CompletedPhase 1/2

Transplantation of Autologous Oral Mucosal Epithelial Sheets for Limbal Stem-cell Deficiency

Thailand6 participantsStarted 2013-04-17

Plain-language summary

The study purpose is to evaluate the efficacy and safety of cultivated oral mucosal epithelial sheet transplantation as a novel therapy for limbal stem cell deficiency, for which no effective approaches has thus far been available, for the purpose of establishing this therapy as an effective strategy for this disease with an aim of improving visual acuity and corneal transparency.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients in whom the eye(s) (subject to the interventional therapy) show(s) loss or dysfunction of corneal epithelial stem cells throughout the total\* circumference of the cornea
✓. Patients in whom the corneal surface of the eye(s) (subject to the investigational therapy) is(are) entirely enveloped by conjunctival tissue
✓. Patients of both genders aged ≥20 years when they give their informed consent
✓. Patients who have given their own written consent to participate in this clinical research (The target disease is bilateral limbal stem-cell deficiency, although it is not always necessary that the both eyes of the patient meet the inclusion criteria.)

Exclusion criteria

✕. Patients who are or may be pregnant, and patients who are breast feeding
✕. Patients with infections (HBV, HCV, HIV, HTLV-1)
✕. Patients with extreme hypolacrimation resistant to therapy
✕. Patients from whom oral mucosal specimens cannot be collected because clear scar formation or inflammatory findings are noted in a cell-collection site of the mucosal membrane
✕. Patients whose score of Performance Status (PS\*) is 3 or more
✕. Any others who are judged by the chief subinvestigator to be ineligible for this clinical research, due to the presence of complications, etc.

What they're measuring

Evaluation of conjunctivalization and corneal epithelial defect

Timeframe: 1 year after transplantation

Trial details

NCT IDNCT02415218

SponsorSiriraj Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09-03

View on ClinicalTrials.gov More Limbal Stem-cell Deficiency trials