Volume 6.21 | May 16

Volume 6.21, May 16, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Laboratory Model of Immune System Overcomes Ethical Constraints on Studies of Hematopoietic Stem Cells in Humans

Story: UPMC Study to Use Adult Stem Cells in Bid to Help Faltering Hearts


Researchers Discover Mechanism For Multiplying Adult Stem Cells

As reported in the May 6 issue of the journal Cell, researchers in the lab of Whitehead Institute Member Rudolf Jaenisch have discovered a mechanism that might enable scientists to multiply adult stem cells quickly and efficiently.

Stem Cell Treatment Improves Mobility After Spinal Cord Injury
A treatment derived from human embryonic stem cells improves mobility in rats with spinal cord injuries, providing the first physical evidence that the therapeutic use of these cells can help restore motor skills lost from acute spinal cord tissue damage.

New Hope for Alzheimer’s Vaccine
A study stopped early on safety grounds may still hold the key to a vaccine for Alzheimer’s disease, say researchers.
Article 1, Article 2

Nine-year Survival of Transplanted Pig Islet Cells in a Diabetic Patient
Living Cell Technologies Ltd today reported the long-term survival of encapsulated pig islets in a man with type 1 diabetes.

A Bioartificial Kidney?
Despite advances in dialysis, acute kidney failure while in the hospital carries a mortality rate that tops 50 percent. Current therapies filter body waste but fail to compensate for other renal functions, such as immune surveillance and metabolic activity.

UCLA Cancer Researchers Shake Loose Hidden Biomarker
Using a common chemotherapy agent, researchers at UCLA’s Jonsson Cancer Center and the Department of Pathology and Laboratory Medicine found a way to move an important biomarker expressed in prostate cancer, shaking it loose from one location in a cell – where it could not be accessed by blood – to another, easier to target area.

University of British Columbia Research Finds New Predictor for Blood Transplant Success
The success of blood stem cell transplants used to treat diseases such as leukemia, Hodgkin’s lymphoma and aplastic anemia may soon become more predictable, thanks to a discovery made by researchers at the University of British Columbia.


Artificial and Engineered Chromosomes: Non-integrating Vectors for Gene Therapy

Enhanced Hypothermic Storage of Neonatal Cardiomyocytes

Enhancement of Gene Delivery to Cancer Cells by a Retargeted Adenovirus

Immunotherapy: Target the Stroma to Hit the Tumor

The Pathophysiology of Acute Graft-versus-host Disease

Therapeutic Benefit of TH-engineered Mesenchymal Stem Cells for Parkinson’s Disease


No Research on Embryonic Stem Cells (India)
Union Health Minister Anbumani Ramadoss on Friday ruled out research in the area of embryonic stem cells till the Government framed ethical guidelines on the issue.

Massachusetts Governor Sends Back Stem-Cell Bill
Gov. Mitt Romney is refusing to sign a recently approved stem cell bill unless lawmakers amend it to ban cloning for research, a practice he describes as ethically wrong.

San Francisco Chosen as California’s Stem Cell Headquarters
San Francisco has been chosen as the new headquarters for California’s three billion dollar stem cell agency.

California Stem Cell Initiative Taps UF Scientist to Help Direct Research
An internationally regarded authority on adult stem cells at the University of Florida will help oversee research spending at the newly established California Institute of Regenerative Medicine, a landmark initiative to supply $3 billion for stem cell research at California universities and research institutions.

Stem Cells May Help a City Heal
Still bleeding from the dot-com crash, San Francisco stakes future health on institute.

Hospitals Urge FDA to Require Bar Codes on Medical Devices; Bar Coding of Drugs, Biologicals, Blood Products and Devices Seen as Tool for Improved Patient Safety, Care Quality and More Efficient Delivery
On the heels of an internal report critical of the Food and Drug Administration’s post-market safety surveillance of medical devices–as well as its oversight of the manufacturers, themselves–hospital groups are urging the agency to act. They have appealed to the FDA to take swift action on a February 2004 pledge to investigate and ultimately pursue a regulation requiring the bar coding of medical devices.



Geron Announces Publication of Studies Demonstrating Hematopoietic Stem Cells Differentiated From Human Embryonic Stem Cells Engraft and Establish Hematopoiesis in Animals
Geron Corporation announced today the publication of studies demonstrating that hematopoietic stem cells (HSCs) derived from human embryonic stem cells (hESCs) can establish hematopoiesis in mouse models, leading to production of all major human blood cell types.

