Cell Therapy News Volume 13.30 | Aug 6 2012

Spray-Applied Cell Therapy with Human Allogeneic Fibroblasts and Keratinocytes for the Treatment of Chronic Venous Leg Ulcers: A Phase II, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
HP802-247 is a novel spray-applied cell therapy containing growth-arrested allogeneic neonatal keratinocytes and fibroblasts. Researchers compared different cell concentrations and dosing frequencies of HP802-247 for benefit and harm when applied to chronic venous leg ulcers. [Lancet] Abstract | Press Release

Targeting Nuclear RNA for In Vivo Correction of Myotonic Dystrophy
In a transgenic mouse model of myotonic dystrophy type 1, systemic administration of antisense oligonucleotides caused a rapid knockdown of expanded CUG RNA in skeletal muscle, correcting the physiological, histopathologic and transcriptomic features of the disease. [Nature] Abstract | Press Release

Scl Represses Cardiomyogenesis in Prospective Hemogenic Endothelium and Endocardium
Scl^-/- endothelium upregulated the expression of Wnt antagonists, which promoted rapid cardiomyocyte differentiation of ectopic cardiogenic cells. These results reveal unexpected plasticity in embryonic endothelium such that loss of a single master regulator can induce ectopic cardiomyogenesis from endothelial cells. [Cell] Abstract | Press Release

Small Molecule-Mediated TGF-β Type II Receptor Degradation Promotes Cardiomyogenesis in Embryonic Stem Cells
1,4-dihydropyridine inducer of type II TGF-β receptor degradation-1 (ITD-1) selectively enhanced the differentiation of uncommitted mesoderm to cardiomyocytes, but not to vascular smooth muscle and endothelial cells. ITD-1 is a highly selective TGF-β inhibitor and reveals an unexpected role for TGF-β signaling in controlling cardiomyocyte differentiation from multipotent cardiovascular precursors. [Cell Stem Cell]
Abstract | Press Release

The Role of MicroRNA-146a in the Pathogenesis of the Diabetic Wound-Healing Impairment: Correction with Mesenchymal Stem Cell Treatment
Correction of the diabetic wound-healing impairment with mesenchymal stem cell treatment was associated with a significant increase in the microRNA-146a (miR-146a) expression level and decreased gene expression of its proinflammatory target genes. These results provide the first evidence that decreased expression of miR-146a in diabetic wounds in response to injury may, in part, be responsible for the abnormal inflammatory response seen in diabetic wounds and may contribute to wound-healing impairment. [Diabetes] Abstract

Inhibition of Mechanistic Target of Rapamycin Promotes Dendritic Cell Activation and Enhances Therapeutic Autologous Vaccination in Mice
Researchers showed that brief exposure to inhibitors of mechanistic target of rapamycin in dendritic cells (DCs) during the period that they are responding to TLR agonists makes them particularly potent activators of naive CD8+ T cells and able to enhance control of B16 melanoma in a therapeutic autologous vaccination model in the mouse. [J Immunol] Abstract | Press Release

1α,25-Dihydroxyvitamin D₃ Modulates the Hair-Inductive Capacity of Dermal Papilla Cells: Therapeutic Potential for Hair Regeneration
In a rat model of de novo hair regeneration by murine dermal papilla cell transplantation, pretreatment with 1α,25-dihydroxyvitamin D₃ significantly enhanced hair folliculogenesis. Specifically, a greater number of outgrowing hair shafts and higher maturation of regenerated follicles were observed. [Stem Cells Transl Med]
Abstract | Press Release

Ischemia-Reperfusion Increases Transfection Efficiency of Intracoronary Adenovirus Type 5 in Pig Heart In Situ
Researchers tested whether transfection efficiency of adenoviral vector following intracoronary infusion is improved by nitrates or by ischemia. [Hum Gene Ther Methods] Abstract | Press Release

Advaxis Reports Updated Phase II Cervical Cancer Trial Data
Advaxis, Inc. (ADXS) presented updated preliminary data from an ongoing randomized Phase II trial of ADXS-HPV being conducted in India in women with recurrent/refractory cervical cancer who have failed previous cytotoxic therapy. ADXS-HPV is an immunotherapy that is designed to target cells expressing the HPV gene E7. [Press release from Advaxis, Inc. discussing research presented at the Immunotherapy Subcommittee Workshop of the Gynecologic Oncology Group (GOG) Meeting, Boston] Press Release

Alnylam Presents New Data from Its Conjugate Delivery Platform, Enabling Subcutaneous Administration of RNAi Therapeutics with Wide Therapeutic Index
Alnylam Pharmaceuticals, Inc. is presenting new data from its GalNAc-conjugate siRNA programs for the systemic delivery of RNAi therapeutics. GalNAc-conjugate siRNA are designed to achieve targeted delivery of RNAi therapeutics to hepatocyte cells of the liver through uptake by the asialoglycoprotein receptor. [Press release from Alnylam Pharmaceuticals, Inc. discussing research to be presented at the XX International Roundtable on Nucleosides, Nucleotides and Nucleic Acids, Montreal] Press Release

Hopes Dashed for Solo Serbian Science Ministry
The newly formed Serbian government has defied recommendations from the country’s scientific community: it will not re-establish the dedicated science ministry that was abolished last year. [Serbian Government, Serbia] Press Release

