Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease (MSCSecretome)

February 20, 2024 updated by: Ali R Djalilian, University of Illinois at Chicago
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The "Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease" study is designed to evaluate the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops in patients with chronic ocular surface disease through a dose-escalation study under a 28-day topical application protocol, and also obtain a preliminary observation on the following:

  1. Incidence of treatment emergent adverse events (TEAE) assessed at 28 days following treatment initiation
  2. Proportion of patients with improved corneal epithelial barrier at 28 days compared to baseline
  3. Final visual acuity, corneal epithelial thickness, corneal stromal haze, corneal sensation, and treatment tolerability

The objective is to determine the dose of MSC Secretome through a first-in-human study through a dose-escalation strategy targeting a toxicity rate of 33% or less.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low dose of allogenic MSC drops
Escalating doses of allogenic MSC eye drops will be assigned at the lowest dose level.
Biological: MSC Secretome Eye Drops
MSC Secretome eye drop will be dispensed.
Active Comparator: Medium dose of allogenic MSC drops
Escalating doses of allogenic MSC eye drops will be assigned at the medium dose level.
Biological: MSC Secretome Eye Drops
MSC Secretome eye drop will be dispensed.
Active Comparator: High dose of allogenic MSC drops
Escalating doses of allogenic MSC eye drops will be assigned at the high dose level.
Biological: MSC Secretome Eye Drops
MSC Secretome eye drop will be dispensed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelial Status Assessment
Time Frame: Day 28
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: Baseline, Days 7, 14, 28, 56, 90
Best-corrected distance visual acuity will be measured using standard ETDRS protocols.
Baseline, Days 7, 14, 28, 56, 90
Corneal Epithelial thickness
Time Frame: Baseline, Days 14, 28, 56, 90
Corneal epithelial thickness measured by anterior segment OCT imaging (Cirrus 6000, Pachymetry, a-scans and b-scans) will assess the treatment effect on thickness on DAY #28 and compared relative to baseline.
Baseline, Days 14, 28, 56, 90
Corneal Scarring / Haze
Time Frame: Baseline, Days 14, 28, 56, 90
Corneal scarring/haze will be assessed via anterior segment OCT imaging (Cirrus 6000; HD cornea, a-scans) to assess the treatment effect on DAY #28 relative to baseline(Images analysis done by Image-J/Metamorph)
Baseline, Days 14, 28, 56, 90
Tolerability of MSC secretome drops
Time Frame: Baseline, Days 7, 14, 28, 56, 90
Drop discomfort will be measured at DAYS #7, #14, and #28 using a visual analogue scale (VAS; range 0 -100), where 0 represents no discomfort and 100 the worst discomfort.
Baseline, Days 7, 14, 28, 56, 90
Durability of Corneal Epithelial Status Improvement
Time Frame: Baseline, Days 7, 14, 28, 56, 90
Durability of the improved corneal epithelial barrier function/integrity will be assessed an outcome measure at DAY #56 and DAY #90. Participants with improved corneal epithelial barrier function/integrity to DAY #28 will be assessed at each subsequent follow-up visits (e.g., DAYS #56, #90) to assess persistence of the healing response.
Baseline, Days 7, 14, 28, 56, 90
Time to Improvement of Corneal Epithelial Barrier
Time Frame: Baseline, Days 7, 14, 28, 56, 90
The time required for an improved epithelial barrier function will be assessed at each visit throughout the trial.
Baseline, Days 7, 14, 28, 56, 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Eye Institute (NEI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0754
  • 1UG3EY031809-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Defect

Clinical Trials on MSC Secretome Eye Drops

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe