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Tests treatment safety and results for Solid Organ Transplant Complications
Official title Phase I Trial on the Safety of Delayed Infusion of a Naïve T Cell-Depleted Hematopoietic Graft With Memory T Cells in Solid Organ Transplant Recipients
ClinicalTrials.gov ID: NCT06997471
What this study is testing
What is Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytes?
Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytes is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for solid organ transplant complications.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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.
See the full eligibility 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.
- 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 how well it works and/or safety evaluation of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.