Volume 6.16 | Apr 11

Volume 6.16, April 11, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: LCT Reports Nine-year Survival of Transplanted Pig Islet Cells in a Diabetic Patient

Story: Mologen Obtains Order for the First Cell and Gene Therapy Center in Saudi Arabia and Receives Down Payment


Gene Therapy Shows Effect in Heart Patients
The first double-blind, placebo-controlled randomized trial of VEGF gene injections into the heart muscle of patients with coronary artery disease with the intention of spurring growth of new blood vessels showed significant effects on heart wall motion, although blood flow was not significantly better in treated patients.

Researchers Test New Therapy For Advanced Melanoma 
Researchers at H. Lee Moffitt Cancer Center & Research Institute and the University of South Florida are testing a promising new therapy that prompts the immune system to aid in the fight against melanoma tumors. 

Human Blood Cells Coaxed to Produce Insulin
Tantalising experiments that seem to have made human blood cells start producing insulin have raised the prospect of a new treatment for diabetes.

Biolaser Lights Up Stem Cells
Scientists have developed a laser that could illuminate stem cells in greater detail than ever, revealing the important steps they take to become neuron, heart or other types of cells.

Placenta Is A Rich Source Of Blood Stem Cells
Researchers at Children’s Hospital Boston and the Dana-Farber Cancer Institute report a surprising finding about embryonic development: the blood system begins to form not only in the embryo itself, but also in the placenta, the organ that nurtures the baby in utero.

Researchers Closer To Helping Hearing-Impaired Using Stem Cells
Researchers at Indiana University School of Medicine are several steps closer to the day when a profoundly deaf patient’s own bone marrow cells could be used to let him or her hear the world.

Infants Under One Year of Age Can Accept Heart Transplants from Donors of Different Blood Groups
A study showing that infants under one year of age can accept heart transplants from donors of different blood groups without the risk of organ rejection means a better chance of survival for infant patients and more efficient use of donor organs overall.

New Therapy Appears Effective Against Melanoma
A new immunotherapy technique significantly reduced the size of cancer in patients with advanced melanoma who didn’t respond to previous treatments.

Researchers Pioneer New Gene Therapy Technique Using Natural Repair Process
Harnessing the strength of a natural process that repairs damage to the human genome, a researcher from UT Southwestern Medical Center has helped establish a method of gene therapy that can accurately and permanently correct mutations in disease-causing genes.

Gene Therapy for Retinal Diseases Advances With New Viral and Capsule Mechanisms to Place Genes Directly in Eye
Tests of three new gene therapies to treat inherited, blindness-causing diseases such as retinitis pigmentosa and age-related macular degeneration are showing much promise, according to a UCLA professor and leading authority in retinal diseases.

‘Gene-editing’ Technique Cuts Out Diseased DNA
A gene-editing process that corrects mutations without weaving foreign genetic material into the chromosome has been demonstrated in diseased human cells for the first time.

Long-Term Survival in Lung Transplantation

Bionic Eye Will Let the Blind See
US scientists have designed a bionic eye to allow blind people to see again.


Stem Cell Plasticity: Tools for Investigation and Repair

Genetic Therapy in Gliomas: Historical Analysis and Future Perspective

Involvement of Human Natural Killer Cells in Asthma Pathogenesis: Natural Killer 2 Cells in Type 2 Cytokine Predominance


Gene Therapy Boom in the United Kingdom
British authorities approved a total of eleven trials of gene therapy last year, it was announced yesterday.
Article 1, Article 2

Indian Council of Medical Research Okays Stem cell Research by AIIMS

Bush Rules on Stem Cells Faulted
Article 1, Article 2



Avigen Drops ‘Gene Therapy’ Research
After twelve unprofitable years, Avigen Inc. has decided to stop funding its experimental gene therapy platform and instead focus its limited capital on developing traditional pharmaceuticals.

