Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cornea
  • Corneal Defect
  • Mesenchymal Stromal Cells
  • Safety
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: A longitudinal assessment using a classic dose-escalation study design to assess the safety of locally delivered allogenic mesenchymal stromal cells for promoting corneal repair.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The "Safety of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair Study" otherwise known as the "MSC Study," is designed to assess the safety of allogeneic bone marrow-derived MSC secreted factor on the ocular surface via subconjunctival injection of MSC, and also obtai...

The "Safety of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair Study" otherwise known as the "MSC Study," is designed to assess the safety of allogeneic bone marrow-derived MSC secreted factor on the ocular surface via subconjunctival injection of MSC, and also obtain a preliminary observation on the following: Epithelial Wound Closure. Development of Scarring. Final Visual Acuity. The objective is to improve clinical outcomes in significant non-healing corneal wounds. To achieve these goals, the MSC Study will include a Phase I dose-escalation safety study.

Tracking Information

NCT #
NCT04626583
Collaborators
United States Department of Defense
Investigators
Principal Investigator: Ali R Djalilian, MD University of Illinois Chicago Principal Investigator: Charlotte E Joslin, OD, PhD University of Illinois Chicago