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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03226015

Enrollment

Registered

2017-07-21

Start date

2015-07-31

Completion date

2017-05-31

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limbal Stem-cell Deficiency

Keywords

Limbal Stem-cell Deficiency, Oral mucosa transplantation, Amniotic membrane, Mesenchymal stem cells

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

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

Outcome results