Volume 5.07 | Nov 15

Cell Therapy News 5.7, November 15, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: UN Nears Showdown on Pact to Ban Stem Cell Study
Article

Story: Tiny Exosomes Extracted From Donor Dendritic Cells May Be ‘Magic Bullet’ For Drug-Free Organ Transplants
Article

Science

NIH Researcher Predicts Stem Cell Based Tissue Will Replace Metallic Prosthetics
Article

Regenerative Medicine at the Medical College of Georgia Examines Stem Cells’ Potential to Repair, Replace Damaged Tissue
Article

Myoblast Cell Therapy For Congestive Heart Failure 
Article

Stem Cell Therapy Effectively Treats Heart Attacks In Animals
Article 1  Article 2  Article 3

Method Developed for Collecting Heart Stem Cells from Tissue
Article 1 Article 2

Key Discovery Made Toward Understanding Shared Molecular Mechanisms that Cause Alzheimer’s,Parkinson’s,Lou Gehrig’s, & Huntington’s
Article

Impaired Neuromotor Function Following Cancer Treatment Can Improve
Patients who suffer a loss of cognitive and motor function as a result of stem cell transplantation for severe blood disorders are likely to see those functions return to previous levels after one year
Article

Researchers Identify Protein Long Considered to be the Missing Link in Hearing Research: Finding May Lead to Gene Therapies for Deafness
Article

Doctors Transplant Ovary to Woman’s Arm to Preserve Fertility
Article

Engineered Stem Cells Can Home In On Tumors And Deliver Drug Payload In Mice
Article

Mayo Clinic Researchers Discover One Mechanism for Why Men and Women Differ in Immune Response
Article

Long-Term Immune Memory Cells Do Not Develop During Chronic Viral Infections
Article

First In Vivo Demonstration of RNA Interference via Systemic Delivery is Published by Alnylam Scientists
Article

How Ubiquitin Silences Genes: Study Uncovers Mechanism of Histone Monoubiquitylation and Gene Silencing
Article

                                                                  CLINICAL TRIAL RESULTS

AnorMED Expands AMD3100 Stem Cell Transplant Programme in Cancer Patients
Article

Antegren One-Year Data from Phase III AFFIRM Study Showed Compelling Results in Meeting Primary Endpoint in Multiple Sclerosis
Article 1

Medimmune Initiates Pivtoal Phase III Study for Numax
Article

Preliminary Results Of Trabio(R) Phase II/III Clinical Trial; Failed To Meet The Primary Endpoint
Article

New Clinical Trial Data Showed the Addition of INTEGRILIN® (Eptifibatide) Injection Achieved Superior Platelet Inhibition and Less Heart Muscle Damage When Compared to a Commonly Used Antiplatelet Regimen Alone
Article

New England Journal of Medicine Publishes Response Results of Abbott’s Investigational Anti-Interleukin-12 (IL-12) Fully Human Monoclonal Antibody in Crohn’s Disease Study
Article

Zymogenetics Presents Results of Healthy Volunteer Study with TACI-IG 
Article

                                                            ABSTRACTS, REVIEWS & REPORTS

Cancer Stem Cell Biology: From Leukemia to Solid Tumors
Abstract

A New Theory of the Origin of Cancer: Quantum Coherent Entanglement, Centrioles, Mitosis, and Differentiation
Abstract 

Heal Thyself: Potential Applicability of Stem Cell Therapy in the Management of Heart Disease
Abstract

Hematopoietic Stem Cell Transplantation from Alternative Sources in Adults with High-risk Acute Leukemia
Abstract

Hormonal Replacement Therapy After Stem Cell Transplantation
Abstract

CNS Stem and Progenitor Cell Differentiation into Functional Neuronal Circuits in Three-dimensional Collagen Gels
Abstract

Immunotherapy of Autoimmune Encephalomyelitis with Re-directed CD4+CD25+ T-lymphocytes
Abstract

Long-term Outcome After Haploidentical Stem Cell Transplantation in Children
Abstract

Cancer-specific Activation of the Survivin Promoter and Its Potential Use in Gene Therapy
Abstract

