NCT04626583

Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells

Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells for Promoting Corneal Repair

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 obtain a preliminary observation on the following: 1. Epithelial barrier integrity and/or wound closure. 2. Development of Scarring. 3. 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.

Conditions

• Mesenchymal Stromal Cells
• Cornea
• Safety
• Corneal Defect

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic MSC	Subconjunctival Injection of Allogeneic Mesenchymal Stromal Cells

Timeline

• Start date: 2021-03-05
• Primary completion: 2023-04-21
• Completion: 2023-04-21
• First posted: 2020-11-12
• Last updated: 2024-12-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study