At a glance
ClinicalIndex Comparison Record- ✓Patient under two years of age who meets all necessary requirements for heart transplant
- ✓No contraindication to immunosuppressive drugs
- ✓Parents/guardians willing and able to understand purpose and risks, and sign informed consent
- ✕DiGeorge Syndrome (due to affected thymic function)
- ✕HIV positive serology
- ✕EBV active infection
- ✕Hyperimmunized with cytotoxic anti-HLA antibodies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Exploratory and Prospective Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of the Transfusion of Autologous Treg Cells Obtained From Thymic Tissue in the Prevention of Rejection in Heart Transplant Children
In Brief
A Phase 2 clinical trial evaluating Autologous thyTreg for Heart Transplantation. Currently recruiting, targeting 11 participants across 1 site.
Detailed Summary
The investigators developed a protocol to isolate Treg cells from thymic tissue (thyTreg) discarded in pediatric cardiac surgeries. After completing the pre-clinical studies, the investigators have initiated a phase I/II clinical trial to test the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children. Condition or disease: Heart Transplantation Intervention/treatment: Regulatory T Cell (Treg) Infusion
Study Details
Timeline
Interventions
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)