Volume 6.14 | Mar 28

Volume 6.14, March 28, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Adult Stem Cells from the Olfactory Mucosa Develop into Many Different Cell Types
Article

Story: Scaffolding Allows Stem Cells To Become Working Fat Cells
Article

Science

Stem-cell Operation on New Zealand Woman in China has Immediate Effect
Article

Johns Hopkins Begins Human Trials With Donor Adult Stem Cells To Repair Muscle Damaged From Heart Attack
Researchers at Johns Hopkins have begun what is believed to be the first clinical trial in the United States of adult mesenchymal stem cells to repair muscle damaged by heart attack, or myocardial infarct.
Article

Human Stem Cells Can Develop Into Functional Vascularized Muscle Tissue, Weill Cornell Team Finds
The discovery by Weill Medical College of Cornell University researchers that a specific type of human fetal stem cell can co-differentiate simultaneously into both muscle and blood vessel cells may unlock the door to therapies that replace damaged tissue in the heart and other organs.
Article

Cord Blood Cells Proven to Differentiate into Heart Muscle and Brain Cells
Scientists at the Duke Comprehensive Cancer Center have scientifically validated for the first time that stem cells in umbilical cord blood can infiltrate damaged heart tissue and transform themselves into the kind of heart cells needed to halt further damage.
Article

Chicks Used to Create Nerve Cells
Scientists have transformed stem cells from adult human bone marrow into nerve cells by transplanting them into damaged chicken embryos.
Article 1, Article 2

All India Institute of Medical Science Uses Robot to Inject Stem Cells in Human Heart
Article

Early Trial Indicates Prostate Cancer Vaccine Increases Immunity And Reduces Tumor Cells
Article

UCLA Launches $20M Stem Cell Institute to Investigate HIV, Cancer, and Neurological Disorders
Experts in bioengineering, imaging, molecular genetics, immunology, ethics, hematology/oncology and cellular biology to collaborate on Proposition 71 research.
Article

Novel Ultrafast Laser Detection of Cancer Cells Also May Improve Understanding of Stem Cells
To investigate tumors, pathologists currently rely on labor-intensive microscopic examination, using century-old cell-staining methods that can take days to complete and may give false readings.
Article

Benefits of Allergen Immunotherapy Persist
Article

Advances in Immunotherapy for Allergies Presented
Article

Regulatory T Cells Checks the Immune System
The April issue of Nature Immunology* examines the state-of-the-art understanding in the biology of regulatory T cells and how they may directly affect many conditions, including autoimmune diseases, cancer, allergy, infectious diseases and transplantation.
Article

A New Setback for Gene Therapy
Article

Hong Kong Develops Novel Gene Therapy for Colon Cancer
The Faculty of Medicine of the University of Hong Kong announced Friday its discovery of a novel method of gene therapy for Colon Cancer.
Article

Antibody Enhances Effect of Leading Cancer Drug
Article

Three Risk Factors Have the Greatest Impact on Patient and Graft Survival Rates for Liver Transplantation
Article

Harvard Provost OK’s Cloning of Cells
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

A Modified Cord Blood Collection Method Achieves Sufficient Cell Levels for Transplantation in Most Adult Patients
Abstract

Development of a Perfusion Fed Bioreactor for Embryonic Stem Cell-derived Cardiomyocyte Generation: Oxygen-mediated Enhancement of Cardiomyocyte Output
Abstract

Multipotent Stem Cells from Adult Olfactory Mucosa
Abstract

Specific Targets in Tumor Tissue for the Delivery of Therapeutic Genes
Abstract

Policy

California High Court Dismisses Stem Cell Challenge
Article

Washington House Approves Bill Endorsing Human Embryonic Stem Cell Research, Banning Reproductive Cloning
Article

Medical Research Council’s Response to Budget Speech, UK
UK Chief Executive of the Medical Research Council Professor Colin Blakemore Responds to the Budget Statement on Stem Cell Research
Article

