Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

NCT05204329 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 2021-07541UG3EY031809-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops. The study will be conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicago. The study will use anterior segment Optical Coherence Tomography (OCT)/Scheimpflug Imaging, esthesiometry, and visual analogue scale (VAS) to assess treatment tolerability.

Conditions

Mesenchymal Stromal Cells; Cornea; Corneal Defect; Corneal Epithelium Defect

Keywords

Mesenchymal Stromal Cells; Corneal Defect; Corneal Epithelium Defect

Outcome Measures

Primary Outcomes (1)

• Epithelial Status Assessment

  The primary outcome measure is improved corneal epithelial barrier function at DAY #28assessed by viewing the cornea under slit lamp examination after instillation of sodium fluorescein, assessing the change from baseline in corneal fluorescein staining score. The presence/absence of an epithelial defect on DAY #28 will also be recorded.

  Day 28

Secondary Outcomes (6)

• Visual Acuity

  Baseline, Days 7, 14, 28, 56, 90

• Corneal Epithelial thickness

  Baseline, Days 14, 28, 56, 90

• Corneal Scarring / Haze

  Baseline, Days 14, 28, 56, 90

• Tolerability of MSC secretome drops

  Baseline, Days 7, 14, 28, 56, 90

• Durability of Corneal Epithelial Status Improvement

  Baseline, Days 7, 14, 28, 56, 90

Study Arms (3)

Low dose of allogenic MSC drops

ACTIVE COMPARATOR

Escalating doses of allogenic MSC eye drops will be assigned at the lowest dose level.

Biological: MSC Secretome Eye Drops

Medium dose of allogenic MSC drops

ACTIVE COMPARATOR

Escalating doses of allogenic MSC eye drops will be assigned at the medium dose level.

Biological: MSC Secretome Eye Drops

High dose of allogenic MSC drops

ACTIVE COMPARATOR

Escalating doses of allogenic MSC eye drops will be assigned at the high dose level.

Biological: MSC Secretome Eye Drops

Interventions

MSC Secretome Eye Drops BIOLOGICAL

MSC Secretome eye drop will be dispensed.

High dose of allogenic MSC drops; Low dose of allogenic MSC drops; Medium dose of allogenic MSC drops

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older
• Chronic corneal epithelial disease with fluorescein staining score ≥ 6 by NEI grading scale
• Reduced corneal sensation (≤ 4 cm measured by Cochet Bonnet esthesiometry) in at least one corneal quadrant
• A stable ocular surface with no objective clinical evidence of significant (\> 50%) improvement/worsening of the epithelial disease in the last 30 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)

You may not qualify if:

• Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).
• Evidence of corneal ulceration with stromal loss \> 10%
• Presence of an epithelial defect ≥1.0 mm in the largest diameter in the affected eye
• Presence of any size epithelial defect that has been persistent for more than 30 days
• Patients unable to discontinue or intermittently remove therapeutic contact lens in the study eye (to apply drops) during the 4-week study period
• History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the 3 months prior to study enrollment
• History of chemical injury within the last 6 months prior to study enrollment Known hypersensitivity to one of the components of the study or procedural medications (e.g.,fluorescein)
• History of drug, medication or alcohol abuse or addiction
• Use of any investigational agent within 4 weeks of screening visit
• History of previous enrollment in the MSC Secretome Study at a lower dose
• 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

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

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (22)

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Related Links

• U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products.

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Ali R Djalilian, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

• Charlotte E Joslin, OD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

• Elmer Y Tu, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: A longitudinal assessment using a classic dose-escalation study design to evaluate the safety and maximal tolerated dose of topical MSC Secretome eye drops

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 24, 2022
• Study Start: January 24, 2024
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: January 29, 2026

Record last verified: 2024-12

Locations

US (1)