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Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

NCT06919081•University of Illinois at Chicago

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
•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.

Locations (1)

University of Illinois at Chicago

Chicago, Illinois, United States

Key Dates

Start Date

August 1, 2025

Primary Completion Date

March 15, 2026

Completion Date

June 15, 2026

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Persistent Corneal Epithelial DefectCorneal Epithelial Disorders

Interventions

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

DRUG

Vehicle Control

OTHER

Contacts

Ali R Djalilian, MD

CONTACT

3129968937 adjalili@uic.edu

Charlotte E Joslin, OD

CONTACT

3129965410 charjosl@uic.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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