Please use this identifier to cite or link to this item:
Title: A study protocol for a multicentre randomised clinical trial evaluating the safety and feasibility of a bioengineered human allogeneic nanostructured anterior cornea in patients with advanced corneal trophic ulcers refractory to conventional treatment.
Authors: González-Andrades, Miguel
Mata, Rosario
González-Gallardo, María Del Carmen
Medialdea, Santiago
Arias-Santiago, Salvador
Martínez-Atienza, Juliana
Ruiz-García, Antonio
Pérez-Fajardo, Lorena
Lizana-Moreno, Antonio
Garzón, Ingrid
Campos, Antonio
Alaminos, Miguel
Carmona, Gloria
Cuende, Natividad
Keywords: corneal transplantation;corneal ulcer;limbal stem cell deficiency;randomized controlled trial;stromal fibrosis;tissue bioengineering
metadata.dc.subject.mesh: Adult
Case-Control Studies
Corneal Diseases
Corneal Keratocytes
Corneal Transplantation
Epithelium, Corneal
Pilot Projects
Tissue Engineering
Treatment Outcome
Issue Date: 24-Sep-2017
Abstract: There is a need to find alternatives to the use of human donor corneas in transplants because of the limited availability of donor organs, the incidence of graft complications, as well as the inability to successfully perform corneal transplant in patients presenting limbal deficiency, neo-vascularized or thin corneas, etc. We have designed a clinical trial to test a nanostructured fibrin-agarose corneal substitute combining allogeneic cells that mimics the anterior human native cornea in terms of optical, mechanical and biological behaviour. This is a phase I-II, randomised, controlled, open-label clinical trial, currently ongoing in ten Spanish hospitals, to evaluate the safety and feasibility, as well as clinical efficacy evidence, of this bioengineered human corneal substitute in adults with severe trophic corneal ulcers refractory to conventional treatment, or with sequelae of previous ulcers. In the initial phase of the trial (n=5), patients were sequentially recruited, with a safety period of 45 days, receiving the bioengineered corneal graft. In the second phase of the trial (currently ongoing), subjects are block randomised (2:1) to receive either the corneal graft (n=10), or amniotic membrane (n=5), as the control treatment. Adverse events, implant status, infection signs and induced neovascularization are evaluated as determinants of safety and feasibility of the bioengineered graft (main outcomes). Study endpoints are measured along a follow-up period of 24 months, including 27 post-implant assessment visits according to a decreasing frequency. Intention to treat, and per protocol, and safety analysis will be performed. The trial protocol received written approval by the corresponding Ethics Committee and the Spanish Regulatory Authority and is currently recruiting subjects. On completion of the trial, manuscripts with the results of phases I and II of the study will be published in a peer-reviewed journal. identifier: NCT01765244 (Jan2013). EudraCT number: 2010-024290-40 (Dec2012).
metadata.dc.identifier.doi: 10.1136/bmjopen-2017-016487
Appears in Collections:Producción 2020

Files in This Item:
File SizeFormat 
PMC5623476.pdf1,44 MBAdobe PDFView/Open

This item is protected by original copyright

This item is licensed under a Creative Commons License Creative Commons