Volume 9.36 | Sep 15

Cell Therapy News 9.36, September 15, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem Cell Regeneration Repairs Congenital Heart Defect: Mayo Clinic investigators have demonstrated that stem cells can be used to regenerate heart tissue to treat dilated cardiomyopathy, a congenital defect.


STEMCELL Technologies Webinar
High-Throughput Production of Size-Controlled, Reproducible Cellular Aggregates using AggreWell(TM)
September 18, 2008
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Scientists Find Gene Expression Profile Shared by Pluripotent Stem Cells
Using a collection of about 150 human cell samples, The Scripps Research Institute researchers created a database of global gene expression profiles that revealed all pluripotent stem cell lines showed remarkable similarity in the analysis, while other cell types were more diverse.

Worms Wiggle into Gene Therapy
Egg secretions from a worm that causes a deadly human disease may prove useful in gene therapy, according to research presented at the British Pharmaceutical Conference in Manchester.

DNA ‘Tattoos’ Link Adult, ‘Daughter’ Stem Cells Formed in Process that Guides Human, Animal Development
Using the molecular equivalent of a tattoo on DNA that adult stem cells pass to their “daughter” cells in combination with gene expression profiles, University of Utah researchers have identified two early steps in adult stem cell differentiations.

Researchers to Start Breeding Pigs for Human Organ Transplants
Scientists in London and California have begun experiments to create genetically modified organs to tackle the shortage of organs needed.

Gene Therapy Prevents Blindness in an Animal Model of Mitochondrial Dysfunction
Scientists at the Universite Pierre et Marie Curie Paris have created an animal model suitable for testing and validating gene therapies for treatment of a common mitochondrial dysfunction that causes loss of vision.

Human Embryonic Stem Cell Secretions Minimized Tissue Injury after Heart Attack
Using a novel method, researchers found that the administration of secretion from stem cells minimized heart injury by enhancing reperfusion therapy (angioplasty and cardiac bypass surgery) and reducing tissue death by another 60%.

Pluristem Successfully Concludes Final Pre-Clinical Safety Studies with PLX-PAD in Preparation for Human Trials
Pluristem Therapeutics Inc. announced recently the successful conclusion of its pre-clinical studies utilizing PLX-PAD, for the treatment of critical limb ischemia, prior to the initiation of human clinical trials. 

Bostwick Therapeutics Announces Initiation of Novel Phase I/II Personalized Medicine Immunotherapy Trial for Advanced Prostate Cancer
Bostwick Therapeutics announced recently that it has received clearance from the U.S. Food and Drug Administration and the Institutional Review Board of Community Memorial Hospital, Ventura, CA., to initiate the CRITICAL (CRyotherapy and IntraTumoral Immunotherapy with immature dendritic Cells (AutoLogous)) trial.

Safety Study Indicates Gene Therapy for Blindness Improves Vision
All three people who received gene therapy at the University of Florida to treat a rare, incurable form of blindness have regained some of their vision.

Cell Medica Announces Treatment of First Patient in Late Stage Clinical Trial of Adoptive Cell Therapy
Cell Medica has recently announced the treatment of the first patient in its CMV IMPACT clinical study, a late-stage randomized confirmatory trial aimed at demonstrating the clinical effectiveness of immunoprophylactic adoptive cellular therapy for the treatment of cytomegalovirus infections in immunosuppressed patients.

Argos Therapeutics Initiates Phase II Trial in Renal Cell Carcinoma for its Arcelis(TM) Personalized Immunotherapy Platform
Argos Therapeutics recently announced the initiation of a Phase IIa trial of its AGS-003 therapy, in combination with sunitinib, for the treatment of newly diagnosed advanced renal cell carcinoma.


Neuroprotective Effect of Transplanted Human Embryonic Stem Cell-Derived Neural Precursors in an Animal Model of Multiple Sclerosis
This paper describes that transplanted human embryonic stem cells-derived neural precursors significantly reduced the clinical signs of experimental autoimmune encephalomyelitis.

