Volume 10.46 | Nov 23

Cell Therapy News 10.46, November 23, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Your Own Stem Cells Can Treat Heart Disease: In the 12-month Phase II, double-blind trial, subjects’ own purified stem cells, called CD34+ cells, were injected into their hearts in an effort to spur the growth of small blood vessels that make up the microcirculation of the heart muscle. [Northwestern University, Chicago]
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Science

On Your Last Nerve
Researchers have identified a gene that tells embryonic stem cells in the brain when to stop producing nerve cells called neurons. [North Carolina State University, Raleigh]
Article

ReNeuron Presents Positive Pre-clinical Efficacy Data with ReN009 Stem Cell Therapy for Peripheral Arterial Disease at Leading US Scientific Conference
In two studies, a significant and dose-dependant recovery of blood flow to the ischaemic limb was seen as soon as three days after ischemia, with significantly increased revascularization of the damaged tissue after 21 days, as measured by increased capillary and arteriole density. [ReNeuron Group plc, Guildford]
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Stem Cells May Improve Heart Bypass Results
Patients who received bone marrow stem cell transplants during coronary bypass surgery experienced “excellent long-term safety and survival”. [University of Rostock, Rostock]
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Phase 1/2 Results for Aldagen’s ALD-301 Critical Limb Ischemia Clinical Study Presented at AHA
In the study, researchers showed that the company’s cell product ALD-301 was well-tolerated, and patients in the treatment group were shown to have increased blood flow and improved clinical status. [Aldagen, Inc., Durham]
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Alnylam Presents New Pre-clinical Data on ALN-VSP, an RNAi Therapeutic for the Treatment of Liver Cancer
Alnylam Pharmaceuticals, Inc.’s new data demonstrated robust anti-tumor activity in orthotopic liver tumor models comprised of both HCC- and colorectal cancer-derived cell lines, using its RNAi therapeutic. [Alnylam Pharmaceuticals, Inc., Cambridge]
Article

Pluristem Therapeutics Announces Three Month Follow-Up Data from the First Patient to Receive PLX-PAD
Pluristem Therapeutics Inc. recently announced that safety and potential efficacy parameters were demonstrated by the three month follow up data from the first patient ever to receive its placenta derived cell therapy product, PLX-PAD. [Pluristem Therapeutics Inc., Haifa]
Article

Embryonic Stem Cell Therapy Closer to Human Trials
Embryonic stem cell therapy got a step closer to the clinic Thursday after US researchers said they filed a request for government approval of human trials. [Advanced Cell Technology, Santa Monica]
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Interim Results from Aastrom’s IMPACT-DCM Cardiac Trial
Aastrom Biosciences, Inc. recently presented encouraging interim data suggesting that the majority of patients treated to date with Cardiac Repair Cells have shown improvements in their heart failure classification, while patients in the control group, who did not receive CRCs, did not have a similarly improved outcome. [Aastrom Biosciences, Inc., Ann Arbor]
Article

Sustained Six-Month Improvement in Heart Muscle Function by “Off-the-shelf” Adult Stem Cells
Mesoblast Limited announced recently that the first group of patients who received the lowest dose of Revascor(TM), its proprietary “off-the-shelf” adult stem cell product for heart failure, continued to show sustained improvement in heart muscle function at six months. [Mesoblast Limited, Melbourne]
Article

Researchers to Test First Gene Therapy for Alzheimer’s Patients
Mount Sinai School of Medicine is one of 12 sites nationwide participating in the first Phase 2 clinical trial to test gene therapy treatment for Alzheimer’s disease. [Mount Sinai, Queens]
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ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Interrogating Functional Integration Between Injected Pluripotent Stem Cell-derived Cells and Surrogate Cardiac Tissue
Using a cardiac tissue model, engineered heart tissue, and quantitative molecular and electrophysiological analyses, transplantation conditions and specific cell populations were tested for embryonic stem cells’ potential to functionally integrate with the host tissue. [PNAS]
Article

Deleterious Effect of Human Umbilical Cord Blood Mononuclear Cell Transplantation on Thioacetamide-induced Chronic Liver Damage in Rats
In the present study, human umbilical cord blood cells transplanted into rats with thioacetamide-induced liver cirrhosis, developed a hepatorenal syndrome. [Cell Transplant]
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Propagation of Human Spermatogonial Stem Cells in Vitro
To establish in vitro propagation of human spermatogonial stem cells from small testicular biopsies to obtain an adequate number of cells for successful transplantation. [JAMA]
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Policy

Diagnostics Makers Sweat Out a Supreme Court Ruling
The diagnostics industry is carefully watching the Supreme Court as a ruling in the case could up end the diagnostics industry by rendering the algorithms underlying molecular diagnostics unpatentable.
Article

Business

STEMSOFT Software Inc. Licenses StemLab® Software to Cord Blood America
STEMSOFT Software Inc is pleased to announce the licensing of StemLab, the leading cell therapy and cord blood banking laboratory software, to Cord Blood America’s cord banking laboratory in Las Vegas, NV.
Article

International Stem Cell Corporation Announces Collaboration with Scripps Research Institute’s Center for Regenerative Medicine to Study Parthenogenetic Stem Cells
International Stem Cell Corporation announced recently that it is collaborating with renowned stem cell researcher Jeanne F. Loring, Ph.D., and the Scripps Research Institute to study parthenogenetic stem cells and potentially therapeutic cells that can be derived from them. [International Stem Cell Corporation, Oceanside]
Article

Fate Therapeutics Closes $30 Million Series B Financing
Fate Therapeutics, Inc. announced recently that it has completed a $30 million Series B financing led by OVP Venture Partners.
Article

NIH

NIH Appoints Eric D. Green, M.D., Ph.D. to be Director of the National Human Genome Research Institute
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CBER

CBER: Proper Biologic Application Format May Speed Review
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Complete List of Licensed Products and Establishments
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December 15, 2009: Vaccines & Related Biological Products Advisory Committee Meeting Announcement
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Form FDA 3486 and Addendum 3486A
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November 18-19, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents
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HUMAN TISSUE AUTHORITY (United Kingdom)

Revised Codes of Practice Published
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