Volume 6.18 | Apr 21

Volume 6.18, April 21, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Old Stem Cells Can Turn Cancerous

Story: UCLA Researchers Discover New Method To Generate Human Bone


Second Stem Cell Operation Planned for Previously Paralyzed Patient
A second round of stem cell therapy will be conducted on a woman who walked again last year after being paralyzed for 19 years via a first-round operation.

Pancreatic Cell Transplant from Living Donor Could Treat Diabetes
Japanese researchers have successfully reversed a woman’s diabetes by transplanting insulinmaking cells (islets) from a living donor’s pancreas into her.This is the first successful operation of its kind using the islets from a living donor.
Article 1, Article 2

Gene Therapy Completely Corrects Hemophilia in Laboratory Animals
Newborn mice and dogs with hemophilia A were restored to normal health through gene therapy developed by researchers at Washington University School of Medicine in St. Louis. The technique introduced into the animals’ cells a gene that makes clotting factor VIII, a protein missing because of a genetic defect.

Scientists Infuse Rat Spines with Brain-derived Human Stem Cells
Unveiling a delivery method that may one day help surgeons treat the deadly neurodegenerative disease amyotrophic lateral sclerosis (ALS), researchers at the University of Wisconsin-Madison have inserted engineered human stem cells into the spinal cords of ALS-afflicted rats.

Scientists Weaponize an Antibody to Deliver Continuous Attacks on Cancer Cells
In a recent study published in Molecular Cancer Therapeutics, researchers at the Weizmann Institute of Science paired the active ingredient of a garden remedy with advanced bio-technology to deliver a powerful punch against cancer. The cancer killing effectiveness lies in their technique of arming a cancer-targeting antibody with the destructive potential of the dietary molecule otherwise known as “allicin.”

Cancer Patients May One Day Benefit from Treatment with Mixtures of Customized Antibodies
In a study published recently in the Proceedings of the National Academy of Sciences (USA), a team of Weizmann Institute scientists have demonstrated how the right combination might form a web that destroys the cancer cell’s communication network, ultimately demobilizing the cell.

Enzyme that Helps Trigger the Development of Leukemia Discovered
The enzyme hDOT1L activates a set of genes that plays a key role in the rare and largely incurable acute myeloid leukemia (AML).

City College Unveils Stem Cell Training Program
City College of San Francisco students hoping to work in the field of stem cell research will have a leg up on the competition soon, courtesy of a new, state-funded training program.

Genetic Basis of Autoimmune Diseases
A gene associated with susceptibility to a group of autoimmune diseases, including rheumatoid arthritis, thyroid disease and lupus, is identified in the May issue of Nature Genetics.

High Levels of Immunosuppressant May Lead to Tumor Recurrence
A new study on the incidence of liver cancer after transplant found that high levels of the immunosuppressant cyclosporine favored tumor recurrence and identified blood levels of the drug that should not be exceeded. Lower levels of cyclosporine levels did not affect rejection rates.

Race to Human Stem-Cell Trials 
Several scientists have used embryonic or fetal stem cells to help rodents with spinal cord injuries walk again. The researchers travel the country showing videos of rats dragging their hind legs, followed by clips of them miraculously hopping around following stem-cell injections.

Scientists Ask Nations to Allow Therapeutic Human Cloning for Stem Cell Work
An international group of scientists on Wednesday urged nations to allow some human cloning for stem-cell research – but not for reproduction – saying a blanket cloning ban could set back efforts to develop new medical treatments.

Czech Lab On Cutting Edge Of Human Stem-Cell Research
A humble laboratory in the southeastern Czech city of Brno is on the cutting edge of research into the controversial area of human embryonic stem cells.


Aldehyde Dehydrogenase Activity as a Marker for the Quality of Hematopoietic Stem Cell Transplants

Effects of Dendritic Cells from Cord Blood CD34(+) Cells on Human Hepatocarcinoma Cell Line BEL-7402 in Vitro and in SCID Mice

Immunopathogenesis and Therapy of Cutaneous T Cell Lymphoma

Methods for Expansion of Human Embryonic Stem Cells


World’s Largest Newborn Stem Cell Bank Supports Institute of Medicine Report
Cord Blood Registry, (CBR) supports the Institute of Medicine (IOM) recommendation that all pregnant patients be provided with a “balanced perspective” on all cord blood banking options.

European Union Funds Biggest Ever Immunotherapy Programme
A Sixth Framework Programme (FP6) project is spearheading cutting edge stem cell research to improve the survival chances of bone marrow transplant patients.

Stem-cell Issue Costs University a $20M IT Grant
The University of Tasmania has lashed the federal Government for stripping it of $20 million in IT research funding over “blatantly political” concerns on embryonic stem cell research.

