Efficacy of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The proposed Conventional Cohort Expansion Study involves the use of Mesenchymal Stromal Cells (MSCs) are derived from the bone marrow. We previously studied the safety of subconjunctival injection of allogeneic bone marrow-derived MSCs in patients with nonhealing epitheliopathy (IRB Protocol 2020-0334). In the present study, we want to study the efficacy of this treatment on chronic epitheliopathies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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 non-resolving corneal epitheliopathy or epithelial defect after two or more weeks of standard non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy, soft bandage contact lens).

• No objective clinical evidence of improvement in the last 2 weeks (≤50% reduction in fluorescein staining or ≤50% reduction in longest diameter of the epithelial defect).

• If both eyes have chronic epithelial disease, the eye with the worse epithelial disease will be treated.

• Evidence of impaired epithelial barrier manifested by fluorescein staining of the epithelium with a score 10 or higher by National Eye Institute grading.

• 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 keratopathy25-27 limited to ≤80% corneal diameter.

⁃ Study Procedures:

• Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representatives must have been approved by the IRB for the current study.

• Patients must have the ability and willingness to comply with study procedures.

Locations
United States
Illinois
Department of Ophthalmology and Visual Sciences
RECRUITING
Chicago
Massachusetts
Mass Eye and Ear Infirmary
ACTIVE_NOT_RECRUITING
Boston
Maryland
University of Maryland at Baltimore
ACTIVE_NOT_RECRUITING
Baltimore
Pennsylvania
University of Pennsylvania, Scheie Eye Institute
ACTIVE_NOT_RECRUITING
Philadelphia
Contact Information
Primary
Ali R Djalilian, MD
adjalili@uic.edu
312-996-8937
Backup
Charlotte E Joslin, OD, PhD
charjosl@uic.edu
312-996-5410
Time Frame
Start Date: 2023-09-29
Estimated Completion Date: 2025-09-28
Participants
Target number of participants: 38
Treatments
Active_comparator: Medium dose of allogenic MSC drops
Dose of allogeneic MSC subconjunctival injection will be assigned 3,000,000 cells/150 µL.
Sham_comparator: Control Group
For the control group, 50 µL of the freezing media (vehicle) will be injected.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov