Volume 6.17 | Apr 18

Volume 6.17, April 18, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Breakthrough Isolating Embryo-quality Stem Cells from Blood

Story: New Method May Be Alternative to Gene Therapy


Breakthrough in Stem Cell Research: Australians Develop Three Clones From Human Embryonic Stem Cells
“This cloning of cells involves a new technique, which is a very accurate way of extracting and then growing a single cell,” said UNSW Senior Lecturer Dr Kuldip Sidhu, who is leading the research and is based at the Diabetes Transplant Unit (DTU) at the Prince of Wales Hospital, a major teaching hospital of UNSW. “There has only been one report of cloning of cells from human embryonic stem cells anywhere else in the world – in Israel.”

Cardiac Stem Cells Come Closer to Clinic
The laboratory of MDA grantee Kenneth Chien at the University of California-San Diego announced in a recent issue of Nature that its researchers have discovered in the hearts of mice, rats and humans a new type of stem cell that can become a mature cardiac cell.

Mouse with Designer Liver has Enhanced Glucose Tolerance and Improved Insulin Response

Gene Therapy for Tumors, Including Gliomas
Researchers at Columbia University Medical Center have discovered a way to overcome one of the major hurdles in gene therapy for cancer: its tendency to kill normal cells in the process of eradicating cancer cells.

Gene Transplanted in Experimental Therapy Procedure
An experimental and controversial form of “genetic therapy” involving transplanting a gene in the body of the patient was recently administered to a heart patient at Petah Tikva’s Beilinson Hospital, Rabin Medical Center.

Researcher Grows New Insulin-secreting Beta Cells from Pancreatic Tissue
The treatment caused primitive “precursor” cells in the islets – known as ductal cells – to develop into beta cells, increasing overall beta cell mass and boosting insulin levels within the islets.

Antibodies May Help Alzheimer’s, Study Finds
Antibodies that attack the protein believed responsible for Alzheimer’s disease may offer a new way to treat the brain-destroying illness, U.S. researchers reported on Tuesday.

RNAi Consortium Unites Big Pharma and Academia
Investigators from three major pharmaceutical firms – Bristol-Myers Squibb, Eli Lilly & Co., and Novartis AG – are joining forces with the Broad Institute and other leading academic centers to create the RNA Interference (RNAi) Consortium.

Researcher Takes Stem Cell Research Another Step
Treena Arinzeh, a young professor who last year won a Presidential Award, the nation’s highest scientific honor, is bringing the promise of stem cell research one step closer to reality.

Tissue Engineering to Grow Bone, Ligaments and Cartilage
A future in which laboratory-grown organs and stimulated growth of muscle, bones and nerves could play a major role in treating medical conditions was revealed at a recent Tissue Engineering Symposium at Wake Forest University Baptist Medical Center.

Cells That Go Back in Time
Lop off a newt’s leg or tail, and it will grow a new one. The creature’s cells can regenerate thanks to built-in time machines that revert cells to early versions of themselves in a process called dedifferentiation.


Adult Stem Cell Lines in Regenerative Medicine and Reconstructive Surgery

Designing Babies: What the Future Holds

Effects of Medium Composition on the Production of Plasmid DNA Vector Potentially for Human Gene Therapy

Gene Therapy in the Management of Oral Cancer: A Review of Recent Developments

Muscle Stem Cells and Exercise Training


Pell Hails Stem Cell Discovery
Catholic Archbishop George Pell will refer to Rome an Australian scientific breakthrough that could make obsolete the moral and ethical debate surrounding embryonic stem cell research.

Stem Cell Institute Committee to Consider Finalists for Headquarters Site
The California Institute for Regenerative Medicine (CIRM) will hold the first of three public hearings Wednesday on where its permanent headquarters should be.

Cord Blood Stem Cells – Institute of Medicine Advisory
Establishing a National Cord Blood Bank Program, a new congressionally mandated report from the Institute of Medicine of the National Academies, proposes a structure for a fully coordinated, national cord blood bank program.


