Volume 10.07 | Mar 2

Cell Therapy News 10.07, March 2, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Make Active Motor Neurons from Induced Pluripotent Stem Cells: Stem cell scientists at UCLA showed for the first time that human induced pluripotent stem cells can be differentiated into electrically active motor neurons, a discovery that may aid in studying and treating neurological disorders.


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Tokyo Team Develops Safe Way to Grow iPS Cells
A Japanese team has developed a new method of growing human induced pluripotent stem cells that uses a gel chemical compound instead of animal cells.


Researcher Seeks to Turn Human Stem Cells Into Blood Vessels
A Johns Hopkins engineer is trying to coax human stem cells to turn into networks of new blood vessels with a $150,000 two-year grant from the March of Dimes Foundation.

Stem Cell ‘Fabrics’ Promise Universal Tissue
Embryonic stem cells can survive being spun into polymer threads – a technique that could be used to weave flexible synthetic tissues able to adapt to any transplant environment, say UK biophysicists.

Cell Microenvironments Hold Key to Future Cancer and Regenerative Medicine Therapies
Working with unique microenvironment micro arrays (MEArrays) of their own creation, researchers have shown that the ultimate fate of a stem or progenitor cell in a woman’s breast may depend upon signals from multiple microenvironments.

Gladstone Scientists Find Clues That Guide Division and Expansion of Heart Cells for Regenerative Therapies
Researchers have unraveled a complex signaling process that reveals how different types of cells interact to create a heart.

World’s Smallest Periscopes Peer At Cells From Several Sides At Once
A team of Vanderbilt scientists has invented the world’s smallest version of the periscope and is using it to look at cells and other microorganisms from several sides at once.

Human Stem Cells Provide a New Model for Lou Gehrig’s Disease
Overcoming the limited success of previous models, a report published in Disease Models & Mechanisms describes how neurons can be derived from human stem cells, and engineered to mimic inherited ALS.

Adipose-Derived Stem and Regenerative Cells Prevent Mortality and Reduce Kidney Damage in Preclinical Study
Cytori Therapeutics, Inc. finds adipose tissue-derived stem and regenerative cells significantly reduce mortality and improve renal function in an acute kidney injury model.

First Group of Heart Failure Patients Treated with “Off-the-Shelf” Adult Stem Cells Successfully Pass Key Safety Milestone
Mesoblast Limited recently announced successful achievement of the key safety milestone in the first low-dose cohort of patients treated with their adult stem cell product Revascor.


Cells Extract from Fetal Liver Promotes the Hematopoietic Differentiation of Human Embryonic Stem Cells
This paper describes a new inducing system to promote the differentiation of human stem cells toward hematopoietic lineages by the treatment with cells extract of human fetal liver tissue.

Functional Implications of CD34 Expression in Human Adipose-derived Stem/Progenitor Cells
This study sorted shortly cultured hASCs into CD34+ and CD34– fractions and compared their biological functions to assess the implications of decreased CD34 expression in human adipose-derived stem cells over time in culture.

ROCK Inhibitor Improves Survival of Cryopreserved Serum/Feeder-free Single Human Embryonic Stem Cells
The researchers describe a novel method to increase freeze-thaw survival and proliferation rate of single hES cells in serum-free and feeder-free culture conditions.

Human Embryonic Stem Cell-derived Motor Neurons Expressing SOD1 Mutants Exhibit Typical Signs of Motor Neuron Degeneration Linked to ALS
Here, the researchers demonstrate the expression of a mutant gene, superoxide dismutase 1(SOD1), linked to familial amyotrophic lateral sclerosis in hESC-derived motor neurons.

Ctip2/Bcl11b Controls Ameloblast Formation During Mammalian Odontogenesis
This research describes how Ctip2 also plays a key role in tooth development.


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Stem Cell Research Supporters Offer Senate Bill
Two prominent supporters of stem cell research said on Thursday they had reintroduced a Senate bill that would allow federal funding for human embryonic stem cell research, in anticipation of President Barack Obama’s support for the work.

Bill Would Open Stem Cell Funds Up to All Maryland Biotechs
The state’s push to allow private companies to grab a share of its $18 million stem cell fund is igniting a battle between the state’s largest academic researchers and its biotech executives.

Sebelius: No Talks with Obama about Health Post
Kansas Governor Kathleen Sebelius, mentioned as a top candidate for health secretary, said Sunday she has not talked with President Barack Obama about joining his Cabinet.


The Medical Research Council Partners with the Californian Institute of Regenerative Medicine in its Disease Team Request for Applications
The MRC is calling for proposals from UK groups active in the preclinical domain that can link to Californian research teams to establish high quality, multidisciplinary translational research programs.

BioTime’s Subsidiary Enters Agreement Adding New Embryonic Stem Cell Lines to Its Product Portfolio
BioTime, Inc., announced recently that its wholly-owned subsidiary Embryome Sciences, Inc. has entered into an agreement with Reproductive Genetics Institute (RGI) granting Embryome Sciences rights to market new human embryonic stem cell lines selected by Embryome Sciences from 294 hES lines derived by RGI.

Pluristem Therapeutics Collaborates with Pharmicell Europe GmbH to Distribute Pluristem’s Cell Therapy Product for Clinical Trials in Germany
Pluristem Therapeutics Inc. announced recently hat it has signed a collaboration agreement with Pharmicell Europe Gmbh which will distribute PLX-PAD, Pluristem’s placental-derived adherent stromal cell product, to various clinical sites in Germany.

Roche Seen Upping $42 Bln Genentech Bid After Rebuff
Roche will likely have to up its bid for the 44 percent of Genentech it does not own, analysts said on Tuesday, after the U.S. biotech group urged shareholders to reject the offer.

Genzyme on the Hunt for New Products
Genzyme, the world’s largest maker of drugs for rare genetic disorders, will seek opportunities to purchase “personalized drugs, highly specialized medicines where you can easily explain their value,” chief executive Henri Termeer said Monday.

Patent Lawsuit Against Histogen Forces Layoffs And A Scramble For New Funding
A patent infringement lawsuit filed last month against Histogen has triggered a funding crisis at the San Diego biomedical startup, which was forced to lay off all 36 of its employees at the end of January.

Genentech Pushes More Diagnostic-test Regulation
Genentech says the Food and Drug Administration should regulate laboratory-developed tests used for in-house testing by that lab only and to immediately stop clinical labs that don’t have the science to back up claims about their LDTs’ use, effectiveness or value.


Career Enhancement Award for Stem Cell Research (K18) (PA-09-110)

Manufacturing Processes of Medical, Dental, and Biological Technologies (SBIR [R43/R44])

Manufacturing Processes of Medical, Dental, and Biological Technologies (STTR [R41/R42])


Human Cell & Tissue and Cellular & Tissue-based Products (HCT/P) – Inspections Performed in Fiscal Years 1998 to 2008

Biological Product Deviation Reporting Electronic Form Instructions – Update



FDA Perspective on “Where Are We? Where Can We Go?” – Presentation

Congress Probes FDA Ban of Panelist
Congressional investigators are probing the U.S. Food and Drug Administration’s decision to remove a scientist from an advisory panel that reviewed Eli Lilly and Co and Daiichi Sankyo’s proposed blood thinner prasugrel, a spokesman told Reuters on Thursday.

F.D.A. Consolidates at Former Navy Site
The Food and Drug Administration has moved into the Naval Surface Warfare Center in White Oak, consolidating its previously scattered labs and offices.


Good Clinical Practice: Accredited Phase I Units

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