Volume 6.38 | Sep 19

Volume 6.38, September 19, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
Cell Therapy News on Facebook  Cell Therapy News on Twitter

Top Stories

Story: Utah Hospital Begins Injecting Bone Marrow Stem Cells Directly into a Patient’s Hearts During Open-heart Surgery

Story: Mice Stem Cells Used To Treat Sheep


Gene Therapy Boosted by Nanoscale Delivery to Cancer Cells
Cancer Research UK scientists have developed a system for treating hard-to-reach tumours, using nanoparticles to guide a  tumour busting gene to cancer cells.  The results of this study are published today (Thursday) in the journal Cancer Research*.

Researchers Discover Key To Human Embryonic Stem-cell Potential
Now, researchers at Whitehead Institute for Biomedical Research working with human embryonic stem cells have uncovered the process responsible for the single-most tantalizing characteristic of these cells: their ability to become just about any type of cell in the body, a trait known as pluripotency.

Novel Strategy for Repairing Lung Damage Proposed in Tissue Engineering Journal
It may be possible to repair or replace damaged cells that line the inner surface of the lung and are essential for proper lung function by recruiting regenerative cell populations from other sites in the body such as the bone marrow to the damaged lung tissue, according to a paper in the July/August issue  of Tissue Engineering.

UCSF Launches Institute for Stem Cell and Tissue Biology
Capitalizing on the strength of its research and clinical enterprise, UCSF is launching the Institute for Stem Cell and Tissue Biology, providing a framework for close collaboration among investigators from the University’s Schools of Dentistry, Medicine, Nursing and Pharmacy.

Childrens Hospital Los Angeles the Only Pediatric Institution in California to Receive a Stand-Alone Stem Cell Training Grant from the California Institute for Regenerative Medicine
The Saban Research Institute of Childrens Hospital Los Angeles has received an initial three-year, $2.4 million stem cell training grant from the California Institute for Regenerative Medicine (CIRM), according to Donald B. Kohn, M.D., director of the Gene, Immune and Stem Cell Therapy Program at Childrens Hospital Los Angeles, and professor of pediatrics, molecular microbiology and Immunology at the Keck School of Medicine of the University of Southern California.

San Francisco’s Gladstone Institutes Assists with Exploratorium Stem Cell Exhibit
The display, the first-ever exhibit allowing the public to view living embryonic stem cells with an advanced microscope, is open Fridays through Sundays, 10 a.m.-5 p.m. Carlson estimates that more than 20,000 visitors will view the exhibit and its companion media pieces this year.


Advances in Inner Ear Gene Therapy: Exploring Cochlear Protection and Regeneration

Cell Transplantation Improves Ventricular Function After a Myocardial Infarction: A Preclinical Study of Human Unrestricted Somatic Stem Cells in a Porcine Model

Maximizing Ventricular Function with Multimodal Cell-based Gene Therapy

Strategies to Preserve or Regenerate Spiral Ganglion Neurons


A Proposition for Stem Cells 
Last fall Robert Klein got Californians to vote for embryonic stem cell work. That was a piece of cake compared with getting the resulting research agency off the ground 

Using Chimeric Embryos for Transplants a ‘No-brainer’ – Ethicist
There is no halachic or ethical barrier to growing chimeric embryos composed of animal and human cells as an endless supply for human organs for transplant, except for brains, said Dr. John D. Loike, director of graduate studies in physiology and faculty member of the Columbia University Center for Bioethics.



Dendreon Announces Plans to Submit Application for FDA Approval of Provenge for the Treatment of Advanced Prostate Cancer
Dendreon Corporation today announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market Provenge(R), the Company’s investigational immunotherapy for the treatment of advanced prostate cancer. 

MultiCell Technologies Awarded Pilot Grant for Study of Type 1 Diabetes Therapeutic
MultiCell Technologies, Inc., a leading adult stem cell company and a supplier of immortalized non-tumorigenic human hepatocytes for drug discovery applications, announced today that it has been awarded a pilot grant for an A Pilot Study for type 1 diabetes using its properitary Immunoglobulin Therapeutic.

Cytori Therapeutics Demonstrates Adipose-Derived Adult Stem and Regenerative Cells Enhance Cardiac Function in Preclinical Study
Cytori Therapeutics, Inc. (Frankfurt: XMP), today announced preclinical results that support therapeutic opportunities for adult stem and regenerative cells derived from adipose, also known as fat tissue, in the treatment of cardiac injury following acute myocardial infarction (heart attack).

Phase I ProCord Study Results Published in the Journal of Neurosurgery: Spine, September 2005 Issue ProCord Phase I Study Results Suggest Evidence of Safety
The FDA-sanctioned study was an uncontrolled, Phase I clinical trial designed to assess the safety and tolerability of ProCord (autologous incubated macrophages), an experimental immune cell therapy.

Introgen’s INGN 225 Cancer Vaccine Shows Promising Safety and Efficacy Results in Phase 2 Lung Cancer Trial
Introgen Therapeutics, Inc. presented updated interim results from an ongoing Phase 2 trial of its investigational cancer vaccine, INGN 225, in patients with advanced small cell lung cancer.

MedImmune to Acquire Cellective Therapeutics, Inc.
MedImmune, Inc. announced today that it has expanded its pipeline of potential drug candidates by signing a definitive agreement to acquire privately held Cellective Therapeutics, Inc.

Protein Design Labs, Inc. Announces Successful Closing Of Global Alliance With Biogen Idec To Develop And Commercialize Three Phase II Antibody Products
Protein Design Labs, Inc. today announced the successful closing of its previously-announced collaboration with Biogen Idec following the satisfaction of all closing conditions, including expiration of the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

Galapagos, Amsterdam Molecular Therapeutics, Netherlands Institute for Brain Research and Vrije Universiteit Amsterdam Announce Collaboration to Develop Innovative Treatments for Traumatic Spinal Cord and Peripheral Nerve Injuries
The project will focus on developing innovative therapeutics to promote nerve regeneration and to diminish the effect of neural scarring, one of the main causes for the failure of the traumatically injured spinal cord and peripheral nerve to regenerate.

Sangamo BioSciences, Inc. Announces Second Expansion Of Research Collaboration With LifeScan, Inc. Focused On Novel Diabetes Treatments
Sangamo BioSciences, Inc. announced today the second expansion of its research collaboration with LifeScan, Inc. to use Sangamo’s proprietary zinc finger DNA binding proteins (ZFPs) to develop therapeutic cell lines as a treatment for diabetes.

Stem Cell Therapy International Corp. is Acquired by Altadyne
Stem Cell Therapy International Corp., a company devoted to the sale and distribution of biological solutions containing stem cell products, today announced it has been acquired by Altadyne, Inc., a Nevada corporation.


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


NATIONAL INSTITUTES OF HEALTHDevelopment and Improvement of Inbred ES Cell Lines for Use in Generation of Mouse Mutants (RFA-DA-06-009)


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

Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002

Exemptions and Alternative Procedures Under 21 CFR Part 1271.155

10th Annual GMP by the Sea Conference (Slides)

2005 Biological Approvals – Update

Substantially Equivalent 510(k) Device – COBE Angel Whole Blood Separation System – COBE BCT


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 



Gene & Cell Therapy
December 1-2
Paris, France

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]

Cell Processing Tech I NEW!
Houston, Texas (Baylor College of Medicine Center for Cell & Gene Therapy)

Hospital Scientist 

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

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

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/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 4 / September 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.

 Learn more about Cell Therapy News:  Archives  |  Events  |  Update Profile  |  Contact Us