Texas Cancer Research Board Approves Slate of Delayed Grants
One of the key issues in an uproar over grant making that has roiled Texas’s $3 billion cancer research fund receded when the agency’s board approved $39 million in research grants that it had set aside earlier this year. [Cancer Prevention and Research Institute of Texas, United States] Press Release

Court Orders Temporary Closure of Italian Dog-Breeding Premises
One of the largest suppliers of dogs for drug research in Europe could struggle to survive after an Italian court ordered that it be closed temporarily. [Italian Court, Italy] Press Release

Novartis and University of Pennsylvania Form Broad-Based R&D Alliance to Advance Novel T-Cell Immunotherapies to Treat Cancer
Novartis and the University of Pennsylvania (Penn) announced an exclusive global collaboration to research, develop and commercialize targeted chimeric antigen receptor immunotherapies for the treatment of cancers. In addition, the parties will jointly establish a new research and development facility on the Penn campus, called the Center for Advanced Cellular Therapies. [Novartis AG] Press Release

Cleveland BioLabs Signs Contract for Approximately $4 Million with Russian Ministry of Industry and Trade for Development of CBLB612
Cleveland BioLabs, Inc. announced that, through a wholly-owned Russian subsidiary, it has signed a contract valued at 139 million rubles, or approximately $4 million, with the Ministry of Industry and Trade of the Russian Federation for development of CBLB612, a drug in development for stimulation of hematopoietic stem cell proliferation and mobilization. [Cleveland BioLabs, Inc.] Press Release

ABL Awarded NIH Contract to Fund up to $102 Million in Biologics Manufacturing and Characterization Services
Advanced BioScience Laboratories, Inc. (ABL) announced the award of a contract to provide the NIH National Institute of Allergy and Infectious Diseases (NIAID) with preclinical development and cGMP manufacturing support for multiple vaccine and biologic products identified by NIAID Program staff.  The contract has a funding potential of up to $102 million over ten years, subject to availability of annual appropriations. [Advanced BioScience Laboratories, Inc.] Press Release

ImmunoCellular Therapeutics Announces Clearance of IND Application for Phase I Study of Company’s Second Vaccine Product Candidate in Recurrent GBM
ImmunoCellular Therapeutics (IMUC) announced that the U.S. Food and Drug Administration has given clearance to a physician sponsored investigative new drug (IND) application to initiate a Phase I clinical trial of ICT-121, IMUC’s novel dendritic-cell-based vaccine targeting CD-133, an antigen that is highly expressed by multiple solid tumors. [Business Wire] Press Release

Pluristem’s PLX Cells Show Efficacy in Treating Lung Disease
Pluristem Therapeutics, Inc. announced the results of new preclinical tests that show its PLacental eXpanded (PLX) cells may be effective in reducing pulmonary fibrosis and improving lung function in a group of diseases collectively called interstitial lung disease. [Pluristem Therapeutics, Inc.] Press Release

FDA Gives Miami Project to Cure Paralysis Green Light to Begin Human Clinical Trial
The Miami Project to Cure Paralysis has received permission from the Food and Drug Administration (FDA) to begin a revolutionary Phase I clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal cord injuries. [Miami Project to Cure Paralysis, University of Miami] Press Release

NEW: StemSpan™ ACF, the First Plasma Component-Free Hematopoietic Expansion Media
STEMCELL Technologies Inc. announced the launch of StemSpan™ ACF, a new animal component-free (ACF) and chemically-defined hematopoietic stem cell expansion medium, which contains no animal and human plasma-derived components. [STEMCELL Technologies Inc.] Press Release

NIH Announces Winners of Undergraduate Biomedical Engineering Competition
The National Institute of Biomedical Imaging and Bioengineering announced the winners in the three categories of the DEBUT challenge, a biomedical engineering design competition for teams of undergraduate students. [National Institutes of Health, United States] Press Release

National Heart, Lung, and Blood Institute; Notice of Closed Meetings (FR Doc No: 2012-18477)

National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting (FR Doc No: 2012-18788)

Government-Owned Inventions; Availability for Licensing (FR Doc No: 2012-18651)

Clinical Center; Notice of Meeting (FR Doc No: 2012-18877)

2012 Biological License Application Approvals

2012 Biological Device Application Approvals

Food and Drug Administration (United States)

Biosimilar User Fee Rates for Fiscal Year 2013 (FR Doc No: 2012-18712)

Blood Products Advisory Committee; Notice of Meeting (FR Doc No: 2012-18724)

Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability (FR Doc No: 2012-18603)

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

Scientific Communications & Publishing Coordinator (STEMCELL Technologies, Inc.)

Quality Control Operations Coordinator (STEMCELL Technologies, Inc.)

Research Technologist – Research and Development (STEMCELL Technologies, Inc.)

Research Technologist – Media Development (STEMCELL Technologies, Inc.)

Postdoctoral Research Position (University Lille 2 France)

Postdoctoral Position – Stem Cells (Children’s Hospital of Chicago Research Center)

Postdoctoral Position – Induced Pluripotent Stem Cell Research (University of Washington)

Chief Scientific and Medical Officer (Living Cell Technologies)

Postdoctoral Fellowship (Vaccine & Gene Therapy Institute, Florida)


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