Volume 6.37 | Sep 12

Volume 6.37, September 12, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Review of the First Commercially Approved Gene Therapy Product Presented in Human Gene Therapy

Story: Stem Cells That Can Repair Cardiac Muscle Found In Human Heart


‘Virgin Conception’ First for UK
Human embryos created using a so-called “virgin conception” technique have been made in the UK for the first time.

Concern Over Three-parent Embryo
Critics have expressed horror about research to create a human embryo with genetic material from three parents.

New Drug May Help Cancer Patients Who Need Stem Cell Transplants, Trial
A new drug may help cancer patients mobilize the cells necessary to restore their blood-forming system after high-dose chemotherapy, according to results from a clinical trial at the Kimmel Cancer Center at Thomas Jefferson University Hospital in Philadelphia and at other centers across the nation.

Key to Stem Cell Transplant Success is Tricking Immune System
Tricking the bodys immune system into ignoring stem cells will be the key to successful stem cell transplants, according to Professor Maggie Dallman , Imperial College London, speaking today at the BA Festival of Science.

Adult Stem Cells from Adipose Tissue Could Save Lives
National and international scientists, including those from the University of Virginia Health System, will announce findings from a significant number of studies showing that adult stem cells from adipose tissue (fat) could eventually be used to treat injured or damaged tissues.

Nanotechnology Used to Develop Artificial Kidneys
Animal studies for artificial-kidney prototypes should begin one or two years from now, and clinical trials would follow a year or two afterward, reported scientists at Biophiltre in Burlingame, Calif., the medical-device company developing the artificial-kidney technology.

Transplanting Animal Organs Could Soon Be a Reality
Dr Anthony Warrens, from Imperial College London and Hammersmith Hospital, says: “Although the idea of xenotransplantation is far from new, it is only in recent years that many of the potential immunological problems, such as transplant rejection, have been solved, meaning the process of transplanting organs from one species into another, could soon be a reality.”

Severe Hypoglycemia is Rare After Islet Transplantation
Episodes of dangerously low blood glucose, or hypoglycemia, were greatly reduced in people who received an islet transplant for poorly controlled type 1 diabetes, according to an analysis of outcomes in 138 patients who had the procedure at 19 medical centers in the United States and Canada.

New DFG Research Centre for Regenerative Medicine Established in Dresden, Germany
The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) will establish a DFG Research Centre on “Regenerative Therapy” at the Dresden University of Technology.

Liverpool Leads New European Tissue Engineering Project
Scientists at the University of Liverpool are leading a major European clinical engineering project that should see human tissue grown from stem cells available for transplant in the next four years.

Gene Therapy Scientist Won’t Face Trial
A renowned geneticist accused of molesting a girl in California will not face trial on charges that he abused a Maryland boy.

Californian Heart Disease Patient Shows Improvement After Stem Cell Therapy
Improvement of California woman stuns her cardiologist one month after receiving stem cell treatment in Bangkok, Thailand.


Bone Marrow Transplantation and Approaches to Avoid Graft-versus-host Disease (GVHD)

CD4(+) Regulatory Cells as a Potential Immunotherapy

Current Status of Gendicine in China: Recombinant Human Ad-p53 Agent for Treatment of Cancers

Gene Therapy, Cell Transplantation and Stroke

Nuclear Reprogramming by Human Embryonic Stem Cells


California Institute for Regenerative Medicine Press Release: Zach Hall Appointed Permanent President of the CIRM
The Independent Citizens Oversight Committee (ICOC) for the California Institute for Regenerative Medicine (CIRM) announced today that it has appointed Zach Hall, Ph.D. as permanent President of the CIRM, following an extensive search.

Stem Cell Law Review Hearings Continue in Sydney
Leading Australian stem cell researchers and the outspoken Sydney Anglican and Catholic dioceses are today having their say about the future of Australia’s ban on human embryo cloning.

India Plans Clinical Trials Body Styled on US FDA
Amid plans to streamline its healthcare regulation, India could create a new agency to monitor clinical trials, with standards modelled along US FDA lines.



Cord Blood America Launches Revolutionary Pricing Plan to Provide Affordable Umbilical Cord Blood Stem Cell Preservation
The plan is simple: No money down and no payment until six months after the child is born.

Progenitor Cell Therapy Inks Manufacturing Deal with Cellerant Therapeutics to Bring Stem Cell Treatment to Market
Progenitor Cell Therapy, LLC (PCT), a leading cell engineering and cell therapy services company,  announced today that its cGMP facility in Mountain View, California  will serve as the manufacturing site for Cellerant Therapeutics, Inc.’s (Cellerant) premier product.

Saneron CCEL Therapeutics, Inc. And University of Minnesota Sign An Exclusive License For An Umbilical Cord Blood Stem Cell Line
According to the agreement, Saneron CCEL will provide research funding and make milestone payments in return for worldwide exclusive development, marketing, and manufacturing rights to the cell line developed.

CryoLife Announces First Human Implants of BioDisc(TM) Spinal Disc Repair System
CryoLife, Inc., a biomaterials and biosurgical device company, announced today that BioDisc(TM) Spinal Disc Repair System, a nucleus pulposus repair device, was successfullyimplanted in two patients.

Bystander Effect of Introgen’s INGN 241 Increases Cancer-Killing Activity in Breast Cancer Cells 
Researchers at Introgen Therapeutics, Inc. and their collaborators at The University ofTexas M. D. Anderson Cancer Center today reported that MDA-7 protein released from cells treated with INGN 241 can kill nearby, untreated breast cancer cells resulting in additional therapeutic effect.

Knock-out US Deal Means Mice Could Roar for Stem Cell
Stem Cell Sciences is to receive £650,000 and “a large number” of genetically-engineered “knock-out” mice as part of a new licensing deal with the US’s Deltagen, the company announced yesterday.

MedImmune, Inc. And VasGene Therapeutics Inc. Announce Collaboration To Develop Monoclonal Antibodies Targeting Cancer
MedImmune, Inc. and VasGene Therapeutics, Inc. announced today that they have entered into a collaborative agreement to develop cancer- focused monoclonal antibodies (MAbs) targeting a novel member of a subfamily of receptor tyrosine kinases, EphB4, as well as its ligand, EphrinB2.

Microbix Biosystems Inc. Announces Update On Vaccine Technology; Ends Talks With Vaccine Manufacturer
Microbix Biosystems Inc announced today that the Company has ceased negotiations with the previously announced vaccine manufacturer currently evaluating Microbix’ yield enhancement technology.

MultiCell Technologies Inc. Forms New Company To Develop Novel Therapies For Diabetes And Other Autoimmune Diseases
Alliance Pharmaceutical Corp. (“Alliance”) and its wholly owned subsidiary, Astral, Inc. (“Astral”) today announced that they have transferred substantially all of the assets of Astral and the business of Astral to Astral Therapeutics, Inc., a newly created entity formed solely for this purpose, and to be re-named MultiCell Immunotherapeutics, Inc. (“MCTI”), as set forth below.

Progenics Reports Positive Results from Phase 1 Clinical Trial of PRO 140, a Novel Monoclonal Antibody That Blocks HIV Entry; Single Dose Coats Immune Cells for Two Months, Potential Long-Acting HIV Therapy

Oxxon Therapeutics Presents Positive Data Evaluating DNA/MVA PrimeBoost Immunotherapy in Metastatic Melanoma Patients
Oxxon’s PrimeBoost immunotherapy delivers multiple melanoma specific epitopes in a priming and boosting regimen.


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 September 9, 2005

NIH Announces A Grants Query Report To Identify NIH Contact Information For Grantees Affected By Hurricane Katrina

Delayed Receipt Dates for Principal Investigators who Assist in Recovery Efforts for Hurricane  Katrina

NIH Grantees Affected by Hurricane Katrina

NIH Announces Plans to Eliminate Mailing of Paper Notifications: Summary Statements & Peer Review  Outcome Letters

Announcing the NIA Aged Non-Human Primate Tissue Bank

Completion of a Comprehensive Mouse Knockout Resource (RFA-HG-05-007)

A Data Coordination Center for the Knockout Mouse Project (KOMP)(RFA-HG-05-008)

Centers of Excellence in Genomic Science (CEGS) (PAR-05-163)


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

Blood Products Advisory Committee Meeting

Vaccines and Related Biological Products Advisory Committee Meeting

Recall of Level 1 H-31B Air Detector / Clamping Devices and Level 1 H-1200 Fast Flow Fluid Warmers – Smiths Medical ASD, Inc

Licensed Products and Establishments List – Update

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

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update




Cellular, Tissue and Gene Therapies Advisory Committee – Research Review Subcommittee
The program is intended to provide dynamic, responsive, cutting edge research to contribute to OCTGT’s regulatory mission and facilitate development of safe and effective biological products.

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 



The 2005 International Cytokine Society Conference: Cytokines, Immunity, Immunotherapy and Vaccine”
October 27-31
Seoul, Korea

5TH Meeting of the Cancer Vaccine Consortium: “Future Opportunities & Challenges for Cancer Vaccines”
November 13-14
Alexandria, Virginia

27th Annual Meeting of The American Society for Apheresis (ASFA)
May 23-26
Las Vegas, Nevada

4th ISSCR Annual Meeting
June 29-July 1, 2006
Toronto, Ontario


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]

Hospital Scientist 
Sydney, Australia (Bone Marrow Stem Cell Laboratory of St. Vincent’s Hospital)

Scientist/Immunologist (Research and Development
Gaithersburg, Maryland (Maxcyte)

Acting President

San Diego, California (California Institute of Regenerative Medicine)

Clinical Consultant  
Deerfield, Illinois (Baxter Healthcare)

Cord Blood Director 
Minneapolis Minnesota (The National Marrow Donor Program™)

Cytotherapy Technologist Stem Cell 
New York, New York (Memorial Sloan-Kettering Cancer Center)

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

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

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

Vice President of Manufacturing Operations 
Dallas, Texas (ODC Therapy Inc.)


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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