Autologous Oral Mucosa Transplantation for Limbal Stem Cell Deficiency

Autologous Oral Mucosa With Amniotic Membrane Transplantation for Limbal Stem Cell Deficiency: Clinical and Immunohistochemical Study

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).

Study Overview

• Status: Completed
• Conditions: Limbal Stem-cell Deficiency

• Study Type: Observational
• Enrollment (Actual): 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients treated with oral mucosa with amniotic membrane transplantation in Klinikum Chemnitz 2015-2017

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Klinikum Chemnitz gGmbH
• Collaborators: Institute of Anatomy TU Dresden
• Investigators: Principal Investigator: Katrin Engelmann, PhD, Klinikum Chemnitz

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Mesenchymal stem cells; Amniotic membrane; Limbal Stem-cell Deficiency; Oral mucosa transplantation
• Other Study ID Numbers: EK-BR-64/15-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No