The Improvement of Limbal Epithelial Culture Technique by Using Collagenase to Isolate Limbal Ste… (NCT02202642) | Clinical Trial Compass
UnknownPhase 1
The Improvement of Limbal Epithelial Culture Technique by Using Collagenase to Isolate Limbal Stem Cells
Taiwan10 participantsStarted 2012-01
Plain-language 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".
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: between 18-70 years old.
✓. Lesion eye should have limbal insufficiency more than 180 degrees.
✓. Lesion eye should have recurrent corneal erosions, corneal neovascularisation and poor vision caused by limbal insufficiency.
✓. The symptoms should be more than 1/2 year, and have no possibility of improvement by medical treatment.
✓. The patients will to received the operation and the long term post- operative follow-up.
✓. The patients are not infected by AIDS, hepatitis B/C , and willing to received the associated examinations.
✓. The patients does not plan to be pregnant from the day of cell culture and transplantation for 1 year. They also agree to receive the pregnant test.
✓. The condition of cell culture from the 1st to the clinical trial is successful.
Exclusion criteria
✕. Bilateral limbal insufficiency.
✕. No recurrent corneal erosion, corneal neovascularisation or poor vision was found due to limbal insufficiency. If corneal neovascularisation was found deeper than the anterior 1/2 of corneal stroma, or corneal thickness was less than 200 um evaluated by anterior segment OCT and ultrasound pachymetry, the patients should be excluded from the operation criteria. If corneal thickness becomes thicker, the patients can be enrolled for operation.
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What they're measuring
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Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment.
. About corneal sedation, if the value checked by Cocet-Bonnet esthesiometer is less than 5 mm, the patients should be excluded from operation.
✕. The condition can be improved by medication, or resolve spontaneously.
✕. Post-operative follow up is less than 1/2 year
✕. The patient can't receive long term postoperative follow up
✕. No light perception, or can be expected to have very poor prognosis
✕. If the intraocular pressure was more than 21 mmHg under necessary glaucoma surgery and anti-glaucoma medication, or optic disc cupping was more than 90%, or visual field was found to have severe defects, the patients were excluded from the clinical trial.