Volume 5.06 | Nov 8

Cell Therapy News 5.6, November 8, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: US Stem Cells Tainted by Mouse Material
Article

Story: Blood Transplants Riskier Than Bone Marrow Transplants In Pediatric Leukemia Patients
Article

Science

Hair Cloning Nears Reality as Baldness Cure
Article

Researchers Grow Sperm Stem Cells in Laboratory Cultures
Advance Could Lead To New Infertility Treatments, Source of Adult Stem Cells
Article 1, Article 2, Article 3, Article 4

Stem Cells Engineered to Attack Cancer
Article 1, Article 2, Article 3

Biochemists At U.Virginia Health System Identify Molecular Switch That Regulates Cancer Cell Survival
Article

Antisoma Telomere Targeting Agent Stops Tumour Growth In Prostate Cancer Model
Article

Interim Phase 2 Data Suggest Activity of Panitumumab with Chemotherapy in First-Line Treatment of Metastatic Colorectal Cancer
Article

Allergy Link to Blood Cancer Risk
Article

Stem Cells Found in Adult Skin Retain their Embryonic Capability of Making Many Types of Cells
Article

New Hope For ALS Seen With Genetic Techniques, Growth Factors
Article


Cell Transplants Restore Lost Skin Color
Article

Retinal Stem Cells Can Regenerate After Transplant
Article

Certain Diseases May Affect Success of Stem Cell Transplants
Article

Endocrinologists See Hope for Stem Cell Use as Diabetes Cure
Article

Link Between Immune Protein And Longer Survival In Melanoma Patients Identified 
Article

Hollis-Eden Pharmaceuticals Describes New Data with Potent Second Generation Immune Regulating Hormones in Preclinical Models of Autoimmune and Inflammatory Conditions
Article

Doubt Over Stem Cell Blood Theory
Article

Promises and Perils of Genetic Engineering
Article

Promise Of Stem Cells Amplified; New Evidence Shows Cells May Help Treat Many Disorders Including Paralysis And Brain Cancer
Article


Human Genome Sciences Characterizes Panel Of Novel Human Monoclonal Antibodies That Specifically Antagonize The CCR5 Receptor And Block HIV-1 Entry
Article

Embryos to be Screened for Cancer
Article

Watchdog Faces Questions about Approval for ‘Designer Baby’ Tests
Article



Stem Cells: Saving Lives or Crossing Lines
Conference at Rice University November 20-21 will address ways to better inform the American public about the importance of a US role in human embryonic stem cell research
Article

ABSTRACTS, REVIEWS, & SPECIAL REPORTS

Higher Mortality After Allogeneic Peripheral-Blood Transplantation Compared With Bone Marrow in Children and Adolescents: The Histocompatibility and Alternate Stem Cell Source Working Committee of the International Bone Marrow Transplant Registry
Link

Autologous Peripheral Blood Stem Cell Transplantation for Myocardial Regeneration: A Novel Strategy for Cell Collection and Surgical Injection
Abstract

Cellular Sources of New Pancreatic  Cells and Therapeutic Implications for Regenerative Medicine
Abstract

Clinical Strategies for the Expanson of Haematopoietic Stem Cells
Abstract

Derivation and Characterisation of New Human Embryonic Stem Cell Lines in Czech Republic
Full Text

Gene Transfer of Constitutively Active Caspase-3 Induces Apoptosis in a Human Hepatoma Cell Line
Abstract

Haematopoietic Stem Cell Transplantation in Europe 2002:
Changes in indication and impact of team density. 
Link

LRP6 Expression Promotes Cancer Cell Proliferation and Tumorigenesis by Altering -Catenin Subcellular Distribution
Abstract

Making Structures for Cell Engineering
Abstract

New and Viable Cells to Replace Lost and Malfunctioning Myocardial Tissueiable Cells
Abstract

Opinion: The nature of stem cells: state rather than entity
Abstract

Isolation and Expansion of Adult Cardiac Stem Cells From Human and Murine Heart
Abstract

Strategies to Enhance T-Cell Reconstitution in Immunocompromised Patients
Abstract

Policy

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

UN Delays Vote on Cloning Ban — Again
Article

Experts: Stem cell Research May Get Post-Election Boost
Article

California Voters Back $3 Billion Stem Cell Measure
Article 1, Article 2, Article 3

National Academies of Science Guidelines for Human Embryonic Stem Cell Research

Article

Business

 BUSINESS NEWS

CalbaTech Announces Creation of New Subsidiary LifeStem; Believes Its Stem Cell Research Programs and Proprietary Stem Cell Delivery System Will Benefit From Passage of Proposition 71, California’s $3 Billion Stem Cell Research Program
Article

Chemicon International Inc., A Division Of Serologicals Corporation, Acquires Mouse Embryonic Stem Cell Product Lines From Primogenix Incorporated
Article

