Volume 5.00 | Jan 30

Cell Therapy News 5.0, January 30, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Cell Therapy 2004 Announces Record Abstract Numbers

Story: FDA Mtg – Cellular Therapies For Cardiovascular Disease: Trial Design


Drug Prevents Diabetes Recurrence after Islet Cell Transplanation
A new anti-inflammatory compound called Lisofylline (LSF) has been shown to prevent diabetes from recurring after insulin-manufacturing islet cells are transplanted into diabetic mice, according to a new study. Pancreatic islet cell transplantation has become a promising treatment for Type 1 diabetes; however, without several powerful immunosuppressive drugs, the bodys immune system would destroy the engrafted islet cells in transplant patients resulting in the return of diabetes. According to researchers, LSF has the potential to help prevent this cellular destruction. In the three-week study, diabetic mice were given islet transplants in the kidney and then daily injections of either LSF or saline. Results of blood glucose tests showed that the LSF-treated mice maintained healthy glucose levels, without immunosuppressants and insulin, for more than 65 days, whereas mice treated with saline maintained healthy glucose levels for only six days.

Survey of release criteria for cellular products
Link [doc]  Link [PDF]

Hope for new source of stem cells
Scientists have found a way to turn adult cells back into immature cells with the potential to become many different types of tissue.

One Dose Of Designer Gene Therapy May Target Specific Body Area

Stem Cell Breakthrough: Cited as Yet Another Reason Human Embryo Source Unnecessary
Scripps Research Institute in La Jolla, California, announced an alternative to embryonic stem cells. The company research team discovered a synthetic substance known as reversine that is able to trigger human adult cells to revert back to more primitive, undifferentiated stem cell-like cells. Scripps stem cells were created from adult muscle cells.

Gene therapies get safety boost.
Scottish scientists believe they have found a way to target gene therapy more precisely – avoiding the need for potentially harmful higher doses.

Designer Virus Delivers Long-lasting Gene Therapy

Modified Gene Therapy Better for Heart

Cells Are Resourceful When It Comes To Copying DNA, Even When The DNA Is Damaged

Hematopoiesis Promoter Database, an information resource of transcriptional regulation in blood cell development

November 23 Issue of Semin. Liver Dis. is dedicated to reviews on hepatic stem cells

Shifting foci of hematopoiesis during reconstitution from single stem cells

New clues in bubble boy gene therapy: Study finds rare gene combo behind leukemia development

Japanese university produces first human embryo stem cells for domestic research

Cell Transplantation, 2003, vol. 12, no. 8
Neural Precursor Cells as Carriers for a Gene Therapeutical Approach in Tumor Therapy – Link

Expression of Neuronal Markers in Differentiated Marrow Stromal Cells and CD133+ Stem-Like Cells – Link

Improved Efficacy of Stem Cell Labeling for Magnetic Resonance Imaging Studies by the Use of Cationic Liposomes – Link

The Bag Method for Islet Cell Infusion – Link

Generex Reports on Novel Mechanism for Immunotherapy Cure of Prostate

U.S. human clone experiment repeated successfully

Unrelated cord blood transplantation for childhood acute myeloid leukemia: a Eurocord Group analysis

Researchers Get Stem Cells to Form Blood Vessels

Single Antibiotic Dose Best for Kids with Stem Cell Transplants



U.S. Legislation to Create a National Cord Blood Stem Cell Bank Program Passed by Congress
Clinical Data Provided by ThermoGenesis Scientific Advisory Board Members Persuasive to Legislators

Ireland to avoid stem cell debate during EU term

Multiple sclerosis patient hopes stem-cell bill can aid him

US – Funding key in stem cell research fight

US – Dean Blasts Bush for Stem-Cell Decision

UK – Doctors claim to have cloned embryo met with revulsion

UK – Experts demand cowboy cloners ban
Maverick scientists attempting to clone humans should be outlawed across the world, a leading expert has said.

United States – The Presidents Council on Bioethics
   January 15: Session 1: Stem Cells: Councils Report to the President – Link

   January 15: Session 2: Biotechnology and Public Policy – Link

   January 15: Session 3: Neuroscience, Neuropsychiatry, and Neuroethics:  An Overview – Link

   January 15: Session 4: Neuroscience and Neuroethics: Reward and Decision – Link

   January 16: Session 5: Toward a “Richer Bioethics”: Councils Report to the President – Link

   January 16: Session 6: Discussion of the Councils Future Work – Link

   January 16: Session 7: Public Comments – Link

Bioethics journal wins award, praise

EU – European Parliament Backs New Human Tissue Law

EU – Safety of human tissues and cells: David Byrne welcomes adoption of directive

Germany – Listening to normal people: German project asks real folks what they think about stem cell research

