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Mesenchymal Stromal Cells
Mesenchymal Stromal Cell Therapy for Corneal Ulcers
Phase 2
Recruiting
Led By Ali R Djalilian, MD
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 baseline, days 1-7, 28, 60, 90
Awards & highlights
Study Summary
This trial involves using cells from bone marrow to treat chronic eye conditions. Previous studies showed it was safe. We want to study if it's effective.
Who is the study for?
This trial is for patients with persistent corneal ulcers not improving over the last 2 weeks, despite standard treatments. They must have a certain level of visual acuity and be able to follow study procedures. Excluded are those with recent ocular drug toxicity, prior specific eye surgeries (except amniotic membrane transplantation under conditions), anticipated need for punctual occlusion, severe corneal damage, systemic diseases affecting study outcomes, current use of investigational agents or participation in other studies.Check my eligibility
What is being tested?
The trial tests the effectiveness of Mesenchymal Stromal Cells (MSCs) derived from bone marrow on chronic epitheliopathies. MSCs will be compared to a control solution to see if they can heal corneal ulcers better. The MSCs are administered through subconjunctival injection near the affected area.See study design
What are the potential side effects?
While specific side effects related to MSC treatment aren't detailed here, potential risks may include local reactions at the injection site like redness or pain, inflammation within the eye, and possible immune response due to allogeneic (donor-derived) cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, days 1-7, 28, 60, 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 1-7, 28, 60, 90
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Rate)
Secondary outcome measures
Conjunctival injection
Corneal Epithelial Thickness
Corneal Neo-vascularization
+6 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Medium dose of allogenic MSC dropsActive Control1 Intervention
Dose of allogeneic MSC subconjunctival injection will be assigned 3,000,000 cells/150 µL.
Group II: Control GroupPlacebo Group1 Intervention
For the control group, 50 µL of the freezing media (vehicle) will be injected.
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
609 Previous Clinical Trials
1,559,271 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,661 Total Patients Enrolled
Ali R Djalilian, MDPrincipal InvestigatorUniversity of Illinois at Chicago
2 Previous Clinical Trials
26 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had eye surgery in the last 3 months.I have an eyelid issue that prevents me from closing my eyes properly.I have severe eye damage, including deep corneal ulceration or cornea melting.My eye condition hasn't improved after 2 weeks of standard treatment.My eye condition affects less than 80% of my cornea's diameter.I do not have any current eye infections or inflammation.I have not experienced eye-related side effects from medication in the last two weeks.I might need tear duct surgery during the study.I need a corneal transplant due to long-term cornea damage.I have no eye or health conditions that could affect the study treatment.I have had surgery for a long-term cornea problem in my eye.My eye condition hasn't improved in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Medium dose of allogenic MSC drops
- Group 2: Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has a moderate dosage of allogenic MSCs been granted regulatory approval?
"While Phase 2 trials have shown some evidence of safety, there is yet to be any data indicating efficacy. Therefore our team at Power has rated the medium dose allogenic MSC drops with a score of two on a scale from one to three."
Answered by AI
Are new participants being welcomed for this research project?
"The clinicaltrials.gov website reveals that this medical trial is not presently enrolling patients, despite being posted on May 1st 2023 and last updated January 21st 2023. Fortunately, there are currently 7 other trials actively recruiting participants."
Answered by AI
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