Status:
NOT_YET_RECRUITING
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Lead Sponsor:
Instituto de Investigación Biomédica de Salamanca
Collaborating Sponsors:
Spanish Clinical Research Network - SCReN
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Conditions:
Dry Eye Disease (DED)
Graft-Versus-Host Disease(GVHD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This Phase IIB, multicenter, double-blind, randomized, and uncontrolled clinical trial aims to assess the efficacy and safety of subconjunctival injection of Mesenchymal Stem Cells (MSCs) in patients ...
Eligibility Criteria
Inclusion
- Patients over 18 years of age who understand and sign the informed consent form.
- Diagnosis of severe GVHD (graft versus host disease) according to NIH criteria (revised by Lee SJ in 2017) with ocular involvement in the form of severe SOD (severe ocular disease) in both eyes for more than 3 months, objectively defined as superficial punctate keratitis \>2 on the Oxford scale (range 0-5) and/or the presence of epithelial defect, and subjectively as severe symptoms, \>33 points on the OSDI questionnaire (0-100).
- Patients must have previously been treated for at least three months with blood derivatives and/or insulin eye drops and topical cyclosporine or tacrolimus (unless any of these treatments were not tolerated and had to be discontinued).
- Patients must be using ocular lubricants at least 4 times a day and, despite this, still meet the criteria for severe SOD as outlined in point 2.
- Patients on low doses of topical corticosteroids for maintenance should have a stable dose for at least one month prior to inclusion.
- The dose and frequency of all topical medications the patient begins the trial with must remain unchanged throughout the duration of the trial, unless otherwise judged by the investigator.
- The chronic GVHD systemic treatment should be stable regarding the use of systemic immunosuppressors for at least one month prior to patient inclusion or before starting treatment.
- Negative result in the urine pregnancy test at the baseline visit for women of childbearing age. Subjects must be advised to use contraceptive methods during their participation in the clinical trial and undergo a new pregnancy test at the treatment visit if more than 28 days have passed since the baseline visit.
Exclusion
- Uncontrolled systemic disease or any condition that, in the medical judgment, could put the patient at risk or affect the interpretation of the results.
- Uncontrolled systemic GVHD.
- Active ocular infection.
- Ocular surgery within the last 3 months.
- Initiation of topical therapies for SOD indicated in the inclusion criteria less than 3 months prior to inclusion.
- Start of topical corticosteroid use within 4 weeks prior to inclusion.
- Cognitive impairments that could interfere with study compliance.
- Pregnant women or women during the lactation period.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06905834
Start Date
June 1 2025
End Date
June 1 2028
Last Update
April 4 2025
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