Volume 5.03 | Oct 18

Cell Therapy News 5.3, October 18, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Death of actor Reeve fuels volatile stem cell debate

Story: Unfertilized Eggs May Be Viable Source for Stem Cells


Umbilical Matrix Is Rich Source Of Stem Cells
Wharton’s jelly, the material that forms the matrix in the umbilical cord, could provide a potentially inexhaustible source of stem cells, according to researchers at Kansas State University. These cells, called cord matrix stem cells, have been shown to differentiate into multiple cell types.

Stem Cells from Umbilical Cord Blood Reduce Stroke Size and Damage
Article 1
Article 2

Embryo Stem Cells Make Biological Pacemakers

Transplanted into the heart, could help regulate activity and repair tissue
Article 1
Article 2

Stem Cells Could Rebuild Failing Hearts


Gamida-Cell Announces Studies That Show Human Bone Marrow Stem Cells May Effectively Treat Cardiac Disease.

Marrow Stem Cells Fix Heart Attack Damage

Findings reinforce treatment approach’s potential

Adipose-derived Stem Cells Improve Heart Function After Heart Attack

Some Scientists Look To Fat For Stem Cells

New Research on Stems Cells from Fat

Muscle Stem Cells ‘Morph’ Into Nerve Cells

Stem Cells Find Cancer Metastasis in Animals :Gene Therapy Targets Solid and Blood Tumors

New Fruit Fly Model of Diabetes Has Future Implications For Pancreatic Cell Transplantation

First Derivation of Retinal Cells From Human Embryonic Stem Cells: Potential Use To Treat Blindness

Stem Cells May Stem Blindness: Potential Treatment For Retinitis Pigmentosa And Other Retinal Degenerations
Article 1
Article 2

First Marrow Transplant In Vietnam Underway In Central Military Hospital

Mini Stem Cell Transplants May Boost Cancer Survival

A series of mini stem cell transplants, combined with lower doses of chemotherapy, appears to lead to higher survival rates in patients with cancer.

Safer Route To Gene Therapy Found

Alpha-1 Gene Therapy Safely Tested In First Three Patients


Gene Therapy Expert Group
The EMEA published on 17 August 2004 a report from the CPMP Gene Therapy Expert Group Meeting that took place on 26-27 February 2004.

Novel Gene Therapy Holds Promise For Treating Bladder Cancer

Ceregene Begins Phase I Clinical Trial of Novel Gene Therapy Product For Patients With Alzheimer’s Disease

Gene Therapy For Cystic Fibrosis

Cystic Fibrosis Stem Cells Made
The first human stem cell line with the mutation for cystic fibrosis (CF) has been developed by UK researchers.

Sperm And Eggs From Embryonic Stem Cells?

Study Identifies Possible Stem Cells In Pancreas – Diabetes Therapy

Cell Transplants For Type 1 Diabetes
Almost 60% of Patients Skipped Insulin Injections for 1 Year After Transplant

Bone Marrow Cells Routinely Help With Wound Healing


Bone Marrow Stem Cells May Be Used to Treat Child In The Womb

Stem Cells ‘Arrest Brain Damage’

Newborn babies with brain damage could be treated by stem cell therapy using cells taken from their bone marrow.


Contribution Of Bone Marrow-Derived Cells To Skin: Collagen Deposition And Wound Repair

Treated Allogeneic Stem Cell Transplants Rebuild Liver In Mice
Liver progenitor cells removed from mice, treated with a healthy human gene and returned to the mice, begin to rebuild the liver with cells that express the human gene

Amifostine Stimulates The Formation Of Hematopoietic Bone Marrow Progenitors From B-Cell Chronic Lymphocytic Leukemia

Uptake Of Magnetic Beads by Dendritic Cells, A Major Obstacle for the Use of Beads in Biological Assays

High-dose Chemotherapy With Autologous Stem Cell Transplantation In Patients With Oligometastatic Breast Cancer

Clinical Outcomes Of Patients With Impaired Left Ventricular Ejection Fraction Undergoing Autologous Bone Marrow Transplantation: Can We Safely Transplant Patients With Impaired Ejection Fraction?

Transmission Of Donor Illness By Stem Cell Transplantation: Should Screening Be Different In Older Donors?

Antileukemic And Long-term Effects Of Two Regimens With Or Without TBI In Allogeneic Bone Marrow Transplantation For Childhood Acute Lymphoblastic Leukemia

The PLETHORA Genes Mediate Patterning Of The Arabidopsis Root Stem Cell Niche

Human Umbilical Cord Blood Cells Successfully Treat Strokes In Rats


A Proposal To Spend $3 Billion In California State Funds On Stem-cell Research Is Likely To Attract Scientists And Create Jobs

California Voters Asked To Defy Stem Cell Limits

Cord Blood Registry Expands By Three Banks
The National Marrow Donor Program (NMDP) has added three new cord blood member banks, increasing the number of units on its public cord blood registry by more than 20 percent.

