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 11, 2023
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|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|
|Actual Study Start Date :||September 30, 2020|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||December 31, 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Main inclusion Criteria:
- Male or female ≥18 years of age.
- Best corrected visual acuity in the affected eye of 20/200 or less.
- Documentation of a LSCD diagnosis and the central cornea is affected.
- Absence of lagophthalmos and eyelid abnormality
- Adequate forniceal depth is ≥ 5 mm.
- LSCD fails to resolve by surgical treatments of the ocular surface during the previous 6 months of screening visit.
- If the etiology of LSCD is due to chemical injury, a minimal interval of 1 year since the initial chemical injury is required.
- A Schirmer test result at 5 minute of ≥5 mm of wetting.
- Absence of active infectious keratitis in either eye at the Enrollment Visit.
- Have a life expectancy ≥ 2 years after enrollment.
Main exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Exposure keratopathy or lagophthalmos of the study eye.
- Persistent severe ocular surface inflammation and/or meibomian gland dysfunction
- Chemical injury occurred less than 12 months ago.
- Presence of ocular surface tumor.
- Uncontrolled diabetes with last hemoglobin A1C (HgA1C) >8.5.
- Presence of known allergies to any of the cLSC components.
- Current participation in another simultaneous medical investigation or trial.
- Unable to be compliant with or complete the requirements of the study.
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: Sofia Gudiel||SGudiel@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|
|Responsible Party:||Sophie Deng, MD, PhD, Professor, University of California, Los Angeles|
|Other Study ID Numbers:||
R01EY021797 ( U.S. NIH Grant/Contract )
|First Posted:||May 21, 2019 Key Record Dates|
|Last Update Posted:||January 11, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Limbal Stem Cell Deficiency