Stem Cell Therapy for Limbal Stem Cell Deficiency

Description

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).

Conditions

Limbal Stem-cell Deficiency

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Study Overview

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Study Details

Study overview

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).

Safety and Feasibility of Cultivated Autologous Limbal Stem Cells (cLSC) for Limbal Stem Cell Deficiency

Stem Cell Therapy for Limbal Stem Cell Deficiency

Condition
Limbal Stem-cell Deficiency
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, California, United States, 90095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female ≥18 years of age.
  • 2. Best corrected visual acuity in the affected eye of 20/200 or less.
  • 3. Documentation of a LSCD diagnosis and the central cornea is affected.
  • 4. Absence of lagophthalmos and eyelid abnormality
  • 5. Adequate forniceal depth is ≥ 5 mm.
  • 6. LSCD fails to resolve by surgical treatments of the ocular surface during the previous 6 months of screening visit.
  • 7. If the etiology of LSCD is due to chemical injury, a minimal interval of 1 year since the initial chemical injury is required.
  • 8. A Schirmer test result at 5 minute of ≥5 mm of wetting.
  • 9. Absence of active infectious keratitis in either eye at the Enrollment Visit.
  • 10. Have a life expectancy ≥ 2 years after enrollment.
  • 1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  • 2. 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.
  • 3. Exposure keratopathy or lagophthalmos of the study eye.
  • 4. Persistent severe ocular surface inflammation and/or meibomian gland dysfunction
  • 5. Chemical injury occurred less than 12 months ago.
  • 6. Presence of ocular surface tumor.
  • 7. Uncontrolled diabetes with last hemoglobin A1C (HgA1C) \>8.5.
  • 8. Presence of known allergies to any of the cLSC components.
  • 9. Current participation in another simultaneous medical investigation or trial.
  • 10. Unable to be compliant with or complete the requirements of the study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

Sophie Deng, MD, PhD, PRINCIPAL_INVESTIGATOR, Stein Eye Institute UCLA

Study Record Dates

2025-09-30