Delayed infusion of a naïve T cell–depleted hematopoietic graft with memory T cells for solid organ transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label Phase I study enrolling up to 10 pediatric and adult solid organ transplant recipients to test safety and feasibility. After transplant and a stabilization period, participants will receive low-dose preconditioning (total lymphoid irradiation and thymic irradiation) followed by infusion of a hematopoietic graft enriched for CD34+ progenitors, depleted of naïve T lymphocytes, and supplemented with memory T cells to induce mixed chimerism. The primary focus is safety and feasibility of the delayed graft infusion and monitoring for rejection, infection, and hematologic complications. Exploratory aims include signs of donor-derived chimerism and reduced dependence on long-term immunosuppression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Patients with severe psychiatric or cognitive disorders that may interfere with adherence to study instructions or postoperative care.
* Patients currently enrolled in another clinical trial that could interfere with the outcomes or safety of this study.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and/or safety evaluation of the trial.

Where it's running

• La Paz University Hospital
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Francisco María Hernández Oliveros, MD, PhD
• Email: fhernandezo@salud.madrid.org
• Phone: +34 91 207 17 40

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.