TerminatedPhase 1

The Application of Cultured Cornea Stem Cells in Patients Suffering From Corneal Stem Cell Insufficiency

Stopped: We didn't use this tech in patient.

Taiwan0Started 2008-07

Plain-language summary

Name of the project：The application of cornea stem cells cultured on amniotic membrane in patients suffering from corneal stem cell insufficiency Purpose: To develop the technique of using ex vivo expansion of autologous limbal stem cell cultured on amniotic membrane for treatment of patients suffering from limbal stem cell insufficiency

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * unilateral limbus defect larger than 180 degrees * repeated corneal epithelial ulcer, loss of visual acuity or neovascularization due to limbal stem cell insufficiency * no improvement after medical intervention for more than 6 months * the patient is willing to receive surgery and postoperative follow up Exclusion Criteria: * bilateral limbus defect * limbal stem cell insufficiency does not induce repeated corneal epithelial ulcer, loss of visual acuity or neovascularization * corneal neovascularization deeper than 1/2 depth of surface matrix * peripheral surface matrix is less than 200um thick * no corneal reflex was induced by fiber less than 5mm length measured by Cocet-Bonnet esthesiometer * improvement under medication * perisurgical follow up less than 6 months * unable to be long term followed up postoperatively * glaucoma patients underwent glaucoma surgery, under medication, IOP \> 21mmHg * glaucoma patients underwent glaucoma surgery, under medication, IOP \< 21mmHg, optic disc depression \> 90% * severe incomplete eyelid closure * severe dye eye syndrome, Schirmer test 5 min \< 3 mm * contralateral eye limbus tissue cannot be obtained, or unable to be cultured * pregnant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The extent of corneal epithelium regeneration

Timeframe: one week, two week, one month, two months, three months, six months and one year later

Trial details

NCT IDNCT01377311

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-04

View on ClinicalTrials.gov More Unilateral Limbal Stem Cell Insufficiency trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.