Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

NCT06919081 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-14263UH3EY031809-04S1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Corneal Epithelial Disorders; Persistent Corneal Epithelial Defect

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome)

  Proportion of subjects with improved epithelial barrier and/or integrity from baseline to DAY 56 as determined by the investigator on slit lamp examination: · Improved epithelial barrier, defined as ³ 50 % improvement in corneal fluorescein staining score using NEI grading scale · Improved epithelial integrity, defined as complete closure of persistent epithelial defect, measured with ImageJ on slit lamp images

  Baseline to Day 56

Secondary Outcomes (12)

• Visual Acuity

  Baseline to Day 56

• Corneal staining and NEI grading

  Baseline to Day 70

• Ocular Surface Parameters

  Baseline to Day 70

• Corneal Epithelial Thickness

  Baseline to Day 70

• Subject Symptoms

  Baseline to Day 70

Study Arms (2)

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

EXPERIMENTAL

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

Drug: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Vehicle

PLACEBO COMPARATOR

Vehicle (unconditioned media)

Other: Vehicle Control

Interventions

Vehicle Control OTHER

Eye Drops

Vehicle

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome DRUG

Eye Drops

Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• University of Illinois at Chicago: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Ali R Djalilian, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali R Djalilian, MD

CONTACT

3129968937; adjalili@uic.edu

Charlotte E Joslin, OD

CONTACT

3129965410; charjosl@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 9, 2025
• Study Start: August 1, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-05

Locations

US (1)