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Study on Preventing Heart Transplant Rejection in Children Using Autologous Treg Cells (thyTreg)

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on children who have received a heart transplant. The study is investigating a new treatment to help prevent the body from rejecting the new heart. The treatment involves using special cells called autologous TREG cells, which are taken from the child's own thymic tissue. These cells are then expanded and stimulated with a substance called IL-2 before being infused back into the child. This process is designed to help the immune system accept the new heart more easily.

The purpose of the study is to evaluate how safe and effective this treatment is in preventing rejection of the transplanted heart. Children participating in the study will receive the infusion of these special cells, and their health will be monitored over time to see how well the treatment works. The study will look at how the TREG cells help in maintaining a balance in the immune system and whether they reduce the chances of the heart being rejected.

Throughout the study, doctors will keep track of the children's health by checking their blood for changes in immune cells and watching for any signs of heart rejection. The study will also monitor the overall well-being and survival of the children to ensure the treatment is safe. This research aims to provide a better understanding of how to improve outcomes for children who have undergone heart transplants.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The patient, under two years of age, is assessed to ensure they meet all necessary requirements for a heart transplant.

    The patient must not have any contraindications to immunosuppressive drugs.

    Parents or guardians must understand the study's purpose and risks and sign the informed consent document.

  2. Step 2

    Heart transplant

    The patient undergoes a heart transplant procedure as part of the standard medical care.

  3. Step 3

    Infusion of autologous thyTreg cells

    The patient receives an infusion of autologous thyTreg cells, which are Treg cells obtained from the patient's thymic tissue.

    The infusion is administered intravenously as a solution for infusion.

  4. Step 4

    Monitoring and follow-up

    The primary goal is to monitor the repopulation of Treg cells in the patient, focusing on the increase of their blood values and the recovery of the Treg to T-effector cell ratio.

    Secondary goals include monitoring for episodes of acute myocardial rejection, restoration of immune balance, and overall patient survival.

    Follow-up assessments occur at multiple intervals post-transplant: +7, +14, +21, +30, +60, +90, +120, +150, +180, +270, +365, +545, and +730 days.

    Safety is evaluated according to specific criteria (NCI-CTCAE V4.03).

Who can join the trial?

3 criteria

  • The patient must be under two years old and meet all the requirements needed for a heart transplant.
  • The patient must not have any reasons that would prevent them from taking **immunosuppressive drugs**. These are medicines that help stop the body from rejecting a new heart.
  • The parents or guardians must be willing and able to understand the purpose and risks of the study. They must also sign a document called **informed consent**, which shows they agree to let the child participate in the study.

Who cannot join the trial?

5 criteria

  • Patients who have had a heart transplant but are not children cannot participate.
  • Patients who are not able to receive an infusion of their own special immune cells, called autologous thyTreg cells, are excluded. These are cells taken from the patient, treated, and then given back to help prevent the body from rejecting the new heart.
  • Patients who have any medical condition that makes it unsafe for them to participate in the study will be excluded.
  • Patients who are not able to follow the study procedures or attend all required visits cannot participate.
  • Patients who are part of another clinical trial that might interfere with this study are excluded.
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Investigated drugs

Autologous TREG Cells: These are special immune cells taken from the patient's own thymic tissue. The purpose of using these cells in the trial is to help prevent the body from rejecting a new heart after a transplant. By using the patient's own cells, the treatment aims to reduce the risk of rejection and improve the overall success of the heart transplant.

What is already known about the treatment

Autologous thyTreg cells – This treatment involves the transfusion of regulatory T cells derived from the patient's own thymic tissue. It is currently being studied in a Phase I/II clinical trial to assess its safety and effectiveness in preventing rejection in children who have undergone heart transplants. The main therapeutic indication is to prevent acute rejection of the transplanted heart. At the molecular level, these cells work by modulating the immune response to reduce the likelihood of the body attacking the transplanted organ. This treatment falls under the pharmacological classification of cell-based immunotherapy.

Investigated diseases

Heart Transplant Rejection – This condition occurs when the body's immune system attacks the transplanted heart, viewing it as a foreign object. It can happen at any time after the transplant, but it is most common in the first few months. Symptoms may include fatigue, shortness of breath, and fluid retention. The immune response involves various cells, including T cells, which play a crucial role in the rejection process. Monitoring and managing the balance of immune cells is essential to prevent rejection. Regular follow-up and testing are necessary to detect and address any signs of rejection early.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2024-519845-30-00Protocol codeTHYTECH1-2018-005Estimated enrolment11 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

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