Volume 11.00 | Jan 11

Cell Therapy News 11.00, January 11, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Unsubscribe


TOP STORY


Biologists Develop Efficient Genetic Modification of Human Embryonic Stem Cells
Biologists have developed an efficient way to genetically modify human embryonic stem cells. Their approach, which uses bacterial artificial chromosomes to swap in defective copies of genes, will make possible the rapid development of stem cell lines that can both serve as models for human genetic diseases and as testbeds on which to screen potential treatments. [University of California, San Diego]

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SCIENCE

Scientists Identify Protein that Keeps Stem Cells Poised for Action
Researchers have identified the role of Jarid2 in embryonic stem cells. Jarid2 was found to recruit other regulatory proteins to genes important in differentiation and also, modulate their activity to keep them in a state of ongoing readiness. [Stanford University School of Medicine, Stanford]

Study Identifies a Protein Complex Possibly Crucial for Triggering Embryo Development
Researchers have discovered a protein complex that appears to play a significant role in erasing epigenetic instructions on sperm DNA, essentially creating a blank slate for the different cell types of a new embryo to develop. [UNC School of Medicine, Chapel Hill]

Growing Blood Vessels: Bioengineered Materials Promote the Growth of Functional Vasculature
Using synthetic polymers called hydrogels, researchers have been able to induce significant vasculature growth in areas of damaged tissue. [Georgia Institute of Technology, Atlanta]

Leukaemia Vaccine Being Developed
Scientists have developed a vaccine treatment for Leukaemia that can be used to stop the disease returning after chemotherapy or bone marrow transplant. [King's College London, London]

Geron Announces Publication of Data on its Telomerase Inhibitor in Glioblastoma
Geron Corporation announced the publication of preclinical data demonstrating that its telomerase inhibitor drug, imetelstat (GRN163L), inhibited telomerase activity and reduced tumor size in xenograft models of glioblastoma, and inhibited the activity of glioblastoma stem cells in culture. [Geron Corporation, Menlo Park]

Gene Therapy Makes Mice Breathe Easier: Preventing Progression of Emphysema
Researchers have discovered a new gene therapy that may prevent the progression of emphysema. [Boston University School of Medicine, Boston]

ReNeuron Press Release: Regulatory Update
ReNeuron Group plc recently provided a regulatory update regarding its ReN001 stem cell therapy for stroke and its ReN009 stem cell therapy for peripheral arterial disease. [ReNeuron Group plc, Guildford]

Advanced Cell Technology Provides Update on Clinical Trials Using Embryonic Stem Cells to Treat Eye Disease
Advanced Cell Technology, Inc. announced that it has received notification from the US Food and Drug Administration that the Agency is currently drafting a response to the Company relating to the Investigational New Drug Application it filed in November seeking clearance to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy. [Advanced Cell Technology, Inc., Worcester]

Stem Cell Treatment Restores Sight to Partially Blind Man
A man who was partially blinded when ammonia was squirted in his eye during an attack 15 years ago has regained his sight after receiving a pioneering stem cell treatment. [North East England Stem Cell Institute, Newcastle]

PUBLICATIONS, REVIEWS AND SPECIAL REPORTS

Human-Induced Pluripotent Stem Cells from Blood Cells of Healthy Donors and Patients with Acquired Blood Disorders
Researchers report derivation of human-induced pluripotent stem cells from postnatal human blood cells and the potential of these pluripotent cells for disease modeling. [Blood]

The Battle to Prevent the Transmission of Mitochondrial DNA Disease: Is Karyoplast Transfer the Answer?
Recent advances in assisted reproductive technologies have provided opportunities to determine whether specific manipulations can be used to generate offspring free of their mother's transmissible mutant mtDNA. The researchers strongly suggest, however, that considerable caution should be taken when interpreting these results. [Gene Ther]

Lgr5+ve Stem Cells Drive Self-Renewal in the Stomach and Build Long-Lived Gastric Units In Vitro
Lgr5 expression in the stomach was investigated and the stem cell potential of the Lgr5+ve cells by using in vivo lineage tracing was assessed. [Cell Stem Cell]

Functional and Morphological Maturation of Implanted Neonatal Cardiomyocytes as a Comparator for Cell Therapy
Knowledge of the rate of development of immature cardiomyocytes after implantation into a host heart is important for studies using cell therapy. To assess this functionally, researchers implanted rat neonatal cardiomyocytes in normal and infarcted rat heart and reisolated them for functional assessment. [Stem Cells Dev]

China Surpasses Canada in Stem Cell Advances
Scientists in China, many of them trained at North American and European universities, published 1,116 articles on stem cells in international peer-reviewed journals in 2008, up from just 37 papers in 2000, says a team at the University of Toronto documenting China's aggressive bid to become a major player in regenerative medicine.

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POLICY

Frozen Embryos 'Have No Right to Life'
In a landmark decision, Mr. Justice Brian McGovern found the term “unborn” refers only to a fetus or a fertilized egg implanted in the womb. The judge insisted it was not the role of the courts to decide when life begins. [High Court, Ireland]

£70 Million Boost for UK Manufacturing
Under a new £70M Government investment, three new Engineering and Physical Sciences Research Council centres will focus research efforts in the fields of photonics, regenerative medicine and liquid metals. [Engineering and Physical Sciences Research Council, England]

Post-Election Budget Squeeze May Bring About Cuts in Health Research
Entire fields of health research are likely to be shut down if the next government cuts spending on medical science to reduce Britain’s £178 billion budget deficit. [Labour Party, United Kingdom]

