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Autologous Oral Mucosa Transplantation for Limbal Stem Cell Deficiency

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ClinicalTrials.gov Identifier: NCT03226015
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Institute of Anatomy TU Dresden
Information provided by (Responsible Party):
Katrin Engelmann, Klinikum Chemnitz gGmbH

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).


Condition or disease
Limbal Stem-cell Deficiency

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Autologous Oral Mucosa With Amniotic Membrane Transplantation for Limbal Stem Cell Deficiency: Clinical and Immunohistochemical Study
Actual Study Start Date : July 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017



Primary Outcome Measures :
  1. change in number of acute surgeries [ Time Frame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months ]
  2. change in days of acute inpatient treatment [ Time Frame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months ]

Secondary Outcome Measures :
  1. change in number of curative surgical procedures after oral mucosa transplantation [ Time Frame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months ]
  2. change in conjunctival inflammation [ Time Frame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months ]

Biospecimen Retention:   Samples Without DNA
oral mucosa tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients treated with oral mucosa with amniotic membrane transplantation in Klinikum Chemnitz 2015-2017
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226015


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

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Responsible Party: Katrin Engelmann, Head of Ophthalmology, Klinikum Chemnitz gGmbH
ClinicalTrials.gov Identifier: NCT03226015     History of Changes
Other Study ID Numbers: EK-BR-64/15-1
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katrin Engelmann, Klinikum Chemnitz gGmbH:
Limbal Stem-cell Deficiency
Oral mucosa transplantation
Amniotic membrane
Mesenchymal stem cells