Secretome Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Persistent Corneal Epithelial Defect Corneal Epithelial Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

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

Group Type EXPERIMENTAL

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Intervention Type DRUG

Eye Drops

Vehicle

Vehicle (unconditioned media)

Group Type PLACEBO_COMPARATOR

Vehicle Control

Intervention Type OTHER

Eye Drops

Interventions

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Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Eye Drops

Intervention Type DRUG

Vehicle Control

Eye Drops

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No