Volume 6.31 | Aug 1

Volume 6.31, August 1, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: New Method Shows It Is Possible To Grow Bone For Grafts Within A Patient’s Body

Story: Veering From Bush, Frist Backs Funding for Stem Cell Research


Swedish Stem Cell Researchers Create New Brain Cells
Swedish researchers have created new functioning brain cells from stem cells drawn from the brains of living adults, sparking hope that effective treatments for devastating illnesses like Parkinson’s and Alzheimer’s could be at hand, media reported.

New Finding May Aid Adult Stem Cell Collection
Cincinnati scientists have discovered how blood-regenerating stem cells move from bone marrow into the blood stream.

Stem Cell Therapy Successfully Treats Heart Attack In Animals
Final results of a study conducted at Johns Hopkins show that stem cell therapy can be used effectively to treat heart attacks, or myocardial infarction, in pigs.

Trial to Test Stem Cells for Heart Attacks
A clinical trial to test the safety of treating heart attack damage with stem cells is about to get under way, following a study that showed the therapy helped in pigs.

Stem-cell Technique May Spare Embryo
U.S. scientists have devised a technique in a mouse model to obtain embryonic stem cells without harming or destroying an embryo — an approach that, if successful on human embryos, could circumvent some of the moral objections to the research.

Combination Therapy Leads to Partial Recovery from Spinal Cord Injury in Rats
Combining partially differentiated stem cells with gene therapy can promote the growth of new “insulation” around nerve fibers in the damaged spinal cords of rats, a new study shows.

Gene Found in 90 Percent of Breast Cancers May be Cancer Vaccine Target
A gene that appears to help regulate normal embryonic development is found at high levels in virtually all forms of breast cancer, according to a new study led by Laszlo Radvanyi, Ph.D., associate professor of breast and melanoma medical oncology at The University of Texas M. D. Anderson Cancer Center.

Scientists Discover Protein To Repair Damaged Nerves And Brain Cells
Scientists say they have discovered a protein that could be injected to repair damaged nerves and brain cells.

INGN 241 Therapy Helps Kill Cancer Cells
Researchers at Introgen Therapeutics, along with their collaborators at The University of Texas M. D. Anderson Cancer Center, have published new findings on the role of IL-24 in regulating the immune system in the current online issue of the Journal of Leukocyte Biology.

Cell Therapy Beats Knee Replacement
The Faculty of Health Sciences at the University of Stellenbosch and the Cartilage Research and Assessment Unit have begun cultivating cartilage cells (also known as chondrocytes) for several operations on those who suffer form various knee and foot injuries.

Participants in the Gene Therapy Market Discover New Ways to Improve Clinical Efficiency and Generate Revenue
research involving novel designs for vectors, methods of introducing ‘naked’ deoxyribonucleic acid (DNA), and the use of electroporation to improve DNA uptake into cells have been successful in pre-clinical studies.

Circulating Stem Cells Play Small Role in Lung Repair
Reporting in today’s edition of the journal Transplantation, lead author Dani Zander, M.D., of The University of Texas Medical School at Houston, and colleagues at the University of Florida College of Medicine found that less than 1 percent of a certain type of reparative lung stem cell originated in the bone marrow of the transplant recipient.

Stem Cells in Bone Marrow Replenish Mouse Ovaries
Previously unrecognized stem cells found in the bone marrow and blood of mice can “restock” a depleted ovary with new egg cells within weeks, according to new research published in this week’s issue of the journal Cell.

Tandem Stem Cell Transplants Offer Promise in Metastatic Breast Cancer
High-dose chemotherapy (HDC) and autologous stem cell transplantation, followed by a mini allogeneic stem cell transplant, results in remission in some women with metastatic breast cancer, according to a study in The Lancet.


