Cell Therapy News Volume 15.34 | Sep 1 2014

In Vitro Generation of Neuromesodermal Progenitors Reveals Distinct Roles for Wnt Signaling in the Specification of Spinal Cord and Paraxial Mesoderm Identity
Researchers show that these neuromesodermal progenitors (NMPs) can readily be generated in vitro from mouse and human pluripotent stem cells by activating Wnt and Fgf signaling, timed to emulate in vivo development. Similar to NMPs in vivo, these cells co-express the neural factor Sox2 and the mesodermal factor Brachyury and differentiate into neural and paraxial mesoderm in vitro and in vivo. [PLoS Biol] Full Article

The Promotion of Functional Urinary Bladder Regeneration Using Anti-Inflammatory Nanofibers
Utilizing an established urinary bladder augmentation model, a highly pro-inflammatory biologic scaffold (decellularized small intestinal submucosa) was treated with anti-inflammatory peptide amphiphiles (AIF-PAs) or control peptide amphiphiles and used for augmentation. Functional urinary bladder testing revealed greater bladder compliance and similar capacities in groups treated with AIF-PAs. [Biomaterials] Abstract | Press Release

Mesenchymal Stem/Stromal Cells Protect the Ocular Surface by Suppressing Inflammation in an Experimental Dry Eye
Scientists investigated the therapeutic potential of mesenchymal stem/stromal cells in a murine model of an inflammation-mediated dry eye that was induced by an intraorbital injection of concanavalin A. [Mol Ther] Abstract

Anti-CD22 ⁹⁰Y-Epratuzumab Tetraxetan Combined with Anti-CD20 Veltuzumab: A Phase I Study in Patients with Relapsed/Refractory, Aggressive Non-Hodgkin Lymphoma
A lingering criticism of radioimmunotherapy in non-Hodgkin lymphoma is the use of cold anti-CD20 antibody along with the radiolabelled anti-CD20 antibody. Investigators instead combined radioimmunotherapy with immunotherapy targeting different B-cell antigens. [Haematologica] Abstract | Full Article

Systemic Infusion of Mesenchymal Stem Cells Improves Cell-Based Bone Regeneration via Upregulation of Regulatory T Cells
The authors show that bone marrow mesenchymal stem cells (BMMSCs) possessed an immunomodulatory function in vitro. Furthermore, they show that systemic BMMSC infusion significantly improved cell-based repair of critical-sized calvarial defects in a murine model. [Tissue Eng Part A] Abstract

Prolonged Prophylactic Protection from Botulism with a Single Adenovirus Treatment Promoting Serum Expression of a VHH-Based Antitoxin Protein
Scientists show that VHH-based neutralizing agents (VNAs) consisting of two or more linked, toxin-neutralizing heavy-chain-only V_H domains (VHHs), each binding distinct epitopes, can potently protect animals from lethality in several intoxication models including Botulinum neurotoxin serotype A1. A recombinant, replication-incompetent, adenoviral vector was engineered that induces secretion of biologically active VNA, H7/B5/ABP, from transduced cells. [PLoS One] Full Article | Press Release

Reconstruction of Beagle Hemi-Mandibular Defects with Allogenic Mandibular Scaffolds and Autologous Mesenchymal Stem Cells
Researchers tested whether treatment of graft with mesenchymal stem cells can increase the integration of massive allografts (hemi-mandible) in a large animal model. [PLoS One] Full Article

Gene Therapy for the Nervous System: Challenges and New Strategies
The recent development of genome editing technology, such as zinc finger nucleases, TALENS, and CRISPR, has made the ultimate goal of gene correction a step closer. This review summarizes the challenges faced by gene-based neurotherapeutics and the current and recent strategies designed to overcome these barriers. [Neurotherapeutics] Abstract

Visit our reviews page to see a complete list of reviews in the cell, gene and immunotherapy research field.

Asterias Biotherapeutics Receives U.S. FDA Clearance to Initiate Phase I/IIa Clinical Trial of AST-OPC1 in Patients with Cervical Complete Spinal Cord Injury
Asterias Biotherapeutics Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase I/IIa clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury. AST-OPC1 is a population of cells derived from human embryonic stem cells that contains oligodendrocyte progenitor cells. [Asterias Biotherapeutics Inc.] Press Release

White House Orders Biosafety Review at Federal Labs
The White House is asking federally funded labs studying infectious agents to take “immediate action” to inventory samples and review safety and security procedures in the wake of several high-profile accidents. [ScienceInsider] Editorial

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Advaxis and Merck Form Collaboration to Evaluate Investigational Combination of Two Novel Immunotherapy Candidates for Advanced Prostate Cancer
Advaxis, Inc. has entered into a clinical trial collaboration agreement with Merck to evaluate the combination of Advaxis’s Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck’s investigational anti PD-1 antibody, pembrolizumab. [Advaxis, Inc.] Press Release

OncoMed Pharmaceuticals Announces Removal of Partial Clinical Hold by the FDA for Vantictumab
OncoMed Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on enrollment in the company’s vantictumab (anti-Fzd7, OMP-18R5) Phase I clinical trials. Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase Ib clinical trials in patients with advanced non-small cell lung cancer, advanced HER2-negative breast cancer and advanced pancreatic cancer. [OncoMed Pharmaceuticals, Inc.] Press Release

Herbert Irving Comprehensive Cancer Center Has Designation Renewed by National Cancer Institute; Awarded $18 Million Grant
Outstanding basic research, a growing focus on translating discoveries into treatments, and a dedication to patient care have earned the Herbert Irving Comprehensive Cancer Center of Columbia University Medical Center and New York-Presbyterian Hospital an $18 million, five-year Cancer Center Support Grant from the National Cancer Institute. [Columbia University Medical Center] Press Release

Sorrento Awarded NIH Grant to Advance Immunotherapy Targeting Idiopathic Pulmonary Fibrosis (IPF)
Sorrento Therapeutics, Inc. announced that it has received funding to advance an immunotherapy targeting WNT1-inducible signaling protein-1 for the potential treatment of IPF, which affects more than 100,000 Americans. [Sorrento Therapeutics, Inc.] Press Release

TxCell Granted Five New Patents in Major Global Territories for Core Technology and ASTrIA Platform since January 2014
TxCell SA, a biotech developing innovative, personalized cell-based immunotherapies using antigen-specific regulatory T-cells for chronic inflammatory and autoimmune diseases, announced that five new patents for their technologies have been issued in the Unites States, Asia and Australia since the beginning of 2014. [TxCell SA] Press Release

Cellular Dynamics Awarded U.S. Patent Covering Automated Production of All Human Pluripotent Stem Cells
Cellular Dynamics International announced that the U.S. Patent and Trademark Office (PTO) awarded the company Patent No. 8,815,585 on the automated production of human pluripotent stem cells, including induced pluripotent stem cells. This patent has broad-reaching effects, covering research, cellular therapy development and stem cell banking. [Cellular Dynamics International, Inc.] Press Release

Glenmark Enters Oncology with the Discovery and the Initiation of IND Enabling Studies of an Innovative Bispecific Antibody
Glenmark Pharmaceuticals S.A. announced the discovery and initiation of IND enabling studies of a novel clinical development candidate, GBR 1302, a HER2xCD3 bispecific antibody. [Glenmark Pharmaceuticals S.A.]
Press Release

AFL Approves Use of Regeneus’ Stem Cell Therapy, HiQCell for Injured Players
Regeneus Ltd. announced that the Australian Football League (AFL) has granted case-by-case approval for the use of its innovative stem cell therapy, HiQCell^® as a treatment option for injured AFL players, typically including impact related osteoarthritis and tendonitis. [Regeneus Ltd.] Press Release

Center for Scientific Review; Notice of Closed Meetings (FR Doc. No: 2014-20544)

Final NIH Genomic Data Sharing Policy (FR Doc. No: 2014-20385)

Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Availability (FR Doc. No: 2014-20483)

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

NEW Postdoctoral Fellow – Cardiac Animal Surgery (Stanford University)

NEW Postdoctoral Position – Transplantation Aspects of Hepatocytes Derived from Human Pluripotent Stem Cells (INSERM UMR 1064)

Associate Research Fellow – Cell Therapy Manufacturing Process (Pfizer, Inc.)

Research Associate – Gene Therapy Center (University of Massachusetts)

Postdoctoral Fellow – Induced Pluripotent Stem Cell Based Therapeutics (Fred Hutchinson Cancer Research Center)

Postdoctoral Fellow – New Combination Immune Therapies for Cancer (Massachusetts General Hospital)

Postdoctoral Position – Scaffolding and Drug Delivery for Regenerative Medicine Applications (Ospedale Niguarda)

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.)

Scientist – Immunology/Cell Separation (STEMCELL Technologies Inc.)

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