CompletedPhase 1

Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells

United States8 participantsStarted 2021-03-05

Plain-language summary

This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of locally delivered allogeneic mesenchymal stromal cells (MSC) for promoting corneal repair. The study will be conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicago. The study will use digital conjunctival and corneal photography and corneal Scheimpflug Imaging, densitometry, and pachymetry for assessment of safety and corneal wound healing.

Who can participate

Age range

18 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: Age: • Patients 18 years of age or older Visual Acuity: • Best corrected distance visual acuity (BCDVA) score ≤ 75 ETDRS letters, (≥ 0.2 LogMAR, ≤ 20/32 Snellen or ≤ 0.625 decimal fraction) in the affected eye. Ocular Health: * Patients with moderate to severe chronic corneal epithelial disease in the setting of neurotrophic keratitis, limbal stem cell deficiency, or inflammatory dry eye disease. * Epithelial disease refractory to all applicable standard / FDA approved non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy, and soft bandage contact lens). * Evidence of impaired epithelial barrier manifested by fluorescein staining of the epithelium with a score 6 or higher by National Eye Institute grading. * No objective clinical evidence of improvement since the last visit (≤50% reduction in fluorescein staining or ≤50% reduction in longest diameter of the epithelial defect). * Patients with stage 1 (no epithelial defect) stage 2 (persistent epithelial defect, PED; without stromal loss) or stage 3 (corneal ulcer; with stromal loss) neurotrophic keratopathy 28-30 limited to ≤80% corneal diameter. Stromal loss in corneal ulcers cannot exceed 50%. * Etiology of all persistent epithelial defects and corneal ulcers will be neurotrophic in nature. Neurotrophic keratopathy may be due to previous trauma such as chemical and thermal burns, systemic diseases …

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

Primary Safety Outcome: Incidence of treatment emergent adverse events (TEAE) assessed at 28 days.

Timeframe: Day #28

Primary Efficacy Outcome: Proportion of participants with improvement in epithelial defect or barrier integrity relative to baseline (based on fluorescein staining)

Timeframe: Day #28

Trial details

NCT IDNCT04626583

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-21

View on ClinicalTrials.gov More Mesenchymal Stromal Cells trials

Plain-language summary

Who can participate

Age range

18 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.

What they're measuring

Primary Safety Outcome: Incidence of treatment emergent adverse events (TEAE) assessed at 28 days.

Timeframe: Day #28

Primary Efficacy Outcome: Proportion of participants with improvement in epithelial defect or barrier integrity relative to baseline (based on fluorescein staining)

Timeframe: Day #28