Volume 6.42 | Oct 17

Volume 6.42, October 17, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Advanced Cell Technology to Announce Alternative Approach for Derivation of Embryonic Stem Cell Lines: Advanced Cell Technology, Inc. (OTCB:ACTC) reported today the generation of embryonic stem cell lines using an alternative approach that does not interfere with the developmental potential of embryos.
Article

University Of Minnesota Researchers Use Human Embryonic Stem Cells To Kill Cancer Cells: For the first time, stem cell researchers at the University of Minnesota have coaxed human embryonic stem cells to create cancer-killing cells in the laboratory, paving the way for future treatments for various types of cancers (or tumors). The research will be published in the Oct. 15 issue of the Journal of Immunology.
Article

Science

Stem Cell Heart Cure to Be Tested
Doctors have launched a trial to test whether heart disease can be treated using a patient’s own stem cells.
Article

Stem Cells to Be Supplied to Thai Hospitals
Chief of the Medical Sciences Department Paijit Warachit said yesterday that stem cells developed by Mahidol University and the National Research Council of Thailand will be channelled via the department to hospitals where they are needed.
Article

Amniotic Stem Cells Fix Defective Windpipes
Using cells from amniotic fluid, researchers at Children’s Hospital Boston were able to reconstruct defective tracheas (windpipes) in fetal lambs.
Article

Japanese Researchers Develop Technology to Reproduce Cord Blood Stem Cells
A health ministry team has developed technology to safely and effectively reproduce stem cells from umbilical cord blood, sources close to the matter said Saturday.
Article

Embryonic Cells, No Embryo Needed: Hunting for Ways Out of an Impasse
If there were no controversy over human embryonic stem cells, Dr. Rudolf Jaenisch of M.I.T. and Dr. George Daley of Harvard Medical School would probably never have started some unusual, and difficult, experiments.
Article

Adding Precision to Gene Therapy
Researchers developed a technique for inserting genes into specific sites on the genome in liver cells.
Article

Immune Therapy Could Treat Leukemias, Autoimmune Diseases, Transplant Rejection
In studies with mice, treatment with a new monoclonal antibody that targets immune system B cells has shown considerable promise for treating leukemias, autoimmune diseases and transplant rejection, according to immunologists at Duke University Medical Center.
Article

Researchers Seeking Alternative to Surgery for Brain Cancers
Kranz’s team will use a bioengineering method called yeast display- created by Kranz and former U. of I. chemical engineer K. Dane Wittrup- to remove and rebuild T-cell receptors for strong binding to tumor cells. Reintroduction into the body would alter T cells so they would bind only to a tumor and destroy it.
Article

Surgeons Perform Germany’s First Crossover Kidney Transplantation
In a crossover transplantation a healthy person in one couple donates his or her kidney to the ill person in another couple, in exchange for a kidney from the recipient’s healthy spouse.
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

Embryonic and Extraembryonic Stem Cell Lines Derived from Single Mouse Blastomeres
Here we report an alternative method of establishing ES cell lines-using a technique of single-cell embryo biopsy similar to that used in pre-implantation genetic diagnosis of genetic defects- that does not interfere with the development potential of embryos.
Article

A Model-Based Hematopoietic Stem Cell Tracker
As an important application of image cytometry, this paper presents a probabilistic model based cell tracking method to locate and associate HSCs in phase contrast microscopic images.
Abstract

Adult and Cord Blood T Cells Can Acquire HA-1 Specificity Through HA-1 T-cell Receptor Gene Transfer
The HA-1 TCR alpha beta transduced T cells show that the HA-1 TCR can be functionally transferred into donor mononuclear cells, which can be exploited in immunotherapeutic settings of SCT and CBT for hematologic malignancies.
Abstract

Increasing Donor Age Adversely Impacts Deneficial Effects of Bone Marrow But Not Smooth Muscle Myocardial Cell Therapy
In conclusion, donor age adversely impacts the efficacy of cellular therapy for myocardial regeneration and is cell-type dependent. SMCs from old donors retain their ability to improve cardiac function after implantation into ischemic myocardium.
Abstract

