Cell Therapy News Volume 13.45 | Nov 19 2012

Distinct Metabolic Flow Enables Large-Scale Purification of Mouse and Human Pluripotent Stem Cell-Derived Cardiomyocytes
Researchers reported a nongenetic method for mass-producing cardiomyocytes from mouse and human pluripotent stem cell (PSC) derivatives that is based on the marked biochemical differences in glucose and lactate metabolism between cardiomyocytes and noncardiomyocytes, including undifferentiated cells. They cultured PSC derivatives with glucose-depleted culture medium containing abundant lactate and found that only cardiomyocytes survived. Using this approach, the authors obtained cardiomyocytes of up to 99% purity that did not form tumors after transplantation. [Cell Stem Cell] Abstract

Optogenetic and Potassium Channel Gene Therapy in a Rodent Model of Focal Neocortical Epilepsy
Scientists reported the potential efficacy of gene therapy in focal neocortical epilepsy using a rodent model in which epilepsy is induced by tetanus toxin injection in the motor cortex. [Sci Transl Med]
Abstract | Press Release

iPS Cell Modeling of Best Disease: Insights into the Pathophysiology of an Inherited Macular Degeneration
Investigators employed human iPS cell technology to generate retinal pigment epithelium from Best disease patients and unaffected siblings in order to examine the cellular and molecular processes underlying this disease. [Hum Mol Genet] Abstract | Press Release

High-Frequency Hippocampal Oscillations Activated by Optogenetic Stimulation of Transplanted Human ESC-Derived Neurons
Using multielectrode array recordings, researchers reported activation of high-frequency oscillations in the ß and γ ranges (10-100 Hz) in the host hippocampal network via targeted optogenetic stimulation of transplanted human embryonic stem cell (ESC)-derived neurons. [J Neurosci] Abstract | Press Release

Systemic TNFα Gene Therapy Synergizes with Liposomal Doxorubicine in the Treatment of Metastatic Cancer
A single intravenous injection of tumor necrosis factor alpha (TNFα) gene vector promoted accumulation of liposomal doxorubicine (Doxil) in murine neuroblastoma and human hepatoma by enhancing tumor endothelium permeability. The expression of transgenic TNFα was restricted to tumor tissue. Three treatment cycles with TNFα gene vectors and Doxil significantly delayed tumor growth in subcutaneous murine Neuro2A neuroblastoma. [Mol Ther] Abstract | Press Release

Integration and Long Distance Axonal Regeneration in CNS from Transplanted Primitive Neural Stem Cells
Following transplantation of primitive neural stem cells (pNSCs) into the lesioned rat spinal cord, grafted pNSCs survive, differentiate into neurons, and extend long distance axons through the scar tissue at the graft-host interface and into the host spinal cord to form terminal-like structures near host spinal neurons. [J Biol Chem] Abstract | Full Article

Adult Pancreas Side Population Cells Expand after β Cell Injury and Are a Source of Insulin-Secreting Cells
In adult tissues the ‘side population’ (SP) of cells that effluxes the DNA binding dye Hoechst 33342 through ATP-binding cassette transporters has stem cell properties. In serum-free medium with defined factors, SP cells proliferated and differentiated into islet hormone-expressing cells that secreted insulin in response to glucose. Insulin expression was maintained when tissue was transplanted within vascularized chambers into diabetic mice. [PLoS One] Full Article | Press Release

E1B-55 kDa-Defective Adenoviruses Activate p53 in Mesothelioma and Enhance Cytotoxicity of Anticancer Agents
Investigators examined possible antitumor effects of adenoviruses with a deletion of the E1B-55kD gene on mesothelioma and investigated combinatory actions with the first-line chemotherapeutic agents. [J Thorac Oncol] Abstract

Protective Effects of BDNF Overexpression Bone Marrow Stromal Cell Transplantation in Rat Models of Traumatic Brain Injury
Researchers showed that treatment of traumatic brain injury with bone marrow stromal cells transfected with brain-derived neurotrophic factor (BDNF) could attenuate neuronal injury as indicated by measurement of biological behavior assessment. [J Mol Neurosci] Abstract | Full Article

Autologous Adipose-Tissue Derived Regenerative Cells for the Treatment of Complex Cryptoglandular Fistula-in-Ano: A Report of Three Cases
Investigators report the successful treatment of three consecutive patients with long-standing cryptoglandular fistula-in-ano with a novel combination of mucosal advancement flap and adipose-tissue derived regenerative cells from the stromal vascular fraction obtained from a simple lipoaspiration procedure, using Celution technology. [BMJ Case Rep] Abstract | Press Release

Printing and Prototyping of Tissues and Scaffolds
New manufacturing technologies under the banner of rapid prototyping enable the fabrication of structures close in architecture to biological tissue. An exciting prospect is the printing and patterning in three dimensions of all the components that make up a tissue (cells and matrix materials) to generate structures analogous to tissues; this has been termed bioprinting. [Science] Abstract | Press Release

