Clinical Trial: The Improvement of Limbal Epithelial Culture Technique by Using Collagenase to Isolate Limbal Stem Cells

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Improvement of Limbal Epithelial Culture Technique for the Treatment of Unilateral Limbal Insufficiency by Using Collagenase to Isolate Limbal Stem Cells

Brief Summary: Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment of patients suffering from unilateral limbal stem cell insufficiency based on the concept of "limbal stem cells need special cell-cell contact and cell-extracellular matrix interaction to support their survival".

Detailed Summary: Patients suffering from unilateral limbal stem cell insufficiency and understand the benefits and risk factors of the operation will be enrolled in this clinical trial. Two weeks before transplantation, the investigators first take 1-2 mm2 of limbal tissues from the healthy eye, digest the tissue with collagenase, and get an epithelial cell cluster. The cell cluster will be cultured on amniotic membrane with SHEM medium which contains Dulbecco's modified Eagle's medium/F12 (1:1), 5% dimethyl sulfoxide, 10 ng/ml human epidermal growth factor, 5μg/ml insulin, 0.5 μg/ml hydrocortisone, 1 nM cholera toxin, 50μg/ml gentamicin, 1.25μg/ml amphotericin B. Seven to ten days later after successful culture, transplantation will be performed after the cells reaches 1.5-2 cm2 compact confluent epithelial sheets without evidence of contamination. During the operation, lamellar keratectomy will be performed to remove the abnormal corneal neovascularization and scar tissue. The cultivated epithelial sheets will be transplanted to denuded corneal surface with fibrin glue and suture technique. The patients are planed to be admitted for 2 weeks. After discharge, follow up of the patients will be performed on one week, two week, one month, two months, three months, six months and one year later. Pictures of external eyes will be taken and the extent of corneal epithelium regeneration, visual acuity, and complications will be recorded during follow-up visits. The investigators plan to collect 10 patients.
Sponsor: National Taiwan University Hospital

Current Primary Outcome: Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment. [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Taiwan University Hospital

Dates:
Date Received: April 21, 2011
Date Started: January 2012
Date Completion: December 2015
Last Updated: July 24, 2014
Last Verified: July 2014