Allogeneic Tissue Engineering (Nanostructured Artificial Human Cornea) in Patients With Corneal Trophic Ulcers in Advanced Stages, Refractory to Conventional (Ophthalmic) Treatment

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

January 17, 2014

Primary Completion Date

January 14, 2021

Study Completion Date

January 14, 2021

Conditions
Severe Trophic Corneal Ulcers Refractory to Conventional TreatmentSequelae of Previous Trophic Corneal Ulcers
Interventions
DRUG

Anterior lamellar nanostructured artificial human cornea.

Implantation of an anterior lamellar nanostructured artificial human cornea with allogeneic cells from dead donors embedded in a fibrin-agarose scaffold

OTHER

Amniotic membrane transplantation

Implantation of an amniotic membrane graft to cover the corneal scarring using the mixed graft/patch technique.

Trial Locations (11)

11009

University Hospital Puerta del Mar, Cadiz

18012

University Hospital San Cecilio, Granada

18014

University Hospital Virgen de las Nieves, Granada

41009

University Hospital Virgen Macarena, Seville

41013

University Hospital Virgen de Rocío, Seville

Unknown

Hospital San Juan de Dios, Bormujos

Hospital la Arruzafa, Córdoba

Hospital Universitario Reina Sofía, Córdoba

Hospital Costa del Sol, Marbella

Marina Rodriguez Calvo-Mora, Málaga

Hospital Nuestra Señora de Valme, Seville

All Listed Sponsors
collaborator

Iniciativa Andaluza en Terapias Avanzadas

OTHER

lead

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

OTHER

NCT01765244 - Allogeneic Tissue Engineering (Nanostructured Artificial Human Cornea) in Patients With Corneal Trophic Ulcers in Advanced Stages, Refractory to Conventional (Ophthalmic) Treatment | Biotech Hunter | Biotech Hunter