← Back to Search

Mesenchymal Stromal Cells

MSC Therapy for Corneal Repair

Phase 1

Recruiting

Led By Charlotte E Joslin, OD, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment, treatment, and days #1, #7, #14, #28, #90

Awards & highlights

Study Summary

This trial is testing if locally delivered allogeneic mesenchymal stromal cells (MSC) are safe and effective for promoting corneal repair.

Who is the study for?

Adults with certain corneal diseases like neurotrophic keratitis, who haven't improved with standard treatments, can join this trial. They should have moderate to severe chronic corneal epithelial disease and decreased corneal sensitivity. Those with active eye infections, recent ocular surgery or severe vision loss without potential for improvement are excluded.Check my eligibility

What is being tested?

The study tests the safety and best dose of allogeneic mesenchymal stromal cells (MSC) applied directly to the eye for repairing the cornea. It's a step-by-step trial that increases doses over time at Illinois Eye and Ear Infirmary using advanced imaging techniques to monitor healing.See study design

What are the potential side effects?

While specific side effects aren't listed here, MSC therapy could potentially cause local reactions at the site of application, immune responses or infection risks due to cell transplantation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment, treatment, and days #1, #7, #14, #28, #90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment, treatment, and days #1, #7, #14, #28, #90

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, treatment, and days #1, #7, #14, #28, #90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Efficacy Outcome: Proportion of participants with improvement in epithelial defect or barrier integrity relative to baseline (based on fluorescein staining)

Primary Safety Outcome: Incidence of treatment emergent adverse events (TEAE) assessed at 28 days.

Secondary outcome measures

Secondary Efficacy Outcomes: Corneal epithelial thickness

Secondary Efficacy Outcomes: Corneal stromal haze

Secondary Efficacy Outcomes: Durability of the Corneal Epithelialization and Healing

+2 more

Trial Design

3Treatment groups

Active Control

Group I: Medium dose of allogeneic MSCActive Control1 Intervention

Escalating doses of allogeneic MSC subconjunctival injection will be assigned 3,000,000 cells/150 µL at the medium dose level.

Group II: Low dose of allogeneic MSCActive Control1 Intervention

Escalating doses of allogeneic MSC subconjunctival injection will be assigned 1,000,000 cells/50 µL at the low dose level.

Group III: High dose of allogeneic MSCActive Control1 Intervention

Escalating doses of allogeneic MSC subconjunctival injection will be assigned 6,000,000 cells total consisting of injection at 2 sites of 3,000,000 cells/150 µL each at the high dose level.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

613 Previous Clinical Trials

1,560,984 Total Patients Enrolled

United States Department of DefenseFED

866 Previous Clinical Trials

327,416 Total Patients Enrolled

Charlotte E Joslin, OD, PhDPrincipal InvestigatorUniversity of Illinois Chicago

2 Previous Clinical Trials

56 Total Patients Enrolled

Media Library

Allogeneic MSC (Mesenchymal Stromal Cells) Clinical Trial Eligibility Overview. Trial Name: NCT04626583 — Phase 1

Corneal Dystrophy Research Study Groups: Medium dose of allogeneic MSC, Low dose of allogeneic MSC, High dose of allogeneic MSC

Corneal Dystrophy Clinical Trial 2023: Allogeneic MSC Highlights & Side Effects. Trial Name: NCT04626583 — Phase 1

Allogeneic MSC (Mesenchymal Stromal Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04626583 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open spots left for individuals to participate in this clinical research?

"Affirmative, the related clinicaltrials.gov entry reveals that this trial is actively recruiting participants. This medical experiment was initially shared on March 5th 2021 and has since been revised in April 19th 2022. A total of 18 patients are required at a solitary location to complete this study."

Answered by AI

What are the aims of this medical experiment?

"The primary aim of this trial, which can be evaluated after day 28, is to assess the extent to which fluorescein staining reveals an improvement in epithelial defect or barrier integrity. Secondary goals include measuring visual acuity using standard e-ETDRS protocols; calculating time till complete corneal epithelization at each visit throughout the test period; and comparing treatment effect on corneal haze through Scheimpflug imaging and anterior segment OCT images (with Image J software) against baseline data by day 28."

Answered by AI

How many individuals have taken part in this clinical experiment?

"Affirmative. Information hosted on clinicaltrials.gov demonstrates that this medical study, which was initially posted on March 5th 2021 is currently recruiting participants. A total of 18 patients need to be acquired from a single site."

Answered by AI

Has a Medium dose of allogeneic MSC ever been validated by the Food and Drug Administration?

"Based on the low amount of available data, our team at Power estimated a score of 1 for medium dose allogeneic MSCs in terms of safety. This is due to it being evaluated during Phase 1 trials with limited evidence supporting efficacy and security."

Answered by AI

Recent research and studies

Stem CellsJournal

Reconstruction of Chemically Burned Rat Corneal Surface by Bone Marrow–derived Human Mesenchymal Stem Cells

Ma, Yanling, Yongsheng Xu, Zhifeng Xiao, Wei Yang, Chun Zhang, E. Song, Yiqin Du, and Lingsong Li. 2005. “Reconstruction of Chemically Burned Rat Corneal Surface by Bone Marrow–derived Human Mesenchymal Stem Cells”. Stem Cells. Oxford University Press (OUP). doi:10.1634/stemcells.2005-0046.

Clinical OphthalmologyJournal

Diagnosis and Management of Neurotrophic Keratitis

Lambiase, Alessandro, and Marta Sacchetti. 2014. “Diagnosis and Management of Neurotrophic Keratitis”. Clinical Ophthalmology. Informa UK Limited. doi:10.2147/opth.s45921.

Molecular TherapyJournal

Mesenchymal Stem/stromal Cells (mscs): Role as Guardians of Inflammation

Prockop, Darwin J, and Joo Youn Oh. 2012. “Mesenchymal Stem/stromal Cells (mscs): Role as Guardians of Inflammation”. Molecular Therapy. Elsevier BV. doi:10.1038/mt.2011.211.

Stem CellsJournal