Stem Cell Therapy for Limbal Stem Cell Deficiency
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|ClinicalTrials.gov Identifier: NCT03957954|
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : January 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Limbal Stem-cell Deficiency||Biological: cLSC Device: Scleral contact lens (SCL)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Feasibility of Cultivated Autologous Limbal Stem Cells (cLSC) for Limbal Stem Cell Deficiency|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2023|
Experimental: Cultivated Limbal Stem-Cells (cLSC)
One dose of cultivated limbal stem-cells (cLSC), size between 7.6 to 15 mm in the average diameter.
Transplantation of cLSC
Active Comparator: Scleral Contact Lens Device (SCL)
Scleral contact lens device (SCL) will be fitted to stabilize and improve ocular surface.
Device: Scleral contact lens (SCL)
Scleral contact lens device (SCL) will be used to stabilize and improve ocular surface.
- Safety of cLSC Transplant pertaining to Infection and/or Corneal Perforation [ Time Frame: 12 months for all participants ]Safety assessed by incidence of Serious Adverse Events (SAEs) directly related to cLSC: infection and/or corneal perforation.
- Feasibility of cLSC Transplant pertaining to Manufacturing meeting Release Criteria [ Time Frame: 12 months for all participants ]Feasibility assessed by successful manufacturing of cLSC from biopsy that meets release criteria.
- Feasibility of cLSC Transplant pertaining to Manufacturing without Contamination [ Time Frame: 12 months for all participants ]Feasibility assessed by successful cLSC manufacturing without contamination.
- Changes in the Area of Corneal Epithelial Defect [ Time Frame: At 6 months and 12 months in both cLSC and the control groups ]Evaluate changes in the area of corneal epithelial defect (ED) or lack of ED.
- Changes in the Clinical Score [ Time Frame: At 6 months and 12 months in both cLSC and the control groups ]Evaluate changes in the clinical score determined by slit lamp examination using fluorescein staining and confocal imaging.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957954
|Contact: Clemence Bonnet, MD||310-794-7813||CBonnet@mednet.ucla.edu|
|Contact: Niree Dingizian||NDingizian@mednet.ucla.edu|
|United States, California|
|University of California||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Clemence Bonnet, MD 310-794-7813|
|Principal Investigator:||Sophie Deng, MD, PhD||Stein Eye Institute UCLA|