Volume 6.25 | Jun 13

Volume 6.25, June 13, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Stroke Victims Improve with Stem-cell Therapy From South Korean Reseachers

Story: Results Of World’s First Gene Therapy Trial For Arthritis Show Approach Is Safe And Feasible


Mount Sinai Hospital Researcher Develops Canada’s First Embryonic Stem Cell Lines
A senior scientist at Mount Sinai Hospital has developed Canada’s first two human embryonic stem cell lines, giving researchers across the country new potential and hope for eventually discovering treatments and cures for many chronic and fatal diseases.

Fetal Cells Nix Rules, Fix Hearts
Ten heart failure patients who received controversial fetal stem cell injections are all showing signs of rapid recovery three months after the treatment, surgeons who performed the first-time procedure said this weekend.

Banking Baby, Wisdom Teeth for Stem Cells
Baby and wisdom teeth, along with jawbone and periodontal ligament, are non-controversial sources of stem cells that could be “banked” for future health needs, according to a National Institutes of Health researcher who spoke today at the American Dental Association’s national media conference.

Scientists Attempting to Create Embryonic Stem Cells without Destroying Embryos
Although research on producing embryonic stem cells without creating or destroying embryos is “still young,” “largely unpublished” and mostly limited to animal cells, there is a “gathering consensus among biologists that that embryonic stem cells are “made, not born, and that embryos are not an essential ingredient,” according to the Post.

Scientists Find Key to Stem Cell Immortality
MicroRNAs short-circuit cellular ‘stop signals’.

Breast Cancer Survives by Using Growth Factors to Lure Stem Cells
Like a siren song, breast cancer secretes growth factors to attract stem cells then uses those cells – which normally promote healing – to help it survive, researchers have found.

A Baby for Ovary Transplant Woman
A woman who became infertile in her teens has given birth to a baby girl after receiving healthy ovary tissue from her identical twin sister.

Math Optimizes Kidney Matches
Many more people could get kidney transplants thanks to new mathematical techniques designed to optimize a novel matching program at the national level, according to MIT graduate student Sommer Gentry and her husband, a transplant surgeon at Johns Hopkins.


Donald Metcalf’s Blood Lines: An Introduction to Characterizing Blood Diseases of the Post-Genomic Mouse.

A Phase I Clinical Trial of the Treatment of Crohn’s Fistula by Adipose Mesenchymal Stem Cell Transplantation

Differentiation of In Vitro-Modified Human Peripheral Blood Monocytes Into Hepatocyte-like and Pancreatic Islet-like Cells

Long-term Extensive Expansion of Mouse Hepatic Stem/Progenitor Cells in a Novel Serum-Free Culture System

New Method for DNA Microarrays Development: Applied to Human Platelet Antigens Polymorphisms


US Senate Hears Requests to Lift Limits on Stem Cell Research
Some of the nation’s top scientists and medical researchers – and one former NBA star – headed to Capitol Hill yesterday to plead with the Senate to loosen federal limits on embryonic stem cell research.

Australia’s $100 Million Bio21 Institute Opens for Business with the Discoveries Already Flowing
International adult stem cell leader Cygenics will expand its Melbourne research base at the Bio21 Institute, as part of the company’s efforts to grow and differentiate adult stem cells outside the body – for cancer treatment and for drug discovery.

South Korean Stem-cell Pioneer Says He Will Meet with Religious Groups Who Object to His Work
To ensure that his research is done transparently and in an ethical manner, Hwang said he would meet religious and civic groups to listen to their views, as long as it doesn’t compromise the security of his work.



Major Study Shows MabThera(R), an Innovative B Cell Therapy, to be Highly Effective in Treating Rheumatoid Arthritis
Results from the DANCER study presented today revealed that MabThera significantly improves symptoms in heavily treated patients who are affected by moderate-to-severe rheumatoid arthritis (RA), a painful and debilitating disease of the joints.

Arrowhead Licenses Nanotech Stem Cell Device From Stanford
Arrowhead Research has exclusively licensed intellectual property from Stanford University for a nanotech device that controls the behavior of adult stem cells.

Cell Genesys, Inc. (CEGE) Announces Strategic Restructuring of Business To Focus On Most Advanced Programs; Close Plant, Cut 95 Jobs
Cell Genesys, Inc. today announced that it is implementing a strategic restructuring of its business operations to focus resources on its most advanced and most promising product development programs.

CellGenix registers FDA Drug Master Files for ex-vivo CellGro(R) TNF-alpha and GM-CSF
After filing a DMF for IL-4, this contributes further to the strategy of producing highest quality cytokines for the use in clinical ex-vivo cell culturing in connection with cell processing kits.

IDM’s European Manufacturing Facilities Have Been Granted “Cell Therapy Establishment” Designation by the French Drug Agency, Afssaps
IDM is the first private company in France to receive this designation, which authorizes the company to perform activities in the preparation, storage, distribution and transfer of cell therapy products.

Publications in Molecular Therapy Identify Molecular Pathways Underlying Activity of Introgen’s INGN 241 Anti-Cancer Therapy
Researchers at Introgen Therapeutics, Inc. (Nasdaq: INGN – News) and The University of Texas M. D. Anderson Cancer Center have identified the molecular pathways by which mda-7, the active component of INGN 241, induces growth arrest and programmed cell death (apoptosis) in cancer cells.

MultiCell Technologies Commences Sales of Immortalized Porcine Hepatocytes
MultiCell Technologies, Inc. a leading supplier of immortalized human hepatic cell lines for pharmaceutical candidate optimization, announced today that it has commenced sales of HepLiu immortalized porcine (pig) hepatocytes and porcine media dry powder.

