Volume 5.04 | Oct 25

Cell Therapy News 5.4, October 25, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Embryonic Stem Cells Correct Congenital Heart Defect in Mouse Embryos
Article

Story: Boy Cured by Stem Cells of Brother Born to Help Him
Article

Science

Gene Therapy for Erectile Dysfunction on Horizon
Article

Harvard Seeks Permission to Clone Human Embryos to Make Stem Cells
Article

Reconstituted Blood Better For Young Hearts
Article

Stem Cells Mend Hearts at a Distance
Article 

Stem Cells Derived from Skin May Soon Be Used to Treat Brain Tumours
Article

Stem Cells Secrete Healing Chemicals
Article

Technique For Genetically Modifying Blood Stem Cells Brings Cure For Blood Diseases Closer
Article

Researchers Provide Road Map For Generating B Cells From Stem Cells
Article

Results of Islet Transplant Study Now Available
Article

Taken from Teeth, Stem Cells Regenerate Tissue
Researchers have isolated stem cells from the ligament that holds human teeth in place and shown that, in laboratory mice, these cells are able to grow new ligament cells.
Article

U-M Team Treating Mouth Wounds By Engineering Tissue Grafts
Article

Scientists Use Embryonic Stem Cells To Prevent Birth Defect Death in Mouse Embryos
Article

Stem Cell Research for Stroke
Article

Stem Cells Cure Boy of Brittel Bone Disease
Article

Stem Cell Therapy May Cure Incontinence
Article

Gene Therapy Found Effective for Epilepsy Cure
Article 1
Article 2

Immune Therapy Appears to Reduce Risk of Second Attack of Multiple Sclerosis Symptoms
Article

Umbilical Cord Stem Cells Can Save Lives
Unlike embryonic stem cells, those drawn from umbilical cords are treating diseases -and without any controversy
Article

The Potential of Hematopoietic Stem Cell Therapy in Hepatology: A Critical Review
Derivation of Functional Endothelial Progenitor Cells from Human Umbilical Cord Blood Mononuclear Cells Isolated by a Novel Cell Filtration Device  (Letter to the Editor)
Article

Biologists Seek Consensus on Guidelines for Stem-cell Research
Article

ABSTRACTS

The Societal Unit Cost of Allogenic Red Blood Cells and Red Blood Cell Transfusion in Canada
Article

Acute Lung Injury After Allogeneic Stem Cell Transplantation: Is the Lung a Target of Acute Graft-Versus-Host Disease?
Article

Favorable Outcome of Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Acute Promyelocytic Leukemia in Childhood
Article

Contribution of Bone Marrow-Derived Cells to Skin: Collagen Deposition and Wound Repair
Article

Fusarium Dimerum Infection in a Stem Cell Transplant Recipient Treated Successfully with Voriconazole
Article

Self-Renewal, Multipotency, and the Existence of Two Cell Populations within an Epithelial Stem Cell Niche
Article

Outcome of Allogeneic Stem Cell Transplantation in Patients with Myelofibrosis
Article

Policy

Bush and Kerry on the Issues: Stem-cell Research
Article

Lara Bush Defend’s Husband’s Policy on Human Embryonic Stem Cell Research
Article

GOP Hits Edwards on Stem-Cell Talk
Article

California’s Governor Schwarzenegger Endorses Stem Cell Research
Article

UN Considers Cloning Again
Article

Scientists, Patients Fight UN Stem Cell Study Ban
Article

Student Society for Stem Cell Research: Global Petition to the UN for Stemcell Research
Link

UN ‘Must Ignore Cloning Ban Call’
The United Nations should ignore a call by George Bush to ban all forms of human cloning, say UK scientists.
Article

France Welcomes Human Stem Cell Research
Article 1
Article 2

Network Aims to Boost Swiss Stem Cell Research
Article

Business

MARKET REPORTS

Malachite Management has joined forces with an established and reputable author to bring you a report outlining the very latest in the Cell Therapy industry. “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 and to order see:

Cell Therapy Report Summary
Cell Therapy Sample Chapter

Table of Contents
Order Form

Malachite Management has joined forces with an established and reputable author to bring you a report outlining the very latest in the Gene Therapy industry. “Gene Therapy – Technologies, Markets and Companies” is 560 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the gene therapy industry worldwide.
For more information and to order see:

Gene Therapy Report Summary
Gene Therapy Table of Contents Vol. 1 Vol. 2
Gene Therapy Order Form

Malachite Management Inc. has teamed up with an established publisher to bring you the latest reports in immunotherapeutic approaches to cancer. For more information and to order see:

A Shift in Cancer Immunotherapy Stategies?
Immunotherapy Strategies Executive Summary

Immunotherapy Strategies Table of Contents

Future Perspectives in Cancer Immunotherapy
Future Perspectives Executive Summary
Future PerspectivesTable of Contents
Immunotherapy Reports Order Form

BUSINESS NEWS

MultiCell Gains Japanese Pharma Licensee for Its Proprietary Hepatocytes
Article

Immunoassay Market in Japan, Fuji Keizai Releases Report
Article

Norak Biosciences and Curis Sign Research Agreement
Under terms of the agreement, Norak will utilize its proprietary Transfluor Technology, related intellectual property and scientific expertise to developed Transfluor cell lines expressing Curis’ receptors.
Article

TxCell Raises EUR10.5 Million Series A To Finance Phase I-IIA Clinical Trials
Article

Targeted Genetics Named One Of Washington State’s Fastest Growing Technology Companies In Deloitte Technology Fast 50 Program
Article

Dallas-based Law Firm Winstead Sechrest & Minick PC Centers Biotech Group in Houston
Article

Biological Breakthrough in Stem Cell Research Backed by Gulf Investors
Article

For Job Stimulus, Boston Mulls Direct Investments
Boston officials are considering plans to invest city funds directly into biotechnology companies, part of a broader effort to stimulate the hot industry within city limits and create jobs.
Article

DNA Pioneer James Watson Defends Stem Cell Research
Article

New Genome and Biomedical Sciences Facility at the University of California, Davis Promotes Cross-Cutting Research
Article

NIH

National Institutes of Health

Center for Scientific Review Special Emphasis
Panel, Stem Cell Therapy and Ion Channels in the Heart.
Date: 10:30 a.m. to 12 p.m. October 29, 2004, Bethesda, MD
Agenda: To review and evaluate grant applications.
Contact Person: Anshumali Chaudhari, PhD, Scientific Review
Administrator [email protected].

Novel Approaches to Enhance Animal Stem Cell Research
(PA-04-125) Expiration date:  November 2 2007, unless reissued
National Center for Research Resources, National Cancer Institute, National Eye Institute, National Heart, Lung and Blood Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Biomedical Imaging and Bioengineering, National Institute of Child Health and Human Development, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Environmental Health Sciences, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Deafness and Other Communication Disorders, National Institute on Drug Abuse,
APPLICATION RECEIPT DATE(S): Multiple dates, see announcement
Link

NIH Funds Centers to Study Islet Transplantation
Article

Regulatory

Emerging Issues Internationally in Disclosure of Clinical Trial Results
Disclosure of clinical trial results is becoming a major issue internationally on several fronts – patient safety, regulatory integrity and effect on a company’s stock value. These summaries highlight a few of the recent critical developments in clinical trials disclosure.
Article


FDA Comments to Docket 2004D-0198 Re: Draft Guidance for Industry: Acceptable Full-Length Donor History Questionaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components (April 2004)
Link

  
                                                                    RESOURCES

ISCT’s Cell Therapy Legal & Regulatory Affairs Online Resources Center:
 Link

The Rules Governing Medicinal Products in the European Union

WHO Quality Assurance and Safety of Medicines (QSM)

ISPE Regulatory Information (International regulatory agencies and documents)

International Conference on Harmonisation (ICH) Guidances – Topics and Guidelines

Code of Practice for the Production of Human-derived Therapeutic Products (UK)

The 21CFRPart11.com Web site provides access to information on the rules and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators.