Cell-Based Approaches for the Treatment of Systemic Inflammation
The use of an immunomodulatory role of renal epithelial progenitor cells to treat acute renal failure and multiorgan failure arising from acute kidney injury is reviewed. [Nephrol Dial Transplant] Abstract

Alnylam Presents New Pre-Clinical Data on RNAi Therapeutics for the Treatment of Alpha-1 Antitrypsin (AAT) Deficiency
Alnylam Pharmaceuticals, Inc. announced that it has presented new pre-clinical data with an RNAi therapeutic targeting AAT for the treatment of liver disease associated with AAT deficiency. [Press release from Alnylam Pharmaceuticals, Inc. discussing research presented at the 63^rd Annual Meeting of the American Association for the Study of Liver Diseases, Boston] Press Release

First Pediatric Sickle Cell Disease Patient Receives NiCord® Stem Cell Transplantation in Gamida Cell Pilot Study at Duke University
Gamida Cell Ltd. announced that the first patient, enrolled in its pilot study of NiCord^® as an investigational treatment for sickle cell disease, has been transplanted at Duke University in North Carolina. NiCord^® is an expanded cell graft derived from an entire unit of umbilical cord blood and enriched with stem cells. [Gamida Cell Ltd.] Press Release

European Court Bans Patents Based on Embryo Destruction
The highest court in Europe ruled that stem cell research based on the destruction of human embryos is contrary to morality and cannot be patented. The Court of Justice of the European Union sided with arguments by its advocate general, who earlier this year termed stem cell patents “contrary to ethics and public policy.” [The Court of Justice, European Union] Press Release

Scientists Lobby Three E.U. Presidents to Prevent Budget Cuts
A delegation led by two Nobel laureates held sequential meetings with the European Union’s three presidents-European Parliament President Martin Schulz, European Council President Herman Van Rompuy, and European Commission President José Manuel Barroso-to lobby them to spare research funding from looming cuts in the European Union’s budget. [European Council, European Union] Press Release

Irish Science Adviser Office Axed
The Irish government has abolished the chief science adviser’s office and transferred its responsibilities to the head of Science Foundation Ireland, the country’s largest research-funding agency. [Science Foundation Ireland, Ireland] Press Release

Berlin Aims to Create Research Powerhouse
The mayor of Berlin proudly announced an opulent deal to boost the city’s scattered health-research base, sweetened with a hefty chunk of federal funding. Those in charge of the new Berlin Institute of Health that was created by the deal believe that it could rival research powerhouses in the United States and Britain. [Berlin Institute of Health, Germany] Press Release

Ontario Genomics Institute Invests in Stem Cell Technology at Tissue Regeneration Therapeutics
The Ontario Genomics Institute has invested in Toronto-based Tissue Regeneration Therapeutics (TRT), a company that aims to use umbilical mesenchymal stem cells to treat a variety of serious medical conditions. TRT will use this investment to conduct studies required to apply for approval to initiate human clinical trials. [Ontario Genomics Institute] Press Release

Geron Announces Non-Binding Letter of Intent with BioTime Regarding Stem Cell Assets
Geron Corporation announced that the company has entered into a non-binding letter of intent (LOI) with BioTime, Inc. and BioTime’s recently formed subsidiary, BioTime Acquisition Corporation (BAC). The LOI contains broad terms of a potential transaction through which Geron would contribute to BAC its intellectual property and other assets related to Geron’s discontinued human embryonic stem cell programs. [Geron Corporation] Press Release

Colby and MannKind Sign License and Joint Development Agreement to Develop and Commercialize Cancer Immunotherapy Products
Colby Pharmaceutical Company and MannKind Corporation announced a license agreement granting Colby exclusive worldwide rights to develop and commercialize disease-specific antigen compounds and intra-lymph node delivery technologies from MannKind’s novel MKC1106 active immunotherapy programs, which are currently being developed for the treatment of melanoma, prostate, hematological disorders and other human cancers. [MannKind Corporation] Press Release

Stem Cell Clinical Trials to Tackle Diabetes
NUI Galway has been awarded a major new €6 million European project, designed to address complications associated with diabetes. The research project will examine the ability of stem cells to safely control glucose levels and alleviate the damage caused by six different diabetic complications. [National University of Ireland, Galway] Press Release

Smart Scaffolding Aims to Rebuild Tissue from the Inside
Smart scaffolding that can guide cells, proteins and small-molecule drugs to make new tissue and repair damage inside the body is in the works at Rice University. Scientists at Rice and the Texas A&M Health Science Center Baylor College of Dentistry received a $1.7 million, five-year grant from the National Institutes of Health to develop a hydrogel that can be injected into a patient to form an active biological scaffold. [Rice University] Press Release