Neurologix Completes Procedures in Landmark Phase I Gene Therapy Trial; Co-Founder Presents Trial Update at Parkinson’s Disease Conference
Neurologix, Inc. today announced the completion of all neurosurgical gene transfer procedures in its landmark, 12-patient, dose-escalating Phase I clinical trial of gene therapy for Parkinson’s disease.

Osiris Therapeutics, Inc. Raises $50 Million To Commercialize First Stem Cell Products; Proceeds Will Advance Three Promising Treatments Currently In Human Trials
The financing will fund the company’s three ongoing clinical trial programs using their proprietary adult stem cell technology platform.

Pegasus Biologics Inc. Raises $10M in Series B Financing; Breakthrough Technologies Create “Intelligent Bioimplants” for Orthopedic Soft Tissue Repair
Pegasus Biologics has licensed patented technologies from Biomedical Design that the Company is utilizing to develop advanced bioimplants.

Progenitor Cell Therapy, LLC Welcomes Dr. Onyenoha Chukwumerije as Vice President, Quality Systems
Progenitor Cell Therapy, LLC is pleased to announce that Dr. Onyenoha “Chuck” Chukwumerije has joined the Company’s Executive Management Team as Vice President, Quality Assurance.

StemCell Technologies Signs Worldwide Distribution Deal for ALDEFLUOR™ with StemCo Biomedical
StemCell Technologies, Inc. today announced that it has signed a worldwide distribution agreement with StemCo Biomedical, Inc. whereby StemCell Technologies will distribute StemCo’s ALDEFLUOR™ product.

Thomas Schreck Named CEO of Iken Tissue Therapeutics
Iken President Michael Siani-Rose presented Mr. Schreck to shareholders at the company’s annual meeting on Thursday, June 9, 2005 in San Francisco. Mr. Schreck most recently served as Chief Financial Officer and Director of DURECT Corporation, an emerging specialty pharmaceutical company he co-founded in 1998.

Vical Incorporated Licenses Three Cancer Vaccine Targets To Merck & Co., Inc.
Vical Incorporated announced today that Merck & Co., Inc. has exercised three options under a 2003 amendment to an existing research collaboration and license agreement, granting Merck rights to use Vical’s patented non-viral gene delivery technology in cancer vaccine applications.


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



NIH Encouraging Stem-cell Banks for Teeth
U.S. medical officials are encouraging private companies to create banks for stem cells obtained from baby and wisdom teeth that one day could prove useful for regenerating diseased or damaged tissue.

NIH Guide for Grants and Contracts – Week Of June 10, 2005


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

Draft Guidance for Industry: Bar Code Label Requirements – Questions and Answers

Licensed Products and Establishments List – Update


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


This meeting has been added to the calendar this week:

Curative Cell Therapies for Autoimmune Diseases. Berlin, Germany
June 21-22, 2005

To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit The Meetings Page  On The Cell Therapy News Website


To View a List of Cell Therapy-Related Journals, Please Visit The Journals Page On The Cell Therapy News Website


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

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

Assistant Supervisor (Human Cellular Therapy) 
Rochester, Minnesota (Mayo Clinic)

Cell Processing Medical Technologists 
Oldsmar, Florida (Cryo-Cell International Inc.)

Cell Therapy Scientist 
Philadelphia, Pennsylvania (RheoGene, Inc.)

Cell Therapy Specialist 
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, Washington (Fred Hutchinson Cancer Research Center)

Clinical Laboratory Scientist
Los Angeles, California (Cedars-Sinai Medical Center)

Clinical Consultant  
Deerfield, Illinois (Baxter Healthcare)

Consultant– (AABB)

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

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

Faculty Positions 
Singapore (John Hopkins Singapore)

Instrumentation Engineer II 
Gaithersburg, Maryland (Maxcyte)
Interdisciplinary Scientist (Pharmacology/Toxicology) 
Rockville, Maryland (CBER)

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

Laboratory Supervisor (Stem Cell Lab)
Charlottesville, Virginia (University of Virginia Health System)

Lead Assessor (Part Time) 
Bethseda, Maryland (AABB)

Manager, Device Engineering
Gaithersburg, Maryland (Maxcyte)

Manager, Quality Assurance 
Gaithersburg, Maryland (Maxcyte)

Marketing Manager 
Denver, Colorado (Gambro BCT)

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

Post Doctoral Fellowship 
Memphis, Tennessee (St. Jude Children’s Research Hospital)

Program Leader: Cell Biology (Professor/Associate Professor) 
Melbourne, Australia (Peter MacCallum Cancer Centre)

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

Quality Manager 
Sydney, Australia (Bone Marrow Transplant Network NSW)

Research Associate II 
Gaithersburg, Maryland (Maxcyte)

Scientific Director 
Boston, Massachusetts (CBR Insitute for Biomedical Research CHCT)
Scientific Review & Program Officers 
San Diego, California (California Institute of Regenerative Medicine)

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)

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

Senior Officer for Medical & Ethical Standards 
San Diego, California (California Institute of Regenerative Medicine)

Senior Scientist 
Brussels, Belgium (Beta-Cell NV)

Stem Cell Lab Lead Technologist
Boston, Massachusetts (Beth Israel Deaconess Medical Center)

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

Stem Cell Techonologist 
Salt Lake City, Utah (University of Utah Hospital and Clinics Stem Cell Laboratory)

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

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

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

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


International Society for Cellular Therapy

Upcoming Meetings & Conferences:

2005 Cell Therapy Audioconference Series

5th Annual Somatic Cell Therapy Symposium. Bethesda, Maryland
Sept. 15-18, 2005

Profiled Journal



Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”

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

Current Volume: Volume 7, Number 2 / May 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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