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

Study Status: Available
Recruit Status: Available
Study Type: Expanded Access

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

Brief Summary: 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.

Detailed Summary:

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
Sponsor: Seoul National University Hospital

Current Primary Outcome:

Original Primary Outcome: Epithelization of corneal surface [ Time Frame: 6 months after cell sheet transplantation ]

Epithelization area in total corneal surface (%)

= Epithelized corneal surface area / Total corneal surface area x 100 (%)

Corneal diameter = R Diameter in non-epithelized area = r Epithelized corneal surface area = 3.14x(R2-r2)/4 Total corneal surface area = 3.14xR2/4



Current Secondary Outcome:

Original Secondary Outcome: Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 months after cell sheet transplantation ]

Best Corrected Visual Acuity (BCVA) will be converted logMAR scale for the statistical analysis.


Information By: Seoul National University Hospital

Dates:
Date Received: May 14, 2014
Date Started: May 2014
Date Completion: December 2016
Last Updated: April 18, 2016
Last Verified: April 2016