Business

BUSINESS NEWS

26 Xcyte Workers to Lose Their Jobs
Xcyte Therapies Inc., a Seattle-based biotechnology company, said yesterday that it gave 26 employees their pink slips as part of a strategy to focus on two key medical products.
Article

Proneuron’s ProCord Granted European Patent
ProCord is an experimental procedure for the treatment of complete spinal cord injury now being studied in an international Phase II trial.
Article

U.S. BioDefense and University of Minnesota Sign Option Agreement to License Selective Engraftment of Drug-Resistant Hematopoietic Stem Cells
Article

Advanced Biotherapy Appoints Mr. Paul Hopper as Director of Business Development
Article

BrainStorm Appoints Prof. Ole Isacson to Scientific Advisory Board; Award Winning Neurologist and Advisor to Michael J. Fox Foundation to Provide Compelling Research Direction
Article

Crucell and DSM Announce PER.C6 Licensing Agreement with Mitsubishi Pharma for Protein Production
Article

GammaCan Announces Commencement of Phase II Clinical Trial
Article

Pluristem Obtains Notice of Allowance from U.S. Patent Office Providing Broad Coverage of Proprietary Stem Cell Expansion Technology
Article

Welcome Mats Out for Stem Cell Agency
Ocean vistas. A ‘perfect place.’ Private jets. A Capitol view. Cities go all out for the prestige of being home to the cutting-edge institute.
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/NHLBI-funded PACT Group Re-opens Cell Therapy Survey

Link

Makeover May Be Coming For NIH
Link

Antonio Scarpa, M.D., Ph.D., Named New Director of the Center for Scientific Review
Link

NIH Guide for Grants and Contracts – Week Of March 25, 2005
Link

Notice of Limited Competition Request for Competing Applications: Strong Heart Study
Link

RFP Availability Announcement: RFP NIH-NINDS-05-01 – Clinical Trials in Neurology
Link

RFP Availability Announcement: RFP NIH-NINDS-05-02 – Domain Specific Tasks of Executive Function in Neurological Disorders
Link

Non-Human Lentiviral Models of the Neurological Complications of AIDS; Program Announcement
Link

CBER

Guidance for Industry: Premarketing Risk Assessment
Link

Guidance for Industry: Development and Use of Risk Minimization Action Plans
Link

Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
Link

Draft Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials
Link

Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection System (Haemonetics Corp)
Link

Recall of Modified Alsever’s Solution, Blood Cell Diluent (Gamma Biologicals)
Link

Food and Drug Administration Regulations; Drug and Biological Product Consolidation; Addresses; Final Rule; Technical Amendment
Link

DIA Conference: The New Regulatory Framework for Marketing Pharmaceuticals – Slides
Link

2005 PDA International Congress – Slides
Link

Approval document – Alpha-1-Proteinase Inhibitor (Human), Zemaira
Link

11th Annual Surviving the Challenges of FDA & Other Regulatory Authorities’ GMPs – Slides
Link

Guidance for Industry: Pharmacogenomic Data Submissions
Link

Attachment to Guidance on Pharmacogenomic Data Submissions
Link

Thimerosal in Vaccines – Update Tables 1 and 3 (Menactra)
Link

Regulatory

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

NEWS & UPDATES

UNITED STATES

FDA
Center For Biologics Evaluation And Research: Vaccines And Related Biological Product; Advisory Committee Meeting
Link

Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems; Availability
Link

Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Fluorescence in situ Hybridization Enumeration Systems; Final Rule
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 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)

Pharmacologist (enter Requisition Code 0412768)
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)

Regulatory Information Specialist, OBE NEW!
Rockville, MD (Center for Biologics Evaluation and Research)

Senior Scientist 
Brussels, Belgium (Beta-Cell NV)

Scientific/Technical Officer,Stem Cell Transplant Laboratory/Haematology NEW!
Sydney, Australia (SWAPS, Liverpool Hospital) 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

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

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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