Human-Serum Matrix Supports Undifferentiated Growth of Human Embryonic Stem Cells

Adult Bone Marrow Stem/progenitor Cells (MSCs) are Preconditioned by Microenvironmental “Niches” in Culture: A Two-stage Hypothesis for Regulation of MSC Fate

Donor Islet Endothelial Cells Participate in Formation of Functional Vessels within Pancreatic Islet Grafts


U.S. BioDefense Sponsors 1-800-STEM-CELLS.com, a Major Success for New Stem Cell Industry Council Non-Profit
U.S. Biodefense, Inc. announced today that it has recently sponsored the successful launch of 1-800-STEM-CELLS.COM, a major success for the Stem Cell Industry Council, a newly formed IRS approved 501C3 Non-Profit Organization “Advocating Stem Cell Education, Research, and Fundraising”. 


Abbott’s Cell-Dyn Sapphire Gets FDA Clearance
Abbott has received 510(k) clearance from the FDA for its automated, high-volume hematology instrument, the CELL-DYN Sapphire – the latest CELL-DYN hematology analyzer to incorporate monoclonal antibody tests for additional cellular analysis.

Advanced Cell Technology and The Burnham Institute Announce Collaboration to Isolate Stem Cell-Specific Differentiation Markers
Advanced Cell Technology, Inc. announced today it has entered into a research collaboration agreement with the The Burnham Institute, a California based non-profit medical research institution, to conduct research that aims to isolate stem cell specific differentiation markers.

Bio-Matrix Scientific Signs Letter of Intent to Acquire Former American Red Cross Facility for Its New Stem Cell Bank and Research Center
Bio-Matrix Scientific Group Inc. announced today that it has signed a letter of intent on the long-term lease of a facility formerly operated by the American Red Cross.

Chemicon International, Inc. Enters into a License to Commercialize Research Products Utilizing Human Embryonic Stem Cell Technology from Wisconsin Alumni Research Foundation (WARF)
Serologicals Corporation announced today that Chemicon International, Inc., its wholly-owned subsidiary based in Temecula, CA, and the Wisconsin Alumni Research Foundation (WARF) have signed a license to commercialize research products derived from patented human embryonic stem (ES) cell technology.

Data Safety Monitoring Board Recommends Continuation of MyVax(R) Personalized Immunotherapy Pivotal Phase 3 Trial for Treatment of Follicular Non-Hodgkin’s Lymphoma
Genitope Corporation today announced that its independent Data Safety Monitoring Board (DSMB) reviewed the first planned interim analysis of data for efficacy in its pivotal Phase 3 clinical trial for treatment of follicular non-Hodgkin’s Lymphoma (fNHL) and recommended that the trial continue as planned.

Bone Graft Clinical Trial Expanded
Aastrom Biosciences announced that it has expanded the U.S. Phase I/II clinical trial of its adult stem cell-based Tissue Repair Cells (TRCs) in the treatment of severe long bone open or non-union fractures to include the University of Nebraska Medical Center (UNMC) in Omaha, Neb.

GenVec Appoints Thomas A. Davis, M.D., Chief Medical Officer; Will Lead Clinical Development of Company’s Product Candidates
GenVec, Inc. today announced that Thomas A. Davis, M.D., has joined the company as its chief medical officer. Dr. Davis will be responsible for directing the clinical development of GenVec’s growing portfolio of gene-based therapies for the treatment of cancer, cardiovascular disease and diseases of the eye.

GammaCan Reports on Patient Enrollment in Phase II Clinical Trial
GammaCan International, a developer of immunotherapies for cancer, today announced that the Phase II clinical trial of GCAN 101 for the treatment of metastatic melanoma, prostate and/or colon cancers is underway.

Invitrogen to Acquire BioSource for $130M
Invitrogen Corp., a maker of products used in gene cloning and analysis, on Tuesday said it has agreed to acquire BioSource International Inc. for $130 million in cash.

Kirin Brewery Co., Ltd. To Acquire Hematech – Aims To Accelerate Development Of Fully Human Polyclonal Antibody Medicines
Through this acquisition, Kirin has acquired Hematech’s core technology and research infrastructure for production of bovine-derived human polyclonal antibodies.

