Volume 5.09 | Nov 29

Cell Therapy News 5.9, November 29, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Stem Cell Therapy Helps South Korean Patient Walk Again

Story: Scientists Generate Human Islet Precursor Cells in Culture from Cadaveric Insulin-Producing Cells


Biological Tools and Cloning Technology to Create Powerful Embryonic-type Stem Cells Without Creating an Embryo


First Monoclonal Antibody Treatment For MS Approved


Stem Cells Can Repair Your Decaying Teeth

Skeletal Muscle Cells Could Be Source Of Stem Cells For Regenerating Nerve Tissue

Stem Cells’ Repair Skills Might Be Link To Cancer

UCI Researchers Use Human Embryonic Stem Cells to Aid Spinal Cord Injury Repair
Article 1, Article 2

Tissue Engineered Blood Vessels Have Potential for Use in Heart Bypass Surgery

Protein Stops Heart Attack Damage

Detecting the Genes That Contribute to Transplant Rejection

Umbilical Cord Blood Can Help Treat Adults with Leukemia: Studies

Leukamia Drug Under the Microscope

Arsenic Trioxide and Pixantrone Highlighted in 42 Abstracts and Presentations at The American Society of Hematology Meeting

Cytogen Announces Publication of Novel Protein Pathway Linked to Aggressive Progression of Breast Cancer

New Protein Structure May Aid In Design Of Therapeutics For Autoimmune Disease

Impaired Thinking After Stem Cell Therapy Temporary

Largest Newborn Stem Cell Bank Welcomes FDA Regulation in Fast-Growing Industry


Epithelial-to-Mesenchymal Transition Generates Proliferative Human Islet Precursor Cells

In Vivo Tracking of Stem Cells for Clinical Trials in Cardiovascular Disease

Risks and Methods for Peripheral Blood Progenitor Cell Collection in Small Children

Expression of Notch1 Gene in the Differentiation of the Human Embryonic Neural Stem Cells to Neurons

Mismatched Hematopoietic Stem Cell Transplantation using GIAC Protocol: Report of 100 Cases

Direct Effects of Interleukin-6 on Liver Progenitor Oval Cells in Culture

Can the Injection of the Patients Own Bone Marrow-derived Stem Cells Preserve Cone Vision in Retinitis Pigmentosa and Other Diseases of the Eye?

Encapsulation of Biologics in Self-assembled Fibers as Biostructural Units for Tissue Engineering

Exploiting Dendritic Cells for Cancer Immunotherapy: Genetic Modification of Dendritic Cells

Growth Factor Displayed on the Surface of Retroviral Particles without Manipulation of Envelope Proteins is Biologically Active and Can Enhance Transduction

Lead and Follow: The Dance of the Dendritic Cell and T Cell

Neurally Selected Embryonic Stem Cells Induce Tumor Formation after Long-Term Survival following Engraftment into the Subretinal Space

Therapeutic Use of Stem Cells II. Adult Stem cells


Student Society for Stem Cell Research: Global Petition to the UN for Stem Cell Research

UN Proposes Cloning Compromise

Australian Stem Cell Policy Change

State Stem Cell Funding Proposed in Illinois



Amgen Published Head-to-Head Data Show Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Once-a-Week

Abgenix to Receive Milestone Payment from CuraGen for Advancement of CR002 Antibody Product Candidate into Clinic

Antisoma AGM update: AS1404 lung cancer trial on track; ovarian and prostate studies confirmed Lead candidate for trials selected from TTA programme

BD Releases New Version of BD.ID Patient Identification System for Specimen Management

Cambridge Antibody Technology Group and AstraZeneca Announce Major Strategic Alliance To Discover And Develop Human Antibody Therapeutics In Inflammatory Disorders

Human Genome Sciences Names H. Thomas Watkins As CEO to Replace Founder William Haseltine 

MedImmune and Medarex Announce Collaboration To Develop And Commercialize Fully Human Antibodies For Autoimmune Diseases