Geron Announces Publication Describing Animal Cell-Free Derivation of Human Embryonic Stem Cells
Geron Corporation announced today the publication of studies which show that human embryonic stem cells (hESCs) can be derived without the use of animal cell feeders.

Geron Announces Publication of Studies Showing Oligodendrocyte Progenitors Derived From Human Embryonic Stem Cells Induce Functional Recovery After Spinal Cord Injury
Geron Corporation (Nasdaq: GERN) announced today the publication of studies showing that oligodendrocyte progenitors, differentiated from human embryonic stem cells (hESCs), produce functional improvements in rats with spinal cord injuries.

Cellerant Therapeutics Raises $16 Million to Advance Stem Cell-Based Therapies for Life-Threatening Diseases
Cellerant Therapeutics Inc. announced that it has raised $16 million in a series B financing led by Novel Bioventures.

CryoLife Announces Implant of its Cryopreserved Orthopaedic Tissues Treated With the Clearant Process
CryoLife, Inc., a biomaterials and biosurgical device company, announced today the first human implant of its cryopreserved orthopaedic tissues utilizing the Clearant Process(R).

CryoLife Selects Clearant, Inc. to Sterilize Implant of its Cryopreserved Orthopaedic Tissues; Leading Tissue Bank Adopts The CLEARANT PROCESS-R- For The First Time
Clearant, Inc., the developer of the CLEARANT PROCESS(R) for pathogen inactivation announced today that CryoLife, Inc., a biomaterials and biosurgical device company, had completed their first human implant of its cryopreserved orthopaedic tissues utilizing the CLEARANT PROCESS(R).

Dow and Cytogen Agree to Develop PSMA Antibody
Cytogen Corporation, a product-driven biopharmaceutical company, and Dowpharma contract manufacturing services, a business unit of The Dow Chemical Company, announced a collaboration to create a targeted oncology product designed to treat prostate and other cancers.

European Patent For Trovax® Covering 5T4 Tumour Antigen-Targeted Immunotherapy, Oxford Biomedica
Oxford BioMedica, the leading gene therapy company, today announced that the European Patent Office has granted a key patent that provides broad protection for Oxford BioMedica’s lead product, TroVax.

Favrille, Inc. Announces Phase 2 Clinical Trial Results For FavId(R) Following Autologous Stem Cell Transplantation To Be Presented During American Society of Clinical Oncology

ImmunoGen, Inc. Announces Appointment of Daniel M. Junius as Chief Financial Officer

Ono Pharmaceutical Company, Ltd. And Medarex, Inc. (MEDX) Enter Into Collaborative Research Agreement On Antibody Product
Ono Pharmaceutical Co., Ltd. and Medarex, Inc. announced today that they have entered into a collaborative research agreement to research and develop a fully human anti-PD-1 antibody for the potential treatment of cancer.

PhereSys Therapeutics Extends Its National Therapeutic Apheresis Services Roll-out to San Diego and Appoints Jerry Kolins, MD As Western Regional Medical Director
Pheresys Therapeutics Corporation (“PhereSys”) announced today that it has expanded its therapeutic apheresis (“TA”) services to the greater San Diego area, and continues to build its top-tier management team with the appointment of Jerry Kolins, MD, FACHE as its Western Regional Medical Director.

Viragen Licenses ‘Anti-CD55 Antibody’ Cancer Therapy from Cancer Research Technology
Viragen, Inc. (AMEX: “VRA”) and Cancer Research Technology Limited (U.K.) today announced a license agreement that provides Viragen with worldwide exclusive rights to commercialize the anti-CD55 antibody, which is currently in preclinical development for the treatment of a broad range of cancers.


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 13, 2005


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

“Processing Methods for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Public Meeting” to be held in Rockville, Maryland, June 22-23

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and FDA Staff

Licensed Products and Establishments List – Update





FDA Officials Highlight Role of Risk Management in cGMP Inspections
Risk management plays a critical role in determining an investigator’s approach to a current good manufacturing practice (cGMP) inspection, dictating everything from how the inspection is conducted to who is placed on the investigative team, FDA officials told a recent industry conference.

FDA Names New Associate Commissioner for Regulatory Affairs
The FDA has named Margaret Glavin to be the new associate commissioner for regulatory affairs, a position that oversees the agency’s field staff that enforces FDA regulations.

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 


These meetings have been added to the calendar this week:

ESACT 2005 Conference: Cell Technology for Cell Products. Harrogate, United Kingdom
June 5-8

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  NEW!
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)

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 Assurance Director 
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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