Volume 11.03 | Feb 1

Cell Therapy News 11.03, February 1, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Unsubscribe


TOP STORY


Researchers Directly Turn Mouse Skin Cells into Neurons, Skipping Induced Pluripotent Stem Cell Stage
Scientists have succeeded in the ultimate switch: transforming mouse skin cells in a laboratory dish directly into functional nerve cells with the application of just three genes. [Press release from the Stanford University School of Medicine discussing the online prepublication in Nature]

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SCIENCE NEWS

Scientists Achieve First Rewire of Genetic Switches
Researchers in Manchester have successfully carried out the first rewire of genetic switches, creating what could be a vital tool for the development of new drugs and even future gene therapies. [Press release from The University of Manchester discussing the online prepublication in the Proceedings of the National Academy of Sciences]

Platelet Finding Challenges Understanding of Blood Cell Development
An international team of scientists is the first to report on the previously undescribed ability of platelets to reproduce themselves in the circulation. [Press release from University of Utah discussing the online prepublication in Blood]

Lab-Grown Liver Cells Provide Model for Hepatitis C Infection
Howard Hughes Medical Institute researchers and their colleagues at the Rockefeller University have developed a new method for growing human liver cells outside the body. [Press release from Howard Hughes Medical Institute discussing the online prepublication in the Proceedings of the National Academy of Sciences]

Researchers Develop New Tool for Gene Delivery
Researchers have developed a new tool for gene therapy that significantly increases gene delivery to cells in the retina compared to other carriers and DNA alone. [Press release from Tufts University School of Medicine discussing the online prepublication in the Journal of Gene Medicine]

Making Old Stem Cells Act Young Again
A team of researchers has found that in old mice, a several-week exposure to the blood of young mice causes their bone marrow stem cells to act “young” again. [Press release from Howard Hughes Medical Institute discussing the online prepublication in Nature]

University of Florida Researchers Continue ‘Extraordinary Measures’ to Tackle Pompe Disease
Clinical trials of a gene therapy for Pompe-related breathing problems in six infants are expected to begin this summer. [University of Florida Press Release]

Osiris Completes Enrollment in Stem Cell Trial for Type 1 Diabetes
Osiris Therapeutics, Inc. announced that it has achieved a $750,000 milestone payment from the Juvenile Diabetes Research Foundation for completing enrollment in a Phase II clinical trial evaluating Prochymal, an adult mesenchymal stem cell therapy, as a treatment for patients recently diagnosed with type 1 diabetes. [Osiris Therapeutics, Inc. Press Release]

Gene Therapy Study Seeks to Improve Brain Function in Alzheimer's Disease
Alzheimer's disease researchers are testing the effectiveness of gene therapy for the first time to treat patients with this common brain disease. [Emory University Press Release]

CURRENT PUBLICATIONS

Systemic Signals Regulate Ageing and Rejuvenation of Blood Stem Cell Niches
Using complementary in vivo and in vitro heterochronic models, researchers show that age-associated changes in stem cell supportive niche cells deregulate normal haematopoiesis by causing haematopoietic stem cell dysfunction. [Nature]

Direct Conversion of Fibroblasts to Functional Neurons by Defined Factors
Starting from a pool of nineteen candidate genes, researchers identified a combination of only three factors, Ascl1, Brn2 (also called Pou3f2) and Myt1l, that suffice to rapidly and efficiently convert mouse embryonic and postnatal fibroblasts into functional neurons in vitro. [Nature]

Derivation of Human T-Lymphocytes from Cord Blood and Peripheral Blood with Antiviral and Antileukemic Specificity from a Single Culture as Protection Against Infection and Relapse After Stem Cell Transplantation
Researchers generated cytotoxic T-lymphocyte lines from peripheral blood or cord blood units that recognize multiple common viruses and provide antileukemic activity by transgenic expression of a chimeric antigen receptor targeting CD19 expressed on B-ALL. [Blood]

Relative Roles of Direct Regeneration Versus Paracrine Effects of Human Cardiosphere-Derived Cells Transplanted Into Infarcted Mice
Researchers characterized paracrine effects in cardiosphere-derived cell transplantation and investigated their relative importance versus direct differentiation of surviving transplanted cells. [Circ Res]

Fibronectin Synthesis by High Glucose Level Mediated Proliferation of Mouse Embryonic Stem Cells: Involvement of ANG II and TGF-Beta1
This study sought to characterize the relationship between the effects of glucose on embryonic stem cell proliferation and fibronectin synthesis, and to assess the mechanisms responsible for these cellular effects of glucose. [J Cell Physiol]

