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 range18 Years – 60 Years
SexALL
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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
✓. 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,
What they're measuring
1
Measurement of any ocular or systemic adverse effects