Volume 6.12 | Mar 14

Volume 6.12, March 14, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: U.N. General Assembly Adopts Nonbinding Statement Urging Governments To Ban All Forms of Human Cloning
Article

Story: Tumor-targeted Immune Cells Cure Prostate Cancer in Mice without Causing Systemic Immune Suppression
Article

Science

Stem Cells Regenerate Damaged Heart
Article

Umbilical Stem Cells Save Boy with No Immune system
Article

Stem Cell Therapy Safety Boosted
A new way of growing human embryonic stem cells in the laboratory will reduce the risk that their use in therapy could go wrong, say scientists.
Article 1, Article 2

Stem Cells Offer Hope to Student
Quadriplegic hopes surgery in Portugal can cure his paralysis
Article

Harvard Institute at Center of Stem Cell Storm
Article

Gene Therapy Cures Inherited Liver Disease in Rats
Article

Gene Therapy Still Benefits Heart After 2 Years
People with severe angina given gene therapy to improve the blood supply to the heart continue to benefit 2 years after the treatment was given, investigators report.
Article

Genetic Therapy Reverses Nervous System Damage in Animal Model of Inherited Human Disease
Article

British Success Heralds Gene Therapy Revolution
Article

Gene Therapy Strategy for Alleviating Chronic Pain Associated with Inflammation Described in Human Gene Therapy
Article

Early Trial Indicates Prostate Cancer Vaccine Increases Immunity and Reduces Tumor Cells
A prostate cancer vaccine that trains a patient’s own dendritic cells to attack a protein antigen expressed by tumors can robustly boost a patient’s immune system and clinically reduce the level of tumor cells in the body.
Article

How Diabetes Transplants Could Herald the End of the Daily Agony of Insulin Jabs
Article

Three Year Phase I Myoblast Cell Transplantation Study Data Presented at American College of Cardiology Scientific Sessions
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

Efficient Derivation of New Human Embryonic Stem Cell Lines
Abstract

From Bench to Bedside for Gene-directed Enzyme Prodrug Therapy of Cancer
Abstract

Outpatient Stem Cell Transplant: Effectiveness and Implications
Abstract

Toxin-based Selection of Insulin-producing Cells with Improved Defense Properties for Islet Cell Transplantation
Abstract

Policy

Is the UK Losing Its Way with Stem Cells?
Scientists believe they are very close to finding a miracle cure for heart disease.
Article

UK to Vote Against UN Human Cloning Decision
Article

UK Plans to Spend £1bn on Biotech
The UK government will spend £1bn on biotechnology by 2008.
Article

Otago Medical School Experts in New Zealand Hope to Trial Stem Cells
Article

Stem Cell Therapy Under Consideration in New Zealand
Article

Lawsuits Filed to Invalidate California’s $3 Billion Stem Cell Institute
Article

Business

BUSINESS NEWS

Bio-Matrix Scientific Group Appoints Dr. Geoffrey O’Neill — Formerly of Cryo-Cell International as New Bio-Matrix President
Article

AmCyte Announces First North American Encapsulated Islet Transplant without Long-Term Immune Suppression into a Patient with Type 1 Diabetes
Article

Cell Genesys CFO Matthew Pfeffer to Resign; Robert Dow Is Appointed to Medical Affairs Post
Article

Geron Announces Publication of Studies Demonstrating That Human Embryonic Stem Cells Can Be Grown with Defined Growth Factors Enabling Scaled Production of Therapeutic Cells
Article

Genitope Corporation Appoints Vice President of Research
Article

Living Cell Technologies Buys Drug-delivering Technology
Biotech company Living Cell Technologies Intends to Buy Intellectual & Property Rights to “Tea Bag”-like cell replacement therapy devices from United States companies Theracyte and Baxter.
Article

The Immune Response Corporation Announces Encouraging Results from REMUNE Phase II HIV Trials; Results from Clinical Studies in Italy and Spain
Article

ThermoGenesis Seeks New Patent Review
Fresh off a U.S. Patent and Trademark Office ruling that overturned a patent related to the collection and preservation of stem cells, ThermoGenesis Corp. — which makes equipment used to store such cells — has asked the government to consider rejecting the claims made in two more.
Article

MARKET REPORTS

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, including order forms, please see:

Cell Therapy Report Summary
Cell Therapy Sample Chapter
Cell Therapy Table of Contents Vol. 1  Vol. 2
Cell Therapy Order Form

“Gene Therapy – Technologies, Markets, and Companies” is over 500 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the gene therapy industry worldwide.
For more information, including order forms, please 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 Strategies?
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

NIH


NATIONAL INSTITUTES OF
HEALTH

NIH Guide for Grants and Contracts – Week Of March 11, 2005
Link

NOTICES

June Northwest Association for Biomedical Research Regional IACUC Conference
Link