Japan – Homegrown embryonic stem cells in offing: Hurdles ahead but scientists see medical, property rights benefits

Australia – Scientists prepare for stem cell experiments under eye of cloning police

Australia – Embryo research go-ahead in weeks


Drug and Market Development Publications (D&MD) predicts that the cell therapy market will near $30 billion by 2010.  D&MD has recently published a Market Analysis Report called Cell Therapy: Technology, Markets & Opportunities.  This Report describes the strategies and technologies corporations are employing to capture their share of this growing market.  In addition, the Report answers many important questions, including what diseases will significantly benefit from current and future research, how regulatory and ethical hurdles will come into play, and which corporations are poised to win.  For more information, including a FREE copy of the complete Table of Contents and Executive Summary, and sample Report excerpts, send an email to [email protected] or for more information online click here.

                                   Business News

StemCell Technologies launches new website

CellGenix Obtains Active Masterfile for IL-4

Amgen Cell Therapy Investment – ViaCell abandons plan for IPO
Shortly after securing a $20 million investment from Amgen, ViaCell announced that it was dropping plans to go public. The biotech firm cited a “downturn” in market conditions for its sudden reversal on the last day of 2003. In the last two years ViaCell has lost more than $37 million, and the company doesn’t expect to make money for some years to come. Its lead drug candidate is CB001, an umbilical cord blood stem cell product used to replace bone marrow.
story    story 

Former Chief of FDA Cell Therapy Branch Joings Biologics Consulting Group
Darin Weber, Ph.D. will be joining the Biologics Consulting Group, LLC (BCG) on February 1, 2004.
press release

NewNeural LLC Adds Leading Cell Therapy Executive to Management Team
NewNeural, an emerging biotechnology company that is developing products to treat diseases of and injuries to the central nervous system, today announced that Madhusudan V. Peshwa, Ph.D., has joined the company as executive vice president, research and development. Peshwa will lead the continued development of the companys portfolio of neural regenerative technologies.
press release

Xcyte Therapies & Fresenius Biotech GmbH Enter HIV Gene Therapy Collaboration

Athersys Provides Technology to Johnson & Johnson
Athersys announced that it has entered into an agreement with Johnson & Johnson and its subsidiary, 3-Dimensional Pharmaceuticals (J&J), to provide cell lines expressing drug targets for use in certain pharmaceutical development programs. The agreement provides J&J researchers with non-exclusive access to engineered cell lines that express targets for drug discovery in a variety of therapeutic areas.
press release

Invitrogen Enters into Definitive Agreement to Acquire BioReliance Corporation

HemoCue Donor Hb Checker Control Granted Substantially Equivalent Status

Mississippi Blood Services WebLab Online Laboratory System 2.0  Granted Substantially Equivalent Status

Stemco Biomedicals Aldecount Progenitor Cell Enumeration Kit Granted Substantially Equivalent Status

Dendreon Releases Provenge Trial Tesults
Shares of Seattle-based Dendreon surged 28 percent (up $2.57) after the company released encouraging results from human trials of its experimental cancer drug Provenge. Dendreon’s Phase III trial of Provenge showed that patients suffering from late-stage prostate cancer gained a median 8.4 months of added longevity when taking the drug. “This is the longest survival benefit ever reported in a Phase III study in late stage prostate cancer,” said Dr. John M. Corman Director of the Virginia Mason Comprehensive Prostate Cancer Clinic and Assistant Clinical Professor of Urology at the University of Washington in Seattle. Patients taking Provenge with a Gleason Score of seven or less had a “significant survival advantage.” The average patient had an 89 percent increase in survival time compared to a placebo. The median survival time for patients taking Provenge was 30.7 months compared to 22.3 months with a placebo. At 30 months from randomization, patients treated with Provenge had a survival rate 3.7 times greater than a placebo.

Enzon, Inex partner on new oncology drug
Enzon Pharmaceuticals and Inex Pharmaceuticals are partnering to develop one of Inexs oncology products. In exchange for an up-front payment of $12 million and another $20 million upon FDA approval, Enzon will get the North American commercialization rights to Onco TCS. Additional milestone payments and bonuses could top $43 million. Inex is seeking a new drug application to use Onco TCS for relapsed aggressive non-Hodgkins lymphoma.

Edwards Lifesciences (EW) Concludes Arbitration With Baxter International, Inc. (BAX) Related To Spin-Off


CordLife Secures US Department of Defence Contract – US$1.7 million contract for stem cell technology 
NIH awards $11.6M for immune system research
The National Institutes of Health has awarded Corixa Corporation $11.6 million to develop synthetic molecules that activate the immune system to ward off infections. The company says that its early studies show that its molecules stimulate receptors to help ward off infectious agents, particularly those transmitted by inhalation. Corixa is focusing on a toll-like receptor known as TLR4 and an experimental nasal spray that has demonstrated effectiveness in preventing the influenza virus in mice.

