Volume 8.04 | Feb 5

Volume 8.04, February 5, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Create Heart Muscle With Built-In Blood Supply: Researchers at the Technion-Israel Institute of Technology have created new heart muscle with its own blood supply using human embryonic stem cells.
Article

LCT to Start Clinical Trial of Type 1 Diabetes Treatment: Living Cell Technologies Ltd has announced its DiabeCell(R) Type 1 diabetes treatment has been approved for a Phase I/IIA clinical trial in Russia designed according to FDA guidelines.
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Science

Researchers Find Pancreatic Cancer Stem Cells
Researchers have discovered a small population of stem cells in pancreatic cancer that appear to drive tumor growth, opening the door for a potential new approach for treating this particularly deadly disease.
Article

Critical Stem Cell Survival Factors Found
As researchers attempt to take advantage of the potential of adult stem cells in regenerative medicine, understanding the mechanisms that delimit lifespan and longevity of stem cells will be critically important. Researchers have now identified a family of proteins that contributes to the survival and regenerative potential of blood-forming stem cells.
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Master at Regeneration: Learning Why the Liver Thrives
Researchers have now found one clue that may tell them why the liver is a master of regeneration.
Article

Study Finds Genes that Predict Transplant Rejection
Canadian researchers believe they have come up with a way to predict whether transplants from specific bone marrow donors are likely to trigger rejection – an advance that could help doctors weed out so-called "dangerous donors” and cut back on immune suppressant drugs for some transplant recipients.
Article

Pluristem Announces Evidence That PLX-I Cells Are Immune Privileged
Being immune privileged, the PLX-1 cells carry significant positive implications in the development of Company products for a variety of degenerative, malignant and immune diseases.
Article

Gene Therapy Tackles Severe Burns
Severe burns are not only painful, they also put patients at risk of serious infection. Now researchers are using gene therapy to rev up the wound healing process in skin cells, hoping to fight potentially lethal infections.
Article

Gene Therapy for AIDS
Specialists of the V.A. Engelgardt Institute of Molecular Biology, Russian Academy of Sciences, and the "Vector" Main Research Center of Virology and Biotechnology created and tested three genetic structures capable of suppressing reproduction of human immunodeficiency virus (HIV-1) in human cells.
Article

Scientists Develop Gene-Activating Technique
U.S. scientists have developed a new laboratory technique that uses ribonucleic acid (RNA), a tiny chemical cousin of DNA, to switch on genes. This approach may help in the development of treatments for diseases in which prompting genes into activity could benefit patients.
Article

B-Cell Chronic Lymphocytic Leukemia Clinical Trial Initiated with Argos Therapeutics’ AGS-005 Personalized Immunotherapy
Argos Therapeutics today announced that dosing has been initiated in a Phase 1/2 clinical trial to test the activity and safety of AGS-005 in B-cell chronic lymphocytic leukemia (CLL).
Article

MultiGene Vascular Systems Begins Clinical Trials of Blood Vessel Therapy
MultiGene Vascular Systems Ltd. has begun Phase I human clinical trials of its MultiGeneGraf cell therapy for growing blood vessels.
Article

Introgen’s INGN 225 Molecular Cancer Vaccine Demonstrates Promising Results in Phase 2 Trial
Approximately half of patients with advanced small cell lung cancer responded to Introgen Therapeutics, Inc.’s INGN 225 molecular cancer vaccine in combination with subsequent chemotherapy.
Article

Opexa Achieves Midpoint in Patient Admissions in Phase IIb Trial of Tovaxin(TM) for Multiple Sclerosis
Opexa Therapeutics, Inc.has announced that it has admitted the first 75 patients in its 150-patient Phase IIb clinical trial of Tovaxin™ in multiple sclerosis. Enrollment is expected to be completed by mid-2007. There are currently 34 trial sites in the U.S., all of which are actively recruiting patients.
Article

Aastrom Receives Orphan Drug Designation from FDA for Dilated Cardiomyopathy
Aastrom Biosciences, Inc., a company focused on the use of autologous cells for regenerative medicine, has announced that the Company’s proprietary Tissue Repair Cells (TRCs) received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for use in the treatment of dilated cardiomyopathy (DCM), a severe chronic disease of the heart.
Article

