Stem Cell Therapy for Limbal Stem Cell Deficiency

About

Brief 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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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.