Volume 6.28 | Jul 11

Volume 6.28, July 11, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: South Korean Firm Plans Hospital for Stem Cell Therapy

Story: New Approach Works Against Leukemia, Lymphoma


Bone Marrow Cells Transformed Into Muscle Cells
Could lead to treatments for diseases like muscular dystrophy, researchers say.

Stem Cells Might Replace Ailing Immune System, Cow Study Finds
Injections of embryonic stem cells, versatile building blocks that can take on many functions, can reconstitute aging immune systems, according to a study of cows appearing today in the journal Cloning and Stem Cells.

Mulitple Stem Cells Appear to Maintain Human Small Intestines
The adult small intestine is composed of millions of crypts and cells that constantly divide and die.

U-M Scientists Discover Identifying Markers that Change as Primitive Blood-forming Stem Cells Morph into Progenitor Cells
Scientists at the University of Michigan Medical School have discovered the biological equivalent of a grocery store bar code on the surface of primitive, blood-forming stem cells in mice.

South Korean Scientists Develop Trigger For Stem Cell Differentiation
The team led by Moon Shin-Yong of the state-financed Stem Cell Research Centre said they had found that the PDX-I protein, produced in the human pancreas, can work as an agent to trigger stem cell differentiation.

Stem Cells, Live and On Display, Featured at Educational Exhibit
These heart cells – pulsing and throbbing in a petri dish, magnified and visible on an overhead screen – are alive because they just emerged from a culture of embryonic stem cells, also on display, that have grown in a petri dish for years – and, as long as they are fed and nurtured, will continue to thrive.

Stem-Cell Research: Signposts and Roadblocks
Embryonic stem-cell research, more than virtually any other scientific field, has been mired in political and ethical controversy. In recent weeks, however, important movement has occurred on ethical, scientific, and political fronts alike.

Interview with John Gearhart on Recent Events in Stem-cell Research
Supplement to Okie S. Stem-Cell Research — Signposts and Roadblocks. N Engl J Med 2005:353(1);1-5. John Gearhart is a stem-cell biologist at the Institute for Cell Engineering, Johns Hopkins School of Medicine.

Researchers Identify Genes Involved With Blood Stem Cell Development
Researchers at the University of Minnesota have identified for the first time a group of genes that impact the development and function of blood stem cells, a discovery that brings researchers a step closer to harnessing the power of stem cells for disease treatments.

Identifying Blood Stem Cells Is a SLAM Dunk
Researchers have developed a simple technique to identify hematopoietic, or blood-forming, stem cells based on a set of characteristic markers that the cells display on their surface.

A New Stem Cell Niche – No Kidneying Around
In a new study appearing in the July 1 print issue of The Journal of Clinical Investigation, Jeremy Duffield and colleagues from Harvard study kidney repair in mice harboring markers in their bone marrow.

Islet Transplantation Success Continues
Normally islets from two or three donor pancreases are used for the transplants but last week the Royal Free Hospital in London announced positive results after a woman with Type 1 diabetes received islets from just one donor pancreas.

Allernon, Formulated By Allervax Lab, a More Effective Way to Fight Allergies
Research presented at this year’s annual meeting of the American Academy of Allergy, Asthma, and Immunology has shown that sublingual immunotherapy, or placing drops under the tongue, can be a highly effective approach to administering allergy medications and is safe and effective in children under 5.

Adding Up Tolls for Immune Cell
The immune system has to recognize potential threats from microbes and react quickly and specifically. Researchers have now shown human immune cells integrate multiple signals obtained by ‘tasting’ their microbial invader through sensors known as Toll-like receptors (TLRs), according to the August issue of Nature Immunology.

Genetically Modified Cells Migrate To Brain And Treat Neurodegeneration In St. Jude Model
Physicians might one day be able to treat a disease that destroys brain cells in children using genetically modified cells to transport a “drug” to the site of the dying neural cells.


Functional Analysis of Human Hematopoietic Stem Cell Gene Expression Using Zebrafish

Turning Stem Cells into Mesenchymal Tissues


California Institute for Regenerative Medicine Media Advisory: ICOC To Address Legeslative Policy Enhancements, Governance And Intellectual Property In Irvine
This Tuesday (7/12/05), the Independent Citizens’ Oversight Committee (ICOC) for the California Institute for Regenerative Medicine (CIRM) will discuss the establishment of an governance oversight subcommittee, policy enhancements recommended by the ICOC’s legislative subcommittee as well as the consideration of a joint CIRM/State legislative task force on intellectual property for CIRM grants.