The FDA home page
 Electronic FOI 
 The  FDA Dockets 
 The FDA Modernization Act of 1997 (FDAMA) 
 Current Guidances 
 Regulatory Affairs Professionals Society 
 RAPS Combination Products Resource Page

OTHER REGULATORY RESOURCES

Advanced Cell and Gene Therapy Consulting

Biologics Regulatory Training Institute

The Biologics Consulting Group


Meetings

FEATURED CONFERENCE

Plan to attend the symposium “Cellular Therapy: Progressing to Clinical Practice?”, which takes place on Friday, December 3, 2004.

Location: San Diego Marriott Hotel & Marina, San Diego, CA

For more information or to pre-register online go to Click Here
Sponsored by Zenalta and supported by Miltenyi Biotec and Kirin Corporate Symposium

MALACHITE’S ONLINE CONFERENCE CALENDAR

For a more complete listing of conferences, see Malachite Management’s new online, interactive Cell Therapy Calendar

OTHER ONLINE CALENDARS

by The BioMaterials Network 
by The Pittsburgh Tissue Engineering Initiative
by The Tissue Engineering Pages 
by the American Society of Hematology
by the International Society for Stem Cell Research

CONFERENCES 2004

Oct. 23-26 Amer. Assoc. of Blood Banks Annual Meeting – Baltimore, Maryland.

Oct. 26-30  American Society of Human Genetics (ASHG) 54th Annual Meeting. Toronto, Canada. 

Oct 29, 2004 (7:30 AM – 7:00 PM) Biotech & Life Sciences Global Venture Congress 2004. Madison Square Garden, New York
Nobel Laureate Dr. James Watson Keynote Speaker with 20 top-tier Biotech Venture Capitalists

Nov. 3-6  4th Annual Stem Cell Network Annual General Meeting, Montreal, Canada. 

Nov. 4-6  BioStar Congress in Stuttgart, Germany

Nov. 4-7.  European Society of Gene Therapy (ESGT) 12th Annual Meeting. Tampere, Finland. 

Nov. 10-12 2nd Annual International Clinical Trials Summit, Westin Grand Hotel, Washington, DC 

Nov. 17-20 7th International congress of the Cell Transplant Society.  Boston, MA. 

Nov.18-19  Commercialisation of Tissue Engineering and Regenerative Medicine. London, UK.

Nov. 19 Advances In Bone Marrow Transplantation Conference– Sydney Australia

Nov. 19 – 21   2004 Hanson Symposium “Stem Cells: From Biology to Therapy”.  Adelaide, South Australia. 

Nov. 22-24  2nd National Stem Cell Centre Annual Scientific Conference.  Sydney, Australia. 

Dec. 1-3 Immunogenicity for Protein-Based Therapeutics – Washington, DC

Dec. 3 Cellular Therapy: Progressing to Clinical Practice?- San Diego Marriott Hotel & Marina, San Diego, CA

Dec. 3-7  Amer. Society for Hematology: 46th Annual Mtg – San Diego, California – San Diego, CA

Dec. 4-8  American Society for Cell Biology (ASCB) 44th Annual Meeting. Washington, D.C.

Dec. 9-10 DIA/EMEA Workshop on Gene Therapy & Cell Therapy Products.  London, UK. 

COURSES

Oct. 5-Nov. 15 The Zitter Group: Managed Care Webcast Series – New series for biotech and pharma marketers aiming to enhance reimbursement, coverage, managed care strategy, and tactical effectiveness.

Oct. 26 Inside FDA’s New cGMP Guidance: Map Your Quality System to the Requirements

Nov. 5 Analytical Validation and Regulatory Compliance Issues for the Pharma, Biotech, Medical Device and Related Industries – San Francisco, California.

