The purpose of this FOA is to solicit applications to participate in a clinical studies program to improve the long-term outcome of adult and pediatric transplant recipients (thoracic organ, abdominal organ, vascular composite tissue, and cellular replacement).
The Clinical Trials in Organ Transplantation
in Children and Adults (CTOT-CA) program will support cooperative, multi-institutional consortia for the conduct of interventional trials (Phase 1, 2, or 3) or observational clinical studies in organ, vascularized composite tissue, or cellular replacement allotransplantation.
Each applicant institution must represent a consortium of 2 or more clinical sites.
Each clinical study must include associated mechanistic studies that focus on immune-mediated processes that are relevant to the proposed clinical study.
The goals of this research will be to further our understanding of and ultimately reduce immune- and infection-mediated morbidity and mortality of allotransplantation.