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Tests treatment safety and results for Corneal Ulcer
Official title Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
ClinicalTrials.gov ID: NCT05705024
What this study is testing
What is Mesenchymal Stromal Cells?
Mesenchymal Stromal Cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for corneal ulcer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The proposed Conventional Cohort Expansion Study involves the use of Mesenchymal Stromal Cells (MSCs) are derived from the bone marrow. We previously studied the safety of subconjunctival injection of allogeneic bone marrow-derived MSCs in patients with nonhealing epitheliopathy (IRB Protocol 2020-0334).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Visual Acuity:
- Best corrected distance visual acuity (BCDVA) score ≤ 75 ETDRS letters, (≥ 0.2 LogMAR, ≤ 20/32 Snellen or ≤ 0.625 decimal fraction) in the affected...
- Patients with non-resolving corneal epitheliopathy or epithelial defect after two or more weeks of standard non-surgical treatments (e.g...
- No objective clinical evidence of improvement in the last 2 weeks (≤50% reduction in fluorescein staining or ≤50% reduction in longest diameter of...
- If both eyes have chronic epithelial disease, the eye with the worse epithelial disease will be treated.
You likely can't join if
- Visual Acuity:
- Best-corrected distance visual acuity (BCDVA) score better than 75 ETDRS letters, or 0.2 LogMAR, or 20/32 Snellen or 0.625 decimal fraction in the...
- Ocular drug toxicity less than two weeks ago
- Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation in the affected eye.
- History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the three months before study...
- Prior surgical procedure(s) for the treatment of a chronic corneal epitheliopathy (e.g., complete tarsorrhaphy, conjunctival flap, etc.) in the...
See the full eligibility criteria
- Visual Acuity:
- Best corrected distance visual acuity (BCDVA) score ≤ 75 ETDRS letters, (≥ 0.2 LogMAR, ≤ 20/32 Snellen or ≤ 0.625 decimal fraction) in the affected eye. Ocular Health:
- Patients with non-resolving corneal epitheliopathy or epithelial defect after two or more weeks of standard non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of...
- No objective clinical evidence of improvement in the last 2 weeks (≤50% reduction in fluorescein staining or ≤50% reduction in longest diameter of the epithelial defect).
- If both eyes have chronic epithelial disease, the eye with the worse epithelial disease will be treated.
- Evidence of impaired epithelial barrier manifested by fluorescein staining of the epithelium with a score 10 or higher by National Eye Institute grading.
- Patients with stage 1 (no epithelial defect), stage 2 (persistent epithelial defect, PED; without stromal loss) or stage 3 (corneal ulcer; with stromal loss) neurotrophic keratopathy25-27 limited to ≤80% corneal...
- 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...
- Patients must have the ability and willingness to comply with study procedures.
- Visual Acuity:
- Best-corrected distance visual acuity (BCDVA) score better than 75 ETDRS letters, or 0.2 LogMAR, or 20/32 Snellen or 0.625 decimal fraction in the affected eye Ocular Health:
- Ocular drug toxicity less than two weeks ago
- Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation in the affected eye.
- History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the three months before study enrollment. (An exception to the preceding statement will be allowed if the...
- Prior surgical procedure(s) for the treatment of a chronic corneal epitheliopathy (e.g., complete tarsorrhaphy, conjunctival flap, etc.) in the affected eye with the exception of amniotic membrane transplantation...
- Chronic corneal epitheliopathy in the background of endothelial decompensation that needs corneal graft
- Anticipated need for punctual occlusion during the study treatment period. Patients with punctual occlusion or punctual plugs inserted prior to the study are eligible for enrollment provided that the punctual occlusion...
- Evidence of corneal ulceration involving the posterior third of the corneal stroma, corneal melting or perforation in the affected eye.
- Presence or history of any ocular or systemic disorder or condition that might hinder the how well it works of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or...
- Patients with uncontrolled eyelid abnormality that preclude appropriate eyelid closure or including eyelash abnormality Study Procedures:
- 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.
- Participation in another clinical study at the same time as the present study.
- Participants who are pregnant at the time of study enrollment will be excluded; pregnancy is identified according to the patient's self-report /positive βhCG
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Philadelphia, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.