Argos Therapeutics Announces Initiation of Melanoma Vaccine Trial
Argos Therapeutics has announced the start of a clinical trial using a novel personalized melanoma vaccine based on the company’s proprietary technology. The product is made from the patient’s own tumor RNA and immune cells and Argos says it is the first of its kind to be developed for melanoma.

HepaLife Surpasses Research Objectives: Continues to Advance Optimization of Proprietary Liver Cell Line for Final Use in Artificial Liver Device

Lipid Sciences, Inc. Presents Latest Viral Immunotherapy Data at Keystone Symposium

QLT Announces Senior Management Changes; Chief Financial Officer Stepping Down

Seattle Genetics, Protein Design Labs In License Pact
Seattle Genetics Inc. licensed exclusive rights to a potential anti-cancer therapy from Protein Design Labs Inc.

Targeted Genetics Announces Breakthrough Research on Huntington’s Disease
Targeted Genetics has announced that Beverly Davidson of the University of Iowa published encouraging preclinical results for a potential treatment of Huntington’s disease (HD).


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 Guide for Grants and Contracts – Week Of April 15, 2005


NICHD Administrative Supplements for Human Embryonic Stem Cell Research (NOT-HD-05-011)

Modifications to NHLBI Policy for Distribution of Data from Clinical Trials and Epidemiology Studies (NOT-HL-05-115)

Stem Cells and Cancer- Program Announcement (PA-05-086)


Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product– Guidance for Industry and FDA Staff

Recall of Platelet Sampling Device (Charter Medical Ltd)

Assessing Donor Suitability and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection- Draft Guidance for Industry

2005 Biological Approvals – Update

Fast Track Designation Request Performance – Update

RAPS 2005 West Coast Conference – Slides



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


These meetings have been added to the calendar this week:

6th International Symposium on Organogenesis: “Stem Cells and Organogenesis”. Ann Arbor, Michigan
May 6 – 7

Cellular Niches Workshop (NIDDK). Bethesda, Maryland
May 16 – 17

Genetics Policy Institute’s Stem Cell Policy and Advocacy Summit. Houston, Texas
June 10-12

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


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


For information on posting an opportunity email: [email protected]

Acting President

San Diego, California (California Institute of Regenerative Medicine)

Cell Therapy Specialist NEW!
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Cell Therapy Supervisor 
New York, New York (New York Blood Center)

Cell Therapy Technologist 
New York, New York (New York Blood Center)

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

Consultant– (AABB)

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)

Lab Technician 
Sunrise, Florida (Bioheart Inc.)

Laboratory Manager NEW!
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Medical Laboratory Technologist (Stem Cell)
Roswell Park Cancer Institute (Buffalo, New York)

Medical Officer (CEB/DCEPT/OCTGT)
Rockville, MD (CBER)

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)

Quality Assurance Associate NEW!
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Quality Assurance Director NEW!
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Senior Hospital Scientist 
Sydney, Australia (Australian Stem Cell Facility Sydney Children’s Hospital)

Senior Scientist 
Brussels, Belgium (Beta-Cell NV)

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

Scientist, Bacteriology
Potters Bar, Hertfordshire, England (National Institute for Biological Standards and Control)

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

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

Supervising Medical Laboratory Technologist (Quality Assurance)
Roswell Park Cancer Institute (Buffalo, New York)

Supervising Medical Laboratory Technologist (HLA, Stem Cell, Therapeutic Apheresis)
Roswell Park Cancer Institute (Buffalo, New York)

Supervisor Cellular Activities 
New York, New York (Memorial Sloan-Kettering Cancer Center)

Technical Sales Representative 
Vancouver, BC (StemCell Technologies)

Therapy Scientist
(Therapeutic Aphaeresis and Cell Therapy)
Denver, Colorado (Gambro BCT)


International Society for Cellular Therapy

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)

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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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.

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