Volume 6.19 | Apr 28

Volume 6.19, April 28, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Alzheimer’s Gene Therapy Hailed

Story: Stem Cells from Brain Transformed to Produce Insulin at Stanford


Donor Stem Cells Restore Sight
Therapy which kickstarts repair could cut transplant need.

Pulsating Ultrasound Enhances Gene Therapy for Tumors
High-intensity focused ultrasound emitted in short pulses is a promising, non-invasive procedure for enhancing gene delivery to cancerous cells without destroying healthy tissue, according to a study in the May issue of the journal Radiology.

Artificial Cornea Restores Vision
A severe allergic reaction to a medication robbed Elma Phifer of her vision two decades ago when she was 39. The reaction scarred her corneas and reduced the ability of her eyes to soothe their damaged surfaces by remaining moist.

Antibodies: Two Are Better Than One 
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. 

Junior Scientist at Joslin Diabetes Center Earns Two Prestigious Career Development Grants to Study Stem Cells
In addition to a highly competitive national grant, Amy Wagers, Ph.D., a young scientist at Joslin Diabetes Center, has received another prestigious career-development award. Together, these grants are providing seed money to advance her promising studies of how blood-forming “stem” cells develop, function and migrate — leading to more effective ways to treat diseases.


Cryopreservation Does Not Affect Proliferation and Multipotency of Murine Neural Precursor Cell

Development of Humanized Antibodies as Cancer Therapeutics

Serious Infections After Unrelated Donor Transplantation in 136 Children: Impact of Stem Cell Source

Rapid and Complete Donor Chimerism After Unrelated Mismatched Cord Blood Transplantation in 5 Children with Beta-Thalassemia Major


California Institute for Regenerative Medicine Media Advisory: Site Search Subcommittee to Visit Four Finalist Sites for Permanent Headquarters

US Panel Calls for National Stem Cell Standards
Guidelines would set common standards for embryonic stem cell research

Designer Babies Lawful to Help Sick Siblings, UK Law Lords Decide
The creation of “designer babies” to treat sick siblings is lawful, the Law Lords have ruled, upholding an earlier court decision.

Massachusetts Senate Approves Stem Cell Bill
The state Senate overwhelmingly backed a stem cell research bill Tuesday and sent it to the House, where it could be debated as early as next week.



Agencourt Bioscience to Be Acquired by Beckman Coulter; Wholly-Owned Subsidiary to Continue to Focus on Genomic Services and Reagent Solutions

BrainStorm Cell Therapeutics, Appoints Renowned Neurologists Prof. Warren Olanow and Prof. Andre Lozano to Scientific Advisory Board; Completes Formation of Scientific Advisory Board

Genzyme Corporation Reports Interim Results From Pivotal Study Of Myozyme(R)
Genzyme Corp. announced today that it has completed a planned analysis of interim data from its pivotal clinical trial of Myozyme(R) (alglucosidase alfa), which is being studied for the treatment of Pompe disease.

Insmed Begins Trial With SomatoKine in Type A Extreme Insulin Resistance
Insmed has initiated a Phase II clinical trial examining the therapeutic benefit of treating Type A Extreme Insulin Resistance with SomatoKine, the company’s proprietary once daily IGF-I therapy.

The Immune Response Presents Encouraging Results for Remune
The Immune Response has presented results from a Phase II clinical trial with Remune, the company’s lead HIV immune-based therapy. 

ImmunoGen, Inc. Announces Genentech Has Licensed Rights to Use ImmunoGen’s TAP Technology with Therapeutic Antibodies to a Second Target 

U.S. BioDefense Confirms Provisional Patent Application for Matching Stem Cell and Other Biotechnology Transfer Opportunities

Update of Neurologix Phase I Clinical Trial of Gene Therapy for Parkinson’s Disease Presented at AANS Annual Meeting

OncoGenex Announces In-Licensing, Development Plans for Cancer Therapeutic
OncoGenex Technologies has in-licensed the rights to inhibitors of heat shock protein 27 (Hsp27) from The University of British Columbia.

Pall Debuts Five New Products for Increased Drug Manufacturing Efficiency at INTERPHEX 2005
Pall Corporation introduces five innovative technologies aimed at increasing drug manufacturing efficiency through customization and disposability at INTERPHEX 2005 today. The new technologies deliver a combination of benefits that help drug manufacturers enhance throughput and scalability, eliminate time-consuming steps, shorten processing times and reduce labor.

Neoprobe Receives Cellular Therapy Technology Assessment; Positive Technology Review and Clinical Recommendations Received
The Battelle report indicates that the ACT cell processing technology would be commercially feasible and reproducible with CIRA Bio’s implementation of the recommended Battelle process and procedure development initiatives.

Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with MedImmune

ViRexx Receives U.S. Patent For Immunotherapeutic Compound ProstaRex
ViRexx Medical Corp. a company focused on immunotherapy treatments for cancer and chronic hepatitis B and C and embolotherapy treatments for tumors, today announced that it has been granted U.S. Patent 6,881,405 entitled, “Immunotherapeutic Composition and Method for the Treatment of Prostate Cancer”.

