Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

Official title

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

Overview

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.

Interventions

• Drug Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
  Eye Drops
• Other Vehicle Control
  Eye Drops

Primary outcome measures

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

Secondary outcome measures (12)

• Visual Acuity [Time frame: Baseline to Day 56]
• Corneal staining and NEI grading [Time frame: Baseline to Day 70]
• Ocular Surface Parameters [Time frame: Baseline to Day 70]
• Corneal Epithelial Thickness [Time frame: Baseline to Day 70]
• Subject Symptoms [Time frame: Baseline to Day 70]
• Time to epithelial healing [Time frame: Baseline to Day 70]
• Corneal Opacities/Scars [Time frame: Baseline to Day 56]
• Corneal vascularization [Time frame: Baseline to Day 56]
• Conjunctival injection [Time frame: Baseline to Day 56]
• Subbasal corneal nerve density [Time frame: Baseline to Day 56]
• Ocular Surface Parameters [Time frame: Baseline to Day 70]
• Ocular Surface Parameters [Time frame: Baseline to Day 70]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Illinois at Chicago — Chicago

Identifiers

NCT: NCT06919081 · 2024-1426 · 3UH3EY031809-04S1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