CompletedPhase 1 / Phase 2

Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients

NCT00736307 · Royan Institute

Closed to entry

Status

Not accepting participants

Phase 1 / Phase 2

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Snellen visual acuity
Measured over 6 months
corneal epithelial integrity and stability
Measured over 6 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 75 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: * Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization * Presence of Goblet cells on the cornea * Minimum tear was about 5 mm * Minimum duration of deficiency was 3 years * Vision was Light Perception Exclusion Criteria: * Systemic disease affecting both eyes such as Stevens-Johnson syndrome

Where

2 study sites

Facility	City	Region	Country
Royan Institute	Tehran	Tehran Province	Iran
Labbafinejad Ophthalmic Research Center	Tehran	Tehran Province	Iran

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT00736307 on ClinicalTrials.gov →

Last updated in the registry 2011-07-15. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance