Volume 5.08 | Nov 22

Cell Therapy News 5.8, November 22, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: FDA Finalizes New Rules on Current Good Tissue Practice

Story: Australian Biotech Company Offers Scientists Worldwide Unconditional, Free Access to a New Embryonic Stem Cell Line


Stem Cells ‘Fuel Brain Tumours’
Article 1, Article 2, Article 3, Article 4

Geron Presents Data On Human Embryonic Stem Cell-Based Therapy For Heart Failure

Adult Stem Cells Could be Used to Create Biological Pacemakers for Patients with Heart Failure

Australian Scientists Re-grow Cut Spinal Cord

Geron Presents Data On Human Embryonic Stem Cell-Based Therapy For Diabetes

Bio-insulin Launched for Diabetics

Study Shows Stem Cells Can Preserve Vision

Scientists Hope Success in Mice Study Can Be Used as a Model of Stem Cells’Potential in Fighting Brain Diseases

Chronic Liver Failure to Be Treated Using Stem Cell Therapy

Scientist Demonstrates Basic Active Mechanism of Immune-system Cells

Bioengineer Enhances the Utility of Adult Stem Cells

Researchers Fascinated by Images of Living, Moving Stem Cell

“Painting” Technique Successfully Transfers Gene Therapy To Heart

Gene Therapy Promising for Fabry Disease

Patented Fibrin-based Matrices and Tissue May Open Foors for Tissue and Organ Engineering

Technion Researchers Succeed In Building Cartilage Tissue Outside The Human Body

Researchers Direct Nerve-cell Growth in Real Time Using Protein Walls

Joslin and Stanford Researchers Find Key Clues to Muscle Regeneration

Special Fluorescent Protein Highlights Activity Of Key Cellular Signal
Article 1, Article 2

Researchers Closing In On ‘Death Clock’ Gene that Controls Telomerase Length

Secret Stem Cell Lab in Barbados?

American Association of Blood Banks Gives Canadian Blood Services Medical Director Top Award in Blood Transfusion

Doyle To Focus Resources On Stem Cell Research

UC Berkeley to Host Stem Cell Research Center

Construction Begins on NRC Institute for Nutrisciences and Health in Prince Edward Island, Canada

Marrow and Blood Cell Symposium Focuses on the Promise of Transplantation


Corautus Genetics Announces Publication of Gene Therapy Approach to Heart Disease in Circulation

Crucell Discovers and Validates Human Monoclonal Antibody Product that Protects Against Rabies in Collaboration with CDC and TJU

Positive DX-88 Data for the Treatment of Hereditary Angioedema

Dynavax’s Peanut Immunotherapy Inhibits Allergic Response In Preclinical Studies

Gamida-Cell’s Phase I/II IND Study Results Indicate StemEx for the Treatment of Leukemia to be Safe & Efficacious

Genitope Corporation Provides Update On Progress Of Lead Product Candidate

Geron Announces Publication of Additional Data Supporting the Utility of Telomerase Activation for HIV/AIDS Therapy

Immune Response Presents Preliminary Analysis Of REMUNE Phase II Trial In HIV Positive, Drug Naive Patients

Nabi Biopharmaceuticals Announces Altastaph Phase II Trial Results In Neonates; Results Inconclusive

New U.S. Trial Starts of Tailored Cancer Treatment

Rehabilitation Institute of Michigan Is the First Midwest Rehabilitation Hospital to Participate in Proneuron’s Clinical Research Trial for Spinal Cord Injury

Shriners Hospital for Children Now Enrolling for Proneuron’s Phase II Procord Study


Adult Pancreas Generates Multipotent Stem Cells and Pancreatic and Nonpancreatic Progeny

Bone Marrow Cells Engraft Within the Epidermis and Proliferate In Vivo with No Evidence of Cell Fusion

Cellular Transplantation:This article reviews the scant literature that exists describing the interface between anesthesiologists and marrow donors and islet recipients, introduces the issues surrounding future stem cell transplantation technologies, and describes pretranslational cell transplant applications that are closest to clinical trials.

