To Evaluate the Clinical Safety and Efficacy of Limbal Stem Cell for Treatment of Superficial Cor… (NCT04932629) | Clinical Trial Compass
UnknownEarly Phase 1
To Evaluate the Clinical Safety and Efficacy of Limbal Stem Cell for Treatment of Superficial Corneal Pathologies".
20 participantsStarted 2021-07
Plain-language summary
This study proposes to investigate the transplantation of ex-vivo cultivated allogenic limbal stromal cells for the treatment of the corneal pathologies. The limbus is an ideal source as the stem cells are numerous and located very superficially in the tissue (17). Pre-clinical work suggests human corneal stromal stem cells can be isolated from the cadaveric tissues, cultivated in conditions suitable for cell based therapy and used to prevent fibrosis in a murine model of corneal stromal scarring. Further, these cells are able to successfully engraft, differentiate, and mediate wound healing in the corneal stroma such that the tissue remains healthy, free of fibrotic tissue, and optically transparent. The clinical implications of these findings are substantial in that it represents the potential to lessen the burden on donor tissue necessary for corneal allografts by using cultured cells to regenerate tissue. We foresee the ability of a clinician to and grow and expand the cells in number and after surgically removing the scar tissue from the wounded eye, apply the cultured limbal stem cells to regenerate healthy, transparent tissue.
Who can participate
Age range
18 Years – 60 Years
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
. Male and female participants who are ≥18 and ≤ 60 years of age.
. Patients having unilateral superficial corneal pathologies (defined as involving the anterior 200µM of the corneal stroma on ASOCT imaging)
. Corneal burns, ulcers and scars
. No prior history of corneal transplantation
. No ongoing and other active ocular pathology
. Candidate for stem cell transplant
. No severe pathological and psychological conditions that might interfere with the patient's participation in the study
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
1
Measurement of any ocular or systemic adverse effects
. Able to provide written and audio-visual informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice
Exclusion criteria
. Bilateral corneal disease,
. Corneal scars with limbal dysfunction (clinically defined as absent limbal palisades or conjunctivalization of the cornea)
. Ocular surface disease including dry eye disease (defined as a Schirmer's test of less than 10mm at 5 minutes),
. Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation,
. Children (\<18 years of age),
. Less than 3 months after documented clinical resolution of acute disease
. Inability/refusal to give written informed consent
. Undergo any of the anterior segment imaging tests.