Mesenchymal Cells: A Vehicle for Gene Therapy
Abstract

Mesenchymal Stem Cells: Harnessing Cell Plasticity to Tissue and Organ Repair
Abstract

Growth Factors Essential for Self-renewal and Expansion of Mouse Spermatogonial Stem Cells
Abstract

A New Complication of Stem Cell Transplantation: Measles Inclusion Body Encephalitis
Abstract

Neural Stem Cells Protect Against Glutamate-induced Excitotoxicity and Promote Survival of Injured Motor Neurons Through the Secretion of Neurotrophic Factors
Abstract

On The Road to a Tumor Cell Vaccine: 20 Years of Cellular Immunotherapy
Abstract

Photoswitchable Cyan Fluorescent Protein for Protein Tracking
Abstract

Stromal Cell-Derived Factor-1{alpha} Plays a Critical Role in Stem Cell Recruitment to the Heart After Myocardial Infarction but Is Not Sufficient to Induce Homing in the Absence of Injury
Abstract

Ocular Surface Stem Cells and Disease: Current Concepts and Clinical Applications
Abstract

Policy

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

Swiss Bishops Hit Plan on Embryonic Stem Cell Research
Article

National Research Council of Canada Announced the Inauguration of Work at Six New Research and Innovation Facilities
Article

Business

BUSINESS NEWS

California Stem Cell Research Interests Scientists
A 21st-century gold rush is on in California after the voters approved $3 billion for human embryonic stem cell research
Article

Encouraging Europharma Euphoria
Article

Amgen Announces the Formation of Amgen Ventures; Venture Capital Fund Designed to Provide Resources to Help Advance Early-Stage Biotechnology Companies and Human Therapeutics
Article

Anormed’s Abstracts On AMD3100 Stem Cell Transplant Drug Candidate Accepted For Presentation At The American Society Of Hematology Conference
Article

Bristol-Myers Squibb Company and Medarex, Inc. Announce Worldwide Collaboration to Develop and Commercialize MDX-010, A Fully Human Antibody Investigational Product Targeting the CTLA-4 Receptor
Article

Dendreon Names James Caggiano as Vice President, Sales and Marketing
Article

Dyax Announces Antibody Discovery Collaboration with Biogen Idec
Article

Genmab to Present Data from Phase I/II HuMax-CD20 Study at ASH Conference
Article

Genentech CFO Lavigne to Retire in March
Genentech CFO Lou Lavigne to Retire in March 2005, David Ebersman Is Named As Successor
Article

Geron Announces Studies Showing That Cells Derived from Human Embryonic Stem Cells Can Be Immortalized by Telomerase
 Article

Human Monoclonal Antibodies: A Technical Gold Mine in the Israeli Desert
Article

LifeCycle Pharma Brings Blockbuster ImmunosuppressantInto Clinical Trials
Article

Novartis Selects Drug Candidate For Clinical Development From Protein Kinase Research Collaboration With Vertex Pharmaceuticals Incorporated 
Article

Seattle Genetics and Genentech Expand Antibody-Drug Conjugate Collaboration
Article

With Adult Stem Cell Therapy Showing Promise for Cardiac Patients, NeoStem Launches Targeted Holiday Campaign
Article

           MARKET REPORTS

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 PerspectivesExecutive Summary
Future Perspectives Table of Contents
Immunotherapy Reports Order Form

NIH

Fellowships for Human Embryonic Stem Cell Research (PA-05-013) National Institute of General Medical Sciences
Link

CBER

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

Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Posted: 11/12/2004
Link

Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
Posted: 11/8/2004
Link

Licensed Biological Products
Link

Human Cell, Tissues and Cellular and Tissue-Based Products – List of Registered Establishments – Update
Posted: 11/3/2004, Updated through: 11/2/2004
Link

Substantially Equivalent 510(k) Device – Blood Bank Control System (BBCS) 5.0 – Blood Bank Computer Systems, Inc
Posted: 11/1/2004, Clearance Date: 10/22/2004
Link

Substantially Equivalent 510(k) Device – Quality Donor System 2004 2.0 – Talisman Ltd
Posted: 11/1/2004, Clearance Date: 10/18/2004
Link

