Cell Therapy News Volume 16.04 | Feb 2 2015

Adoptive T-Cell Therapy with Hexon-Specific T_HELPER-1 Cells as a Treatment for Refractory Adenovirus Infection after HSCT
Scientists analyzed safety and efficacy of ex vivo adoptive T-cell transfer with hexon-specific T cells, predominantly of T_HELPER-1 phenotype, in 30 patients with adenovirus disease/viremia. [Blood] Abstract

Evaluation of the Effect of the Structure of Bacterial Cellulose on Full Thickness Skin Wound Repair on a Microfluidic Chip
The hierarchical structure of bacterial cellulose film and their different effects on skin wound healing were studied both in vitro and in vivo. [Biomacromolecules] Abstract

Three-Dimensional Functional Human Myocardial Tissues Fabricated from Induced Pluripotent Stem Cells
Human induced pluripotent stem (iPS) cells were differentiated into cardiomyocytes to fabricate cardiomyocyte sheets. Three-layer human iPS cardiomyocyte sheets were transplanted on subcutaneous tissues of nude rats. [J Tissue Eng Regen Med] Abstract

Inhibition of Human Diffuse Large B-Cell Lymphoma Growth by JC Polyomavirus-Like Particles Delivering a Suicide Gene
Human B-lymphocytes are susceptible to JC polyomavirus (JCPyV) infection, and JCPyV virus-like particles (VLPs) can effectively deliver exogenous genes to susceptible cells for expression, suggesting the feasibility of using JCPyV VLPs as gene therapy vectors for diffuse large B-cell lymphoma (DLBCL). Researches packaged JCPyV VLPs with a suicide gene encoding thymidine kinase to inhibit the growth of DLBCL in vitro and in vivo. [J Transl Med] Abstract | Full Article

The Dose-Effect Safety Profile of Skeletal Muscle Precursor Cell Therapy in a Dog Model of Intrinsic Urinary Sphincter Deficiency
Investigators tested the dose-effect safety profile of skeletal muscle precursor cell (skMPC) therapy in a dog model of intrinsic urinary sphincter deficiency. skMPCs isolated from the hind leg were expanded in culture and injected four weeks later into the sphincter complex. [Stem Cells Transl Med] Abstract

Cold-Preservation of Human Adult Hepatocytes for Liver Cell Therapy
The authors assessed how cold storage in three clinically safe preservative solutions affects the viability and in vitro functionality of human hepatocytes. Then they evaluated whether such cold-preserved human hepatocytes could engraft and repopulate damaged livers in a mouse model of liver failure. [Cell Transplant] Full Article

In Situ Vascularization of Injectable Fibrin/Poly(Ethylene Glycol) Hydrogels by Human Amniotic Fluid-Derived Stem Cells
Investigators utilized fibrin-based hydrogels to serve as a foundation for vascular formation, poly(ethylene glycol) to modify fibrinogen and increase scaffold longevity, and human amniotic fluid-derived stem cells (AFSC) as a source of vascular cell types. They hypothesized that subcutaneously injecting these hydrogels in immunodeficient mice would both induce a fibrin-driven angiogenic host response and promote in situ AFSC-derived neovascularization. [J Biomed Mater Res A] Abstract

Adoptive T-Cell Therapy of Prostate Cancer Targeting the Cancer Stem Cell Antigen EpCAM
To investigate the therapeutic capabilities of peripheral blood lymphocytes (PBLs) expressing EpCAM-specific chimeric antigen receptors (CARs), scientists used two different tumor models, PC3, the human prostate cancer cell line, which has low expression levels of EpCAM, and PC3M, a highly metastatic clone of PC3 that has high expression levels of EpCAM. They demonstrate that CAR-expressing PBLs can kill PC3M tumor cells in vitro and in vivo. [BMC Immunol] Abstract | Full Article

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Stem Cell Therapy for Heart Failure: First Implant of Cardiac Cells Derived from Human Embryonic Stem Cells
Researchers carried out a transplant of cardiac cells derived from human embryonic stem cells. The surgery, coupled with a coronary bypass, was carried out on a woman of 68 years suffering from severe heart failure. [Inserm] Press Release

