Please use this identifier to cite or link to this item:
http://hdl.handle.net/10668/3114
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 |
metadata.dc.contributor.authoraffiliation: | [González-Andrades,M; González-Gallardo,MC; Medialdea,S] Department of Ophthalmology Service, University Hospital Complex of Granada (San Cecilio and Virgen de las Nieves Hospitals), Granada, Spain. [González-Andrades,M; Garzón,I; Campos,A; Alaminos,M] Tissue Engineering Group, Department of Histology, University of Granada, Granada, Spain. [González-Andrades,M] Department of Ophthalmology, Schepens Eye Research Institute of Massachusetts, Harvard Medical School, Boston, Massachusetts, USA. [Mata,R; Martínez-Atienza,J; Pérez-Fajardo,L; Carmona,G; Cuende,N] Andalusian Initiative for Advanced Therapies, Junta de Andalucía, Seville, Spain. [Arias-Santiago,S; Ruiz-García,A; Lizana-Moreno,A] Cell Therapy and Tissue Engineering Unit, University Hospital Complex of Granada (Virgen de las Nieves Hospital), Granada, Spain. [Ruiz-García,A; Carmona,G] PhD program Clinical Medicine and Public Health, University of Granada, Granada, Spain. |
Keywords: | Corneal transplantation;Corneal ulcer;Stromal fibrosis;Limbal stem cell deficiency;Tissue bioengineering;Randomized controlled trial;Transplante de córnea;Úlcera de la cornea;Ingeniería de tejidos;Ensayo clínico controlado aleatorio |
metadata.dc.subject.mesh: | Medical Subject Headings::Persons::Persons::Age Groups::Adult Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Case-Control Studies Medical Subject Headings::Diseases::Eye Diseases::Corneal Diseases Medical Subject Headings::Anatomy::Cells::Connective Tissue Cells::Fibroblasts::Corneal Keratocytes Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Tissue Transplantation::Corneal Transplantation Medical Subject Headings::Anatomy::Tissues::Epithelium::Epithelium, Corneal Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans Medical Subject Headings::Check Tags::Female Medical Subject Headings::Check Tags::Male Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Pilot Projects Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Culture Techniques::Cell Engineering::Tissue Engineering Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome |
Issue Date: | 24-Sep-2017 |
Publisher: | BMJ Publishing Group |
Citation: | 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 |
Abstract: | Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration CT.gov identifier: NCT01765244 (Jan2013). EudraCT number: 2010-024290-40 (Dec2012). |
URI: | http://hdl.handle.net/10668/3114 |
metadata.dc.relation.publisherversion: | https://bmjopen.bmj.com/content/7/9/e016487.long |
metadata.dc.identifier.doi: | 10.1136/bmjopen-2017-016487 |
ISSN: | 2044-6055 (Online) |
Appears in Collections: | 01- Artículos - Hospital San Cecilio 01- Artículos - Hospital Virgen de las Nieves 01- Artículos - Red Andaluza de Diseño y Traslación de Terapias Avanzadas |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
GonzalezAndrades_AStudyProtocolFor.pdf | Artículo publicado | 1,46 MB | Adobe PDF | View/Open |
This item is protected by original copyright |
This item is licensed under a Creative Commons License