Cedars-Sinai’s Live Donor Liver Transplant Program Receives ‘Unos-approved’ Designation
Now, to support quality assurance standards nationwide, the United Network for Organ Sharing (UNOS) – the organization that administers the nation’s policies on organ transplantation – offers institutions the opportunity to qualify as UNOS-approved live donor liver transplant centers, and Cedars-Sinai’s program has become the first to receive this designation.

Stem-cell Protest May Spread to in Vitro
Some reproductive health experts are wondering if opposition to embryonic stem-cell research may spread to in vitro fertilization, a report says.

Consensus Conference Considers Chronic GvHD – Comment Sought on Working Papers
Standards for the diagnosis and evaluation of chronic GvHD and the need for common nomenclature to communicate about the disease were principal concerns at an NIH Consensus Conference on Clinical Trials for cGvHD on June 6 in Bethesda, Md. Public comment is welcome through Aug. 5 for the working papers that will be published in BBMT.

Hong Kong Billionaire Donates $40M to UCal Berkeley  for Stem Cell Research
This donation from the Li Ka Shing Foundation will be used to establish a research center focused on new scientific fields including stem cell biology and brain imaging, according to campus officials.

Independent Body to Review Australian Cloning Laws
An independent committee reviewing Australia’s human cloning and embryonic stem cell research laws will consider whether the nation is slipping behind others in developing the technology.



Applied Biosystems Announces First Licensee Invitrogen Corporation Under Expanded PCR Licensing Program; Key Patents Covering Real-Time PCR Now Included In Program
Applied Biosystems Group, an Applera Corporation business, today announced it has granted a license to Invitrogen Corp. under the expanded Applied Biosystems PCR (polymerase chain reaction) licensing program.

BioPAL Announces the Successful Development of Important New Technologies for Stem Cell Therapy
BioPhysics Assay Laboratory (BioPAL), Inc. announced today that the company has developed a panel of products that will help researchers track and image cells, such as stem cells, in cellular therapies.

Halozyme Announces IND Application for ChemoPhase
Halozyme Therapeutics, a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, announced it has submitted its investigational new drug (IND) application for Chemophase to the FDA.

Osteobiologics Launches Its TruGraft BSG Syringe
The TruGraft BGS Syringe product offers the convenience of TruGraft BGS Granules preloaded in a syringe for bone void filling procedures.

PhereSys Therapeutics Appoints Hal I. Lieberman as President and Chief Operating Officer and Gregory S. Ayers as Chief Financial Officer

Seattle Genetics, Inc. Drops Development Of Cancer Drug
Although the data show an encouraging trend, the company has decided to discontinue development of SGN-15, a first-generation antibody-drug conjugate (ADC), to focus on advancing its other pipeline programs and second-generation ADC technology.

Stem Cell Biotech Firm to List Shares
Medipost, a leading stem cell-related bioengineering company, said it will list its shares on the Korea Stock Exchange early next month, becoming the first biotech venture trading its shares on the main stock exchange.

StemCells Inc. Grants License To ReNeuron, Receives Stake In UK Stem Cell Company
StemCells, Inc. announced today that it has entered into an agreement with ReNeuron, a privately-owned UK biotech corporation.

Xcyte Therapies, Inc. Announces Plan To Explore Strategic Alternatives
Xcyte Therapies, Inc. announced today that the Company has implemented a plan to identify and evaluate its strategic options.


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 July 8, 2005

Short-Term Courses In Human Embryonic Stem Cell Culture Techniques (PAR-05-133)


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

Agenda – Workshop on Leukocyte Reduction of Blood and Blood Components: “An Update”

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

International Conference on Harmonisation (ICH); Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

Compliance Action: AmbioDry Amniotic Membrane Tissue Grafts – OKTOS Surgical Corp

Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance

Approved Biological NDA and ANDA Applications – Update

Cleared Biological 510(k) Device Applications – Update

Approved Biological Premarket Approval (PMA) Device Applications- Update





Request for Nominations for Nonvoting Members Representing Industry Interests on Public Advisory Panels or Committees; Medical Devices Advisory Committee

Cellular, Tissue and Gene Therapies Advisory Committee (formerly Biological Response Modifiers Advisory Committee); Notice of Meeting
The meeting will be held, via teleconference, on July 29, 2005, from 12:30 p.m. to 2:30 p.m.

Blood Products Advisory Committee; Notice of Meeting
The meeting will be held on July 21, 2005, from 8a.m. to 6:30 p.m.

FDA Presentations at ISCT’s 2005 GTP Workshop – 5/3-4/2005:

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:

Antibody World Summit. Jersey City, New Jersey
July 24-27

IBC’s Stem Cell Research Challenges. La Jolla, California
November 7-9, 2005

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)

Clinical Trials Coordinator NEW!
Vancouver, British Columbia (Malachite Management)

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 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)

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)


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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