Volume 6.22 | May 23

Volume 6.22, May 23, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Stem Cells from Cloned Human Embryos and Patients’ Skin Cells, South Korean Breakthrough

Story: UK Scientists Clone Human Embryo


Krabbe’s Therapy Shows Promise:Cord Blood Found to Increase Survival
Kurtzberg, a professor of pediatrics and pathology at Duke University Medical Center, and other researchers reported that transfusing cord blood from unrelated donors into infants with the disease before symptoms appear resulted in 100% survival for the invariably fatal disorder.

Study Holds Implications for Gene Therapy and Stem Cell Biology
The study, conducted by scientists from Cincinnati Children’s Hospital Medical Center, and Hannover Medical School and Hamburg University in Germany, reveals important evidence that tells us more about how blood forming stem cells regenerate.

Long-term Outcomes Studied for Stem Cell Transplant Recipients
The City of Hope Cancer Center and the University of Minnesota assessed 854 cancer patients that had undergone stem cell transplants, taking a detailed look at the after effects of the procedure in the years following the transplant.

Gene Keeps Neural Cells on Correct Developmental Path
Embryonic stem cells with identical genomes grow into distinctive tissues, such as heart, bone, and brain.

Jefferson Researchers’ Results Show Promise For Metastatic Eye Melanoma
By simultaneously revving up the immune system and choking off the tumor’s oxygen supply, oncologists at Jefferson Medical College and the Kimmel Cancer Center at Thomas Jefferson University in Philadelphia may have found a better way to battle this deadly cancer.

Engineers Improve Plastic’s Potential for Use in Implants by Discovering Way to Link It to Biological Materials
Engineers at The University of Texas at Austin have found a way to modify a plastic to anchor molecules that promote nerve regeneration, blood vessel growth or other biological processes.

Dermatologists Use Immunotherapy to Treat Warts
Injection of skin test antigens (preparations used in skin tests for immunity) into warts appears to stimulate the immune system and successfully treat the injected wart and also helps to treat distant non-injected warts, according to a study in the May issue of Archives of Dermatology, one of the JAMA/Archives journals.


Expression of Exogenous Gene in Bone Marrow Stromal Cells by Liposome

Immunotherapy of Murine Prostate Cancer Using Whole Tumour Cells Killed Ex Vivo by Cytosine Deaminase/5-fluorocytosine Suicide-gene Therapy

Specific Targets in Tumor Tissue for the Delivery of Therapeutic Genes

Collection of Autologous Blood for Bone Marrow Donation: How Useful Is It?


Bush Would Veto House Bill on Stem Cells
President Bush said on Friday he would veto legislation that would loosen restrictions on embryonic stem cell research and expressed concern about human cloning research in South Korea.

California Institute for Regenerative Medicine Press Release: ICOC Appoints Members to Scientific and Medical Accountability Standards Working Group

California Institute for Regenerative Medicine Press Release: ICOC Appoints Members to Scientific and Medical Research Funding Working Group

Stanford Bioethicists Want Stronger Protections For Women Donating Eggs For Stem Cell Research
Now that stem cell researchers have devised an efficient way of creating new human embryonic stem cell lines, biomedical ethicists at the Stanford University School of Medicine say it’s crucial to develop a unique set of protections for the women who donate their eggs to make the research possible.



Aastrom Biosciences Reports Positive Bone Repair Results in Clinical Feasibility Trial
Aastrom Biosciences, Inc. announced today the results from its feasibility clinical trial conducted with the Institut de Terapia Regenerativa Tisular (ITRT) in Barcelona, Spain to evaluate the use of Aastrom’s Tissue Repair Cells (TRCs) for the treatment of severe long bone non-union fractures.

Australian Patent Granted for Norwood Immunology
Norwood’s immunology technology is based on the use of U.S. Food and Drug Administration (FDA)-approved GnRH analogue drugs to regenerate the thymus gland and enhance bone marrow function.

Asklepios Biopharmaceutical, Inc. and Bayer Healthcare, LLC Announce Collaboration on Gene Therapy for the Treatment of Hemophilia
Bayer HealthCare, LLC, Biological Products Division (Bayer BP), and Asklepios Biopharmaceutical Inc. (AskBio), a private development-stage biotechnology company, announced today they have entered into an early-stage research and collaboration agreement to evaluate gene therapy for the treatment of hemophilia B.

Cell Genesys, Inc. Receives Special Protocol Assessment From FDA For Second Phase 3 Trial Of GVAX(R) Vaccine For Prostate Cancer

Corautus Genetics Inc. Enters Into Long Term Manufacturing Agreement With Boehringer Ingelheim Austria GmbH For Production Of VEGF-2 Plasmid DNA
Corautus Genetics Inc. and Boehringer Ingelheim Austria GmbH announced today that they have entered into a long term manufacturing agreement to produce VEGF-2 (Vascular Endothelial Growth Factor 2) plasmid DNA for a Phase III trial and future commercial use for the treatment of cardiovascular disease (severe angina) and other indications.

CytoGenix Launches Innovative Vaccine Program Using Proprietary Cell-Free DNA Production Process
CytoGenix, Inc. announced today that it has begun an accelerated program to develop DNA vaccines against several diseases including influenza.

InNexus Teams with Mayo Clinic to Develop Antibodies
InNexus Biotechnology, Inc. today announced a multi-year collaborative research agreement with Mayo Clinic aimed at advancing the leading science of monoclonal antibody development, and for the creation of promising new medicines for cancer, cardiovascular disease and other difficult-to-treat diseases.

Invitrogen to Acquire Immunological Reagent Provider Caltag Laboratories; Deal Adds Expertise in Assays for Flow Cytometry to Strengthen Invitrogen’s Growing Proteomics Portfolio
Invitrogen Corporation today announced it has signed a definitive agreement to acquire privately held immunological assay manufacturer Caltag Laboratories in a cash transaction totaling $20 million.

Takara Bio to Introduce ViroMed’s Proprietary Gene Therapy Vector
Takara Bio announced on May 13 that it has concluded a licensing agreement with ViroMed, one of its consolidated subsidiaries in Korea specializing in gene therapy.

Results of EGF Specific Active Immunotherapy in Patients With Advanced Non-Small-Cell Lung Cancer Presented at ASCO Annual Meeting
CancerVax Corporation announced today that data from a Phase 2 clinical trial showed that treatment with SAI-EGF, a specific active immunotherapy product candidate that targets the epidermal growth factor (EGF) receptor signaling pathway, was well tolerated, stimulated an antibody response to EGF, and reduced circulating EGF in patients with advanced non-small-cell lung cancer.


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 May 20, 2005


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

CANCELLED – Public Meeting: Processing Methods for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Cellular, Tissue and Gene Therapies Advisory Committee Roster-Update

2005 Biological Approvals – Update




Regulatory Consultants-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 


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)

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

Laboratory Supervisor (Stem Cell Lab) NEW!
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)

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

Senior Scientist 
Brussels, Belgium (Beta-Cell NV)

Scientific Director 
Boston, Massachusetts (CBR Insitute for Biomedical Research CHCT)

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)

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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