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

Stevens-johnson Syndrome Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02149732
Study type Expanded Access
Source Seoul National University Hospital
Contact Mee Kum Kim, MD, PhD
Phone 82-10-6277-0798
Email kmk9@snu.ac.kr
Status Available
Phase Phase 1/Phase 2
Start date May 2014
Completion date December 2016
View Details
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