Volume 10.11 | Mar 30

Cell Therapy News 10.11, March 30, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Wisconsin, Morgridge Scientists Excise Vector, Exotic Genes from Induced Stem Cells: A team of scientists from the Morgridge Institute for Research at the University of Wisconsin-Madison reports that it has created induced human pluripotent stem cells completely free of viral vectors and exotic genes.


Researchers Uncover Stem Cell Pathway
Researchers at the Keck School of Medicine of USC have identified a signaling pathway that helps regulate the movement of blood-forming stem cells in the body.

Making Gene Therapy Safer Using Self-inactivating LTRs
By analyzing specific elements of gamma-RVs and another type of viral vector, LVs, in a tumor-prone mouse model, a team of researchers have now provided evidence that LVs are substantially less likely to cause insertional mutagenesis and tumors than gamma-RVs.

Researchers Identify Growth Factor that Stimulates Adult Stem Cells
Researchers have identified for the first time a critical growth factor that stimulates the stem cells that produce sperm to thrive and renew themselves.

Researchers Decipher Blood Stem Cell Attachment, Communication
Researchers at the National Institutes of Health have deciphered a key sequence of events governing whether the stem cells that produce red and white blood cells remain anchored to the bone marrow, or migrate into the circulatory system.

Georgetown University Medical Center Researchers Show Adult Human Testes Cells Can Become Embryonic Stem-like, Capable of Treating Disease
Using what they say is a relatively simple method; scientists at Georgetown University Medical Center have extracted stem/progenitor cells from adult testes and have converted them back into pluripotent embryonic-like stem cells.

First Automated Carbohydrate ‘Assembly Line’ Opens Door to New Field Of Medicine
Scientists from Germany recently reported the development of an automated carbohydrate synthesizer, a device that builds these intricate molecules in a few hours — rather than the months or years required with existing technology.

British Scientists ‘To Create Synthetic Blood from Embryonic Stem Cells’
A major research project is to be announced this week that will culminate in three years with the first transfusions into human volunteers of “synthetic” blood made from the stem cells of spare IVF embryos.

New Stem Cell Therapy May Lead To Treatment for Deafness
A new study from the University of Sheffield has successfully isolated human auditory stem cells from fetal cochleae (the auditory portion of the inner ear) and found they had the capacity to differentiate into sensory hair cells and neurons.

Stem Cell Infusion and Hyperbaric Oxygen Treatment Improve Islet Function in Diabetes
A study to determine if patients with type 2 diabetes can benefit from a combination of autologous stem cell infusions and hyperbaric oxygen treatment before and after ASC has found “significant benefits” in terms of “improvements in glycemic control” along with “reduced insulin requirements.”

Research Identifies Genetic ‘Master Regulator’ in Skin Formation
Researchers at Oregon State University have found one gene in the human body that appears to be a master regulator for skin development.

The French Institute I-Stem Realizes First Innovative Screens Using Stem Cells to Identify Drugs for Myotonic Dystrophy, DM1 Disease
Four research teams of I-STEM[*] have joined forces in a collaborative project that has just achieved a first pilot therapy-oriented screen of compounds and RNA interference aiming at reversing the altered phenotypes observed in human embryonic stem cells carrying the mutant gene for myotonic dystrophy type1.

Therapeutic Cloning Gets a Boost with New Research Findings
A recent paper offers the first direct demonstration that cloning does not lead to an increase in the frequency of point mutations.

Bone Marrow Stem Cells do not Help Regenerate Heart Muscle Tissue, Contradicting Earlier Study
Researchers at the University of Washington School of Medicine have found that bone marrow stem cells do not convert into heart muscle cells in mice, contradicting a study that had prompted human clinical trials for such stem cell therapy in the treatment of heart attack.

Genetic Technique Successfully Treats Duchenne Muscular Dystrophy in Dogs
Using a novel technique called exon skipping to restore partial function to the gene; researchers have successfully treated dogs with the canine form of Duchenne muscular dystrophy.

Osiris Discontinues Enrollment in Crohn’s Study Due to Concerns with Trial Design
Osiris Therapeutics, Inc. announced recently that it has elected to end enrollment at 210 patients in its Phase III trial evaluating Prochymal for Crohn’s disease, due to a trial design flaw.


Endogenous Bone Morphogenetic Proteins in Human Bone Marrow-derived Multipotent Mesenchymal Stromal Cells
In this study, the researchers address the possible role of endogenous osteogenic bone morphogenetic proteins in in situ osteoblastic differentiation of human mesenchymal stromal cells.

SWI/SNF-Brg1 Regulates Self-Renewal and Occupies Core Pluripotency-Related Genes in Embryonic Stem Cells
Here the researchers report that Brg1 is required for embryonic stem cell self-renewal and pluripotency.

JAMA Demands Silence from Those Who Find Conflicts Among Its Authors
The Journal of the American Medical Association has instituted a bizarre new policy requiring silence from anyone who notices a conflict of interest among its authors.

The World’s First ‘Ice Baby’ Grows Up
It is twenty five years ago that the first baby from a frozen embryo came into the world.

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Obama Defends Decision on Stem Cells
President Barack Obama said Tuesday that lifting federal restrictions on embryonic stem cell research was the “right thing to do and the ethical thing to do.”

Notre Dame Obama Commencement Speech Stirs Catholic Opposition
More than 87,000 names have been added to an online petition launched by a conservative Catholic group calling for the University of Notre Dame to rescind its invitation to President Obama to speak at its May 17 commencement ceremony.

Louisiana State Law Forbids Embryonic Stem Cell Research, Stunting Industry
The moral debate over embryonic stem-cell research is now an issue of economics in Louisiana.

US Stem Cell Research Still Limited by a Dickey-Wicker
So, President Obama has rescued US stem cell research from the dark old days of George Bush, right? Er, not just yet…


Salk Institute Signs Strategic Alliance with sanofi-aventis
The Salk Institute recently announced that it has signed a strategic alliance agreement with sanofi-aventis, establishing a joint program that supports cutting-edge research and promotes an exchange of discoveries focused on scientific advances and therapeutic applications.

ArunA Biomedical, Inc. Announces Alliance with Neuromics for Distribution of Normal Human Neural Cells
ArunA Biomedical, Inc., announced recently an agreement with Neuromics, Inc. giving Neuromics the right to non-exclusively market and sell the ArunA hN2(TM) Human Neural Cells and Neural Culture Medium to support applications in neurological research.

Virgin Mega-Brand Launches Stem Cell Bank in Qatar
The country has lofty goals of becoming the world leader in stem cell technologies, and unlike in the West, Qatar does not face some of the ethical issues surrounding stem-cell research.

‘A Buyer’s Market’ for N.J.’s Small Biotechs
Pharmaceutical, biotechnology and venture capital firms in New Jersey are continuing to find licensing, royalty and acquisition deals in an otherwise lackluster environment in the life sciences industry.

HHMI Gives 50 Early Career Scientists a Jump on Their Next Big Idea
Fifty of the nation’s best early career science faculty will have more time and resources to focus on their boldest research ideas with support from a new initiative from the Howard Hughes Medical Institute.

Pasadena City College Receives Nearly $2 Million to Boost Student Stem Cell Training
Pasadena City College has received a nearly $2 million grant from the California Institutes for Regenerative Medicine to fund student training in stem cell technology and research.

Rensselaer Receives More Than $2 Million from New York State to Fund Stem Cell Research
Two groups of Rensselaer researchers each have received a $1.08 million grant from New York through the state’s stem cell research initiative.

CSUCI Receives $1.7 Million Grant for Stem Cell Research Program
California State University Channel Islands was recently awarded a grant of $1,733,406 from the California Institute for Regenerative Medicine as a part of their Bridges to Stem Cell Research program.

Merck Serono Launches Strategic Venture Capital Fund
Merck Serono announced recently the formation of ‘Merck Serono Ventures’, a strategic, corporate venture capital fund to invest in emerging biotechnology companies.

Aastrom Biosciences Receives Notification That NASDAQ Further Extends Suspension of Certain Continued Listing Requirements
Aastrom Biosciences, Inc announced that the Company received Issuer Alert #2009-002 from The Nasdaq Stock Market LLC.

Genentech & Abbott CEOs Roar
Art Levinson and Miles White are “Kings of the Jungle.” At least Barron’s thinks they are. The weekly investment periodical picked the pair as the only two from biopharma to make its annual list of the “30 Most Respected CEOs.”


Enhancing Peer Review: The NIH Announces Consolidation of Review Criteria for Institutional Research Training Grant Applications (T32) Submitted for FY 2010 Funding (NOT-OD-09-074)

Notice Regarding RFA-OD-09-005, “Recovery Act Limited Competition: Biomedical Research Core Centers to Enhance Research Resources (P30)” (NOT-OD-09-076)

Students and Science Educators to Get Boost from NIH ARRA Initiative
The National Institutes of Health recently announced American Recovery and Reinvestment Act funding for administrative supplements to existing NIH grants and $21 million over two years has been allocated for educational opportunities in NIH-funded laboratories for students and science educators.


Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)



Drug Industry Advocates Join Chorus to Split FDA
Drug industry advocates are quietly allying with some of their longtime critics pushing to split the Food and Drug Administration into two agencies, one for food safety and one for medical products.

Physician Group Opposes FDA’s Position on Adult Stem Cells
Recently The American Stem Cell Therapy Association was formed in response to the Food and Drug Administration’s recent position that the adult stem cells found in everyone’s body are drugs, a position the ASCTA opposes.

Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Source Plasma Establishments


Review of the EU Variations Regulation: European Commission Consultation on Draft Guidelines

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