Volume 10.33 | Aug 24

Cell Therapy News 10.33, August 24, 2009.
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Switching on the Power of Stem Cells: Researchers have pinpointed the final step in a complex process that gives embryonic stem cells their unique ability to develop into any of the different types of cells in the body. [Wellcome Trust Centre for Stem Cell Research, University of Cambridge, Cambridge]


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Researchers Identify a Coronary Vascular Progenitor Cell Capable of Growing New Coronary Arteries
Researchers recently demonstrated that the human heart contains a population of stem cells which has the unique property to form large vessels similar to those commonly affected by atherosclerosis, a disease which can lead to heart attack. [Brigham and Women’s Hospital, Boston]

VIDEO: Nano-magnets Guide Stem Cells to Damaged Tissue
Microscopic magnetic particles have been used to bring stem cells to sites of cardiovascular injury in a new method designed to increase the capacity of cells to repair damaged tissue researchers recently announced. [University College London, London]

Synaptotagmin Plays a Critical Role in Initiating Cellular Fusion
Success in cellular fusion — as occurs at the moment of conception and when nerve cells exchange neurotransmitters — requires that a membrane be bent before the merging process can begin researchers have shown. [University of Wisconsin-Madison, Madison]

Scientists Grow Fully Functional Tooth from Stem Cells
Though teeth have been grown in mice before, scientists revealed their success at growing a "fully functional" tooth from stem cells in mice. [Tokyo University of Science, Tokyo]

Watching Stem Cells Repair the Human Brain
Researcher shows viability of bone marrow stem cells with unique MRI tracking methods. [Tel Aviv University, Tel Aviv]

Stemedica Cell Technologies, Inc. Requests Pre-IND Meeting With FDA
Stemedica Cell Technologies, Inc. has requested a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration to discuss a proposed IND to use Stemedica’s proprietary line of allogeneic mesenchymal bone marrow cells as a treatment for ischemic stroke. [Stemedica Cell Technologies, Inc., San Diego]

Geron’s IND for Spinal Cord Injury Placed on Hold
Geron Corporation recently announced that its investigational new drug application for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. [Geron, Menlo Park]

Hard To Treat Diseases to Begin Stem Cell Graft Survival Study
Hard To Treat Diseases has begun preliminary experiments within a project aimed at Promoting stem cell graft survival in the model of traumatic brain injury in rats. [Hard To Treat Diseases, Belgrade]

Treatment May Limit Graft-Versus-Host Disease
People who need a blood stem cell transplant may be able to lessen the chances of graft-versus-host disease by being treated with anti-T-cell globulin. [Universitatsklinikum Freiburg, Freiburg]

Gentium Reports Top Line Results from the Phase III Treatment Trial of Defibrotide for Severe Veno-Occlusive Disease
Italian biopharmaceutical firm Gentium S.p.A. said its experimental drug to treat veno-occlusive disease, a complication of stem cell transplantation, missed the main goal of a late-stage study. [Gentium S.p.A., Villa Guardia]


In vivo Myocardial Distribution of Multipotent Progenitor Cells Following Intracoronary Delivery in a Swine Model of Myocardial Infarction
Using an anterior myocardial infarction swine model, near-infrared fluorescence was used for in vivo tracking of labeled [mesenchymal stromal cells, bone marrow mononuclear and peripheral blood mononuclear cells early after intracoronary injection. [European Heart Journal]

The Natural and Engineered 3D Microenvironment as a Regulatory Cue During Stem Cell Fate Determination
This paper reviews the current understanding of 2D and 3D stem cell control mechanisms and proposes an approach to uncovering the mechanisms that govern stem cell behavior in 3D. [Tissue Engineering Part B: Reviews]

Ovol2 Suppresses Cell Cycling and Terminal Differentiation of Keratinocytes by Directly Repressing c-Myc and Notch1
In this work, the researchers use HaCaT human keratinocytes to investigate the cellular and molecular functions of Ovol2. [Journal of Biological Chemistry]

Senescence Impairs Successful Reprogramming to Pluripotent Stem Cells
This paper has identified has senescence as one barrier to somatic cells reprogrammed into induced pluripotent stem cells. [Cold Spring Harbor Laboratory Press]

Senator Moves to Block Medical Ghostwriting
A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies.

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Japan Relaxes Human Stem-cell Rules
A long-sought loosening of Japan’s guidelines on human embryonic stem-cell research came into effect on 21 August, but may be too late for a struggling field that was once a source of national pride.


Connexon Creative Launches Cord Blood News
Cord Blood News is a weekly e-newsletter that keeps members of the cord blood community informed by providing the latest news from all areas of the field, including its science, research, policy, and business.

BioLife Solutions, Inc. and StemCell Technologies Inc. Announce Worldwide Distribution Agreement
BioLife Solutions, Inc. recently announced that it has entered into a non-exclusive distribution agreement with STEMCELL Technologies, Inc., a leading provider of products that support innovative research in hematology, immunology, cancer research, developmental biology, and many other areas of life science research. [StemCell Technologies, Vancouver]

Stem Cell Center Asks Regents for Help
San Diego’s stem cell consortium has abandoned efforts to get commercial financing for its planned research center. So the group has a new plan to get the project off the ground. [Sanford Consortium for Regenerative Medicine, San Diego]

University of Southern California Gets $2.9M in Stem Cell Funding
Keck School of Medicine of USC researchers have been awarded $2.9 million in grants from the California Institute for Regenerative Medicine to support research into stem cell discoveries that lay the foundation for future therapies. [Keck School of Medicine, University of Southern California, Los Angeles]

State Stem Cell Agency Awards Three New Grants to Stanford Researchers
The California state stem cell agency recently awarded three Stanford University researchers a total of $4.2 million to investigate what makes stem cells tick. [Stanford University, Stanford]

Bio-Matrix Scientific’s Research Subsidiary, Entest BioMedical, Inc., Files Stem Cell Therapy Patent Application for Treatment of Chronic Obstructive Pulmonary Disease
Bio-Matrix Scientific Group, Inc. announced recently its majority owned subsidiary, Entest BioMedical unit, has filed a patent application for the use of adipose derived stem cells in the treatment of Chronic Obstructive Pulmonary Disease. [Bio-Matrix Scientific Group, Inc., San Diego]

Cryo-Save to Create Cell Lines at Bangalore Centre
Cryo-Save India is planning to develop cell lines grown in tissue culture at its stem cell banking facility in Bangalore. [Cryo-Save, Bangalore]

Neuralstem, Inc. Listing Compliance Plan Accepted by NYSE AMEX
Neuralstem, Inc. recently reported that its Exchange listing compliance plan submitted on July 6 has been accepted by the NYSE AMEX LLC. [Neuralstem, Inc., Rockville]


New NIH chief: Turn Science into Better Care, Fast
In taking the reins of the NIH, Collins — best known for unraveling the human genetic code — said he wants a practical focus for the nation’s premier research agency, that new discoveries may even help save precious health care dollars.

Pro-Embryo Group Sues NIH Over Stem Cell Policy
A Christian group has filed a lawsuit against the National Institutes of Health alleging that the Obama Administration’s stem cell policy violates federal law.


Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components



Food and Drug Administration Transparency Task Force; Meeting – Reopening of Comment Period, 41711–41712 [E9–19778]

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Financial Disclosure by Clinical Investigators

Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Revision of the Requirements for Publication of License Revocation; Confirmation of Effective Date, 42175 [E9–20119]

Post Marketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements, 42184–42203 [E9–19682]

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