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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02415218
• Date of registration: 08/04/2015
• Prospective Registration: No
• Primary sponsor: Siriraj Hospital
• Public title: Transplantation of Autologous Oral Mucosal Epithelial Sheets for Limbal Stem-cell Deficiency
• Scientific title: Clinical Study of Transplantation of Autologous Cultivated Oral Mucosal Epithelial Sheets for Limbal Stem-cell Deficiency
• Date of first enrolment: April 17, 2013
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02415218
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Thailand

Contacts

• Name: Adisak Wongkajornsilp, M.D., Ph.D.
• Affiliation: Mahidol University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Among patients with bilateral limbal stem-cell deficiency, those who meet all the
criteria listed below when they give their informed consent to participate in this
research will be included.

1. 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

2. Patients in whom the corneal surface of the eye(s) (subject to the
investigational therapy) is(are) entirely enveloped by conjunctival tissue

3. Patients of both genders aged =20 years when they give their informed consent

4. 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:

1. Patients who are or may be pregnant, and patients who are breast feeding

2. Patients with infections (HBV, HCV, HIV, HTLV-1)

3. Patients with extreme hypolacrimation resistant to therapy

4. 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

5. Patients whose score of Performance Status (PS*) is 3 or more

6. Any others who are judged by the chief subinvestigator to be ineligible for this
clinical research, due to the presence of complications, etc.



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Limbal Stem-cell Deficiency

Intervention(s)

Biological: Mucosal cell sheet transplantation

Primary Outcome(s)

Evaluation of conjunctivalization and corneal epithelial defect [Time Frame: 1 year after transplantation]

Secondary Outcome(s)

Corrected visual acuity (efficacy) [Time Frame: 1 year]

Secondary ID(s)

662/2555(EC2)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Osaka University