The VISICORT Clinical Trial has been designed as a phase 1b clinical trial with the aim of investigating the safety, feasibility and preliminary efficacy of plastic adherent, allogeneic bone marrow‐derived MSC (allo-hBM-MSC) as a novel immunomodulatory cell therapy for corneal transplant recipients at high risk for acute rejection due to loss of a previous corneal transplant. The primary objective of the VISICORT trial is to determine the safety and tolerability of two intravenous (i.v.) infusions of allo-hBM-MSC given during the week prior to corneal re-transplantation. The VISICORT trial will follow a dose‐escalating design. Two sequential groups of 4 patients will be randomly allocated to receive two i.v. infusions of 80 or 160 million cells per infusion of plastic adherent allo-hBM-MSC generated from the bone marrow of healthy adult donors by an approved manufacturing process. Treatment will be administered in the context of on‐going, independent standard of care medical management.
This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 602470. The material presented and views expressed here are the responsibility of the author(s) only. The EU Commission takes no responsibility for any use made of the information set out.