Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/3114
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dc.contributor.authorGonzález-Andrades, Miguel-
dc.contributor.authorMata, Rosario-
dc.contributor.authorGonzález-Gallardo, María del Carmen-
dc.contributor.authorMedialdea, Santiago-
dc.contributor.authorArias-Santiago, Salvador-
dc.contributor.authorMartínez-Atienza, Juliana-
dc.contributor.authorRuiz-García, Antonio-
dc.contributor.authorPérez-Fajardo, Lorena-
dc.contributor.authorLizana-Moreno, Antonio-
dc.contributor.authorGarzón, Ingrid-
dc.contributor.authorCampos, Antonio-
dc.contributor.authorAlaminos, Miguel-
dc.contributor.authorCarmona, Gloria-
dc.contributor.authorCuende, Natividad-
dc.date.accessioned2020-05-15T17:38:14Z-
dc.date.available2020-05-15T17:38:14Z-
dc.date.issued2017-09-24-
dc.identifier.citationGonzález-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-2017-016487es_ES
dc.identifier.issn2044-6055 (Online)es_ES
dc.identifier.otherPMC5623476es_ES
dc.identifier.urihttp://hdl.handle.net/10668/3114-
dc.description.abstractIntroduction 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).es_ES
dc.description.sponsorshipThis Clinical trial is investigator-driven and partially supported by a research grant for the promotion of investigator-driven clinical research from the Spanish Ministry of Health, Social Policy and Equity (Grant Number: EC10-285). This study is also supported by the National Plan for Scientific Research, Development and Innovation from the Spanish Ministry of Economy and Competitiveness (Institute of Health Carlos III), grant code: FIS PI14/0955 (co-financed by FEDER funds, European Union). Finally, the study is supported too by the Regional Ministry of Health of Andalusia, who finances the costs incurred by participating hospitals, and the Andalusian Initiative for Advanced Therapies. The Andalusian Initiative for Advanced Therapies, through the Andalusian Progress and Health Public Foundation, assumes the roles and responsibilities of sponsoring this clinical trial.es_ES
dc.format.extent10 p.es_ES
dc.language.isoenes_ES
dc.publisherBMJ Publishing Groupes_ES
dc.relation.ispartofBMJ openes_ES
dc.subjectCorneal transplantationes_ES
dc.subjectCorneal ulceres_ES
dc.subjectStromal fibrosises_ES
dc.subjectLimbal stem cell deficiencyes_ES
dc.subjectTissue bioengineeringes_ES
dc.subjectRandomized controlled triales_ES
dc.subjectTransplante de córneaes_ES
dc.subjectÚlcera de la corneaes_ES
dc.subjectIngeniería de tejidoses_ES
dc.subjectEnsayo clínico controlado aleatorioes_ES
dc.subject.meshMedical Subject Headings::Persons::Persons::Age Groups::Adultes_ES
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Case-Control Studieses_ES
dc.subject.meshMedical Subject Headings::Diseases::Eye Diseases::Corneal Diseaseses_ES
dc.subject.meshMedical Subject Headings::Anatomy::Cells::Connective Tissue Cells::Fibroblasts::Corneal Keratocyteses_ES
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Tissue Transplantation::Corneal Transplantationes_ES
dc.subject.meshMedical Subject Headings::Anatomy::Tissues::Epithelium::Epithelium, Corneales_ES
dc.subject.meshMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humanses_ES
dc.subject.meshMedical Subject Headings::Check Tags::Femalees_ES
dc.subject.meshMedical Subject Headings::Check Tags::Malees_ES
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Pilot Projectses_ES
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Culture Techniques::Cell Engineering::Tissue Engineeringes_ES
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcomees_ES
dc.titleA 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 treatmentes_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.description.versionYeses_ES
dc.identifier.pmid28947445es_ES
dc.rights.accessRightsAcceso abiertoes_ES
dc.identifier.doi10.1136/bmjopen-2017-016487es_ES
dc.type.versioninfo:eu-repo/semantics/publishedes_ES
dc.relation.publisherversionhttps://bmjopen.bmj.com/content/7/9/e016487.longes_ES
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.es_ES
dc.type.subtypeArtículo originales_ES
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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