Stem Cells The Key Element For Future Transplantology
To achieve successful results of transplantation and treatment of such significant diseases as Parkinson’s disease, Alzheimer’s disease, leukemia, diabetes, stroke, muscular dystrophy, hepatic and renal failure etc., optimum methods have to be developed to obtain stem cells and their cultivation. Such a problem is successfully solved by scientists from Kazakhstan.
Article

Stem Cell Refugees
In the U.S., doctors have only injected small groups of people with stem cells from fetuses or cord blood as part of clinical trials. Chinese doctors insist the concerns are overblown.
Article

ABSTRACT, REVIEWS AND SPECIAL REPORTS

Identification of Pancreatic Cancer Stem Cells
Using a xenograft model in which primary human pancreatic adenocarcinomas were grown in immunocompromised mice, the researchers identified a highly tumorigenic subpopulation of pancreatic cancer cells expressing the cell surface markers CD44, CD24, and epithelial-specific antigen (ESA).
Article

Policy

Scientists Craft Embryonic Stem Cell Ethics Rules
New international guidelines on human embryonic stem cell research called for close scrutiny of scientists and clear consent from people donating cells, but did not settle the issue of paying women who donate eggs.
Article

Members of the European Parliament Drop Ethical Debate in Gene Therapy Vote
Amendments regarding human-animal hybrids and other ethical considerations will be put directly to plenary vote after Parliament’s Environment Committee decided to leave the issue to member states.
Article

DeGette Vows to Find A Way to Get Stem Cell Bill Past Bush Veto
Colorado Democratic Rep. Diana DeGette vowed today to find a way to get the embryonic stem-cell research bill past another veto by President Bush, even if Democrats have to attach it to must-pass legislation.
Article

Senator Coleman Introduces Legislation To Fund Stem Cell Research Using Altered Nuclear Transfer, Embryos That Have ‘Died Naturally’
Senator Norm Coleman (R-Minn.) has introduced a bill that would provide $5 billion in federal funds over 10 years for human embryonic stem cell research using cells from embryos that have “died naturally” and research using altered nuclear transfer.
Article

Massachusetts Attorney General Wants to Rescind Restrictions on Stem Cell Research
Attorney General Martha Coakley said Tuesday that stem cell regulations enacted during the Romney administration are counteracting the intent of legislation passed one year earlier to encourage cutting-edge research in Massachusetts.
Article

Business

Umbilical Cord Blood Industry Matures
Cord blood banks, particularly private ones that allow parents to store it for family members, are a growing industry, hoping to take advantage of legislation to promote cord blood donations.
Article

BioE and M. D. Anderson Cancer Center Form Research Partnership to Evaluate Cord Blood Stem Cell’s Ability to Help Treat Cancer
BioE(R), Inc., a biomedical company that provides enabling, high-quality cellular tools for drug discovery and therapeutic research, and The University of Texas M. D. Anderson Cancer Center announced today a research partnership to evaluate the potential of BioE’s cord blood stem cell — the Multi-Lineage Progenitor Cell(TM) (MLPC(TM)) — to help treat cancer.
Article

Cobra Announces Manufacturing Agreement with Pharmexa
UK-based Cobra Biomanufacturing Plc has announced an agreement with Pharmexa for the manufacture of the protein vaccine PX107 for use in Phase I clinical trials for bone disorders. The program will include cell banking, process development and GMP manufacture.
Article

Stem Cell Firm Licenses Patents
ES Cell International (ESI), a regenerative medicine company, and ITI Life Sciences, which funds early-stage research in life sciences, said they have signed a non-exclusive research license agreement that would allow ITI to take stem cell research to clinics.
Article

Virgin’s Richard Branson to Launch Stem Cell Bank
British entrepreneur Richard Branson is to add a stem cell storage company to his sprawling Virgin empire, a brand that already covers everything from cola and lingerie to airlines and space tourism.
Article

Wisconsin Tries to Woo Another Stem Cell Company
Aruna Biomedical, a Georgia-based maker of neural stem cell kits for researchers, will relocate to Wisconsin if it can raise sufficient amounts of angel capital, a company executive confirmed.
Article