Disease-Specific Induced Pluripotent Stem Cells
In this paper, the researchers describe the generation of induced pluripotent stem cells from patients with a variety of genetic diseases with either Mendelian or complex inheritance.


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Guidelines for Embryonic Stem Cell Research Amended
The National Academies have updated their guidelines for the responsible conduct of research using human embryonic stem cells based on a review of scientific, ethical, and policy issues that have arisen since the guidelines were last updated in 2007.

Biden Faults Palin on Stem Cells
Senator Joe Biden brought a sensitive social issue to the fore of the presidential campaign recently, by suggesting that opposition to stem-cell research signals less dedication to people with disabilities.

Australian Stem Cell Centre’s Work to Go On
The reassurance comes after the centre’s board resigned en masse last week and revealed the organization – Australia’s only centre of excellence in the biotech sector – would not be financially viable by 2011.


STEMCELL Technologies Launches Direct Distribution to Germany & Austria
STEMCELL Technologies Inc. is pleased to announce the opening of a new sales office on September 1, 2008 in Koln, Germany, providing direct service to Germany and Austria.

International Stem Cell Corporation Announces a Manufacturing and Supply Agreement with Millipore Corporation 
International Stem Cell announced recently it has entered into a worldwide distribution agreement with Millipore Corporation to manufacture living cells and cell culture products to be sold through Millipore’s distribution network.

Advanced Cell Technology Announces Cost Reduction Program
Advanced Cell Technology announced recently that it is vacating its Charlestown facility and not renewing its lease on a California research center as part of a plan to trim some $5 million to $6 million from its annual operating budget.

Medical College of Wisconsin Receives Grant to Develop Stem Cells for Treatment of Heart Complications
The Medical College of Wisconsin has received a two-year, $416,625 grant from the National Heart, Lung, and Blood Institute to develop stem cell-based therapies to treat portions of the heart that have died from a heart attack.

Japan University Gets Patent for Stem Cell Breakthrough
Japan has given Kyoto University a patent for groundbreaking stem cell research in what is believed to be a world first for such scientific research.

Progenitor Cell Therapy Secures Industry Accreditation
Progenitor Cell Therapy, LLC announced recently that it has obtained AABB accreditation in the category of ‘Cord Blood Activities – Processing, Storage, Distribution’.


NIH Supports Research Careers by Repaying Student Loan Debt

NIH Nominates Scientific Management Review Board Members 

Delays in Grant Application Submission due to Hurricane Ike

The National Institute of General Medical Sciences Administrative Supplements for Collaborative Science

Change in Peer Review Contact for PAR-08-260, Pre-application for a Biomedical Technology Research Resource (X02)


Approval Information: Blood Grouping Reagent Anti-s (Monoclonal) – Approval History and Related Documents

Approval Information: Blood Grouping Reagent Anti-Fya (Monoclonal) – Approval History and Related Documents

Approval Information: Blood Grouping Reagent Anti-S (Monoclonal) – Approval History and Related Documents

Important Notification: Red Cell Collection Kits – Haemonetics Corporation

Substantially Equivalent 510(k) Device – Pool Results Manager Version 1.0C

Concept Paper: Animal Models – Essential Elements to Address Efficacy Under the Animal Rule (PDF)

Approved Biological NDA and ANDA Applications – Update



Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Petitions for Exemption from Preemption


The European Commission’s Proposal to Harmonise the Handling of Variations to National Licences


8th Annual Somatic Cell Therapy Symposium
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September 22-24, 2008
Bethesda, Maryland

The Somatic Cell Therapy Symposium is a forum designed to engage FDA, academia,
and industry in an open dialogue regarding regulatory issues pertaining to the
translation of basic laboratory research findings into therapeutic procedures suitable
for human clinical trial evaluation.

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