Autologous Oral Mucosa Transplantation for Limbal Stem Cell Deficiency

Completed

• Conditions: Limbal Stem-cell Deficiency

• Registration Number: NCT03226015
• Lead Sponsor: Klinikum Chemnitz gGmbH

Brief Summary

PURPOSE: To report clinical and histochemical results of oral mucosa graft transplantation in eyes with limbal stem cell deficiency.

DESIGN: Prospective observational study.

METHODS: 32 eyes of 27 patients with limbal stem cell deficiency underwent direct oral mucosa graft transplantation with amniotic membrane transplantation with a mean follow-up of 19 months. Clinical course of the disease including emergency surgeries, planned curative procedures, conjunctival inflammation, acute inpatient treatment and best corrected visual acuity were assessed at 3 months postoperatively and at last follow up visit. The unneeded parts of oral mucosa graft were analyzed immunohistochemically with staining for mesenchymal stem cell markers and pericytes (CD 90, CD 146, CD 166, CD 31, CD 68, protein gene product).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2017-07
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-19
• Last Update Submitted: 2017-07-19
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• limbal stem cell deficiency at least in one eye
• undergoing oral mucosa with amniotic membrane transplantation
• obtained written informed consent

Exclusion Criteria

• no written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in number of acute surgeries	baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
change in days of acute inpatient treatment	baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months

Secondary Outcome Measures

Name	Time	Method
change in number of curative surgical procedures after oral mucosa transplantation	baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
change in conjunctival inflammation	baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months