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
1 other identifier
observational
27
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedJuly 21, 2017
July 1, 2017
1.8 years
July 13, 2017
July 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Eligibility Criteria
All patients treated with oral mucosa with amniotic membrane transplantation in Klinikum Chemnitz 2015-2017
You may qualify if:
- limbal stem cell deficiency at least in one eye
- undergoing oral mucosa with amniotic membrane transplantation
- obtained written informed consent
You may not qualify if:
- no written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Klinikum Chemnitz gGmbHlead
- Institute of Anatomy TU Dresdencollaborator
Biospecimen
oral mucosa tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katrin Engelmann, PhD
Klinikum Chemnitz
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Ophthalmology
Study Record Dates
First Submitted
July 13, 2017
First Posted
July 21, 2017
Study Start
July 1, 2015
Primary Completion
April 1, 2017
Study Completion
May 1, 2017
Last Updated
July 21, 2017
Record last verified: 2017-07