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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

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523139-21-00
Enrollment
15
Registered
2026-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

Efficacy The response will be analyzed through clinical and biological parameters

Interventions

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

Sponsors

Fundacion Instituto De Investigacion Sanitaria De Navarra
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Efficacy The response will be analyzed through clinical and biological parameters

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 10, 2026