Volume 12.46 | Nov 21

Issue 12.46 November 21, 2011
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TOP STORY
Recipient’s Immune System Governs Stem Cell Regeneration
A new study describes how different types of immune system T-cells alternately discourage and encourage stem cells to regrow bone and tissue, bringing into sharp focus the importance of the transplant recipient’s immune system in stem cell regeneration. [Press Release from EurekAlert! discussing online prepublication in Nature Medicine] Press Release | Abstract

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PUBLICATIONS (Ranked by Impact Factor of the Journal)
Press Release

Uncoupling Protein 2 Regulates Energy Metabolism and Differentiation Potential of Human Pluripotent Stem Cells
Here, investigators show that human pluripotent stem cells have functional respiratory complexes that are able to consume O2 at maximal capacity. [EMBO J] Abstract | Press Release

Press Release

Press Release

Efficient Gene Therapy for Parkinson’s Disease Using Astrocytes as Hosts for Localized Neurotrophic Factor Delivery
To explore a localized and thus potentially safer alternative for gene therapy of Parkinson’s disease (PD), researchers expressed glial cell line-derived neurotrophic factor exclusively in astrocytes and evaluated the efficacy of this approach in the mouse 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine and rat 6-hydroxy-dopamine models of PD. [Mol Ther] Abstract

dsAAV8-Mediated Gene Transfer and β-Cell Expression of IL-4 and β-Cell Growth Factors Are Capable of Reversing Early-Onset Diabetes in NOD Mice
Here, investigators examined whether double-stranded adeno-associated virus serotype 8 (dsAAV8)-mediated gene delivery to endogenous β-cells of interleukin (IL)-4 in combination with β-cell growth factors can reverse early-onset diabetes in NOD mice. [Gene Ther] Abstract

Press Release

Increase flexibility in planning experiments using frozen primary cells. Learn more.


SCIENCE NEWS
Positive Results from Phase II Trial of Mesoblast’s Adult Stem Cell Therapy Presented
Mesoblast Limited announced positive Phase II heart failure trial results of its allogeneic adult stem cell product Revascor™ after all patients had completed a minimum follow-up of 12 months, and a mean follow-up of 22 months. [Press Release from Mesoblast Limited discussing research presented at the American Heart Association Annual Meeting, Orlando] Press Release

New Heart Cells Increase by 30 Percent After Stem Cell Infusion, Research Shows
Healthy, new heart cells have been generated by animals with chronic ischemic heart disease after receiving stem cells derived from cardiac biopsies or “cardiospheres,” according to research. [Press Release from the University of Buffalo discussing research presented at the American Heart Association Annual Meeting, Orlando] Press Release

Stemedica Neural Stem Cells Successful in Preclinical Study of Spinal Cord Injury
Transplanted neural stem cells developed by Stemedica Cell Technologies, Inc. were successful in treating rats with spinal cord injury. [Press Release from Stemedica Cell Technologies, Inc. discussing research presented at the North American Spine Society Annual Meeting, Chicago] Press Release

Mirna Therapeutics Presents New Data on the Development of miRNA-Based Therapeutic Candidates for Hepatocellular Carcinoma
Mirna Therapeutics, Inc. announced the presentation of new preclinical data on the development of a miRNA-based therapeutic candidate for primary liver cancer. [Press Release from Mirna Therapeutics, Inc. discussing research presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, San Francisco] Press Release

Idera Pharmaceuticals Presents Preclinical Data on its Gene-Silencing Oligonucleotides
Idera Pharmaceuticals, Inc. presented new data on its novel gene-silencing oligonucleotide technology. [Press Release from Idera Pharmaceuticals, Inc. discussing research presented at the 12th Annual EuroTIDES Conference, Berlin] Press Release

Stem Cell Research Hopes to Repair Brain Cell Damage of Parkinson’s Disease
Scientists have developed a new technique using stem cells, in the hope to replace damaged cells in Parkinson’s disease. [The University of Melbourne] Press Release

Clinical Trial Success Brings Researchers Closer to a Cure for Blindness
Researchers have completed a clinical trial that tested the use of gene therapy to restore sight to patients suffering from Leber’s Congenital Amaurosis. [PR Newswire] Press Release

Aastrom Reports Positive 12-Month Results from the RESTORE-CLI Phase II Clinical Trial for Ixmyelocel-T in Patients with Critical Limb Ischemia
Aastrom Biosciences, Inc. reported positive 12-month final results from the RESTORE-CLI Phase II clinical trial of ixmyelocel-T in the treatment of critical limb ischemia patients with no revascularization options. [Aastrom Biosciences, Inc.] Press Release

