Volume 10.12 | Apr 6

Cell Therapy News 10.12, April 6, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Evidence that Patients’ Own Stem Cells Could Treat Their Heart Disease: Preliminary data has shown the first evidence that delivering a potent form of autologous adult stem cells into the heart muscle of patients with severe angina may result in less pain and improved exercise tolerance.


Eye Cells Believed to be Retinal Stem Cells are Misidentified
Cells isolated from the eye that many scientists believed were retinal stem cells are, in fact, normal adult cells, investigators at St. Jude Children’s Research Hospital have found.

Amniotic Fluid May Provide New Source of Stem Cells for Future Therapies
For the first time, scientists have shown that amniotic fluid (the protective liquid surrounding an embryo) may be a potential new source of hematopoietic stem cells for therapeutic applications.

Distinguishing Single Cells with Nothing But Light
Researchers at the University of Rochester have developed a novel optical technique that permits rapid analysis of single human immune cells using only light.

Scientists Prove Human Heart Can Regenerate Cells
Scientists said on Thursday they had shown the human body regenerates heart cells at a rate of about one percent a year, a discovery that could one day reduce the need for transplants.

Building a Better Cell Culture System
Howard Hughes Medical Institute researchers have created a new type of “intelligent scaffold” for growing human cells that mimics conditions inside the body better than the standard, flat Petri dishes often used in laboratories.

Are the Lab Rat’s Days Numbered?
New efforts to build complex living ‘microtissues’ from cultured cells represent some of the most promising progress toward reducing the need for laboratory creatures.

Mice and Men Should Have More in Common in Clinical Trials
Just as no two humans are the same, a Purdue University scientist has shown treating mice more as individuals in laboratory testing cuts down on erroneous results and could significantly reduce the cost of drug development.

Monitoring the On Switch that Turns Stem Cells into Muscle
A team of American researchers have created a “switch” that allows mutations or light signals to be turned on in muscle stem cells to monitor muscle regeneration in a living mammal.

Alnylam Initiates Phase I Clinical Study of ALN-VSP in Patients with Liver Cancer
Alnylam Pharmaceuticals, Inc. recently announced that it has initiated a Phase I human clinical trial of ALN-VSP, an RNAi-based therapy, to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced liver cancers.

Genzyme Gene Therapy Fails to Help People with Leg Disease Walk Longer
Genzyme said recently at a medical meeting that its gene therapy for people with peripheral artery disease failed in a clinical trial to help them regain some mobility.

After Heart Attack, Bone Marrow Stem Cells Increase Blood Flow Within Heart
Patients treated with their own bone marrow stem cells after a heart attack experienced increased circulation within the heart, a study by Emory University School of Medicine physicians found.

Combination Adult Stem Cell Therapy Improves Severe Limb Ischemia
TCA Cellular Therapy researchers treated ten patients during the Phase I safety/efficacy clinical trial using a combination of the patient’s own endothelial progenitor cells and mesenchymal stem cells.

First Patient Treated in Osiris Phase II Stem Cell Trial for Heart Attacks
Osiris Therapeutics, Inc. recently announced the treatment of the first patient in a Phase II clinical trial evaluating Prochymal for the treatment of heart attacks.


Generation of Induced Pluripotent Stem Cells from Human Blood
In this study, the researchers describe the derivation of induced pluripotent stem cells from CD34+ mobilized human peripheral blood cells using retroviral transduction of OCT4/ SOX2/ KLF4/ MYC.

Histone Deacetylase Inhibition Elicits an Evolutionarily Conserved Self-Renewal Program in Embryonic Stem Cells
This study shows that a narrow concentration of the naturally occurring short-chain fatty acid, sodium butyrate, supports the extensive self-renewal of mouse and human ESCs, while promoting their convergence toward an intermediate stem cell state.

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California Stem Cell Program Needs a New Treatment
In the annals of wrongheaded things done with the best intentions, the California stem cell program has always been in a category of its own.

Missouri Beefs Up Incentives to Attract Startup Companies
When states vie for life sciences companies, the competition can be intense. Just ask leaders in Missouri, who’ve been competing since 2004 against Kansas’ formidable Kansas Bioscience Authority.

Kaine Blocks Funding for Embryonic Stem Cell Research
Virginia Governor Tim Kaine, the chairman of the Democratic National Committee, has signed a bill into law banning the use of some state funds for embryonic stem cell research.


StemCells, Inc. Closes its Acquisition of the Operating Assets and Businesses of Stem Cell Sciences PLC
StemCells, Inc. announced recently that it has closed the acquisition of substantially all of the operating assets and liabilities of Stem Cell Sciences Plc.

Advanced Cell Technology and CHA Bio & Diostech to Collaborate on RPE Technology Development in Korea
Advanced Cell Technology, Inc. and CHA Bio & Diostech Co., Ltd. announced recently that the parties have entered into a licensing agreement under which Advanced Cell will license its retinal pigment epithelium technology, to CHA Bio for development and commercialization exclusively in Korea.

ArunA Biomedical Announces Co-development of Fully Validated Induced Pluripotent Stem Cell Kit
ArunA Biomedical, Inc. announced recently that it has co-developed a validated kit to produce induced pluripotent stem cells with Open Biosystems now part of Thermo Fisher.

Google Launches Venture Capital Subsidiary
At a time when many venture capital firms are scaling back their investments in high-tech and life-sciences start-ups, Internet search giant Google Inc. formally launched its own venture arm.

College of Dentistry Awarded $1 Million Grant for Stem Cell Research
The New York State Department of Health recently awarded an NYU dental research team a three-year, $1 million grant to study the potential use of stem cells to regenerate facial muscles.

Mesoblast Raises Capital for New Clinical Programs
Mesoblast Limited recently announced that it has successfully completed a private placement to existing, as well as new, institutional and sophisticated investors, raising $10.81 million.

Geron Corporation Appoints Karin Eastham to Its Board of Directors
Geron Corporation recently announced the appointment of Karin Eastham to its board of directors and chair of the company’s audit committee.

Novocell Awarded Seminal Stem Cell Patent
Novocell, Inc. recently announced that it has received U.S. Patent 7,510,876 with claims covering human definitive endoderm cells.


Notice of Public Meeting: Expansion of the Clinical Trials Registry and Results Data Bank (NOT-OD-09-077)

Novel Statistical Methods for Human Gene Expression Quantitative Trait Loci (eQTL) Analysis (R01) (RFA-RM-09-006)

NIDCD Definitive Phase III Clinical Trial Planning Grant (R34) (PAR-09-142)


Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120



Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease; Availability

Revision of Organization and Conforming Changes to Regulations

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order

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