Grant Supports Gottschalk’s Osteosarcoma Immunotherapy Research
Research on using an immunotherapy approach to treating osteosarcoma by a Baylor College of Medicine pediatric oncologist is being supported by a $100,000 grant from the Cookies for Kids’ Cancer Foundation. [Baylor College of Medicine] Press Release

Opexa Receives Clinical Trial Approval from Health Canada for Novel T-Cell Therapy
Opexa Therapeutics, Inc., a company developing Tcelna™, a novel T-cell therapy for multiple sclerosis, announced that Health Canada has approved the Company’s Clinical Trial Application. [Opexa Therapeutics, Inc.] Press Release

NewLink Genetics Receives European Orphan Designation for Algenpantucel-L Immunotherapy to Treat Pancreatic Cancer
NewLink Genetics Corporation announced that the European Commission (EC) has designated HyperAcute-Pancreas® Immunotherapy (algenpantucel-L) as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products. [NewLink Genetics Corporation] Press Release

Cardium Announces Patent Award for Rights to Cardiovascular Gene Therapy for the Treatment of Heart Disease
Cardium Therapeutics announced a winning patent decision in Europe and successful resolution of a long-standing competition between Cardium and its licensor the University of California, and Boston Scientific Corporation and its licensor Arch Development, over rights to key methods for the application of cardiovascular gene therapy to the treatment of coronary heart disease, as is employed in Cardium’s Generx^® gene therapy candidate currently in late-stage clinical studies. [Cardium Therapeutics] Press Release

Harvest Technologies Corporation Granted CE Mark for Expanded Clinical Indication for Treatment of No-Option Critical Limb Ischemia
Harvest Technologies announced CE Marking for an expanded clinical indication for its SmartPReP^®2 Bone Marrow Aspiration Concentration System (BMAC^®2) product. The British Standards Institution has awarded a certificate indicating that the Harvest BMAC2 is intended to be used at point-of-care for the safe and rapid preparation of autologous nucleated cell concentrate from Bone Marrow Aspiration for administration into ischemic tissues of the affected limb due to No-Option Critical Limb Ischemia. [PR Newswire Association LLC] Press Release

VistaGen Therapeutics Enhances Predictive Liver Toxicology and Drug Metabolism Bioassay System – LiverSafe 3D™
VistaGen Therapeutics, Inc. announced a significant advance in its development of LiverSafe 3D™, a human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism issues in connection with the Company’s drug rescue activities. [VistaGen Therapeutics, Inc.] Press Release

NIH Steps Up Enforcement of Public Access Policy
The National Institutes of Health (NIH) is tightening enforcement of its policy requiring that investigators deposit copies of their papers in a public archive. Starting as soon as next spring, researchers who haven’t complied will not receive the next installment of their grant. Press Release

Upcoming Changes to Public Access Policy Reporting Requirements and Related NIH Efforts to Enhance Compliance (NOT-OD-12-160)

Enhancing GTEx with Molecular Analyses of Stored Biospecimens (U01) (RFA-RM-12-009)

Office of the Director, National Institutes of Health; Notice of Meeting (FR Doc No: 2012-27591)

November 29, 2012: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Waivers for Conflicts of Interest

November 14 – 15, 2012: Vaccines and Related Biological Products Advisory Committee Meeting: Draft Agenda

Food and Drug Administration (United States)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act (FR Doc No: 2012-27881)

Therapeutic Goods Administration (Australia)

Documents Released Under Section 11C of the Freedom of Information Act 1982

Advisory Committee on Biologicals (ACB)

Product Quality Scientist (STEMCELL Technologies, Inc.)

Scientist – Endothelial Cell Research (STEMCELL Technologies, Inc.)

Research Technologist – Cell Separation (STEMCELL Technologies, Inc.)

Scientist or Engineer – hPSC Bioengineer (STEMCELL Technologies, Inc.)

Quality Control Analyst – Cell Separation (STEMCELL Technologies, Inc.)

Postdoctoral Position – Pathophysiology of Brain Tumors (UMR 6301 ISTCT)

Scientist, Postdoctoral and Research Associate Positions (University of Miami – Sylvester Comprehensive Cancer Center)

Postdoctoral Positions in Cell Biology, Biophysics and Neurobiology (University of Missouri – Kansas City)

Postdoctoral Fellow in Stem Cell Tissue Engineering (Stanford University School of Medicine)

Cell Therapy Researcher (Bioiberica SA)

Principal Investigator – Stem Cell and Cardiovascular Diseases (Heart Center, Second Affiliated Hospital, Zhejiang University School of Medicine)

Postdoctoral Position – Tumor Stem Cells (Cancer Institute of New Jersey)

Quality Assurance Manager (The University of Texas Medical School at Houston)


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