Panel Encapsulates State Of Stem Cell Debate

New EU Research Chief Open To Stem Cell Research
The harvesting of stem cells from human embryos will continue to be funded by the EU, the incoming European Union research chief said Friday, vowing to keep an open mind while taking ethical views into account.

First Czech Stem-cell Research Bill On Tap: Proposal Would Create Set Of Guidelines For Embryo Studies

France Authorizes Human Stem Cell Research

India Establishes Stem Cell Research Center
The All India Institute of Medical Sciences in New Delhi, India, is setting up a stem cell research center. The facility is designed to help scientists advance basic and applied research in stem cell technologies, as relevant to India’s health needs.

Summary Of Submissions – Review Of The Regulation Of Human Tissue And Tissue-based Therapies (New Zealand)

Spain To Allow Embryonic Stem Cell Research

Swiss Government Urges Support For Stem-cell Research

UW Stem Cell Guru Outlines Scientific And Political Future
James Thomson, first to cultivate cells from human embryos, dismisses ‘hype’.


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 order information 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 order information 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.

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

Chromos and Ex Vivo Technologies Enter Agreement For Use of Ace System In Adult-Derived Stem Cell Research

Geron Wins Stem Cell Technology Patent, Shares Up
Geron Corp.said on Tuesday it was granted a patent on a type of human embryonic stem cell growth technology, sending shares of the biotechnology company up 10 percent.

In TV Ads, Biotech Legends Go To Bat For Stem-cell Research

Biotech Leader To Open Facility In California
Advanced Cell Technology Inc., the Bay State biotech pioneer that was first to clone a human embryo, plans to move work to California, scientific director Dr. Robert Lanza said.

Three Companies Are Looking At Wisconsin To Possibly Open Labs To Study Stem Cells

Dolly The Sheep Creator Applies For License To Conduct Human Research Cloning, UK

Patent Application Filed For Human Pancreatic Beta Islets Development Method
Vitro Diagnostics Inc., in Aurora, Colo., has filed a patent application with the United States Patent and Trademark Office to cover its method for growing and differentiating human pancreatic beta islets.

Cytovax And Millenium Announce Definitive Merger Agreement

AnorMED To Advance AMD3100 To Phase III Program For Stem Cell Transplant In Cancer Patients

Cleveland Stem Cell Investigators Awarded $3.1 Million
The Center for Stem Cell and Regenerative Medicine in Cleveland has received two grants totaling $3.1 million from the National Institute on Aging to study the role of stem cells in aging.



NIH Guide For Grants And Contracts – Week Of October 08, 2004

Centers of Excellence In Translational Human Stem Cell Research

Application Receipt Date(s): March 24, 2005


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

Licensed Products And Establishments List – Update

Approved Biologics NDA And ANDA Applications – Update

Cleared Biologics 510(k) Device Applications – Update

Approved Biologics Premarket Approval (PMA) Device Applications

Regulatory Site Visit Training Program
The Food and Drug Administration’s (FDA’s) Center for
Biologics Evaluation and Research (CBER) is announcing the initiation
of a Regulatory Site Visit Training Program. This program is intended
to give CBER’s regulatory review staff, compliance staff, and other
relevant staff an opportunity to visit biologics facilities. The visit
is intended to provide first hand experience to CBER staff and to give
a better understanding of the biologics industry, including its
challenges and its operations. The purpose of this notice is to invite
biologics companies interested in participating in this program to
contact CBER for more information.

Guidance For Industry: Sterile Drug Products Produced By Aseptic Processing -Current Good Manufacturing Practice

Draft Guidance For Industry: Quality Systems Approach to Pharmaceutical- Current Good Manufacturing Practice Regulations

Draft Guidance For Industry And FDA: Current Good Manufacturing Practice For Combination Products

Draft Guidance for Industry: Computerized Systems Used in Clinical Trials

Biological Product Deviation Reporting – Product Deviation Codes (Update)


Proposed Tissue Storage And Issuance Standards-Applies To Bone Marrow, Stem Cells, Cord Blood and Other Products

Summary: Navigating FDA Regulations For Human Cells and Tissues


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

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


Malachite’s Online Cell Therapy Conference Calendar

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

Other Online Conference 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. 18-19 4th Annual Stem Cell & Regenerative Medicine Conference, Princeton, USA

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

Oct. 21-25. International Cytokine Society (ICS) and International Society for Interferon and Cytokine Research (ISICR) “Cytokines in Cancer and Immunity“. San Juan, Puerto Rico.

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

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

Nov. 4-6 2004 BioStar Congress in Stuttgart, Germany

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

Nov. 10-12, 2004 2nd Annual International Clinical Trials Summit, Westin Grand Hotel, Washington, DC
The 2nd Annual ICT Summit is the place for international executives involved in global clinical trials.

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 – 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. 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.

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


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.

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.


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

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.

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