Directed Mobilization of Endogenous Neural Progenitor Cells: The Intersection of Stem Cell Biology and Gene Therapy

Granisetron vs Ondansetron for Prevention of Nausea and Vomiting in Hematopoietic Stem Cell Transplant Patients: Results of a Prospective, Double-blind, Randomized Trial

Inflammation-responsive Promoters for Fine-tuned Gene Therapy in Rheumatoid Arthritis

Long-term Follow-up of Nonmyeloablative Allogeneic Stem Cell Transplantation for Renal Cell Carcinoma: The University of Chicago Experience

Nonhematologic Malignancies After Allogeneic Hematopoietic Stem Cell Transplantation: Incidence and Molecular Monitoring

Nuclei of Embryonic Stem Cells Reprogram Somatic Cells

Selective Apoptosis of Pluripotent Mouse and Human Stem Cells by Novel Ceramide Analogues Prevents Teratoma Formation and Enriches for Neural Precursors in ES Cell-derived Neural Transplants

Survival and Neural Differentiation of Adult Neural Stem Cells Transplanted into the Mature Inner Ear

Use of Intrathecal Prophylaxis in Allogeneic Haematopoietic Stem Cell Transplantation for Malignant Blood Diseases: A Survey of the European Group for Blood and Marrow Transplantation (EBMT)


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

UN Fails to Reach Compromise on Human Cloning Issue

U.N. Approves Global Gene-Test Standard

The Stem Cell Research Act of Illinois “Backwards and Dangerous”, According to The Center for Bioethics and Human Dignity

Lab Construction to Tap Stem Cell Fund

Both Legislators & Firms Split on California Stem-Cell Incentives



Celmed BioSciences and Gambro BCT Enter into a Strategic Relationship to Improve the Safety of Blood Stem Cell Transplantation

Cengent Therapeutics Signs Genes-To-Leads Drug Discovery Contract with Dynamis Therapeutics

Dragon Pharma to Market Erythropoietin in Three New Markets

Genaissance Pharmaceuticals And Ipsogen To Offer Comprehensive Package Of Pharmacogenomic Technologies For Oncology Drug Development

Gene Logic K.K. Officially Opens Office in Japan; Gene Logic Solidifies Local Presence to Meet the Needs of Japanese Pharmaceutical Customers

Geron Licenses Nuclear Transfer Technology to Revivicor

India’s Biocon Eyes Global Expansion for Its Insulin Product

Ireland Leading Europe in Life Science

Rigel & Merck to Form Partnership

Sanguine is Discussing a Project with the U.S. Army Medical Corps


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 and order 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 and order 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


NCI Scientists Create Model That Predicts Follicular Lymphoma Survival

NIEHS to Develop New RNAi Library to Help Fight Disease

NIDA Joins Forces With Perlegen To Research Nicotine Addiction


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

Notice of Field Correction: Automated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System (Haemonetics Corp)
Posted: 11/18/2004, Notification Date: 10/18/2004

Increased Rate of Initial and/or Repeat Reactive Results for the Auszyme Monoclonal Test for Hepatitis B Surface Antigen (HBsAg) (Abbott Diagnostics, Becton Dickinson)
Posted: 11/18/2004, Notification Date: 11/18/2004



FDA Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule – 11/18/2004

Questions and Answers for Roll-Out of GTP Final Rule

The teleconference held by CBER’s Director, Dr. Jesse Goodman, is available for replay until November 23rd, 2004 by telephoning 1-866-498-9766.

Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Availability

Health Products and Food Branch Proposals for Summary Basis of Decision (SBD) and Notice of Decision (ND) Documents: Drugs

EU to Launch Sanctions Against Israeli Intellectual Property Infringement



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’s Medicines and Medical Devices Safety Authority:

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:

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


by The BioMaterials Network 
by The Pittsburgh Tissue Engineering Initiative
by The Tissue Engineering Pages 
by the American Society of Hematology
by the International Society for Stem Cell Research


Nov. 22-24  2nd National Stem Cell Centre Annual Scientific Conference.  Sydney, Australia. 

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. 9-10 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. 


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
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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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