Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD

Status Active, not recruiting

Clinical Trial Summary

The aim of this clinical trial is to investigate the efficacy (by monitoring neovascularization and epithelial defects) of up to four doses of the investigational medicinal product (IMP) LSC2 topically administered on the target eye of patients with LSCD. Further, safety of the IMP during and after application will be investigated (by monitoring adverse events [AEs]).

Clinical Trial Description

This is an interventional, open-label, phase I/IIa clinical trial to investigate the efficacy and safety of up to four doses of the IMP topically administered on the target eye of patients with LSCD. Patients will be treated in up to four ascending dose groups. The allogeneic investigational product LSC2 contains ABCB5-positive limbal stem cells (from corneal rims of cadaveric donors, expanded ex vivo, isolated and stored in a donor cell bank). The IMP will be applied on the target eye. Prior to application, the conjunctival pannus will be removed under general or local anesthesia. Patients will be followed up for efficacy for 1 year. Efficacy of the IMP will be monitored by assessing neovascularization and epithelial defects. To assess long-term safety of LSC2 one follow-up visit at Month 24 post IMP application is included. ;

Study Design

Related Conditions & MeSH terms

Limbal Stem Cell Deficiency

Clinical Trial Details

NCT number	NCT03549299
Study type	Interventional
Source	RHEACELL GmbH & Co. KG
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	July 4, 2019
Completion date	September 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02568527` - Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients	N/A
Completed	`NCT00736307` - Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients	Phase 1/Phase 2
Available	`NCT02149732` - Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation	Phase 1/Phase 2
Terminated	`NCT02579993` - ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation	N/A
Recruiting	`NCT03943797` - Cultivated Autologous Oral Mucosal Epithelial Transplantation	Phase 1
Completed	`NCT03217435` - Corneal Epithelial Allograft From Living-related Donor for LSCD	N/A
Recruiting	`NCT03217487` - Corneal Epithelial Autograft for LSCD	N/A
Active, not recruiting	`NCT00845117` - Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency	Phase 1/Phase 2
Enrolling by invitation	`NCT03015779` - Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease	Phase 1/Phase 2
Active, not recruiting	`NCT02739113` - Cultivated Autologous Oral Mucosal Epithelial Transplantation for the Treatment of Ocular Surface Diseases	Phase 1/Phase 2
Not yet recruiting	`NCT06265298` - Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium	N/A
Recruiting	`NCT01756365` - Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency	N/A
Completed	`NCT02592330` - Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft	Phase 1/Phase 2
Recruiting	`NCT02318485` - Limbal Epithelial Stem Cell Transplantation: a Phase II Multicenter Trial	Phase 2
Withdrawn	`NCT01489501` - Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency	Phase 3