Brazil Funds Human Stem Cell Research
The Brazilian government says it will set aside more than $US4 million ($A5.2 million) to finance human stem cell research, including experiments with human embryos.



Big Companies Quietly Pursue Research on Embryonic Stem Cells
Stepping gingerly into a politically charged arena for the first time, some large companies in the U.S. are pursuing plans to study stem cells drawn from early-stage human embryos.

Abiogen Pharma’s New Cell Therapy Starts a Clinical Phase I-II in Peritoneal Carcinosis

Avigen Faces Tough Task of Selling Switch to New Field
It took Alameda’s Avigen Inc. 13 years to give up on its gene therapy business.

Antibodies by Design, JPT Announce Cooperation Agreement
Antibodies by Design, a division of MorphoSys, and JPT Peptide Technologies, a wholly owned subsidiary of Jerini, announced the start of a co-marketing agreement between the two specialist companies.

Bioengineered Wound Care Products Providing Caregivers with Powerful Options; Greystone Associates Assesses Impact on Wound Management Market
The introduction of new technologies and products for the treatment of acute and chronic wounds is providing caregivers with a set of powerful options that will have a profound effect on the field of wound management. These new treatment tools, which mimic the body’s natural physiology and/or regenerative pathways, include tissue-engineered skin substitutes, regeneration matrices, and biologically active cellular therapies.

Trp-p8 Agonists Significantly Inhibit Growth of Trp-p8 Expressing Tumors In Vivo
Dendreon Corporation today announced the presentation of preclinical data showing that modulation of the Trp-p8 tumor target with small molecules may represent a new approach to cancer therapy.

ImmunoGen, Inc. Reports Data at AACR on the Company’s HuC242-DM4 Anticancer Compound

Geron Corporation Announces Multiple Presentations on Its Telomerase Inhibitor Drug GRN163L at the AACR 2005 Annual Meeting

RheoGene Inc. and TissueGene Inc. Sign Collaborative Agreement for Bone Regeneration and Repair
RheoGene Inc. and TissueGene Inc. have entered into a collaborative research and licensing agreement to develop regulated cell therapy treatments for bone restoration and repair.

Stem Cell Therapy International Sponsors Tech Council of Maryland’s ‘The Business of Stem Cell Research Conference’

Tissue Engineering and Cell Therapy Showing Proof-of-Concept, Encouraging Continued Investment and Acquisition, According to New Report from MedMarket Diligence, LLC

Pall Presents Technologies to Streamline Viral and Cancer Vaccine Production at World Vaccine Congress

PharmaStem Enters into a Patent License Agreement with the University of Texas M. D. Anderson Cancer Center
PharmaStem Therapeutics, Inc. announced today that it has entered into an agreement under which The University of Texas M. D. Anderson Cancer Center has obtained a license to PharmaStem’s patent portfolio for the storage and use of umbilical cord blood.


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 22, 2005

NIH/NHLBI-funded PACT Group Announces Audio-Conference Scheduled for April 25, 2005, 1:00 pm ET
The Production Assistance for Cellular Therapies (PACT) Group has announced the scheduling of its audio-conference on April 25, 2005, at 1:00 pm ET.  This will be a free interactive webcast to discuss the project and to answer participants’ questions about the project’s goals, the application process and criteria, and the details surrounding PACT manufacturing assistance.

Interactions Between Stem and Progenitor Cells and the Microenvironment In Vivo (PAS-05-092)

NIDDK Administrative Supplements for Human Embryonic Cell Line Research (NOT-DK-05-012)

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

Standardized Microarrays May Bring Us One Step Closer to Personalized Medical Treatment

Mentored Career Development Award to Promote Faculty Diversity in Biomedical Research (KO1) (RFA-HL-05-015)

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

NIBIB Holds First Regional Grantsmanship Seminar


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

Application User Fees for Combination Products: Guidance for Industry and FDA Staff

Providing Regulatory Submissions in Electronic Format – Content of Labeling: Guidance for Industry

Review Responsibilities for the CMC Section of Biologic License Applications and Supplements: SOPP 8401.4




FDA (Food & Drug Administration)

Science Board to the Food and Drug Administration
– Slides



Labelling Requirements for Medicines
– Consultation Papers

Clinical Trials and Access to Unapproved Therapeutic Products -Consultation Papers

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


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)

Bethsada, Maryland (CBER)

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 NEW!
Los Angeles, California (Cedars-Sinai Medical Center)

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

Lab Technician 
Sunrise, Florida (Bioheart Inc.)

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

Marketing Manager NEW!
Denver, Colorado (Gambro BCT)

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

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
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Quality Assurance Director 
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, PennsylvaniaA (Children’s Hospital of Philadelphia)

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)

Technical Sales Representative 
Vancouver, BritishC (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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