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.
Age range
18 Years
Sex
ALL
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Change in the integrity of the ocular surface
Timeframe: six and twelve months from start of treatment
Change in tear production
Timeframe: six and twelve months from start of treatment
Change in the degree of conjunctival hyperemia
Timeframe: six and twelve months from start of treatment
Change in the parameters related to the Meibomian glands
Timeframe: six and twelve months from start of treatment
Change in any of the findings in the central cornea
Timeframe: six and twelve months from start of treatment
Severity of eye disease measured by WFPRS (Wong-Baker Faces Pain Rating Scale)
Timeframe: six and twelve months from start of treatment
Severity of eye disease measured by Numerical Rating Scale (NRS)
Timeframe: six and twelve months from start of treatment
Esperanza Lopez Franco PhD, PhD in Molecular Biology
Severity of eye disease measured by Modified Symptom Assessment in Dry Eye Questionnaire (mSIDEQ)
Timeframe: six and twelve months from start of treatment
Severity of eye disease measured by Ocular Surface Disease Index (OSDI)
Timeframe: six and twelve months from start of treatment
Severity of eye disease measured by CDES-Q (Contact Lens Dry Eye Symptom Questionnaire)
Timeframe: six and twelve months from start of treatment