CuraGen Publishes Novel Method for Prioritizing Important Genes for Drug Development from Genomics, Proteomics, and Genetic Data in Nature Biotechnology

CryoLife Announces $20 Million Private Placement of Common Stock
CryoLife, Inc. a human tissue processing and bio-surgical device company, announced today that it has sold 3,444,000 shares of common stock at $6.25 per share in a private placement. The net proceeds, estimated to be approximately $20 million after fees and expenses, will be used for general corporate purposes.


Cryolife Registry Demonstrates Positive Adult and Pediatric Long-Term Outcomes Following Heart Valve Implantation
Comprehensive Allograft Heart Valve Registry Tracks More Than 2,600 Patients for 10 Years Following Implantation

Lifebank Announces Strategic Relationship with One of the Largest Obstetrical Groups in Ottawa
press release

ThermoGenesis Complete FDA Master File For the BioArchive System
ThermoGenesis Corp. announced today that it has completed a Master File on the BioArchive System which has been submitted to the FDA. The Master File summarizes pertinent information on the construction and operation of the BioArchive System, internal test reports on the performance of the controlled-rate freezing of cord blood stem cells, clinical outcome data for patients who have received transplants of cord blood stem cells cryopreserved and archived in the BioArchive System, and publications that relate to the performance of the BioArchive System.
press release


NIH Guide for Grants and Contracts – Week Of January 23, 2004 – Link

NIH Guide for Grants and Contracts – Week Of January 30, 2004 – Link

National Center for Research Resources
APPLICATION RECEIPT DATE:  June 18, 2004 and October 15, 2004

(NOT-RR-04-003). National Center for Research Resources

NIH revises conflict rules
Congress will review allegations of financial wrongdoing

(NOT-AG-04-002). National Institute on Aging

(NOT-OD-04-020)National Institutes of Health


All new CBER information can be reached from the Whats New page here.

FDA Statement – Broader Requirements for Tissue Bank Registration and Listing Become Effective
Posted: 1/22/2004, Issue Date: 1/21/2004

Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Opportunity for Public Comment
Posted: 1/23/2004

Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revision 1)

Antibody to HBsAg ELISA Test System 3 (Ortho-Clinical DiagnosticsInc) – Increased reactive rate and false repeat reactive rate

Advisory Committee Meetings 2004 Tentative Schedule

Warning Letter – Eldon Biologicals A/S – CGMP Requirements of the Quality System Regulations/Adulterated

Draft Guidance for Industry: Drug Substance – Chemistry, Manufacturing, and Controls Information

2003 Biological Product Approvals – Update
Posted: 1/12/2004, Updated through: 12/31/2003


Cellular Therapies For Cardiovascular Disease: Trial Design To Be Discussed March 18-19
FDA’s Biological Response Modifiers Advisory Committee will meet March 18-19 to discuss the design of early phase clinical trials of cellular therapies for treatment of cardiac diseases. Link

To watch a live or archived webcast of this meeting, click here. To arrange for live videoconferencing or to order videotapes & CDs, email [email protected] or call 800-332-1370 ext. 7210.

The FDA has asked drug manufacturers if mandated reporting requirements for manufacturing changes for already approved drugs and biologics are appropriate and not overly burdensome.  The agency is seeking comments on the information provided by manufacturers whenever major or minor manufacturing changes are made for approved brand or generic drugs. Comments are due by Feb. 17. The requirements are detailed in a 1999 guidance, which requires major manufacturing changes to an already approved drug to be submitted and approved by the FDA.
To see the Federal Register notice, click here. Comments may be filed electronically here.   To see the existing policy in “Guidance for Industry – Changes to an Approved New Drug Application or Abbreviated New Drug Application,” issued November 1999, click here


2003-4 Cell Therapy Audioconference Series

CME Web Conference Series: Factors to Consider for Optimizing Outcomes with IGIV Therapy
This 1-hour conference is designed for healthcare professionals who provide IGIV therapy. To give you a broader perspective on critical issues that impact outcomes, each conference is conducted in tandem by a pharmacist and a physician. The Web-conferencing format is a convenient way for you to earn CME credit from your home, office, or wherever you have access to a phone line and a Web browser.
Sessions are scheduled on a variety of days and times:
     Wednesday, January 28, 2004, at 5:00 PM EST
     Tuesday, February 3, 2004, at 12:00 PM EST
     Wednesday, February 11, 2004, at 5:00 PM EST
The deadline for registration is 48 hours before the program you wish to attend.  Please register for the time and date that is best for you by calling 1-800-374-1961. More information can be found at Link