The Human Brain and Its Neural Stem Cells Postmortem: From Dead Brains to Live Therapy
This article will provide a brief overview about neural stem cells, their prominent features, and prospects for a cellular therapy, and will furthermore illuminate the cells in particular with respect to their newly discovered postmortem provenience, their advantage as a potential cell source, and several unfolding forensic considerations.
Abstract

Policy

California Institute for Regenerative Medicine: Research Institutions, Hospitals, Universities, Patient Advocacy Organizations File Amicus Brief in Support of CIRM and a Swift Resolution of Lawsuit
Today some of the most notable institutions and patient advocacy organizations from throughout the state and the country filed an amicus brief to support the California Institute for Regenerative Medicine’s motion advocating a quick dismissal of a lawsuit which is obstructing the agency from funding its research.
Article

Public Attitudes on Embryonic Stem Cell Research – Values in Conflict, New Survey Data, USA
The Genetics and Public Policy Center, supported by The Pew Charitable Trusts in partnership with the Phoebe R. Berman Bioethics Institute at Johns Hopkins University, surveyed 2,212 Americans from September 9-19, 2005 to probe respondents’ knowledge, awareness and attitudes toward embryonic stem cell research and their policy preferences for that research.
Article

Business

New Stem Cell Treatment Being Evaluated for Critically Ill Bone Marrow Transplant Patients; Osiris Launches a Phase II Clinical Trial for Severe Graft vs Host Disease
Osiris Therapeutics, Inc. announced today that it has received clearance from the United States Food and Drug Administration (FDA) to conduct a Phase II trial to evaluate the safety and effectiveness of its lead investigational stem cell drug, Prochymal, for the rescue of patients with the most severe form of acute graft vs. host disease (GVHD).
Article

Renal Cell Carcinoma, Trovax Phase II Results Encouraging
The data show that TroVax is safe and well tolerated in this patient group and that the product induces a strong anti-tumour immune response against the 5T4 tumour antigen.
Article

GE Healthcare and ThermoGenesis Announce Worldwide Distribution Agreement and R&D Collaboration
The companies will jointly present the AXP AutoXpress Platform, a closed and automated system for harvesting mononuclear cells (MNC) from cord blood, at the AABB Annual Meeting in Seattle, Washington on October 17th and 18th.
Article

Cryo-Cell Affiliate Awarded Grants for Cell Therapy Research: Saneron CCEL to Evaluate Cord Blood Cells for Cardiac Therapy
Cryo-Cell International, Inc. (OTC Bulletin Board: CCEL – News; the “Company”) announced today that its affiliate, Saneron CCEL Therapeutics, Inc. (“Saneron CCEL”), has been awarded two grants to study the effects of cord blood stem cells for the treatment of myocardial infarction, commonly known as heart attack.
Article

Targeted Genetics Initiates Next Clinical Trial of tgAAC94 in Inflammatory Arthritis
tgAAC94 utilizes Targeted Genetics’ Adeno-Associated Viral (AAV) vector technology to deliver a DNA sequence encoding an inhibitor of TNF-alpha, a potent proinflammatory cytokine that plays a major role in inflammatory arthritis.
Article

Inovio Study Results of Gene-Based Therapies for HIV and Vascular Disease Published in Scientific Journals; Articles Published in Collaboration with Boehringer Ingelheim and Chiron Corporation
Inovio Biomedical Corporation (AMEX:INO), a late stage developer of oncology and other therapies using electroporation to deliver drugs and nucleic acids, announced today that two articles presenting study results relating to gene-based therapies for HIV and vascular disease were published in peer-reviewed scientific journals in September 2005.
Article

Invitrogen Wins Appeals Court Decision against Stratagene; Stratagene’s Competent Cell Products Found to Infringe Invitrogen’s Patent
On appeal from a decision by the U.S. District Court for the Western District of Texas, the U.S. Court of Appeals for the Federal Circuit found that substantially all of the chemically competent cell products sold by Stratagene infringed Invitrogen’s patent. In the decision, the Court of Appeals remanded the case to the district court for further proceedings.
Article

