trophic corneal ulcers refractaries to conventional treatment MedDRA version: 14.1 Level: LLT Classification code 10048492 Term: Corneal ulcer System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: human nanostructured artificial cornea
Pharmaceutical Form: Ophthalmic insert
INN or Proposed INN: expanded human cells in culture from small biopsies of human scleral-corneal limbus fro
Sponsors
FUNDACIÓN PROGRESO Y SALUD
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| 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. 2.- To implant the autologous human artificial nanostructured corneas in a group of patients with severe corneal disease by partial anterior lamellar keratoplasty. 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 | — |
Countries
Spain
Contacts
Public ContactANA CARDESA GIL
INICIATIVA ANDALUZA EN TERAPIAS AVANZADAS
Outcome results
None listed