PhereSys Therapeutics Announces Consulting Agreement with Advanced Cell & Gene Therapy, LLC
PhereSys(TM) Therapeutics Corporation announced today that it has entered into a comprehensive consulting services agreement with Advanced Cell & Gene Therapy LLC (“ACGT”), Scott R. Burger, MD, Principal.

Pall Awarded Long-Term Contract from American Red Cross for Leukoreduction Filter Systems
Pall Corporation announced today the signing of a new long-term agreement with the American Red Cross (ARC) to provide blood collection systems incorporating its proprietary filtration and venting technology.

Oxford BioMedica is Awarded Grant for Monudin(R) From the Motor Neurone Disease Association
Oxford BioMedica, the leading gene therapy company, announced today that the UK Motor Neurone Disease (MND) Association has awarded a research grant to support preclinical evaluation of MoNuDin for the treatment of Amyotrophic Lateral Sclerosis (ALS), the most common form of motor neurone disease.

Spanish Biotechnology Company, Cellerix, Receives Orphan Status Designation By The European Medicines Evaluation Agency For A Stem Cell Medicinal Product
Cellerix, a company belonging to the Genetrix group and specialised in the development of cell-based therapies, has received Orphan Status designation by the European Medicines Evaluation Agency (EMEA) for one of its products in development. Cellerix’s medicinal product is currently in clinical trials and uses stem cells taken from adipose tissue coming from the same patient, and will be used for the treatment of fistulas.

StemCell Treatment Center to Open in Las Vegas
StemCell Pharma Inc. announces the opening Oct. 3, 2005 of the StemCell Treatment Center of Las Vegas, where the placenta/stem cell implant developed by Alfred T. Sapse, M.D. (ret), will be used.

StemCell Technologies Brings Design and Production of RoboSep(TM) Back to Canada
StemCell Technologies, Inc. announced today that StarFish Medical (Victoria, BC) has been chosen to finish the design work and to be the responsible manufacturer of the RoboSep™, the first instrument to offer true walk-away automation of magnetic cell separation.   

US Patents Victory for Stem Cell Sciences
Scottish biotech Stem Cell Sciences has won important extensions to its US patent rights which it expects to boost revenues in the critical American pharmaceuticals market.


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 29, 2005

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) to Develop New Therapeutics and Monitoring Technologies for Type 1 Diabetes (T1D) and its  Complications (RFA-DK-05-010)


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

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update




Follow-on Biologics Guidance Expected in Late Summer
The FDA’s promised guidance to industry on follow-on biologics should be released by late summer or early fall, FDA Commissioner Lester Crawford told House lawmakers this week.

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 


Contact Malachite Management if your company is interested in hosting an educational symposia at a future conference. Upcoming symposia opportunities include:

– World Transplant Congress (WTC). July 22-27, 2006. Boston, MA. Symposia dates: July 20, 21 or 28. Application Deadline: September 11, 2005

– Canadian Blood & Marrow Transplant Group (CBMTG) Biennial Conference. April 22-24, 2006. Edmonton, AB. Symposia dates: April 22. Application Deadline: January 2006.

– American Society for Apheresis (ASFA) Annual Conference. May 23-26, 2006. Las Vegas, NV. Symposia date: May 23. Application Deadline: March 15, 2005.

– International Society for Cellular Therapy (ISCT) Annual Conference. May 4-7, 2006. Berlin, Germany. Symposia dates: May 4, 5, or 7. Application Deadline:  January 2006.

– American Society for Hematology (ASH) December 9-12, 2006. Orlando, FL. Symposia date: December 8. Application Deadline:  early April 2006


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)

Biologist (Therapeutic Proteins)
Bethesda, Maryland (CBER)

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 
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)

Director of Scientific Business Development (Regenerative Medicine)
Cambridge, Massuchusetts/San Francisco, California (3DM PuraMatrix Hydrogels Inc.)

Instrumentation Engineer II 
Gaithersburg, Maryland (Maxcyte)
Interdisciplinary Scientist (Cellular and Gene Therapies)
Rockville, Maryland (CBER)

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)

Medical Officer (Clinical Evaluation and Pharmacology/Toxicology)
Rockville, Maryland (CBER)

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)

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)


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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