Study Evaluating Two Doses of Cord Blood Mesenchymal Stromal Cells with Ruxolitinib for Steroid-Refractory Acute Graft Versus Host Disease in Patients Aged 12 to 80

What this Trial Is About

Researchers are evaluating the addition of cord blood tissue-derived mesenchymal stromal cells cb-MSCs to ruxolitinib in treating patients aged 12 to 80 with steroid-refractory acute graft versus host disease GVHD following allogeneic hematopoietic cell transplant or donor lymphocyte infusion. This early phase I trial aims to understand if combining cb-MSCs with ruxolitinib helps control this severe condition that does not respond to steroid therapy. Participants are randomly assigned to one of three treatment groups. One group receives ruxolitinib orally twice daily for at least 3 days, with possible tapering after 6 months if the response is favorable and corticosteroids are discontinued. The other two groups receive the same ruxolitinib regimen plus either a lower or higher dose of cb-MSCs given intravenously twice weekly over four weeks for a total of eight doses. Following treatment, patients are monitored on day 28 and then for up to six months. During the study, participants will have regular assessments including monitoring of survival, response to therapy, adverse events, and graft versus host disease status at several time points up to six months. Researchers will also observe the durability of organ responses, incidences of infections, toxicities, and other safety measures. The study involves oral medication, intravenous infusions, laboratory tests, and clinical evaluations to understand the treatments effects and safety.

Addition of Cord Blood Tissue-Derived Mesenchymal Stromal Cells to Ruxolitinib for the Treatment of Steroid-Refractory Acute Graft Versus Host Disease