Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/3114
Título : 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
Autor : 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
Filiación: [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.
Palabras clave : 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
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
Fecha de publicación : 24-Sep-2017
Editorial : BMJ Publishing Group
Cita Bibliográfica: 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
Versión del editor : https://bmjopen.bmj.com/content/7/9/e016487.long
DOI: 10.1136/bmjopen-2017-016487
ISSN : 2044-6055 (Online)
Appears in Collections:01- Artículos - Hospital San Cecilio
01- Artículos - Hospital San Cecilio
01- Artículos - Hospital Virgen de las Nieves
01- Artículos - Red Andaluza de Diseño y Traslación de Terapias Avanzadas

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