Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation

April 18, 2016 updated by: Seoul National University Hospital

An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients

To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

Interventional study for treatment of patients with cicatricial change of ocular surface.

Single Group: (Limbal stem cell deficiency group)

Treatment: After cultivating autologous Oral mucosal epithelial cell sheet, the sheet will be transplanted to the ocular surface of the patients

Inclusion criteria

  1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
  2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
  3. patient who agree this clinical trial
  4. patient with the eyes in which best corrected visual acuity is less than counting finger
  5. patient who is older than sixteen year old

Exclusion criteria

  1. patient who has relevant corneal transparency
  2. patient who is on the pregnancy or has a plan of pregnancy within 1 year
  3. patient who has corneal infection
  4. patient who has diagnosis of HBV, HCV, HIV, syphilis
  5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
  6. patient who has malignancy
  7. patient who shows hypersensitivity to bovine protein.

Primary outcome Epithelization of corneal surface (6 months after cell sheet transplantation)

Secondary outcome Visual acuity (6 months after cell sheet transplantation)

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Available
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of, 110-744
        • Available
        • Seoul National Unversity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
  2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
  3. patient who agree this clinical trial
  4. patient with the eyes in which best corrected visual acuity is less than counting finger
  5. patient who is older than sixteen year old

Exclusion Criteria:

  1. patient who has relevant corneal transparency
  2. patient who is on the pregnancy or has a plan of pregnancy within 1 year
  3. patient who has corneal infection
  4. patient who has diagnosis of HBV, HCV, HIV, syphilis
  5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
  6. patient who has malignancy
  7. patient who shows hypersensitivity to bovine protein.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Health & Welfare, Korea

Investigators

  • Principal Investigator: Mee Kum Kim, MD, PhD, Department of Ophthalmology, Seoul National University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 25, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMET trial
  • MKKim (Other Grant/Funding Number: Ministry of Health & Welfare, Republic of Korea (HI11C1590))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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