CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Cultivation of Limbal epithelial cells into a graft +2 morebiological
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/NCT02592330
NCT02592330Phase 2Completed
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Safety and Feasibility of Cultivated Autologous Limbal Epithelial Cell Transplantation in the Treatment of Limbal Stem Cell Deficiency (LSCD)

Massachusetts Eye and Ear Infirmary·interventional·Posted Oct 30, 2015·Updated Jan 15, 2025

In Brief

A Phase 2 clinical trial evaluating Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft, Cultivation of Limbal epithelial cells into a graft, and 1 other intervention for Limbal Stem Cell Deficiency. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLimbal Stem Cell Deficiency
CountriesUnited States
CollaboratorsDana-Farber Cancer Institute

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 30, 2015
Enrollment StartAug 1, 2016
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 10.7 years ago

Interventions

Biopsy to collect limbal epithelial stem cells that will be cultivated into a graftprocedure

Cultivated autologous limbal epithelial cell (CALEC) therapy utilizes a bio-engineered composite of ex vivo expanded autologous corneal epithelial cells and an FDA-approved amniotic membrane (AmnioGraft®, Bio-Tissue, Inc.) to reconstruct the ocular surface. A small biopsy (2-3 mm2) from the patient's contralateral eye serves as a source epithelial (stem) cells that are expanded on the amniotic membrane in culture and the resulting product is surgically transplanted onto the cornea after excision of the fibrovascular pannus.

Cultivation of Limbal epithelial cells into a graftbiological

A graft is manufactured for transplant

CALEC Transplantprocedure

Limbal epithelial cells are obtained from the healthy fellow eye and cultivated in a lab for later transplantation into the diseased eye.