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

NCT01765244 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-01-20

No results posted yet for this study

Summary

This is a prospective, phase I-II, randomised, open-label clinical trial that will evaluate the safety and feasibility, as well as clinical efficacy evidence, of a bioengineered anterior corneal substitute in adults with severe trophic corneal ulcers. This model of human anterior allogeneic cornea will provide an alternative approach in cases where human donor keratoplasty is not an option.

Conditions

  • Severe Trophic Corneal Ulcers Refractory to Conventional Treatment
  • Sequelae 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.

Sponsors & Collaborators

  • Iniciativa Andaluza en Terapias Avanzadas

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Santiago Medialdea, MD, PhD · Hospital U Virgen de las Nieves

  • Miguel Alaminos, MD, PhD · Universidad de Granada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-17
Primary Completion
2021-01-14
Completion
2021-01-14

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01765244 on ClinicalTrials.gov