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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02202642 |
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Date of registration:
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21/04/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Improvement of Limbal Epithelial Culture Technique by Using Collagenase to Isolate Limbal Stem Cells
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Scientific title:
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The Improvement of Limbal Epithelial Culture Technique for the Treatment of Unilateral Limbal Insufficiency by Using Collagenase to Isolate Limbal Stem Cells |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02202642 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Wei Li Chen, MD, PhD |
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Address:
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Telephone:
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886-2-23123456 |
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Email:
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chenweili@ntu.edu.tw |
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Affiliation:
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Name:
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Wei Li Chen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age: between 18-70 years old.
2. Lesion eye should have limbal insufficiency more than 180 degrees.
3. Lesion eye should have recurrent corneal erosions, corneal neovascularisation and
poor vision caused by limbal insufficiency.
4. The symptoms should be more than 1/2 year, and have no possibility of improvement by
medical treatment.
5. The patients will to received the operation and the long term post- operative
follow-up.
6. The patients are not infected by AIDS, hepatitis B/C , and willing to received the
associated examinations.
7. 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.
8. The condition of cell culture from the 1st to the clinical trial is successful.
Exclusion Criteria:
1. Bilateral limbal insufficiency.
2. 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.
3. About corneal sedation, if the value checked by Cocet-Bonnet esthesiometer is less
than 5 mm, the patients should be excluded from operation.
4. The condition can be improved by medication, or resolve spontaneously.
5. Post-operative follow up is less than 1/2 year
6. The patient can't receive long term postoperative follow up
7. No light perception, or can be expected to have very poor prognosis
8. 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.
9. Severe lagophthalmos or trichiasis, and does not received blepharoplasty.
10. Severe dry eye syndrome. Those patients with schirmer's test result less than 1 mm
should be excluded.
11. 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.
12. Pregnancy
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Benign Mucous Membrane Pemphigoid With Ocular Involvement
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Acid Chemical Burn Of Cornea And Conjunctival Sac
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Alkaline Chemical Burn Of Cornea And Conjunctival Sac
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Intervention(s)
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Procedure: collagenase
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Primary Outcome(s)
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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.
[Time Frame: 12 months]
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Secondary ID(s)
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201007032D
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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