Vitro Files New Patent for Stem Cell Therapy of Diabetes
Vitro Diagnostics, Inc. announced the filing of a new patent application with the United States Patent and Trademark Office regarding a procedure for the generation of beta islets from stem cells.


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 Awards Funding to Biotech Firm for Heart Disease, Stem Cell Research
Arteriocyte, the first spin-out company from the Center for Stem Cell and Regenerative Medicine, has received the first installment of its combined Phase I/II “fast track” Small Business Technology Transfer Award grant from the National Heart, Lung, and Blood Institute (NHLBI), one of the components of the National Institutes of Health (NIH).

Amendments to RFA-AI-05-002 “Units for HIV/AIDS Clinical Trials Networks”

Cell Biological Studies of Parkinson’s Disease (RFA-NS-06-001)

Development of Disease Biomarkers (PA-05-098)


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

Processing Methods for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Public Meeting” to be held in Rockville, Maryland, June 22-23

Cellular, Tissue and Gene Therapies Advisory Committee- Meeting

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update

Biological Product Deviation Reports – Annual Summary for Fiscal Year 2004

Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials-Draft Guidance for Industry





Regulatory Information: Consultants

Therapeutic Goods Administration Homepage

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:

SPECIAL Session at ISCT 2005: Development and Commercialization of Cell and Gene Therapy Products for Startup Companies
May 5 at 2:00 – 3:30 in Ballroom C of the Vancouver Convention Center.
Moderator:  Dr. Scott Burger, Ph.D.

Dr. Lorne Taichman, M.D., Ph.D. 
Professor, Health Sciences Center, Stony Brook University, NY
Consultant, Corporate Office of Science and Technology, Johnson & Johnson
Approaching Big Pharma: A View from the Other Side of the Table

Dr. Scott Burger, M.D.
Principal, Advanced Cell & Gene Therapy, LLC, Chapel Hill, NC
Land Mines on the Road to Cell Therapy

Dr. Herbert Bresler, Ph.D.
Chief Scientist, Health & Life sciences, Battelle, Columbus, OH
The Closed Assembly Line: If Henry Ford Worked on Cell Therapy

CHI’s Stem Cell Research: A Technology with the Promise to Contribute to All of Medicine. Cambridge, MA 
August 29-31

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
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 
Denver, Colorado (Gambro BCT)

Medical Laboratory Technologist (Stem Cell)
Roswell Park Cancer Institute (Buffalo, New York) Post Doctoral or Engineer Positions 
Toronto, Ontario (Centre for Computational Biology Hospital for Sick Children)

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

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)

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



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

Current Volume: Volume 7, Number 2 / May 2005

Table of Contents:

Selective allodepletion  p. 101
M Cavazzana-Calvo, I André-Schmutz
Improving immune reconstitution while preventing GvHD in allogeneic stem cell transplantation  p. 102
I André-Schmutz, L Dal Cortivo, A Fischer, M Cavazzana-Calvo
Selective depletion strategies in allogeneic stem cell transplantation  p. 109
S Mielke, SR Solomon, AJ Barrett
Add-back of allodepleted donor T cells to improve immune reconstitution after haplo-identical stem cell transplantation  p. 116
PJ Amrolia, G Mucioli-Casadei, H Huls, HE Heslop, J Schindler, P Veys, E Vitetta, MK Brenner
Selective elimination of alloreactivity from immunotherapeutic T cells by photodynamic cell purging and memory T-cell sorting  p. 126
NT Le, BJ Chen, NJ Chao
Elimination of alloreactive T cells using photodynamic therapy  p. 134
R Sidi Boumédine, DC Roy
Modulation of GvHD by suicide-gene transduced donor T lymphocytes: clinical applications in mismatched transplantation  p. 144
F Ciceri, C Bonini, C Gallo-Stampino, C Bordignon
Improving the ex vivo retroviral-mediated suicide-gene transfer process in T lymphocytes to preserve immune function  p. 150
E Robinet, B Fehse, S Ebeling, D Sauce, C Ferrand, P Tiberghien
Utilizing regulatory T cells to control alloreactivity  p. 158
E Hauben, R Bacchetta, MG Roncarolo
Therapeutic potential of CD4+ CD25+ regulatory T cells in allogeneic transplantation  p. 166
JL Cohen, BL Salomon
Methods for isolating circulating epithelial cells and criteria for their classification as carcinoma cells  p. 171
T Fehm, EF Solomayer, S Meng, T Tucker, N Lane, J Wang, G Gebauer
Pigpen is a cellular binding protein of therapeutic oligonucleotides  p. 186
Z Zhang, HJ Schluesener
Effect of prostaglandin E2, lipopolysaccharide, IFN-? and cytokines on the generation and function of fast-DC  p. 195
L Alldawi, M Takahashi, M Narita, F Ayres, N Tsukada, Y Osman, T Furukawa, Y Aizawa

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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