Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-06-01

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 with Graft-versus-Host Disease (GVHD) and severe ocular involvement (DYD-dry eye disease). The primary objective is to evaluate the clinically and statistically significant improvement in the signs and symptoms associated with the disease.

Secondary objectives include:

• Analyzing adverse events related to the subconjunctival injection of MSCs to confirm the safety of this treatment in patients with GVHD ocular involvement.
• Identifying new biomarkers that can be used to objectively assess the progression of patients with GVHD and severe ocular involvement.
• Studying the relationship between the expression of ocular surface-specific markers by MSCs and their clinical efficacy, as well as the variation in the expression of these markers in relation to cell preservation methods.

Assessing the quality of life of patients treated with two doses of MSCs using the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire).

\- Evaluating whether the cell dose impacts clinical improvement.

The trial includes 30 patients, divided into two groups of 15, and focuses on the assessment of dry eye disease, with the treatment based on MSC administration to improve clinical outcomes and quality of life for the patients.

• Phase: PHASE2

Details

• Lead Sponsor: Instituto de Investigacin Biomdica de Salamanca
• Collaborators: Instituto Universitario de Oftalmobiologa Aplicada (Institute of Applied Ophthalmobiology) - IOBA; Spanish Clinical Research Network - SCReN