizer to Develop Cell Lines for Production of Recombinant Proteins

Amgen Names Willard Dere Senior Vice President, Global Development 

FDA Approves Amgen’s Kepivance for Severe Oral Mucositis in Cancer Patients Undergoing Bone Marrow Transplant

CytoGenix Inc. Invents Revolutionary Large-Scale Manufacturing Process for High-Purity DNA

Dendreon’s APC8024 Immunotherapy Shows Promise in Advanced Breast Cancer

Genmab’s HuMax-CD20 to Treat CLL Awarded Fast Track Status from FDA

Genzyme Announces Gene Therapy Collaboration with Applied Genetic Technologies

MediBIC and DNA 2.0 Enter R&D Agreement for Protein Engineering and Gene Synthesis Distribution in Japan


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


New Contract Allows NIGMS Cell Repository to Continue Providing Key Genetic Research Resources



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

Potential Hemolysis in Red Blood Cells and Whole Blood Leukocyte Reduced Products Manufactured with the Pall BPF4 Filter
(Update) Posted: 12/17/2004, Notification Date: 12/17/2004

Recall of Leukocyte Reduction BPF4 High Efficiency Filter (Pall Medical
Posted: 12/17/2004, Recall Date: 12/17/2004

Potential Hemolysis in Red Blood Cells and Whole Blood Leukocyte Reduced Products Manufactured with the Pall BPF4 FilterPosted: 12/11/2004, Notification Date: 12/10/2004

Cleared Biologics 510(k) Device Applications – Update

Posted: 12/6/2004, Updated through: 11/30/2004

2004 Biological Approvals – Update
Posted: 12/9/2004, Updated through: 11/30/2004

FDA/DIA Scientific Workshop on Follow-on Protein Pharmaceuticals
Posted: 12/17/2004, Workshop Date: 2/14-16/2005

Advisory Committee Meetings – 2005 Schedule
Posted: 12/16/2004


For Country-Specific & International Regulatory Resources, Including Links to Regulatory Agencies Such as the FDA, EMEA, & More Click Here



FDA’s Official Terms, Lists and Training Rules Now at Your Fingertips with this 3-Book Set

FDA’s Medical Devices Premarket Approval Applications, List; Safety and Effectiveness Summaries Availability


The National Health and Medical Research Council (NHMRC) Bans Human Clinical Trials of Animal Cellular Therapies for Five Years

EMEA Issues Guildine, Concept Papers on Generic Biologics Including Erythropoietin, Human Growth Hormone, Granulocyte-colony Stimulating Factor and Insulin




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


 cGMP in the Transfusion Service. An online training course.

NIH and other Stem Cell Training Courses

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

Free CME Program: Prophylaxis & Pre-emptive Therapy in Patients at Risk for CMV Infection After Stem Cell Transplant
This activity has been designated to meet the educational needs of physicians involved in the management of patients undergoing stem cell transplantation


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. 24 Overview of Staged Implementation of GMP During Biological/Biotechnological Product Development. Alexandria, VA

Jan. 25 Current Best Practices in Purification Development & Validation. Alexandria, VA

Jan. 26 Best Practices in Analytical Test Method Validation. Alexandria, VA

Jan. 27 Best Practices in Commissioning cGMP Laboratory Equipment. Alexandria, VA

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

Jan.28 Operational Factors for Improved Laboratory Quality and Compliance. Alexandria, VA 

Jan. 31 Establishing Realistic Process and Test Method Specifications. Alexandria, VAFEBRUARY
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. 3 Key Issues in Formulation Development for Biotechnology Products. Alexandria, VA

Feb. 4 Auditing In-House and Contract Labs for CMC Development Studies and GLP/GMP Compliance. Alexandria, VA

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 Transplantation 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. 


To View a List of Cell Therapy-Related Journals Click Here


For information on posting an opportunity email: tiffany


Business Development Associate NEW!
Vancouver, BC (StemCell Technologies)

Buyer / Purchaser

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)

Chemist  NEW!
Bethesda, MD (CBER)

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

Consumer Safety Officer (Biological Drug & Device Compliance Branch) NEW!
Rockville, MD. (CBER)

Director of Cellular Therapies
Baltimore, Maryland (AABB)

Director of Oncology/Hematology Medical Communications 
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)

Regulatory Information Specialist (Office of Biostatistics and Epidemiology) NEW!
Montgomery County, MD (CBER)

Regulatory Information Specialist (Division of Viral Products) NEW!
Montgomery County, MD (CBER)

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.

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 University) & 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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