Volume 6.34 | Aug 22

Volume 6.34, August 22, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: British Scientists Grow Pure Nerve Stem Cells

Story: NIH Requests Applications for Cardiovascular Cell Therapy Research Network


Microgravity Tech Could Sway Stem Cell Debate: Cord Blood Yields “Ethical” Embryonic Stem Cells

Microgravity technology developed by NASA can multiply stem cells from a newborn’s blood in large enough quantities to be used to regenerate human tissue, London scientists have found.

Score One For ‘Adult’ Stem Cells: First Real Progress In Acute Renal Failure Therapy Shows Fast, Broad Results
In a new study, Westenfelder’s team reported that injecting stem cells similar to the type used in bone marrow transplants is “highly renoprotective, showing almost immediate improvement in both kidney function and degree of tissue injury, followed by accelerated regeneration and return of function,” he said.

Furrier Mice Yield Stem-Cell Discovery
By making mice grow furrier coats, researchers have discovered that an enzyme known to serve as a last-ditch defense against cancer also activates adult stem cells, which the body uses to repair its tissues.

Foetus Stem Cells ‘Can Repair Woman’s Brain’
Being pregnant may help to rejuvenate a woman’s brain cells, according to scientists who made a remarkable discovery in studies on animals.

Gene Therapy Sparks Improvement in Muscular Dystrophy Model
A bit of genetic legerdemain inserted a substitute for an essential muscle protein in a mouse model for congenital muscular dystrophies (CMD) and reversed symptoms.

Gene Therapy Fights Deadly Brain Cancer
Combination gene therapy has proved effective against deadly glioblastoma multiforme (GBM) brain cancer in rats, U.S. researchers report.

Anionic Lipids Help Gene Therapy Reach its Target
A team of US researchers has developed a ‘recipe book’ of non-toxic, non-viral DNA delivery systems that aims to help in the design of genetic medicines that can be delivered safely and effectively.

SmallCap Sentinel: ‘Holy Grail’ of Stem Cell Research Found Says Korean Team
The Korea Times and the U.S.-based weekly Science are reporting that a Korean husband-and-wife scientist team has had a breakthrough in adult stem cell research with the discovery of a gene in charge of differentiating the parent cells in human bodies.

Brain Tumors May Originate with Neural Stem Cells, Researchers Say
Researchers at UT Southwestern Medical Center have determined that stem cells in a certain region of the brain may be the source of a particular type of incurable brain tumor and may be implicated in other types of brain cancers as well.

Korean Scientist Begins Cloning Research For Practical Purposes
South Korea’s stem cell pioneer Hwang Woo-suk said Friday that his team began research for the practical application of their cloning work.


The Bone Formation In Vitro and Mandibular Defect Repair Using PLGA Porous Scaffolds

Development of Novel Method of Non-viral Efficient Gene Transfer into Neonatal Cardiac Myocytes

Genetic Manipulation of Human Embryonic Stem Cells: A System to Study Early Human Development and Potential Therapeutic Applications

Interferon-gamma and Cancer Immunoediting

Niche-Independent Symmetrical Self-Renewal of a Mammalian Tissue Stem Cell


Sponsored By:

Request for Information:National Cord Blood Stem Cell Bank Program
The purpose of this Request for Information (RFI) is to describe the approach that the Health  Resources and Services Administration (HRSA) proposes to follow to implement the National Cord Blood Stem Cell Bank Program.



BioLife Solutions Receives Patent for Cell Preservation Technology
BioLife Solutions has been granted a US patent that covers the methods and compositions for the preservation of cells, tissues or organs in an artificial environment.

Dendreon Signs Agreement to Lease Manufacturing Facility in New Jersey
Dendreon Corporation today announced that it has signed an agreement to lease 158,242 square feet of commercial manufacturing space in Hanover, New Jersey.

Dendreon Appoints Michelle Burris Senior Vice President and Chief Financial Officer 
Dendreon Corporation today announced the appointment of Michelle Burris as senior vice president and chief financial officer.

Dyax Corp. And Merck KGaA Enter Into License Agreement For Discovery Of Therapeutic Antibodies And Peptides
Dyax Corp. announced today that it has granted a non-exclusive license to its proprietary phage display libraries to Merck KGaA (Darmstadt, Germany) for the discovery and development of therapeutic antibodies and peptides.

Cryo StemCell Teams up With StemLife, Malaysia for Stem Cell R&D
Cryo StemCell Karnataka Pvt. Ltd., a stem cell bank for storage of umbilical cord, has inked a pact with Malaysia-based StemLife to sustain research and knowledge sharing in the field of stem cell research and development.

Cryo-Cell International Board Appoints Mercedes Walton As Chief Executive Officer
The Board of Directors of CRYO-CELL International Inc. (the “Company”), the world’s largest family cord blood bank, announced today that Mercedes Walton has been appointed Chief Executive Officer for the Company and has executed a three-year contract, effective September 1, 2005.

Genmab A/S Initiates HuMax(R)-CD20 Phase II Study In Rheumatoid Arthritis
Genmab A/S announced today it has initiated a Phase II study with HuMax-CD20 to treat patients with active rheumatoid arthritis (RA) who have failed one treatment with one or more disease modifying anti-rheumatic drugs (DMARDs).

ImClone, UCB to Develop Tumor Antibody
ImClone Systems and UCB have entered into a partnership for the development and commercialization of CDP-791, a novel, investigational antibody targeting the vascular endothelial growth factor receptor-2 (VEGFR-2) that is currently being developed by UCB.

Targepeutics, Inc. Announces Patent License Agreement With National Institutes of Health (NIH)
Combined with Targepeutics’ other exclusively licensed issued patents and several pending applications, these additionally patents give Targepeutics broad rights to commercialize its Genetically Engineered Interleukin 13 (IL-13) platform.

Pegasus Biologics, Inc. Receives FDA Approval to Market OrthADAPT(TM) Bioimplants
Pegasus Biologics, Inc. developers of novel bioimplants using proprietary technologies announced that the FDA has granted a 510K for the OrthADAPT(TM) Bioimplant, an intelligent, adaptable biologic scaffold which fortifies and promotes tissue remodeling while retaining long-term strength.

Pfizer to Acquire Privately Held Bioren
Pharmaceutical giant Pfizer Inc. on Monday said it has agreed to acquire all the outstanding stock of San Carlos, Calif.-based Bioren Inc., a privately held company focused on antibody optimization technologies.


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 19, 2005

Notice of the NHLBI Exploratory Program in Systems Biology (NOT-HL-06-103)


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

Regulatory Harmonization in a Global Environment (Slides)


Blood Products Advisory Committee:Posted the Transcript for the 07/22/05 meeting

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 



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)

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

Consultant– (AABB)

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

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)

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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