Table of Contents
- Trial overview
- Who was studied
- Trial goals and study phase
- Main endpoints
- Trial status and enrollment
Trial overview
This clinical trial studied ALLOGENEIC ADIPOCYTE-DERIVED MESENCHYMAL STROMAL CELLS TRANSDUCED WITH A LENTIVIRAL PROVIRUS VECTOR CONTAINING THE HUMAN CXCR4 AND IL-10 GENES for acute graft-versus-host disease (acute GVHD).[1]
The study was designed as an interventional trial, which means the researchers planned to give a study treatment and watch what happened.[1]
Who was studied
The trial focused on patients who had developed acute GVHD that was refractory, meaning it did not respond well to treatment.[1]
More specifically, it included patients whose disease was refractory to corticosteroids and ruxolitinib, or patients who were not eligible to receive ruxolitinib.[1]
In simple terms, this was a group of people with difficult-to-treat disease and limited treatment options.[1]
Trial goals and study phase
This was a Phase 1 trial.[1]
Phase 1 studies usually look first at safety and tolerability, which means whether the treatment can be given without causing too much harm and whether patients can handle it reasonably well.[1]
The brief summary said the study aimed to analyze the safety and tolerability of the administration of the study treatment in patients with acute GVHD who had few remaining options.[1]
Main endpoints
The primary outcome was safety, measured by serious adverse reactions after sequential infusions of the study drug during the full follow-up period.[1]
The trial also looked for serious unexpected adverse reactions at the time of infusion or during follow-up.[1]
These endpoints show that the study was mainly checking for harmful reactions and how patients responded over time.[1]
Trial status and enrollment
The trial status was Withdrawn, which means it did not continue as planned.[1]
The planned enrollment was 15 patients.[1]
The trial title described the treatment as a new generation of mesenchymal stromal cells that ectopically express CXCR4 and IL-10, and the intervention was given by intravenous infusion.[1]
