Autologous Oral Mucosa Transplantation for Limbal Stem Cell Deficiency

Limbal Stem-cell Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226015
• Other study ID #: EK-BR-64/15-1
• Status: Completed
• Phase: N/A
• First received: July 13, 2017
• Last updated: July 19, 2017
• Start date: July 2015
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Klinikum Chemnitz gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Limbal Stem-cell Deficiency

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Chemnitz gGmbH	Institute of Anatomy TU Dresden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in number of acute surgeries		baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
Primary	change in days of acute inpatient treatment		baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
Secondary	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
Secondary	change in conjunctival inflammation		baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months