Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children

Launched by RAFAEL CORREA-ROCHA · Jun 9, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach to help prevent heart transplant rejection in young children. Researchers are focusing on a special type of immune cell called regulatory T cells (or Treg cells) that are taken from thymic tissue, which is usually discarded during heart surgeries. The goal is to see if giving these cells back to the child after a heart transplant can help their body accept the new heart better and reduce the risk of rejection.

To be eligible for this trial, children must be under the age of two and meet the requirements for a heart transplant. They also need to be able to safely take medications that help control the immune system. Parents or guardians must understand the study's purpose and agree to participate by signing a consent form. If a child has certain health issues, like a specific immune condition or has had a previous cancer diagnosis, they may not be able to join the study. Participants can expect close monitoring during the trial to ensure their safety as they receive this innovative treatment aimed at improving outcomes after heart transplantation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.
• • 2. Patients without contraindication to immunosuppressive drugs.
• • 3. Parents and/or guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document
• Exclusion Criteria:
• • 1. Patients with DiGeorge Syndrome, since their thymic function is affected.
• • 2. Human immunodeficiency virus positive serology
• • 3. Epstein-Barr virus active infection
• • 4. Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies
• • 5. Patients with a history of previous malignancy
• • 6. Patients who have participated in other intervention studies in the last month.
• • 7. Patients who have received induction therapy with Basiliximab or Thymoglobulin.
• • 8. Patients who have previously been thymectomized or transplanted.
• • 9. Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
• • 10. Patients who will receive an asystole heart