BTHC III, Inc. Changes Its Name and Stock Symbol to International Stem Cell Corporation
International Stem Cell Corporation announced that it has completed a share exchange with BTHC III, Inc.. Immediately preceding the consummation of the share exchange transaction, ISC closed a private placement of its capital stock whereby it received approximately $11.2 million in gross offering proceeds, before payment of commissions and fees.
Article

Next Stem Cell President Should Be Hands-On, Scientific Administrator and Avoid Temptation to Seek ‘Big-Name’ Scientists
California’s stem cell oversight committee should focus on finding a competent, hands-on administrator to replace retiring Dr. Zach Hall as president of the California Institute for Regenerative Medicine, said the Foundation for Taxpayer and Consumer Rights (FTCR).
Article

Institute Grants University of Texas Funds for Stem Cell Heart Research
The National Heart Lung and Blood Institute granted $17.9 million for the research of stem-cell treatments for cardiovascular disease to the UT School of Public Health Coordinated Center for Clinical Trials.
Article

NIH

NIH Leads Effort to Help Women in Science and Medicine Fulfill Potential
NIH Director Dr. Elias A. Zerhouni has created the Working Group on Women in Biomedical Careers to examine issues raised in the recent National Academies report, "Beyond Bias and Barriers, Fulfilling the Potential of Women in Academic Science and Engineering," and to respond to the challenges issued to government funding agencies to maximize the potential of women scientists and engineers.
Article

CBER

Donor Screening Tests for Testing HCT/P Donors – Updated
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Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
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Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container; Final Rule
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Approved Biological NDA and ANDA Applications – Update
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Cleared Biological 510(k) Device Applications – Update
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Approved Biological Premarket Approval (PMA) Device Applications – Update
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Clinical Hold / Refusal to File – 2007 Meeting Schedule
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Collaborative Scientific Training Program
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All new CBER information can be reached from the What’s New page at What’s New Page

Regulatory

FOOD AND DRUG ADMINISTRATION (United States of America)

Industry Exchange Workshop on FDA Clinical Trial Requirements
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Regulatory Site Visit Training Program
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 456h and 2567
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Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infectious Disease in Xenotransplantation
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Memorandum of Understanding Between the United States Food and Drug Administration and the Veterans Health Administration
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THERAPEUTIC GOODS ADMINISTRATION (Australia)

European Union Guidelines
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Payment Options
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Update to Definition of ‘British Pharmacopoeia’ Under the Therapeutic Goods Act 1989 – Adoption of British Pharmacopoeia 2007 (BP 2007) (Stakeholder Consultation)
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ISCT

The Boards of AABB, ASBMT, ASFA, EBMT, FACT, ICCBBA Inc, ISBT, ISCT, ISCT Europe, JACIE, NMDP and WMDA agreed to develop standards for the use of ISBT 128 for coding and labeling of CT products, and established an international advisory group to take forward the development and management of terminology and label design. The International Cellular Therapy Coding and Labeling Advisory Group has been working on this project since October 2005 and a workshop was held at the ISCT meeting in Berlin in 2006.
Two draft standards have been prepared covering the aspects of terminology and labeling, together with a guidance document on implementation. These documents are now available for public comment and we value your feedback.  They may be accessed by clicking here:  http://www.iccbba.org/ctcomments.html

The International Cellular Therapy Coding and Labeling Advisory Group would like to know your current labeling practice. Are you completely automated, completely manual or somewhere in between? Please complete the brief survey accessed at http://www.surveymonkey.com/s.asp?u=959303138614. The information gathered will be valuable as we move toward global standardization for labeling of cellular therapy products. Your participation is greatly appreciated. For more information about this project, please visit: http://www.iccbba.org/cellulartherapy_home.html

Call for Abstracts
On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the ISCT Website. 
Submission deadline: February 16, 2007
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ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.
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AABB-ISCT Cellular Therapy Audioconference Series
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Profiled Journal

Join ISCT and receive the journal as a benefit of membership.

Current Volume: Volume 8 Number 6 / December 2006

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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