The goal of this clinical trial is to evaluate the safety and feasibility of inducing hematopoietic mixed chimerism to promote immune tolerance and potentially reduce the need for lifelong immunosuppression in pediatric and adult patients undergoing solid organ transplantation (SOT), including kidney, lung, and multivisceral transplants.
The main questions it aims to answer are:
* Is it safe to infuse a naïve T cell-depleted hematopoietic graft along with memory T-lymphocytes after SOT? * Can this approach support immune tolerance and reduce the incidence of rejection and infection without long-term immunosuppression?
Participants will:
* Undergo a solid organ transplant from a living or deceased donor. * Wait through a stabilization period to ensure resolution of early transplant-related complications. * Receive low-dose preconditioning (TLI and thymic irradiation) to prepare for hematopoietic stem cell transplantation. * Be infused with a graft containing CD34+ progenitor cells, memory T cells (CD45RO+), and no naïve T cells (CD45RA+); in some cases, NK cells may also be included. * Be followed for graft survival, immune tolerance, infection rates, and adverse events through regular clinical and immune monitoring visits.
Pediatric patients (<18 years old) who are candidates to receive intestinal or lung transplantation (before SOT).
Pediatric (<18 years old) or adult patients (≥18 years old) who are either candidates for renal transplantation or have already undergone renal transplantation and remain candidates for subsequent HSCT.
Patients who provide informed consent (or their legal guardians in the case of minors) before any study-related procedures.
Recipients should have no active infectious disease or other medical condition that would contraindicate the combined transplantation procedure, as determined by the investigational team.
Recipients with existing bone marrow disorders or those receiving medications known to adversely affect bone marrow function.
Patients with advanced organ dysfunction (hepatic, cardiac, or pulmonary) incompatible with successful combined transplantation.
Patients with active or uncontrolled autoimmune conditions that may interfere with transplantation and the induction of chimerism.
Patients with known allergies to medications or products required for conditioning or transplantation.
Francisco Hernández Oliveros
Lead sponsor
Hospital Universitario La Paz
Sponsor institution