Withdrawal from the Independent Scientist Development Award (K02) Program
Link

Answers to Frequently Asked Questions: RFA-HL-05-003, Heart Failure Clinical Research Network
Link

REQUESTS FOR APPLICATIONS

Innovative Grants on Immune Tolerance
Link

Pediatric Heart Network
Link

PROGRAM ANNOUNCEMENTS

Cancer Education (R25E) Grants Program
Link

NIDDK Mentored Research Scientist Development Award (K01)
Link

CBER

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

Approved Biologics NDA and ANDA Applications – Update
Link

Cleared Biologics 510(k) Device Applications – Update
Link

Approved Biologics Premarket Approval (PMA) Device Applications
Link

Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance
Link

Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Link

Licensed Products and Establishments List – Update
Link

Regulatory

For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More Please Visit The Regulatory Page

NEWS & UPDATES

UNITED STATES

FDA

FDA to Provide Guidance on ‘Exploratory’ IND Process

Link

Intravenous Immune Globulins in the 21st Century: Progress and Challenges in Efficacy, Safety, and Paths to Licensure; Public Workshop
Link

Meetings

To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit Our Meetings Page
Journals

To View a List of Cell Therapy-Related Journals, Please Visit Our Journals Page
Careers

JOB POSTINGS IN CELL THERAPY NEWS ARE FREE!
For information on posting an opportunity email: [email protected]

Acting President
San Diego, California (California Institute of Regenerative Medicine)

Cellular Production Lead Technician
Seattle, WA (Fred Hutchinson Cancer Research Center)

Director of Biostatistics & Epidemiology 
Rockville, MD (Center for Biologics Evaluation and Research)

Director of Cell Therapy
New York, NY (New York Blood Center)

Director of Research Programs 
Toronto, Ontario (Ontario Genomics Institute)

Faculty Positions in Stem Cell Research 
Ottawa, Ontario (Ottawa Health Research Institute)

Lead Quality Assessor 
Bethesda, MD (AABB)

Pharmacologist (enter Requisition Code 0412768) NEW!
Exton, Pennsylvania (Therakos, Inc.)

Post Doctoral Fellow (enter Requisition Code 0408577)
Somerville, New Jersey (Ethicon)

Post Doctoral or Engineer Positions 
Toronto, Ontario (Centre for Computational Biology Hospital for Sick Children)

Principal/Senior Scientist (enter Requisition Code 0408581)
Somerville, New Jersey (Ethicon)

Product Manager (Immunology)
Vancouver, BC (StemCell Technologies)

Project Manager (Research & Development) 
Vancouver, BC (StemCell Technologies)

Senior Scientist 
Brussels, Belgium (Beta-Cell NV)

Scientist (enter Requisition Code 0408593)
Somerville, New Jersey (Ethicon)

Stem Cell Specialist
Philadelphia, PA (Children’s Hospital of Philadelphia)

Quality Control Technologist
 Vancouver, BC (StemCell Technologies)

ISCT

 

International Society for Cellular Therapy
www.celltherapy.org

International Society for Cellular Therapy Facility Sanitization Survey
The Facility Sanitization Working Group (organized by the ISCT) has created a survey to assess the current cleaning practices from a wide range of cellular therapy practitioners.The results from this survey will help the working group draft guidelines that strike the appropriate balance between regulatory compliance, product safety and relevance to our varied constituents.

Upcoming Meetings & Conferences:

2005 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)
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

 

ISCT ACQUIRES NEW JOURNAL TO MERGE WITH CYTOTHERAPY
Cytotherapy now incorporates Cytokines, Cellular and Molecular Therapy Journal
 

Join ISCT ($130) and receive the journal as a benefit of membership
http://www.celltherapy.org/mem_app.htm


Current Volume
:Volume 7, Number 1 / March 2005

Table of Contents

Two journals merge  
  
A tribute to David W Golde   
  
BM stem cells and cardiac repair: where do we stand in 2004?  
   
Natural killer cell-based immunotherapeutic strategies  

IL-15: targeting CD8+ T cells for immunotherapy   
  
Mesenchymal stem cells: progress toward promise 
  
Cost-effective manufacture of an allogeneic GM-CSF-secreting breast tumor vaccine in an academic cGMP facility  pp. 46 – 56 
  
Wilms’ tumor 1 (WT1) gene in hematopoiesis: a surrogate marker of cell proliferation as a possible mechanism of action?  pp. 57 – 61 
     
B-cell expansion in the presence of the novel 293-CD40L-sCD40L cell line allows the generation of large numbers of efficient xenoantigen-free APC 
    
Implantation of genetically manipulated BM cells for cardiac repair   
 
Abstracts from the 4th Annual Conference on Mesenchymal and Non-Hematopoietic Stem Cells: Focus on Adult Stem Cells    

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 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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