Genetic Engineering News Publishes Annual Listing of Molecular Millionaires

Anormed Files IND To Evaluate Potential Of AMD3100 To Repair Damaged Heart Tissue In Cardiac Patients
AnorMED Inc. announced today that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration for approval to begin its clinical program for AMD3100 in cardiac patients. The filing is the first step in evaluating the potential of AMD3100, a stem cell mobilizer, to help repair damaged heart tissue in patients who have suffered heart attacks.

Invitrogen Completes Acquisition of Dynal

Chemicon International, Inc. Expands its Exclusive Agreement for Patented Compounds and Methods for Embryonic Stem – ES – Cell Research

Bio-Matrix Scientific Group Announced Today That Collective Technologies Will Manufacture Stem Cell Instrument Molds

Human BioSystems Advances Donor Organ Preservation Results to a New Level

Geron And Exeter Life Sciences Form Joint Venture For Licensing Animal Cloning Technologies
Geron Corporation (Nasdaq: GERN) and Exeter Life Sciences, Inc. announced today the formation of stART Licensing, Inc., a new company that will manage and license a broad portfolio of intellectual property rights related to animal reproductive technologies.

ICOS, Caprion Pharmaceuticals Enter Into Joint Development Collaboration
ICOS and Caprion Pharmaceuticals have entered into an agreement for the joint development of therapeutic antibodies for the treatment of cancer.

Australia’s Mesoblast Makes Rapid Progress Towards Adult Stem Cell Clinical Trials

Mesoblast Receives $1.5 million Adult Stem Cell Grant

Takara Bio, MolMed Conclude R&D Agreement for HIV Gene Therapy Treatment


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 8, 2005


Processing Methods for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Public Meeting
The goals of this meeting are to provide a public forum for gathering scientific data, information and views from interested persons about various methods used to process HCT/Ps, the impact of processing on the HCT/P, and how to evaluate the impact.

Medical Device Notification:HNA Classic 306 Patient Manager Blood Bank Software (Cerner Corp)

SoGAT XVII International Working Group on the Standardization of Genomic Amplification Techniques for the Virological Safety Testing of Blood and Blood Products

Licensed Products and Establishments List – Update

Approved Biologics NDA and ANDA Applications – Update

Cleared Biologics 510(k) Device Applications – Update

Approved Biologics Premarket Approval (PMA) Device Applications– Update




FDA (Food & Drug Administration)

Preparation for the International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting

Blood Products Advisory Committee; Notice of Meeting

Blood Products Advisory Committee; Draft Agenda

Blood Products Advisory Committee;Briefing Information

AABB (American Association of Blood Banks)

AABB-Accredited Cord Blood Banks Prepare for Implementation of New Standards and Regulations

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:

Processing Methods for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Public Meeting. Rockville, Maryland
June 22-23

Gene Therapy: “Clearing Hurdles in Pre-clinical & Clinical Trials”.London, United Kingdom 
June 23-24

GTP Workshops – Implementing the New Regulations and Preparing For FDA Inspections: A Program for Human Cells, Tissues and Cellular and Tissue Based Product Organizations. New Orleans, Louisiana
June 27 – 29, 2005

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 Supervisor NEW!
New York, New York (New York Blood Center)

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

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

Consultant– (AABB) NEW!

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 NEW!
Sunrise, Florida (Bioheart Inc.)

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

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

Rockville, MD (Center for Biologics Evaluation and Research)

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)

Program Support Specialist
Rockville, MD (Center for Biologics Evaluation and Research)

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

Quality Control Technologist
 Vancouver, BC (StemCell Technologies)

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

Senior Hospital Scientist NEW!
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) NEW!
Roswell Park Cancer Institute (Buffalo, New York)

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

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

Technical Sales Representative NEW!
Vancouver, BC (StemCell Technologies)

Therapy Scientist
(Therapeutic Aphaeresis and Cell Therapy) NEW!
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



Join ISCT ($130) and receive the journal as a benefit of membership

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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