Japan's Science Budget Not as Bad as Feared
Japan's researchers let loose a sigh of relief on December 25 when the new administration's first budget revealed only minor changes in science and technology priorities. [Liberal Democratic Party, Japan]

French Research Wins Huge Cash Boost
Universities in France are set to receive an 11-billion Euro windfall from a government initiative intended to create an 'Ivy League' of research centers. [Union for a Popular Movement, France]

Maryland Stem Cell Commission Issues Requests for Applications [Maryland Stem Cell Commission, United States] 

UK National Stem Cell Network Small Awards Scheme 2009/2010 [UK National Stem Cell Network, United Kingdom]

EuroSyStem Innovative Project Awards: Open Funding Call [Eurosystem, United Kingdom]

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BUSINESS

Cell Medica Announces R&D Framework Agreement with the Center for Cell and Gene Therapy at Baylor College of Medicine
Cell Medica announced the signing of an R&D agreement with the Center for Cell and Gene Therapy, a joint program of Baylor College of Medicine, Texas Children’s Hospital and The Methodist Hospital, Houston, Texas.

Living Cell Technologies Signs New Research Collaboration and Option Agreement to License Its Encapsulation Technology
Living Cell Technologies (LCT) Limited announced that it has extended the research collaboration with Centocor Research & Development Inc. and granted an exclusive two year option to take up a world-wide license for LCT's encapsulation technology which is to be made available only for human cell lines for a specific, but undisclosed, field of use.

Athersys Enters Into Global Agreement with Pfizer to Develop and Market MultiStem® for the Treatment of Inflammatory Bowel Disease
Athersys, Inc. announced recently that it has entered into an agreement with Pfizer Inc. to develop and commercialize MultiStem®, an investigational stem cell therapy, for the treatment of Inflammatory Bowel Disease.

Alnylam and Collaborators Discover Key Mechanism for Delivery of RNAi Therapeutics
Alnylam Pharmaceuticals, Inc. announced that it has discovered a key mechanism related to the systemic delivery of RNAi therapeutics using lipid nanoparticles.

Dicerna Signs Research Collaboration and License Agreement for Drug Delivery Systems and Dicer Substrate siRNA (DsiRNA) Pharmaceuticals with Kyowa Hakko Kirin
Dicerna Pharmaceuticals, Inc. and Kyowa Hakko Kirin Co., Ltd. announced that the two companies have entered into a research collaboration and license agreement for the research, development and commercialization of drug delivery systems and DsiRNA pharmaceuticals for therapeutic targets in oncology.

BioTime Commences Shipment of Stem Cell Research Products to Millipore
BioTime, Inc. announced recently that it has initiated shipments of stem cell research products to its worldwide distributor, Millipore Corporation, according to the terms of the co-marketing agreement between the two companies that was announced on July 9, 2009.

Buck Institute Commits to $41 Million Stem Cell Research Building in Novato
The Buck Institute for Age Research will build a $41 million building in which to conduct stem cell research at its Novato headquarters, even if it fails to get any of the $15 million in federal stimulus funds for which it has applied.

Buck Institute Awarded $1.5 Million for Stem Cell Training Program
The Buck Institute for Age Research has been awarded $1,571,229 from the California Institute for Regenerative Medicine for a research training program in stems cells and aging.

FDA Grants 510(K) Marketing Clearance for Cytori's PureGraftTM System; First & Only Device on Market for Aesthetic Body Contouring using Autologous Fat Grafts 
The FDA has granted Cytori Therapeutics 510(K) marketing clearance for its PureGraftTM System. Cytori will now launch the first and only device in the United States cleared for aesthetic body contouring using autologous fat. 

The University of Massachusetts Medical School Announces European RNAi Patent Issues
The University of Massachusetts Medical School announced that the European Patent Office has granted European Patent EP 1,309,726 in the Tuschl I patent series.

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NIH

NIH Stimulus Money Adds Jobs and Research After Lag
The U.S. National Institutes of Health (NIH) aims to create or save 50,000 jobs with its $10 billion in federal stimulus funds, boosting medical research and returning $2.25 on the dollar in goods and services, the agency’s director Francis Collins said.

Shorter NIH Grant Form Launches
The length of applications for most grants at the National Institutes of Health (NIH) — including mainstay 'R01' grants — has been slashed by more than half, from 25 pages to 12.

NIH Announces the Availability of Recovery Act Funds for Administrative Supplements for Comparative Effectiveness Research Workforce Development (NOT-OD-10-037)

Implementation of the Federal Financial Report (SF-425) – Interim Guidance (NOT-OD-10-038)

NIH Fiscal Policy for Grant Awards FY 2010 (NOT-OD-10-039)

Notice of Legislative Mandates in Effect for FY 2010 (NOT-OD-10-040)

Salary Limitation on Grants, Cooperative Agreements, and Contracts (NOT-OD-10-041)

NIH Support for Conferences and Scientific Meetings (Parent R13/U13) (PA-10-071)



CBER

Biologics Sentinel Initiative Projects

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)

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REGULATORY 

FOOD AND DRUG ADMINISTRATION (United States)

After Long March, Scientists Create 'Chinese National Institute of Health'
China's first biomedical research fund debuted last week. The National Natural Science Foundation of China launched a medical department that expects to disburse about 1 billion renminbi ($150 million) in government grants in 2010.

Advisory Committees; Tentative Schedule of Meetings for 2010



EVENTS

Stem Cells and Regenerative Medicine World Congress
January 20-21, 2010
San Francisco, United States

Phacilitate Cell and Gene Therapy Forum 2010
January 25-27, 2010
Washington, DC, United States

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

4th World Congress on Regenerative Medicine
March 12-14, 2010
Bangkok, Thailand

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

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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