Evidence for Organ-Specific Stem Cell Microenvironments
The X-linked Gata1low mutation in mice induces strain-restricted myeloproliferative disorders characterized by extramedullary hematopoiesis in spleen (CD1 and DBA/2) and liver (CD1 only). To assess the role of the microenvironment in establishing this myeloproliferative trait, progenitor cell compartments of spleen and marrow from wild-type and Gata1low mice were compared. [J Cell Physiol]

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POLICY

National Institutes of Health Approves Wisconsin H1 Stem Cell Line for Continued Use in Federally Funded Research
Recently, the National Institutes of Health officially approved the H1, also known as the WA1 line, for continued use in research funded by the U.S. government and added it to the National Stem Cell Registry. [National Institutes of Health, United States]

Stem Cell OK Should Be Law, Backers Say
President Barack Obama's 2009 executive order that lifted some stem cell research restrictions should be codified into law so future lawmakers cannot undo it, a national stem cell research advocate said recently. [Genetics Policy Institute, United States]

Life Sciences Super Cluster Announced as Support for Life Sciences is Bolstered
Recently, the Government announced plans for a new UK Life Sciences Super Cluster, supported by £1 million of Government investment. [The Office for Life Sciences, United Kingdom]

Virginia Governor McDonnell Proposes More Biotech Funding
Virginia Governor Bob McDonnell made biotech initiatives a visible part of a job creation agenda he unveiled recently. [Virginia Republican Party, United States]

Small Business Matching Grant Program
The primary objective of the Small Business Matching Grant Program is to provide grants to commercialization-ready life sciences and technology companies that have received at least the equivalent of a Phase II Small Business Innovation Research or Small Business Technology Transfer grant from federal agencies such as the National Institutes of Health, National Science Foundation, Department of Defense, etc. [Massachusetts Life Sciences Center, United States]

CAS_645x110_v01



BUSINESS

Biotech Vets Launch VenBio for Both Private and Public Deals
Biotech veterans from MPM Capital, OrbiMed Advisors, Pfizer Inc. and Morgan Stanley are out to transcend what they see as the limits of traditional life-sciences venture capital. [Wall Street Journal]

European Medicines Agency Starts Formal Review of Glybera® Dossier
Amsterdam Molecular Therapeutics (AMT) has reached another important milestone in the official marketing authorisation process for its lead product Glybera®, AMT’s proprietary product for lipoprotein lipase deficiency. [Amsterdam Molecular Therapeutics Press Release]

American Medical Systems and Tissue Genesis Sign $1.1 Million Collaboration Deal
Tissue Genesis, Inc. and American Medical Systems Holdings, Inc. announced that they have signed an agreement for the research and development of adipose (fat)–derived regenerative cells for use in treating pelvic health disorders. [Tissue Genesis, Inc. Press Release]

International Stem Cell Corporation Progresses Towards Establishment of the Industry’s First Universal Stem Cell Bank, UniStemCell™
International Stem Cell Corporation announced that it has signed up the first two in vitro fertilization clinics and engaged an experienced pharmaceutical industry executive to lead the establishment of the company’s universal stem cell bank, UniStemCell™. [International Stem Cell Corporation Press Release]

Geron Forms Collaboration to Investigate GRNOPC1 in Alzheimer's Disease Models
Geron Corporation announced that it has entered into a collaboration jointly funded by Geron and a University of California Discovery Research and Training Grant to investigate the therapeutic potential of its human embryonic stem cell-based product, GRNOPC1, for Alzheimer's disease. [Geron Press Release]

Geisinger Researchers Awarded Funds for Personalized Healthcare Project
Researchers recently received funding totaling more than $44,000 from a Geisinger Health System – New York University Langone Medical Center collaborative project focusing on personalized healthcare. [Geisinger Medical Center Press Release]

Roche Establishes New Medical Research Hub in Singapore
Roche announced that it will enter into a strategic alliance with Singapore’s scientific and medical institutions to set up a major new translational research hub in Singapore. [Roche Press Release]

UT-Battelle Licenses Tissue-Regeneration Technologies to NellOne Therapeutics; Advances Oak Ridge National Laboratory Spin-Out on Commercialization Path
In a major step toward commercialization of a promising therapeutic treatment, Oak Ridge National Laboratory contractor UT-Battelle announced at a signing ceremony that it has exclusively licensed patents on inventions based on the Nell-1 gene to NellOne Therapeutics, Inc. [NellOne Therapeutics, Inc. Press Release]

