Volume 6.33 | Aug 15

Volume 6.33, August 15, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Compound Can Hasten Harvest of Stem Cells

Story: NIGMS Funds New Stem Cell Centers


Reprogramming Complicates Stem Cell Debate: Technique Could Revolutionize Therapies
Scientists are working to develop new techniques that may one day allow the body to produce fresh cells to heal itself. 

Repair for Frail Immune Systems
Researchers have discovered a way to improve the immune system that could help donor organ recipients and people with cancer and AIDS fight deadly diseases.

Bringing Safe and Effective Cell Therapies to the Bedside
New rules to assess the safety and efficacy of human cell- and tissue-based products are the culmination of a multiyear, cooperative effort between the US government and the biotech industry.

Tumour Defence System Boosts Immunotherapeutic R&D
The researchers, from the Torrey Pines Institute for Molecular Studies in San Diego, discovered that tumours secrete fatty acids, which inhibit the cytotoxic T lymphocytes’ ability to kill tumour cells.

Gene Therapy to Treat Haemophilia
Gene therapy has been used to successfully treat haemophilia in dogs.

GMP Materials Ready for Cervical Cancer Trial
Advaxis announced that its GMP clinical materials have passed quality control release and are available for use in a Phase I/II clinical trial of Lovaxin C in advance cervical cancer patients.

Canadian Stem Cell Star Shuns US Riches
A leading stem-cell scientist has turned down a multimillion-dollar offer in the United States in favour of heading Canada’s first stem-cell research centre.


Design and Creation of Cytomedicine for Application to Cell Therapy

Endobronchial Gene Therapy

New Agents for the Prevention of Opportunistic Infections in Haematopoietic Stem Cell Transplant Recipients




Tissera Reports the Company’s Scientific Team Has Reached Significant Milestones in its Research on Pig Fetal Liver Transplantation
Tissera, Inc. reports that Tissera’s sponsored research team at the Weizmann Institute of Science has reached significant milestones in its research on xenotransplantation of pig fetal liver.

THP Generates Transgenic Rabbits Producing Human Antibodies
Therapeutic Human Polyclonals Inc. (THP) has created the first transgenic rabbits producing human antibodies. THP is now applying this technology to the development of its first products and clinical trials.

Mount Sinai Receives NIH Funding for Stem Cell Research
The National Institute of General Medicine Sciences (NIGMS) announced today that Mount Sinai School of Medicine and two other centers will receive an estimated $9 million dollar grant over the next three years to further stem cell research.

Cytori Therapeutics, Inc. Completes Development Of The Celution(TM) System; To Submit CE Mark Application For European Approval
Cytori Therapeutics, Inc., today announced it has completed the development of its Celution(TM) System for the isolation and concentration of adipose stem cells and will submit CE Mark application seeking approval for the system in Europe.

Michael Monko Named Vice President Sales, Serologicals Corporation Research Products Group
Serologicals Corporation announced today that Michael Monko has joined the Company as Vice President, Sales for the Research Products Segment, consisting of Chemicon International, Inc. and the Upstate Group, Inc. Mr. Monko will report directly to Jeffrey D. Linton, President and will be a member of Research Segment Executive Operating Committee.


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 Guide for Grants and Contracts – Week Of August 12, 2005

Short Courses on Application of Genomics and Proteomics to Complex Heart, Lung, Blood, and Sleep Disorders (RFA-HL-05-012)
Application Receipt Date(s): January 17, 2006


All new CBER information can be reached from the What’s New page2005 Biological Approvals – Update

Approval Information – Blood Grouping Reagent, Anti-A (Murine Monoclonal); Anti-B (Murine Monoclonal); Anti-A,B (Murine Monoclonal Blend); Anti-D (Monoclonal) (IgM) – Biotest AG

Approval Information – Anti-Human Globulin, Anti-IgG (Rabbit) – Biotest AG

Approval Information – Reagent Red Blood Cells – Medion Diagnostics GmbH

Substantially Equivalent 510(k) Device – Tango Automated Blood Bank Analyzer System – Olympus America Inc

Licensed Products and Establishments List – Update

Substantially Equivalent 510(k) Device – GPS II Platelet Concentrate Separation Kit w/ Plasma Concentrator Accesory – Biomet, Inc


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 


Contact Malachite Management if your company is interested in hosting an educational symposium at a future conference. Upcoming symposia opportunities include:

– World Transplant Congress (WTC). July 22-27, 2006. Boston, MA. Symposia dates: July 20, 21 or 28. Application Deadline: September 11, 2005

– Canadian Blood & Marrow Transplant Group (CBMTG) Biennial Conference. April 22-24, 2006. Edmonton, AB. Symposia dates: April 22. Application Deadline: January 2006.

– American Society for Apheresis (ASFA) Annual Conference. May 23-26, 2006. Las Vegas, NV. Symposia date: May 23. Application Deadline: March 15, 2005.

– International Society for Cellular Therapy (ISCT) Annual Conference. May 4-7, 2006. Berlin, Germany. Symposia dates: May 4, 5, or 7. Application Deadline:  January 2006.

– American Society for Hematology (ASH) December 9-12, 2006. Orlando, FL. Symposia date: December 8. Application Deadline:  early April 2006


Emerging Cardiac Cellular Therapies: Incorporating cGMP Federal Regulations into Clinical Trials. Bethesda, MD
Co-sponsored by AABB and ISCT
September 15 – 16, 2005
This year, a Cardiac Cell Therapy Workshop has been created to precede the annual Somatic Cell Therapy Symposium. This workshop was designed to address questions related to the various cell types being used in the context of cardiac repair.

Fifth Annual Somatic Cell Therapy Symposium. Bethesda, MD
Co-sponsored by AABB, ISCT and FDA
September 16 – 18, 2005
The annual Somatic Cell Therapy Symposium is a forum provided to engage FDA and industry in an ongoing dialogue regarding the regulatory issues pertaining to somatic and other cell therapies.

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)

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)

Instrumentation Engineer II 
Gaithersburg, Maryland (Maxcyte)
Laboratory Supervisor (Stem Cell Lab)
Charlottesville, Virginia (University of Virginia Health System)

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)

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

Research Associate II 
Gaithersburg, Maryland (Maxcyte) 
Scientific Review & Program Officers 
San Diego, California (California Institute of Regenerative Medicine)

Scientific Sales Representative
Vancouver, British Columbia (StemCell Technologies)

Scientific/Technical Officer,Stem Cell Transplant Laboratory/Haematology 
Sydney, Australia (SWAPS, Liverpool Hospital)

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)

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

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)

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


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 3/ July 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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