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Completed

NCT Number: NCT03226015

Autologous Oral Mucosa Transplantation for Limbal Stem Cell Deficiency

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).

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Key information

Conditions

Limbal Stem-cell Deficiency Corneal Diseases Eye Diseases Limbal Stem Cell Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Klinikum Chemnitz gGmbH

Other

Collaborators

  • Institute of Anatomy TU Dresden

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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