Phase III Trial of Autologous Thymus-Derived Regulatory T Cell Therapy to Prevent Rejection in Children Under 2 Years After Heart Transplant

What this Trial Is About

Researchers are evaluating the use of regulatory T cells obtained from thymic tissue thyTreg to prevent rejection in children undergoing heart transplantation. This phase III clinical trial aims to test the safety and effectiveness of transferring these autologous thyTreg cells, which have improved survival and suppressive capacities compared to Tregs isolated from adult blood. The study focuses on children under two years old who require heart transplants and seeks to improve long-term graft survival by leveraging thymus-derived Treg cells. Participants will receive one of two doses of autologous thyTreg cells either 10 million or 20 million cells per kilogram. These cells are expanded and stimulated with interleukin-2 before transfusion. The study is randomized and exploratory, with no masking, and lasts for 24 months post-transplant. The trial builds on preclinical findings and involves the adoptive transfer of the patients own thymus-derived Treg cells to prevent immune rejection. Throughout the 24 months following transplantation, participants will be closely monitored for Treg cell levels in their blood, incidence of acute myocardial rejection episodes, and changes in immune cell subsets and cytokine production. Heart function will be assessed through electrocardiogram and echocardiogram measurements. The research team will also track treatment-related adverse events and overall patient survival. This comprehensive follow-up will help determine the safety and immune effects of thyTreg therapy in young heart transplant recipients.

Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children