Stem Cell Therapy for Limbal Stem Cell Deficiency
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|