Substantially Equivalent 510(k) Device – LifeTec Donor Verification and Collection System (DOVAC) 1.00 – SysTec Computer Associates, Inc
Posted: 11/1/2004, Clearance Date: 10/21/2004
Link

Regulatory

NEWS & UPDATES

UNITED STATES:
FDA Approves Adult Use of Norditropin for Growth Hormone Deficiency
Link

FDA’s Biological Response Modifiers Cmte. Renamed Cellular, Tissue and Gene Therapies
Link

Draft Guidance for Food and Drug Administration Review Staff and
Sponsors: Content and Review of Chemistry, Manufacturing, and Control
Information for Human Gene Therapy Investigational New Drug
Applications; Availability
Link

Clinical Pharmacology Subcommittee of the Advisory Committee for
Pharmaceutical Science; Notice of Meeting
Link

CANADA:
Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs (Canada)
Link

AUSTRALIA
Suspension & Cancellation of Medical Devices
Link

Revised Therapeutic Goods Order for Diagnostic Goods of Human Origin 
Link

                                      

INDIA
Regulatory Requirements of Blood and/or Its Components Including Blood Products
Link

NEW ZEALAND:
Regulatory Guidelines for Medicines
Link

EUROPE:
Pharmaceuticals in the EU
Link

Consultation on Commission Regulation on the condition marketing authorisation for medicinal products. The European Commission wishes to receive comments on a draft Commission regulation on the conditional marketing authorisation for medicinal products falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and the Council of 31 March 2004 
Link

REGULATORY BODIES

NORTH AMERICA

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:
Homepage
Biologics and Genetic Therapies
Biologics and Genetic Therapies Fact Sheet

EUROPE

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

The Rules Governing Medicinal Products in the European Union

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

UNITED KINGDOM

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

ASIA & THE PACIFIC

Australian Therapeutic Goods Administration:
 Homepage

Indonesian Ministry of Health
 Homepage

Japan’s Pharmaceuticals and Medical Devices Evaluation Center:
 Homepage

Korean Food and Drug Administration:
 Homepage

New Zealand’s Medicines and Medical Devices Safety Authority:
 Homepage

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

Singapore’s Health Sciences Authority:
 Homepage

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

INDIA

Central Drug Standard Control Organization:
 Homepage

INTERNATIONAL

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. 
Homepage
                                              

Meetings


MALACHITE’S ONLINE
CONFERENCE CALENDAR

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

OTHER ONLINE CALENDARS

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

CONFERENCES 2004

Nov. 10 Lecture: Life After Darwin: the Open Softrware of Gene Therapy. New Jersey Institute of Technology 

Nov. 10-12 2nd Annual International Clinical Trials Summit, Westin Grand Hotel, Washington, DC 

Nov. 17 The Changing Spectrum of Drug-Induced Immune Hemolytic Anemia. (Part of the Cellular Therapy Audioconference Series)

Nov. 17-20 7th International congress of the Cell Transplant Society.  Boston, MA. 

Nov.18-19  Commercialisation of Tissue Engineering and Regenerative Medicine. London, UK.

Nov. 19 Advances In Bone Marrow Transplantation Conference– Sydney Australia

Nov. 19 – 21   2004 Hanson Symposium “Stem Cells: From Biology to Therapy”  Adelaide, South Australia. 

Nov. 20-22 33rd Annual Autumn Immunology Conference .Chicago, Illnois

Nov 20-22 Stem Cells: Saving Lives or Crossing Lines.Rice University, Houston, Texas

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

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. 

COURSES

Oct. 5-Nov. 15 The Zitter Group: Managed Care Webcast Series – New series for biotech and pharma marketers aiming to enhance reimbursement, coverage, managed care strategy, and tactical effectiveness.

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

CONFERENCES 2005

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

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

February 10 – 15, 2005 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).

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

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

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

March 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. 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).

April 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 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 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)

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. 

ISCT

International Society for Cellular Therapy 
                 www.celltherapy.org

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)
Email

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

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

Profiled Journal

Interested in Advertising in Cytotherapy?
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Read Cytotherapy in 2005!  Join ISCT ($130) and receive the journal as a benefit of membership
http://www.celltherapy.org/mem_app.htm

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.
www.cytotherapy.com



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