Chemicon and Thromb-X N.V. Enter Into Agreement for Exclusive Sale and Marketing of New Embryonic Stem Cell Tissue Culture Media
Article

Dendreon Achieves Commercial Scale of Antigen for Provenge
Article

Genzyme Seeks Therapeutic Indication for Thyrogen
 Article

Immucor Under Investigation for Allegedly Making Improper Payments
Article

ImmuneRegen BioSciences, Inc.Closes Round Of Funding
Article

Inhibitex Presents Data for Their Investigational Humanized Monoclonal Antibody, Aurexis
Article

Mederex’s Mice Produce Human Antibodies
Article

Peptimmune, Inc. Announces Promotion Of Thomas P. Mathers To CEO
Article

Search For New Medicines In Cancer, HIV, Hepatitis, Blindness And Diabetes/Obesity
Article

Progenics Pharmaceuticals, Inc. and Cytogen Corporation Announce Award Of $7.4 Million In NIH Grants For Prostate Cancer Immunotherapies
Article

StemCells Completes Equity Financing; $22.5 Million in Funds to Support Batten’s Trial
Article

ThermoGenesis Submits to FDA for Permission to Market the DAC(TM) System for Separating Blood Components
Article

Vistagen Secures More Key Embryonic Stem Cell Technology For Leading Edge Diabetes Research
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 to order see:

Cell Therapy Report Summary
Cell Therapy Sample Chapter

Table of Contents
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 to order 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. For more information and to order see:

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 PerspectivesTable of Contents
Immunotherapy Reports Order Form

NIH

NATIONAL INSTITUTES OF HEALTH

NIH to Designate Three Centers for Regenerative Medicine Research
Centers of Excellence in Translational Human Stem Cell Research

RFA Number: RFA-NS-05-005
Link

National Institute of Allergy and Infectious Diseases
HLA Region Genetics in Immune-Mediated Diseases – Addendum to RFA-AI-04-039
(NOT-AI-05-005)
Link

National Institute of Allergy and Infectious Diseases Health Resources and Services Administration; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases
Request for Information (RFI): Live Organ Donor Outcomes and Medical Needs
(NOT-AI-05-006)
Link

CBER

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

Substantially Equivalent 510(k) Device – Misys Laboratory Blood Bank and Blood Donor 6.0.1 – Misys Healthcare Systems
Posted: 10/29/2004, Clearance Date: 10/22/2004

Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
– Update
Posted: 10/28/2004, Updated through: 10/28/2004

Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes
Posted: 10/28/2004, Publish Date: 10/28/2004

Regulatory

RESOURCES

ISCT’s Cell Therapy Legal & Regulatory Affairs Online Resources Center:
 Link

The Rules Governing Medicinal Products in the European Union

WHO Quality Assurance and Safety of Medicines (QSM)

ISPE Regulatory Information (International regulatory agencies and documents)

International Conference on Harmonisation (ICH) Guidances – Topics and Guidelines

Code of Practice for the Production of Human-derived Therapeutic Products (UK)

The 21CFRPart11.com Web site 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.

Regulatory Affairs Professionals Society 
RAPS Combination Products Resource Page

The United States Food & Drug Agency
Home page
Current Guidances
 Dockets 
Electronic FOI 
Investigations Operations Manual 2004 
Medical Device GMP Reference Information 
Modernization Act of 1997
(FDAMA) 

 

OTHER REGULATORY RESOURCES

Advanced Cell and Gene Therapy Consulting

Biologics Regulatory Training Institute

The Biologics Consulting Group

                                                                 
                                       

Meetings

FEATURED EVENT

(Scientific Talk)
Tooth Tissue Engineering and the Quest for Dental Stem Cells
Guest Speaker: Dr. Conan S. Young from the Forsyth Institute (Boston, USA)
Date: November 15th, 2004
Time: 10:30AM-11:30AM PST
Location: Terry Fox Institute (in the BCCR Lecture Theatre)
 601 West 10th Avenue, Vancouver, BC
Contact: 604-877-0713 or [email protected]

 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. 17-20 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. 1-3 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. 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. 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

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. 23-25: The Clinical Trials Congress – Philadelphia
Featuring 80+ leading clinical experts incorporating Clinical Technologies, Patient Recruitment, Regulations, Strategic Partnerships, Study Design & Management and Contracts and Budgeting into 4 dynamic tracks. Janet Woodcock, MD, CBER, FDA provides a highly-anticipated update on the FDA Clinical Path Initiative. 

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

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.

April 27-30 American Society for Apheresis 26th Annual Meeting Chicago, IL.  

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 1-5  American Society of Gene Therapy Annual Meeting.  Saint Louis, MO. 

June 23-25  3rd Annual Meeting of the International Society for Stem Cell Research. San Francisco, CA. 

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 Therapywww.celltherapy.org

ISCT’s Quality Assurance Group launches online discussion board to discuss Quality Management issues via open, honest discussion by experienced, interested parties.

Profiled Journal

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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