MSC Therapy for Corneal Repair

Phase 1

Recruiting

Led By Ali R Djalilian, MD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment, treatment, and days #1, #7, #14, #28, #90

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if locally delivered allogeneic mesenchymal stromal cells (MSC) are safe and effective for promoting corneal repair.

Who is the study for?

Adults with certain corneal diseases like neurotrophic keratitis, who haven't improved with standard treatments, can join this trial. They should have moderate to severe chronic corneal epithelial disease and decreased corneal sensitivity. Those with active eye infections, recent ocular surgery or severe vision loss without potential for improvement are excluded.

What is being tested?

The study tests the safety and best dose of allogeneic mesenchymal stromal cells (MSC) applied directly to the eye for repairing the cornea. It's a step-by-step trial that increases doses over time at Illinois Eye and Ear Infirmary using advanced imaging techniques to monitor healing.

What are the potential side effects?

While specific side effects aren't listed here, MSC therapy could potentially cause local reactions at the site of application, immune responses or infection risks due to cell transplantation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment, treatment, and days #1, #7, #14, #28, #90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment, treatment, and days #1, #7, #14, #28, #90

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, treatment, and days #1, #7, #14, #28, #90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Secondary Efficacy Outcomes: Corneal epithelial thickness

Secondary Efficacy Outcomes: Corneal stromal haze

Secondary Efficacy Outcomes: Durability of the Corneal Epithelialization and Healing

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Medium dose of allogeneic MSCActive Control1 Intervention

Escalating doses of allogeneic MSC subconjunctival injection will be assigned 3,000,000 cells/150 µL at the medium dose level.

Group II: Low dose of allogeneic MSCActive Control1 Intervention

Escalating doses of allogeneic MSC subconjunctival injection will be assigned 1,000,000 cells/50 µL at the low dose level.

Group III: High dose of allogeneic MSCActive Control1 Intervention

Escalating doses of allogeneic MSC subconjunctival injection will be assigned 6,000,000 cells total consisting of injection at 2 sites of 3,000,000 cells/150 µL each at the high dose level.

Do I qualify?Apply below to find out