VIRxSYS Completes $30 Million Financing
VIRxSYS Corporation, a privately held company developing genetic therapies for HIV and cancer, announced the final closing of their latest financing round.
Article

Cognate Therapeutics, Inc. Announces Appointment Of Brandon J. Price As Chief Executive Officer
Cognate Therapeutics, Inc. today announced the appointment of Brandon J. Price as Chief Executive Officer and member of the Board of Directors, effective September 12, 2005.
Article

BioE Appoints Vice President of Corporate Development; Dr. Sarah Haecker Brings Significant Bench-to-Business Life Sciences Experience and Strong Leadership, Management Skills to BioE
BioE(R), Inc., a biomedical company providing enabling non-embryonic, human stem cells, announced today it appointed Sarah Haecker, Ph.D. vice president of corporate development.
Article

Leading US Neuroscientist appointed Chief Scientific Officer of LCT BioPharma
LCT announced that Dwaine F. Emerich has been appointed Chief Scientific Officer of LCT BioPharma Inc.
Article

Innate Pharma Completes Its Management Team with the Recruitment of Dr. Patrick Squiban as Chief Medical Officer
Innate Pharma, a French biotechnology company focused on cancer immunotherapy through the manipulation of the innate immune system, announced today the appointment of Patrick Squiban M.D. as Chief Medical Officer.
Article

BioE Selected as a 2005 Tekne Award Finalist; Annual Award Program Honors Companies and Individuals Who Have Shown Superior Technology Innovation and Leadership in Minnesota
BioE(R), Inc., a biomedical company providing enabling non-embryonic, human stem cells, announced today the Minnesota High Tech Association (MHTA) and Minnesota Technology, Inc. (MTI), in partnership with Medical Alley/MNBio, selected it as a 2005 Tekne Award finalist in the emerging biotechnology company category.
Article

Iasis Software Releases Donor and Collections Management Module
Iasis Software this week released I-Collect, our comprehensive solution for managing the collections process and donor information.
Article

NIH

NIH/NHLBI-funded PACT Group Announces Session at AABB
The Production Assistance for Cellular Therapies (PACT) Group announces its participation in a session at the Annual AABB Meeting at Washington State Convention and Trade Center in Seattle, WA.
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NIH Launches Major Program to Transform Clinical and Translational Science
National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., today announced a new program designed to spur the transformation of clinical and translational research in the United States, so that new treatments can be developed more efficiently and delivered more quickly to patients.
Link

NIBIB Launches New Web Site
A completely redesigned and enhanced web site was launched today by the National Institute of Biomedical Imaging and Bioengineering (NIBIB).
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Amendments and Corrections to RFA-DA-06-009 “Development and Improvement of Inbred ES Cell Lines for Use in Generation of Mouse Mutants”
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Institutional Clinical and Translational Science Award (RFA-RM-06-002)
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Planning Grants for Institutional Clinical and Translational Science Awards (RFA-RM-06-001)
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CBER

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

Substantially Equivalent 510(k) Device – Pall Acrodose PL System, Platelet Pool and Store Set with eBDS – Medsep Corp
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Follow-on Biologics Workshop: Scientific Issues in Assessing the Similarity of Follow-on Protein Products
Workshop Date: 12/12-14/2005
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Biological Product Deviation Reporting – Product Deviation Codes – Update
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Recall of Human Tissue Products – LifeCell Corp
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Recall of Plasma Protein Fraction, Plasmanate
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Licensed Products and Establishments List – Update
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Approved Biological Premarket Approval (PMA) Device Applications – Update
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CBER Fast Track Designation Request Performance Report – Update
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Regulatory

Food & Drug Administration (USA)

Blood Products Advisory Committee; Notice of Meeting
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ISCT

2005 Cell Therapy Audioconference Series
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Profiled Journal

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Current Volume:
Volume 7, Number 4 / September 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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