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End of the Road for Myriad Gene Patent Fight
The molecular diagnostics company Myriad Genetics has put an end to a long battle to defend controversial patents on genetic tests for cancer risk. Several of the companies Myriad was suing for patent infringement announced settlements, and The New York Times reports that the company is in discussions to settle the remaining suits. [ScienceInsider] Editorial

Biogen Idec, Fondazione Telethon and Ospedale San Raffaele Announce Global Collaboration to Develop Gene Therapies for Hemophilia
Biogen Idec, Fondazione Telethon and Ospedale San Raffaele have entered into a worldwide collaboration to jointly develop gene therapies for the treatment of both hemophilia A and B. [Biogen Idec] Press Release

Gynecologic Oncology Group (GOG) Phase II Study of Advaxis’s Lm-LLO Immunotherapy, ADXS-HPV, for the Treatment of Persistent or Recurrent Cervical Cancer Achieves Safety and Efficacy Criteria
Advaxis, Inc. announced an update related to the Phase II open-label clinical study of ADXS-HPV in patients with persistent or recurrent cervical cancer with documented disease progression being conducted by the GOG. [Advaxis, Inc.] Press Release

FDA Grants Breakthrough Therapy Designation to LentiGlobin for Treatment of Beta-Thalassemia Major
bluebird bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LentiGlobin^® BB305 Drug Product for the treatment of transfusion-dependent patients with beta-thalassemia major. [bluebird bio, Inc.] Press Release

FDA Grants Breakthrough Therapy Designation for Genentech’s Investigational Cancer Immunotherapy MPDL3280A (Anti-PDL1) in Non-Small Cell Lung Cancer
Genentech announced that it has received a second Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational cancer immunotherapy MPDL3280A. [Genentech, Inc.]
Press Release

Enlivex Granted EU Orphan Drug Designation for Lead Product ApoCell for Graft-Versus-Host Disease
Enlivex Therapeutics announced that the European Medicines Agency has granted orphan drug status to the company’s lead product candidate, ApoCell, for the prevention of graft-versus-host disease. [Enlivex Therapeutics (GlobeNewswire, Inc.)] Press Release

San Diego Team Wins $1.7 Million Grant from Stem Cell Agency to Develop Quality Control Methods
A team at The Scripps Research Institute has won a $1,784,000 grant from the California Institute for Regenerative Medicine. The funding will support the development of a new method for detecting DNA damage in stem cells to ensure that only the highest quality cells are used in transplantation or therapy. [The Scripps Research Institute] Press Release

Friedmann Named 2015 Japan Prize Winner
Theodore Friedmann, MD was named today one of three recipients of the 2015 Japan Prize. Friedmann is being recognized for his pioneering research and contributions to the development of gene therapy. [University of California, San Diego] Press Release

Government-Owned Inventions; Availability for Licensing (FR Doc. No: 2015-01610)

Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Metastatic Melanoma (FR Doc. No: 2014-27680)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing (FR Doc. No: 2015-01670)

Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792 (FR Doc. No: 2015-01404)

Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability (FR Doc. No: 2015-01410)

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Postdoctoral Fellow – Vascular Bioengineering (University of Pittsburgh)

Assistant/Associate Professor – Gastroenterology (North Carolina State University College of Veterinary Medicine)

Director (California Institute for Regenerative Medicine)

Postdoctoral Position – Immunology Animal Models (The Technical University of Denmark)

Postdoctoral Position – Inflammatory Bowel Disease (The Technical University of Denmark)

Postdoctoral Fellow – Wnt Signaling in Development and Disease (Van Andel Research Institute)

Cell Therapy Manufacturing Scientist (SLS Services Ltd.)

Postdoctoral Fellowship – CNS Inflammation (Rutgers University)

Scientist – Reprogramming and Pluripotent Stem Cell Biology (STEMCELL Technologies Inc.)

Scientist – PSC Biology and Bioengineering (STEMCELL Technologies Inc.)

Scientist – Pluripotent Stem Cell Media Development, High Throughput Screening (STEMCELL Technologies Inc.)

Scientist – Cell Culture Support Products (STEMCELL Technologies Inc.)

Scientist – Liver Cell Biology (STEMCELL Technologies Inc.)

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