Roche Diagnostics to Release Diabetic Patient Data Management Software

Sanofi-Aventis, CDC Invest 75 mln Eur to Launch Biotech Venture Capital Fund

V.I. Technologies Provides An Update On The Development Program For INACTINE(TM) Pathogen Inactivation System For Red Blood Cells; Suspends Phase III Enrollment

Vitro/Chemicon Sign Supply Agreement for Vitrocell Products


Malachite Management has joined forces with an established and reputable author to bring you a report outlining the very latest in the Cell Therapy industry.  “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 see:

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

Malachite Management has joined forces with an established and reputable author to bring you a report outlining the very latest in the Gene Therapy industry. 
“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 see:

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

Malachite Management Inc. has teamed up with an established publisher to bring you the latest reports in immunotherapeutic approaches to cancer.

A Shift in Cancer Immunotherapy Stategies?
Immunotherapy Strategies Executive Summary
Immunotherapy StrategiesTable of Contents

Future Perspectives in Cancer Immunotherapy
Future Perspectives Executive Summary
Future Perspectives Table of Contents
Immunotherapy Reports Order Form


Pre-Application Meeting for RFA NS-05-005,
“Centers of Excellence in Translational Human Stem Cell Research”
National Institute of Neurological Disorders and Stroke National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases

HLA Region Genetics in Immune-Mediated Diseases – Addendum to RFA-AI-04-039 


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

Human Cell and Tissue Establishment Registration (HCTERS) Public Query Application
Posted: 11/26/2004

Substantially Equivalent 510(k) Device – wBlood Care 1.0 – Care Fusion, Inc
Posted: 11/22/2004, Clearance Date: 11/10/2004



Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.
(Agency Information Collection Activities; Announcement of Office of Management and Budget Approval) Docket No. 1997N-0484S, OC 2004287. [PRE-PUB] OMB approval no. 0910-0543 expires May 31, 2007

FDA clinical trial statutory and regulatory requirements; public workshop  
The public workshop is scheduled for Wednesday,  January 12, 2005, from 8:15 a.m. to 4:15 p.m. and Thursday, January 13, 2005, from 8:15 a.m. to 4 p.m

The National Research Council (NRC) is now accepting applications for the 2005 H.L. Holmes Awards
This award is available to assist Canadian citizens in carrying-out post-doctoral studies in the fields of chemistry, physics, biology or mathematics as they relate to medical and biological processes at outstanding research institutes in Canada or abroad.

Singapore Bioethics Advisory Committee Releases Report on Human Tissue Research

Singapore Bioethics Advisory Committee Releases Guildines for Research Involving Human Subjects



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. 



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 tranplantation


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


Nov. 30 – Dec. 1 FDA Information Management Summit. Bethesda, Md

Nov. 30-Dec. 3 IBC’s 2nd Annual Antibody Therapeutics.San Diego, California

Nov. 30-Dec. 3 IBC’s 15th Annual Antibody Engineering. San Diego, California

Dec. 1 Error Avoidance By Using Electronic Information Systems in Transfusion Medicine. (Part of the Cellular Therapy Audioconference Series)

Dec. 1-3 Immunogenicity for Protein-Based Therapeutics – Washington, DC

Dec. 3 Cellular Therapy: Progressing to Clinical Practice?- San Diego Marriott Hotel & Marina, San Diego, CA

Dec. 3-7  Amer. Society for Hematology: 46th Annual Mtg – San Diego, California – San Diego, CA

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

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. 


 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. 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. 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, 11th Annual Meeting of the International Society for Cellular Therapy. Vancouver, BC

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

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

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 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).

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)


University of Cinncinatti Masters of Science in Transfusion and Transplantation Sciences
Hoxworth Blood Center, through the College of Allied Health Sciences, University of Cincinnati, offers the two year graduate program leading to a Master of Science degree. The graduate program in Transfusion and Transplantation Sciences contains two tracks: Blood Transfusion Medicine and Cellular Therapies.


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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