Lentigen and UH Case Medical Center Initiate Phase I Trial Using Gene Therapy and Bone Marrow Stem Cells in the Treatment of Brain Cancer
University Hospitals (UH) Case Medical Center, Case Western Reserve University School of Medicine and Lentigen Corporation announced the initiation of a novel Phase I clinical trial of LG631 gene therapy for the protection of hematopoietic stem cells from the dose limiting toxicity of chemotherapy with Temodar. [University Hospitals] Press Release

Stanford/SCVMC Team Treats Final Patient in Landmark Stem Cell Therapy Trial
The Stanford University School of Medicine and Santa Clara Valley Medical Center (SCVMC) treated the fifth patient in the Geron Corp-sponsored trial of a human embryonic-stem-cell-derived treatment for severe spinal cord injury on Nov. 16. [Stanford University School of Medicine] Press Release

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POLICY

NSF Slated for a 2.5% Boost in 2012 Budget
The National Science Foundation (NSF) is due to receive a surprising 2.5% increase in its 2012 budget. That good news came from a conference report filed for three spending bills, expected to be approved by Congress. [National Science Foundation, United States] Press Release

Former HHS Secretary Thompson Urges Obama to Appoint Stem Cell Commission
Former Health and Human Services (HHS) Secretary Tommy Thompson urged President Obama to take the lead in promoting adult stem cell research and give the divisive debate over embryonic stem cells a rest. [White House, United States] Press Release

Congress Slashes Budget of White House Science Office
Frustrated that White House officials have ignored congressional language curtailing scientific collaborations with China, legislators have decided to get their attention through a 32% cut in the tiny budget of the Office of Science and Technology Policy. [Office of Science and Technology, United States] Press Release

Minnesota Supreme Court Questions State’s Handling of Blood Samples from Newborns
The Minnesota Department of Health has improperly retained and distributed for research tens of thousands of blood samples left over from the state’s newborn screening program since 1997, without the written consent of parents, the Minnesota Supreme Court ruled. [Minnesota Supreme Court, United States] Press Release

More from the ‘Minibus’: USDA, NIST Research Programs Survive Rough Ride in New Spending Bill
Both the U.S. Senate and House of Representatives approved a package of spending bills that include money for a range of science programs and President Barack Obama is likely to sign it into law. [U.S. Senate, United States] Press Release

Italy Names New Research Minister: Francesco Profumo
Italy’s new government has chosen Francesco Profumo, the relatively green chief of the national research agency, to be Minister for Education, Universities, and Research. [Italian Government, Italy] Press Release

University Suggests Releasing Info on Primate Experiments Could Break U.K. Law
An animal rights group won the upper hand in its freedom of information request when the United Kingdom’s Information Tribunal Court ruled on 11 November that the Newcastle upon Tyne must release the project licenses of macaque researchers there. Newcastle has not yet decided whether to appeal the ruling, but the university believes that releasing the information would break a U.K. animal experimentation law. [United Kingdom’s Information Tribunal Court, United Kingdom] Press Release

ISCT 2012



BUSINESS
Geron to Focus on its Novel Cancer Programs
Geron Corporation announced that, effective immediately, the Company will focus on its first-in-class oncology programs. As a consequence, the Company will discontinue further development of its stem cell programs and is seeking partners for these novel assets. [Geron Corporation] Press Release

Athersys Announces Recovery of All Rights to Cardiovascular Cell Therapy Program
Athersys, Inc. announced the termination of its collaboration with Angiotech Pharmaceuticals, Inc. to co-develop cell therapy in the cardiovascular field. [Athersys, Inc.] Press Release

Alnylam Pharmaceuticals Grants InterfeRx™ Intellectual Property License to Sylentis for Development and Commercialization of RNAi Therapeutics
Alnylam Pharmaceuticals, Inc. and Sylentis, S.A. announced that Alnylam has granted Sylentis a non-exclusive option for a new target-specific InterfeRx™ license. [Alnylam Pharmaceuticals, Inc.] Press Release

VistaGen Therapeutics and University Health Network Extend Broad Stem Cell Alliance and Expand Scope of Collaborative Research
VistaGen Therapeutics, Inc. and the University Health Network have expanded their existing collaborative pluripotent stem cell research and development program, and extended it through September 2017. [Vistagen Therapeutics, Inc.] Press Release

