Volume 6.27 | Jun 27

Volume 6.27, June 27, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Scientists Succeed In Cloning Human Embryos From Eggs Matured In The Lab

Story: New Method of Obtaining Embryonic Stem Cells Could Reduce Embryo Wastage


Human Embryonic Stem Cells Have the Potential to Develop into Eggs and Sperm in the Laboratory

Scientists in the UK have proved that human embryonic stem cells can develop in the laboratory into the early forms of cells that eventually become eggs or sperm.

Eggs from Embryonic Stem Cells Could Benefit Sterile Women
Monash researchers have developed a process that causes embryonic stem (ES) cells to develop into ovarian structures containing eggs.

Stem Cells to Solve Blood Shortage Problems

The State Government of Victoria, Australia announced that Melbourne scientists at Monash University have developed a unique technology that can grow large numbers of blood cells from human embryonic stem cells.

Blood Cells Develop from Stem Cells
Researchers in Baltimore have discovered that human embryonic stem cells grown in the laboratory develop spontaneously into blood cells.

Stem Cells Grown In Lab Mirror Normal Developmental Steps
Johns Hopkins scientists have developed a way to study the earliest steps of human blood development using human embryonic stem cells grown in a lab dish instead of the embryos themselves.


Researchers Discover Stem Cell ‘Guide’ that May Be Key for Targeting Neural Stem Cell Treatments
UC Irvine School of Medicine researchers have discovered how new neurons born from endogenous neural stem cells are sent to regions of the brain where they can replace old and dying cells, a finding that suggests how stem cell therapies can be specifically targeted to brain regions affected by neurodegenerative diseases or by stroke

Researchers Discover Mechanism that May Enable Stem Cell-based Treatment for Eye Disorders
In discovering a protein that helps organize the development of the retina, UC Irvine researchers have found a new molecular mechanism that may allow for stem cell-based therapies to treat eye disorders such as retinal degeneration.

Researchers Grow Stem Cells from Human Skin
Researchers at Wake Forest University School of Medicine have successfully isolated stem cells from human skin, expanded them in the laboratory and coaxed them into becoming fat, muscle and bone cells.

Engineered Muscles Pump Blood
For years, a major obstacle has dashed the hopes of creating “replacement parts” for the human body: the lack of an internal, nourishing blood system in engineered tissues. Without it, thicker tissues can’t thrive, a fact that has confined tissue engineering’s practical application to thin skin, which can recruit blood vessels from underlying tissue.

Breakthrough: UNC Scientists Have Created World’s Tiniest Uniform, Precisely Shaped Organic Particles
Adapting technology pioneered by the electronics industry in fabricating transistors, the team has figured out for the first time how to create particles for carrying genetic material, pharmaceuticals and other compounds of unprecedented small size and uniformity.

SPECT Imaging Can Evaluate Stem Cell Therapy Effectiveness in Patients with Coronary Heart Disease
Researchers from Seoul National University confirmed that single photon emission computed tomography (SPECT) can be used to evaluate the effectiveness of stem cell therapy with ischemic or coronary heart disease.

Stem Cells Fix Damaged Leg Arteries
“We designed a project to take adult stem cells isolated from a patients’ own bone marrow and inject them into the leg,” Dr. Lawson said.

Aging Stem Cells Linked to Leukemia in Elderly
Aging stem cells may be behind an increased risk of infection and leukemia in older people, according to a Stanford University School of Medicine study.

Conceptual and Practical Implications of Breast Tissue Geometry: Toward a More Effective, Less Toxic Therapy


A Novel Paradigm for Therapeutic Basis of Advanced Heart Failure-assessment by Gene Therapy

Comparison of Five Methods for Concentrating Progenitor Cells in Human Marrow Transplantation

Separation, Enrichment, and Characterization of Human Hematopoeitic Progenitor Cells From Umbilical Cord Blood

Understanding the Response to Immunotherapy in Humans


Catherine Verfaillie on the Work Needed Before Promise of Stem Cell Research Becomes Reality
Verfaillie will return to her alma mater, Belgium’s Catholic University of Leuven, while maintaining her affiliation with the University of Minnesota.

University of Minnesota & Belgium Form Stem Cell Partnership
Leaders from the University and the Catholic University of Leuven in Belgium signed a ceremonial agreement to develop joint and collaborating stem cell institutes.

California Institute for Regenerative Medicine: Legislative Subcommittee Approves Policy Enhancements; Additions Vigorously Respond to California’s Public and Legislature
The Legislative Subcommittee of the Independent Citizens’ Oversight Committee (ICOC) tonight approved policies designed to establish model standards in partnership with the Legislature and the public for the California Institute for Regenerative Medicine (CIRM) and stem cell research.

California Institute for Regenerative Medicine Press Release: CIRM and SF Formalize Relationship; Newsom and Klein Sign Agreement Certifying San Francisco’s Bid



Bio-Matrix Manufactures Set of Stem Cell Devices
Bio-Matrix Scientific Group has manufactured its first complete set of disposable instruments for stem cell research and tissue transfer procedures.

FierceBiotech Honors Cellerant Therapeutics as One of the ”Fierce 15” Biotech Companies of 2005
This distinction honors Cellerant as one of the top 15 emerging biotech companies for 2005.

Geron Publication Describes Human Embryonic Stem Cells Propagated Using Defined Serum-Free Medium in the Absence of Animal-Derived Products or Feeder Cells
Geron Corporation announced today the publication of studies which show that human embryonic stem cells (hESCs) can be cultured at scale in chemically defined serum-free medium without the use of animal-derived products or feeder cells.

Dendreon Completes Enrollment in Phase III Protect Trial
Dendreon has completed enrollment in its Phase III PROTECT clinical trial of Provenge in men with non-metastatic androgen-dependent (hormone-sensitive) prostate cancer. Provenge is Dendreon’s investigational immunotherapy for the treatment of prostate cancer.

INEX Announces Restructuring Plan and Appoints New President and COO
Inex Pharmaceuticals Corporation today announced extensive management changes and a restructuring to conserve cash and to facilitate a new strategic path to advance its lead anticancer drug Marqibo(TM), its other Targeted Chemotherapy cancer products and its promising early-stage Targeted Immunotherapy pipeline.

Invitrogen Launches i-Path — A Unique Systems Biology Platform at BIO 2005; 225 Original Maps Identifying and Visualizing Biologic Pathways, Available Free to Researchers
Invitrogen Corporation, a leading life sciences company with a broad portfolio of technologies to improve and accelerate biomedical research, drug discovery and commercial bioproduction, unveiled its latest concept in bioinformatics and systems biology with the launch of i-Path at the BIO 2005 international conference.

Compound Therapeutics Announces Initiation Of IND-enabling Safety Studies With Lead Oncology Product; First Of A New Class Of Protein Therapeutics
Compound Therapeutics announced that it has initiated IND-enabling animal safety studies with CT-322, its lead product.

MedImmune and Avalon Announce Collaboration
MedImmune and Avalon Pharmaceuticals have announced a collaboration to discover and develop small molecule therapeutic compounds in the area of inflammatory disease.

Vesta Therapeutics Awarded Research Grant
Vesta Therapeutics, Inc., announced today the awarding of a Phase I Small Business Innovation Research (SBIR) Grant from the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK), a division of the National Institutes of Health (NIH). This grant will support exploring the use of adipose derived adult stem (ADAS) cells as a therapeutic modality in liver disease.


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.
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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.
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Gene Therapy Report Summary
Gene Therapy Table of Contents Vol. 1 Vol. 2
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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 June 24, 2005


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

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

Compliance Program 7341.002 – Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Substantially Equivalent 510(k) Device – HCLL Donor 1.0 (Mediware Information Systems, Inc)

Substantially Equivalent 510(k) Device – Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0 (GE Medical Information Technologies)




Update on Leukocyte Reduction of Blood and Blood Components; Public Workshop
The public workshop will be held on July 20, 2005, from 8 a.m. to 5:30 p.m.

Cellular, Tissue and Gene Therapies Advisory Committee: Posted the Transcript for the 05/20/05 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 


This meeting was added to the calendar this week:

Leukocyte Reduction of Blood and Blood Components; Public Workshop
July 20, 2005 (8 a.m. to 5:30 p.m.)

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  
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)

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 Assistant 
Vancouver, British Columbia (StemCell Technologies)

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 Control Technologist 
Vancouver, British Columbia (StemCell Technologies)

Quality Manager 
Sydney, Australia (Bone Marrow Transplant Network NSW)

Research Associate II 
Gaithersburg, Maryland (Maxcyte)

Scientific Director 
Boston, Massachusetts (CBR Insitute for Biomedical Research CHCT)
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)

Scientist, Bacteriology
Potters Bar, Hertfordshire, England (National Institute for Biological Standards and Control)

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)

Senior Scientist 
Brussels, Belgium (Beta-Cell NV)

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

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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