Smart Biomaterials for Tissue Engineering and Regeneration
Registrations are limited to ensure interactive participation so register today at Link

    Wednesday, February 4, 2004
   Time:  Noon – 1:30 p.m.  E.S.T.
Smart Biomaterials for Tissue Engineering and Regeneration, an online real-time presentation, will focus on cells and biologically active macromolecules that are increasingly being used as novel therapeutics in diseases for which there are either no or inadequate current therapies.  The seminar will cover the development of appropriate delivery vehicles that can provide these cells and macromolecules at the desired time/place, and that can guide the function of the cells in the body that ultimately recreate the desired tissue structure and function. 
This 90-minute virtual seminar will address:
    – Advantages of material-based delivery systems for cells and inductive molecules
    – Approaches to regulate the survival and function of transplanted cells by delivery vehicle design
    – Representative polymeric delivery systems
    – Application of these concepts to bone regeneration and therapeutic angiogenesis.

Feb 13-17 Tandem BMT Meetings (IBMTR/ASBMT) – Orlando, FL
May 7-10 Cell Therapy 2004: ISCTs 10th Annual Mtg – Dublin, Ireland.
June 2-6 Amer. Society for Gene Therapy Annual Meeting – Minneapolis, MN
June 10-13 International Society for Stem Cell Research 2nd Annual Meeting. Boston
June 6-9 BIO Annual Meeting. SanFrancisco, CA
June 17-19 Strategies in Tissue Engineering. Würzburg, Germany
July 18-23 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting & 12th International Congress of Immunology (ICI 2004). Montreal, Canada.
September 5-9 13th International Conference of the International Society of Differentiation.  Honolulu
October 1-3 4th Annual Somatic Cell Therapy Symposium. Houston,Texas
October 3-7 Cell & Tissue BioProcessing Conference.  Houston, Texas
October 13 – 16 13th International Conference of the European Association of Tissue Banks. Prague, Czech Republic
October 23-26 Amer. Assoc. of Blood Banks Annual Meeting – Baltimore, Maryland
November 4-7 European Society for Gene Therapy Annual Meeting. Tampere, Finland
December 3-7  Amer. Society for Hematology: 46h Annual Mtg – San Diego, California

April 13-22 – Childrens Hospital of Orange County Research Institute Human Embryonic Stem Cell Culture Training Course (10-day course). Burnham Institute, La Jolla, CA

Fall/Winter 2004 7 or 21-day short-term Course in Human Embryonic Stem Cell Culture – Technion-Israel Institute of Technology Technion City, Haifa, and in the United States

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

1.Managing Clinical Trials: Getting Closer to Investigators and Patients
2.Enhancing Clinical Development Efficiencies
3.Electronic Records Management


Cell Therapy Journal Offers Limited Time Free Access

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.

Access Cytotherapy for Free:
1.  Click here
2.  Enter Username: celltherapy  Password: freeaccess


Journal of Liposome Research

Acta Haematologica

Biology of Blood & Marrow Transplantation
Bone Marrow Transplantation
Cell & Tissue Research
Cells Tissues Organs
Cell Transplantation
Cloning & Stem Cells
Cytokines, Cellular & Molecular Therapy
Experimental Hematology
Journal of Hematotherapy & Stem Cell Research

BioProcess International
Bioscience Technology
Genetic Engineering News


MD Anderson Cancer Center
Cell Therapy Laboratory Positions

ES Cell International
Research Scientist/Biologists – three cell and molecular biologists with at least 2-3 years post-doctoral experience in relevant fields and proven abilities to work in a team environment.

StemCell Technologies
Product Manager (Immunology)


International Society for Cellular Therapy – http://www.celltherapy.org
Upcoming meetings include:

~10th Annual Conference for International Society for Cellular Therapy, May 7-10, 2004, Dublin, Ireland (Republic)

~ 4th Annual Somatic Cell Therapy Symposium (to be held in conjunction with the WilBio Cell & Tissue BioProcessing Conference).  October 1-3, 2004.  Houston, Texas.

2003-4 Cell Therapy Audioconference Series – link

Webcast from 4th International Symposium on Miminal Residual Cancer. Oslo, Norway.  13-16 November 2003 – Link

Nonhematopoietic & Mesenchymal Stem Cells Conference 2003 abstracts online – Link

Profiled Journal

Two ways to enjoy Cytotherapy in 2004:
Join ISCT ($130) and receive the journal as a benefit of membership –  Link

2. Subscribe to the 2004 volume and receive a 25% discount and FREE online access! As a special introductory offer Taylor & Francis are offering the journal Cytotherapy at the special personal rate of US$248*. (Normal 2004 rate: US$330) *Special rate applies only to new personal subscribers. Offer ends 29th February 2004. For further information and to subscribe, click here.

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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