New Way to Grow Embryonic Stem Cells Holds Promise of Dramatic Reduction in Animal Use
The winner of this year's annual NC3Rs 3Rs Prize has developed a new method of priming early embryos to form embryonic stem cells. [National Centre for the Replacement, Refinement and Reduction of Animals in Research Press Release]

BioOhio Launches Scholarship Program
To address financial needs and to promote bioscience career pursuits among Ohio’s students, BioOhio has launched the BioOhio Annual Scholarship program. [BioOhio Press Release]

£5M Funding Partnership to Bring New Innovation and Economic Benefit to United Kingdom
A £5M development at the Norwich Research Park, funded by a partnership including the Biotechnology and Biological Sciences Research Council will provide facilities for start-up and growing businesses that will turn world-class science into products and technologies. [Biotechnology and Biological Sciences Research Council Press Release]

Limb Regeneration and Attosecond Research Each Get $1 Million from Keck Foundation
Two University of California, Berkeley, research projects that push the boundaries of their fields have each received $1 million grants from the W.M. Keck Foundation. [University of California, Berkeley Press Release]

T. Denny Sanford Donates $50 Million to Burnham Institute for Medical Research
Burnham Institute for Medical Research announced that philanthropist T. Denny Sanford has pledged $50 million to support and further expand and accelerate the Institute’s leading-edge medical research. [Sanford-Burnham Institute for Medical Research Press Release]

ReNeuron Regulatory Update
ReNeuron Group plc provides a regulatory update regarding its ReN001 stem cell therapy for stroke. [ReNeuron Group plc Press Release]

Neurologix Gains Broadened U.S. Patent Protection for Its Glutamic Acid Decarboxylase-Based Gene Delivery System
Neurologix, Inc. announced that the U.S. Patent and Trademark Office has expanded the intellectual property protections enabled by a previously issued patent that is central to Neurologix's Parkinson's disease program. [Neurologix, Inc. Press Release]

Financing Woes Delay Stem Cell Lab Construction
A taxpayer-funded stem cell research laboratory planned for the Torrey Pines Mesa is among three such facilities in the works statewide that have hit snags in their construction timelines. [San Diego Business Journal]

Coriell Cites Record of Innovation in Securing $27M National Institutes of Health Grant
Coriell said the latest National Institutes of Health award, announced recently, will allow it to add “a powerful new type of stem cell,” called induced pluripotent stem cells to the human genetic cell repository of the National Institute of General Medical Sciences. [NJ Biz]



NIH

In Tough Economic Times, National Institutes of Health Head Looks to Clinic
As he puts together his budget proposal for the coming year, National Institutes of Health director Dr. Francis Collins plans to do something a little different – emphasizing the “health” in the name of his U.S. agency.

UPDATE TO RFA-OD-10-001: ARRAOS Recovery Act Limited Competition: Behavioral Economics for Nudging the Implementation of Comparative Effectiveness Research: Clinical Trials (RC4) – Announcement of Additional Funds Availability and Increased Allowable Total Costs (NOT-OD-10-053)

Institutional Clinical and Translational Science Award (U54) (RFA-RM-10-001)



CBER

Science Board to the Food and Drug Administration; Notice of Meeting



REGULATORY 

FOOD AND DRUG ADMINISTRATION (United States)

Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567

THERAPEUTICS GOODS ADMINISTRATION (Australia)

Proposed Standards and Code of GMP for Human Blood and Blood Components, Human Tissues and Human Cellular Therapies
As the consultation period for the Code of GMP and the five proposed standards fell during the Christmas and New Year holiday, an extended period of 9 weeks for comment has been provided. Submissions must be received by close of business on Friday, February 12, 2010.



EVENTS

CHI's Molecular Medicine Tri-Conference 2010
February 3-5, 2010
San Francisco, United States

SMi’s Second Annual Stem Cells 2010
February 15-16, 2010
London, United Kingdom

Keystone Symposia: Stem Cell Differentiation and Dedifferentiation (B4)
February 15-20, 2010
Keystone, United States

5th Annual Stem Cell Summit
February 16, 2010
New York, United States

12th Biennial Canadian Blood and Marrow Transplant Consortium Meeting
April 7-10, 2010
Vancouver, Canada

SBE's Second International Conference on Stem Cell Engineering
May 2-5, 2010
Boston, United States

16th Annual ISCT meeting
May 23-26, 2010
Philadelphia, United States

ISSCR 8th Annual Meeting
June 16-19, 2010
San Francisco, United States


 

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