Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

University of Illinois

Status and phase: Enrolling; Phase 2

Conditions: Corneal Epithelial Disorders; Persistent Corneal Epithelial Defect

Treatments: Drug: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome; Other: Vehicle Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06919081

2024-1426

3UH3EY031809-04S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)
  • 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Experimental group

Description:

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

Treatment:

Drug: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Vehicle

Placebo Comparator group

Description:

Vehicle (unconditioned media)

Treatment:

Other: Vehicle Control