Status:
UNKNOWN
The Improvement of Limbal Epithelial Culture Technique by Using Collagenase to Isolate Limbal Stem Cells
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Alkaline Chemical Burn Of Cornea And Conjunctival Sac
Acid Chemical Burn Of Cornea And Conjunctival Sac
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 insufficienc...
Detailed Description
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 transplantatio...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
- Severe lagophthalmos or trichiasis, and does not received blepharoplasty.
- Severe dry eye syndrome. Those patients with schirmer's test result less than 1 mm should be excluded.
- If the cells in the first part of the clinical trial can't be successfully cultivated, the patients should be excluded. If the patients insisted to received further treatment, they can be enrolled 3 months later.
- Pregnancy
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02202642
Start Date
January 1 2012
End Date
December 1 2015
Last Update
July 29 2014
Active Locations (1)
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1
Wei-Li Chen
Taipei, Taiwan, 100