World’s First Stem Cell Bandage in Human Clinical Trials
The company behind a pioneering stem cell bandage, believed to be the world’s first adult and autologous stem cell treatment designed to heal torn meniscal cartilage, can now take the technology to human clinical trials thanks to an investment from one of the UK’s most successful entrepreneurs. [University of Bristol] Press Release

Amsterdam Molecular Therapeutics Receives Orphan Designation in the European Union for Hemophilia B Gene Therapy
Amsterdam Molecular Therapeutics announced that the European Medicines Agency has granted orphan designation for its gene therapy program for the treatment of hemophilia B. [Amsterdam Molecular Therapeutics] Press Release

RNL Opens the World’s Largest Stem Cell Medical Center in Beijing, China
RNL BIO, South Korea’s premier adult stem cell firm, has just founded the world’s largest stem cell medical center in Beijing, China. [MarketWatch] Press Release

Britain and Israel Announce New UK-Israel Fellowship Exchange in Regenerative Medicine
Britain and Israel will establish a new, joint fellowship exchange scheme to enhance collaboration between the countries in the area of regenerative medicine. [Ministry of Science & Technology] Press Release


NIH
NIH Announces FCOI Webinar: What NIH Grantees Need to Know About the 2011 Revised Financial Conflict of Interest Regulation
The National Institutes of Health (NIH) encourages both investigators and administrators to join NIH staff for a webinar on the 2011 Revised Financial Conflict of Interest (FCOI) regulation (42 CFR Part 50 Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought). Press Release

National Human Genome Research Institute; Amended Notice of Meeting (FR Doc No: 2011-29882)

NIH Director’s Early Independence Awards (DP5) (RFA-RM-11-007)

Notice of Expanded Transparency Act Subaward and Executive Compensation Reporting Requirements for FY2012 and Beyond (NOT-OD-12-010)

Office of the Director, National Institutes of Health; Notice of Meeting (FR Doc No: 2011-29883)


CBER
2011 Biological Device Application Approvals

2011 Biological License Application Supplement Noteworthy Approvals

2011 Biologics Recalls

November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Draft Agenda

November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Pre-Meeting Information Document

November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Public Roster

November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Errata – FDA Briefing Document

November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Draft Questions to the Advisory Committee

November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Final Questions for Committee Discussion

Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments


REGULATORY
Food and Drug Administration (United States)

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Food and Drug Administration Form 3671) [FR Doc No: 2011-29296]

European Medicines Agency (European Union)

Guido Rasi Begins as New Head of European Medicines Agency
Guido Rasi has begun his mandate as Executive Director of the European Medicines Agency. Press Release

European Medicines Agency Welcomes New Head of Finance and Budget
The European Medicines Agency has welcomed Michael Lenihan as the new Head of Sector for Finance and Budget. Press Release

Therapeutic Goods Administration (Australia)

Advisory Committee on the Safety of Medicines (ACSOM)


EVENTS
NEW EMBO Molecular Medicine – Molecular Insights for Innovative Therapies
December 1-3, 2011
Heidelberg, Germany

NEW American Association for Cancer Research – Noncoding RNAs and Cancer
January 8-11, 2012
Miami Beach, United States

Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.


JOB OPPORTUNITIES

Lab Technologist – Tissue Culture (STEMCELL Technologies)

Research and Development Technologist, hPSC Media (STEMCELL Technologies)

Lab Technologist – Pluripotent Stem Cells (STEMCELL Technologies)

Scientist – Pluripotent Stem Cells (STEMCELL Technologies)

Business Analyst – Product Management (STEMSOFT Software)

Postdoctoral Position – Center for Human Genetics (VIB Research Institute)

Postdoctoral Positions, Extracellular Matrix Research (University of Oulu)

PhD Student Positions, Extracellular Matrix Research (University of Oulu)

Postgraduate Students (Masaryk University)

Senior Development Associate (Genzyme Corporation)

Research Associate – Cell Culture (Stemgent, Inc.)

Scientist – Differentiation Segment (Stemgent, Inc.)

Clean Room Associate – Cell Therapy Manufacturing (Cell Medica Limited)

Scientist II, Innovation – Cell Processing Technologies (Lonza Walkersville, Inc.)

Senior Manager, Innovation – Cell Processing Technologies (Lonza Walkersville, Inc.)

Lab Technologist Position (Michigan State University)

Postdoctoral Fellow – Islet Cell Electrophysiology (Vanderbilt University)


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