Table of contents

• Trial overview
• Target population and eligibility focus
• Study design, phase, and enrollment
• Endpoints and what was measured
• Trial status and what it means

Trial overview

This clinical research studied acute graft-versus-host disease (GVHD) in patients with difficult-to-treat disease.^[1] The study tested ALLOGENEIC ADIPOCYTE-DERIVED MESENCHYMAL STROMAL CELLS TRANSDUCED WITH A LENTIVIRAL PROVIRUS VECTOR CONTAINING THE HUMAN CXCR4 AND IL-10 GENES as an interventional treatment, meaning the research team gave the study treatment and then observed the results.^[1]

Target population and eligibility focus

The trial was designed for patients who had developed acute GVHD that was refractory to corticosteroids and ruxolitinib-refractory, or who were not eligible to receive ruxolitinib.^[1] In simple terms, this means the study focused on people whose disease did not improve with prior standard treatment, or who could not use one of the listed treatments.^[1]

Study design, phase, and enrollment

The trial record lists the study as Phase 1, while the title describes it as a Phase I/IIa clinical trial.^[1] The planned enrollment was 15 participants, which shows this was a small early-stage study.^[1]

Endpoints and what was measured

The main endpoint was safety, especially serious adverse reactions after sequential infusions of the study drug, no matter how many doses a patient received.^[1] The study also measured serious unexpected serious adverse reactions at the time of infusion or during follow-up.^[1] These outcomes show that the trial mainly wanted to see whether the treatment could be given safely and how patients tolerated it.^[1]

Trial status and what it means

The trial status was Withdrawn.^[1] This means the study did not continue as planned and did not complete recruitment or follow-up in the usual way.^[1]