Recruiting
Phase 2

Mesenchymal Stem Cell Secretome

Sponsor:

University of Illinois at Chicago

Code:

NCT06919081

Conditions

Persistent Corneal Epithelial Defect

Corneal Epithelial Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Vehicle Control

Study Details

Brief summary:

In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease/defect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.

Conditions

Persistent Corneal Epithelial Defect

Corneal Epithelial Disorders

Study ID

NCT06919081

Start date

Aug 1, 2025

Status verified date

May, 2025

Completion date

Jun 15, 2026

Anticipated

Primary completion date

Mar 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age · Patients 18 years of age or older
  • Ocular Health

  • Chronic corneal epithelial disease with fluorescein staining score 6 by NEI grading scale or persistent corneal epithelial defect present for longer than 14 days despite standard treatment
  • No objective clinical evidence of significant (> 50%) improvement/worsening of the epithelial disease in the last 14 days
  • Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy)
  • If both eyes of subject meet the inclusion criteria, the eye with the higher fluorescein staining score will be enrolled to the study.
  • 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 representative must have been approved by the UIC IRB for the current study. Patients must have the ability and willingness to comply with study procedures.

Exclusion Criteria:

  • Ocular Health

  • Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).
  • History of any ocular surgery (including laser or refractive surgical procedures) in the study eye within the 3 months prior to study enrollment.
  • Treatment with Oxervate in the study eye within 12 months of enrollment.
  • Study Procedures

  • Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein).
  • Use of any investigational agent within 4 weeks of screening visit.
  • Participation in another clinical study at the same time as the present study.
  • Participants who are pregnant at the time of study enrollment.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome for Topical Eye Drop

placebo comparator: Vehicle

Vehicle (unconditioned media)

Interventions

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Eye Drops

Vehicle Control

Eye Drops

Primary outcome measure

  • Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome) [ Time Frame: Baseline to Day 56 ]

Central Contacts and Locations

Central contacts

Ali R Djalilian, MD

3129968937adjalili@uic.edu

Charlotte E Joslin, OD

3129965410charjosl@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jale Yucel

708-752-6905zjyucel@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jan 29, 2026

Last verified

May, 2025

Keywords

  • persistent corneal epithelial disease/defects
  • persistent corneal epithelial
  • corneal epithelial disease
  • limbal stem cell deficiency
  • neurotrophic keratitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-01-29.