CompletedNot Applicable

Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

Belgium21 participantsStarted 2008-07

Plain-language summary

The purpose of this study is to determine whether cultivated stem cell transplantation is effective for the treatment of patients wtih corneal stem cell deficiency.

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: * Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb. * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. * Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation Exclusion Criteria: * Subjects who are pregnant or lactating * Subjects who have sensitivity to drugs that provide local anesthesia * Subjects suffering from active infection of the external eye * Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)

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

Visual Acuity

Timeframe: Just before surgery and upto 1 years after surgery

Conjunctivalization

Timeframe: Just before surgery and upto 1 years after surgery

Vascularization

Timeframe: Just before surgery and upto 1 years after surgery

Epithelialization

Timeframe: Just before surgery and upto 1 years after surgery

Trial details

NCT IDNCT00845117

SponsorVeerle Van Gerwen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Limbal Stem Cell Deficiency trials

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.

What they're measuring

Visual Acuity

Timeframe: Just before surgery and upto 1 years after surgery

Conjunctivalization

Timeframe: Just before surgery and upto 1 years after surgery

Vascularization

Timeframe: Just before surgery and upto 1 years after surgery

Epithelialization

Timeframe: Just before surgery and upto 1 years after surgery