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Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency

NCT01489501 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-03-25

No results posted yet for this study

Summary

This clinical study is a scientific study on patients who do not have any limbal stem cells. In this clinical study tissue is taken from the inside of the mouth, and cells from that tissue (epithelial cells) will be grown to form a multilayered cell-sheet, called CAOMECS, which is then transplanted onto the cornea. This transplantation method should repair the damage of the cornea.

The aim of this study is to see if the transplantation of CAOMECS renews the surface of the eye, by preventing the growth of the conjunctiva over the cornea and stopping new small blood vessels forming.

Conditions

  • Limbal Stem Cell Deficiency

Interventions

PROCEDURE

Surgical transplantation of CAOMECS to the ocular surface

Surgical transplantation of oral mucosa derived CAOMECS sheet onto eye cornea.

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • CellSeed France S.A.R.L.

    lead INDUSTRY

Principal Investigators

  • Friedrich Kruse, Prof. Dr. · Medizinische Fakultät der Friedrich-Alexander-Universität Erlangen-Nürnberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489501 on ClinicalTrials.gov