Stem Cell Therapy for Limbal Stem Cell Deficiency

  • STATUS
    Recruiting
  • End date
    Oct 30, 2023
  • participants needed
    20
  • sponsor
    University of California, Los Angeles
Updated on 24 February 2022

Summary

This phase I study will collect preliminary information on the activity and safety of cLSC. We will investigate the ability to manufacture and transplant cLSC onto the cornea successfully at the time of surgery (feasibility), and have cLSC begin to populate the ocular surface (efficacy) without serious adverse events (safety).

Description

20 patients with severe to total Limbal Stem Cell Deficiency (LSCD) in one eye attributable to injury or ocular surgery. The first 5 eyes will receive the cLSCs to determine the feasibility and safety. Then the subsequent 15 eyes will be randomized into cLSC group and a scleral lens treatment (SCL) control group in a 2:1 ratio in blocks of 3 or 6 using a random number generator.

Details
Condition Limbal Stem-cell Deficiency
Treatment cLSC, Scleral contact lens (SCL)
Clinical Study IdentifierNCT03957954
SponsorUniversity of California, Los Angeles
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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