Nov. 29-Dec. 1: Current Good Tissue Practice– Amsterdam, Netherlands

Nov. 30-Dec. 1: Monitoring Clinical Trials – Malvern, Pa. 

cGMP in the Transfusion Service. An online training course. Link

NIH and other stem stem cell training courses – Link


Weekly – UCSFs Human Embryonic Stem Cell Training Program (3-day training course).  Link

CONFERENCES 2005

Jan. 24-26  Phacilitate Cell & Gene Therapy Forum.  Washington DC

Feb. 10-14 Tandem BMT Meetings (Combined ASBMT and IBMTR/ABMTR annual meetings).  Keystone, Colo.

Feb. 23-25: The Clinical Trials Congress – Philadelphia
Featuring 80+ leading clinical experts incorporating Clinical Technologies, Patient Recruitment, Regulations, Strategic Partnerships, Study Design & Management and Contracts and Budgeting into 4 dynamic tracks. Janet Woodcock, MD, CBER, FDA provides a highly-anticipated update on the FDA Clinical Path Initiative. 

March 16-20  American Society of Transplantation (AST) and Canadian Society of Transplantation (CST) Annual Winter Symposium. Banff, Canada.

March 20–23  European Group for Blood & Marrow Transplantion Annual Mtg.  Prague, Czech Republic.

April 27-30 American Society for Apheresis 26th Annual Meeting Chicago, IL.  

May 18-20  2nd World Congress on Regenerative Medicine.  Leipzig, Germany. 

May 3-7.  11th Annual Meeting and Scientific Conference of the International Society for Cellular Therapy (ISCT) Vancouver, Canada.  (combined with Good Tissue Practices Workshop & Flow Cytometry for HSC Transplantation Workshop)

June 1-5  American Society of Gene Therapy Annual Meeting.  Saint Louis, MO. 

June 23-25  3rd Annual Meeting of the International Society for Stem Cell Research. San Francisco, CA. 

Sept. 21-25  International Society of Pediatric Oncology Conference.  Vancouver, Canada. 

Sept/Oct  Second International Epithelial Mesenchymal Transfer Conference.  Vancouver, Canada. 

ISCT

International Society for Cellular Therapywww.celltherapy.org

ISCT’s Quality Assurance Group launches online discussion board to discuss Quality Management issues via open, honest discussion by experienced, interested parties.

Profiled Journal

Read Cytotherapy in 2005! 
Join ISCT ($130) and receive the journal as a benefit of membership
http://www.celltherapy.org/mem_app.htm


Volume 6, Number 5 / October 2004
Table of Contents

Stem Cell Transplants For Heavily Transfused Patients With Severe Aplastic Anemia – A Promising New Strategy.

Review: An Antigen-Presenting Cell (APC) For Every Occasion: Induction And Expansion Of Human Antigen-Specific CD4 And CD8 T Cells Using Cellular And Non-Cellular APC.

Radiotherapy-Based Conditioning Is Effective Immunosupression For Patients Undergoing Transplantation With T-Cell Depleted Stem Cell Grafts For Severe Aplasia.

Comparison Of Total Nucleated Cell Measurements Of Umbilical Cord Blood Samples Using Two Hematology Analyzers.

Role of Beta 1-Integrins And Their Associated Tetraspanin Molecules In Fibronectin Enhanced Megakaryopoiesis. .

Mesenchymal Stem/Progenitor Cells Developed In Cultures From Umbilical Cord Blood.

Activated Platelets Rapidly Upregulate CD40L Expression And Can Effectively Mature And Active Autologous, Ex Vivo Differentiated Dendritic Cells.

Impaired Peripheral Blood Progenitor Cell Collection In Patients With Myeloma After High-Dose Melphalan.

Real Time Process/Quality Control For Hematopoietic Progenitor Cell Processing.

Expansion of Human Cytomegalovirus-Specific Cytotoxic T Lymphocytes To a Clinical Scale: A Simple Culture System Using Tetrameric HLA-Peptide Complexes.

Intraoperative Isolation and Processing Of Bone Marrow Derived Stem Cells.

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 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.
www.cytotherapy.com



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