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Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency

Limbal Stem Cell Deficiency Clinical Trial

Official title:
A Single-Arm Open-Label Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency

Clinical Trial Summary

This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or both study eyes. The study is comprised of two identical phases (Dosing Phase I and II) of test article dosing separated by a 31- to 40-day period, the Dosing Holiday, where no test article is administered. Dosing Phase II is followed by an observational, noninterventional phase (Observation Phase).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06452316
Study type Interventional
Source Claris Biotherapeutics, Inc.
Contact Central Operations Representative
Phone 919-354-1299
Email clinicaltrials@clarisbio.com
Status Recruiting
Phase Phase 1
Start date May 15, 2024
Completion date August 2025
View Details
See also
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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
Active, not recruiting NCT03549299 - Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD Phase 1/Phase 2
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