RT Journal Article
T1 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
A1 González-Andrades, Miguel
A1 Mata, Rosario
A1 González-Gallardo, María del Carmen
A1 Medialdea, Santiago
A1 Arias-Santiago, Salvador
A1 Martínez-Atienza, Juliana
A1 Ruiz-García, Antonio
A1 Pérez-Fajardo, Lorena
A1 Lizana-Moreno, Antonio
A1 Garzón, Ingrid
A1 Campos, Antonio
A1 Alaminos, Miguel
A1 Carmona, Gloria
A1 Cuende, Natividad
K1 Corneal transplantation
K1 Corneal ulcer
K1 Stromal fibrosis
K1 Limbal stem cell deficiency
K1 Tissue bioengineering
K1 Randomized controlled trial
K1 Transplante de córnea
K1 Úlcera de la cornea
K1 Ingeniería de tejidos
K1 Ensayo clínico controlado aleatorio
AB IntroductionThere 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.Methods and analysisThis 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.Ethics and disseminationThe 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.Trial registrationCT.gov identifier: NCT01765244 (Jan2013). EudraCT number: 2010-024290-40 (Dec2012).
PB BMJ Publishing Group
YR 2017
FD 2017-09-24
LK http://hdl.handle.net/10668/3114
UL http://hdl.handle.net/10668/3114
LA en
NO González-Andrades M, Mata R, González-Gallardo MdC, Medialdea S, Arias-Santiago S, Martínez-Atienza J, et al. 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. BMJ Open. 2017; 7:e016487. doi:10.1136/ bmjopen-2017-016487
DS RISalud
RD Apr 10, 2025