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Clinical Trials in the EU / 2025-523139-21-00
Authorised Phase I/II

PHASE I/IIa CLINICAL TRIAL FOR THE TREATMENT OF GRAFT VERSUS HOST DISEASE WITH A NEW GENERATION OF MESENCHYMAL STROMAL CELLS ECTOPICALLY EXPRESSING CXCR4 AND IL-10 IN STEROID-REFRACTORY AND INTOLERANT OR RUXOLITINIB-REFRACTORY PATIENTS

2025-523139-21-00 · tracked via the Priya Life Science EU tracker
Sponsor
Fundacion Instituto De Investigacion Sanitaria De Navarra
Sponsor type
Laboratory/Research/Testing facility
Therapeutic area
Immune System Diseases
Decision date
09/04/2026
Enrollment target
15
Sites
Spain

Condition studied

Patients who have developed acute GVHD refractory to corticosteroids and ruxolitinib or that are not eligible to receive ruxolitinib

Investigational medicinal product(s)

Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cells (MSC) ectopically expressing CXCR4 and IL10

Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

Safety: • Serious Adverse Reactions after sequential infusions of the study drug, regardless of the number of doses the patient has received and during the entire follow-up period. • Serious Unexpected Serious Adverse Reactions at the time of infusion or during follow-up

Endpoint detail

Efficacy The response will be analyzed through clinical and biological parameters

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523139-21-00 on CTIS ↗ ← All trials in the EU