CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Implantation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05279157
NCT05279157Phase 2Completed

Implantation of Autologous Mesenchymal Stem Cells of Adipose Origin for the Treatment of Corneal Diseases

Vissum, Instituto Oftalmológico de Alicante·interventional·Posted Mar 15, 2022·Updated May 6, 2023

In Brief

A Phase 2 clinical trial evaluating Implantation and Lipoaspiration for Ophthalmological Disorder and 4 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Cellular therapy of the corneal stroma with implantation of mesenchymal stem cells derived from autologous adipose tissue with or without a carrier (scaffold) composed by decellularized human donor corneal stroma is used in patients with corneal diseases such as corneal dystrophies, and keratoconus. For this purpose, the study planned to assess the enhancement of visual acuity, pachymetric, and aberrometric parameters with implantation of autologous mesenchymal adipose tissue-derived adult stem cells (ADASCs) alone, 120 µm thickness of decellularized or recellularized laminas with ADASCs. Three groups will be included in the study: (1) Implantation of a single dose of ADASCs alone without scaffold. (2) Implantation of decellularized human corneal lamina without ADASCs. (3) Implantation of the recellularized human corneal lamina with ADASCs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 15, 2022
Enrollment StartApr 19, 2022
Primary CompletionFeb 5, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.3 years ago

Interventions

Implantationprocedure

Procedure: Implantation The ophthalmologist will carry out the implantation of the ADASCs cells with or without scaffold in the intrastromal cornea of the patient

Lipoaspirationprocedure

Procedure: Lipoaspiration The patient will have a liposuction surgery from which the autologous ADASCs implant in the cornea will be obtained. Procedure: Implantation The ophthalmologist will carry out the implantation of the ADASCs with or without scaffold in the intrastromal cornea of the patient