Study of an artificial human tissue medicament for patients with severe corneal ulcers that not respond to conventional therapies.

• Conditions: trophic corneal ulcers refractaries to conventional treatment; MedDRA version: 14.1Level: LLTClassification code 10048492Term: Corneal ulcerSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-024290-40-ES
• Lead Sponsor: FUNDACIÓN PROGRESO Y SALUD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Last Update Posted: 14 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients give their informed consent for study participation.
2.Corneal ulcers stage 3 Mackie that do not respond to conventional medical treatment.
3.There must be involvement stromal, but with a depth not reach Descemet's membrane.
4.No active ocular infection
5.Duration of the disease causing corneal ulcer less than 6 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Absence of stromal involvement.
2.Corneal disease that responds well to standard medical treatments in a shorter period of 3 to 5 weeks.
3. Active ocular infection
4.Positive serology for HBV, HCV, HIV or coexistence of other pathology, at the discretion of the investigator, prevent patient monitoring in the trial.
5. Pregnancy or risk or pregnancy
6. History of previous diagnosis of neoplasia, except orbital neoplasia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety, feasibility and evidence of clinical efficacy of a model of human artificial nanostructured lamellar corneal, in patients with severe corneal disease for which there is currently no effective therapeutic.;Secondary Objective: 1.Generate artificial corneas nanostructured lamellar human allogeneic, from cadaver donor origin from sclero-corneal limbus and biomaterials<br>2.Implement the nanostructured artificial corneas human in a group of patients randomized to the experimental group, suffering from severe corneal disease. 3 .To evaluate the biosafety of nanostructured artificial corneas human implanted in patients to rule out adverse reactions of relevance.;Primary end point(s): To evaluate the safety, feasibility and evidence of clinical efficacy of a model of human artificial nanostructured lamellar corneal.;Timepoint(s) of evaluation of this end point: 24 month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.- To generate human artificial nanostructured corneas of autologous origin from tissue biopsies of the corneal limbus of a group of patients and fibrin-agarose biomaterials.<br>2.- To implant the autologous human artificial nanostructured corneas in a group of patients with severe corneal disease by partial anterior lamellar keratoplasty.<br>3.- To evaluate the level of biosafety of the implanted autologous human artificial nanostructured corneas to detect any significant adverse effect.;Timepoint(s) of evaluation of this end point: 24 month