Autologous Oral Mucosa Transplantation for Limbal Stem Cell Deficiency

NCT ID: NCT03226015

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-05-31

Brief Summary

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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

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Conditions

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Limbal Stem-cell Deficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Anatomy TU Dresden

UNKNOWN

Sponsor Role collaborator

Klinikum Chemnitz gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Katrin Engelmann

Head of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katrin Engelmann, PhD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Chemnitz

Other Identifiers

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EK-BR-64/15-1

Identifier Type: -

Identifier Source: org_study_id

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