RECRUITING

Stem Cell Therapy for Limbal Stem Cell Deficiency

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Conditions

Limbal Stem-cell Deficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2020-09-30
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03957954

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female ≥18 years of age.
  2. 2. Best corrected visual acuity in the affected eye of 20/200 or less.
  3. 3. Documentation of a LSCD diagnosis and the central cornea is affected.
  4. 4. Absence of lagophthalmos and eyelid abnormality
  5. 5. Adequate forniceal depth is ≥ 5 mm.
  6. 6. LSCD fails to resolve by surgical treatments of the ocular surface during the previous 6 months of screening visit.
  7. 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. 8. A Schirmer test result at 5 minute of ≥5 mm of wetting.
  9. 9. Absence of active infectious keratitis in either eye at the Enrollment Visit.
  10. 10. Have a life expectancy ≥ 2 years after enrollment.
  1. 1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  2. 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. 3. Exposure keratopathy or lagophthalmos of the study eye.
  4. 4. Persistent severe ocular surface inflammation and/or meibomian gland dysfunction
  5. 5. Chemical injury occurred less than 12 months ago.
  6. 6. Presence of ocular surface tumor.
  7. 7. Uncontrolled diabetes with last hemoglobin A1C (HgA1C) \>8.5.
  8. 8. Presence of known allergies to any of the cLSC components.
  9. 9. Current participation in another simultaneous medical investigation or trial.
  10. 10. Unable to be compliant with or complete the requirements of the study.

Contacts and Locations

Study Contact

Clemence Bonnet, MD, PhD
CONTACT
310-825-6232
CBonnet@mednet.ucla.edu
Sheyla Gonzalez, PhD
CONTACT
310-825-6232
s.gonzalez@jsei.ucla.edu

Principal Investigator

Sophie Deng, MD, PhD
PRINCIPAL_INVESTIGATOR
Stein Eye Institute UCLA

Study Locations (Sites)

University of California
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-30
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2020-09-30
Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Limbal Stem-cell Deficiency