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

NCT06905834 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Dry Eye Disease (DED)
  • Graft-Versus-Host Disease(GVHD)

Interventions

DRUG

Subconjuntival injection of expanded allogenic adult adipose tissue-derived mesenchymal stem cells (ASC

Subconjunctival injection is a widely used technique in ophthalmology due to its effectiveness, minimal invasiveness, and ease of administration. In a subconjunctival injection the cells adult adipose tissue-derived mesenchimal cells are delivered into the subconjunctival space, the area between the conjunctiva and sclera.

Sponsors & Collaborators

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

    collaborator OTHER

  • Instituto de Investigación Biomédica de Salamanca

    lead OTHER

Principal Investigators

  • Fermín Sánchez-Guijo Martín MD, PhD, Medical Degree in Haematology · Centro Asistencial Universitario de Salamanca (CAUSA)

  • Lourdes Vázquez López MD, PhD, Medical Degree in Haematology · Centro Asistencial Universitario de Salamanca (CAUSA)

  • Mi Kwon MD, PhD, Medical Degree in Haematology · Hospital General Universitario Gregorio Marañón (HGUGM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-06-30
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06905834 on ClinicalTrials.gov