Using thymic-derived Treg cells to prevent heart transplant rejection in children

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 clinical trial investigates the use of regulatory T cells (Treg) obtained from thymic tissue to prevent rejection in pediatric heart transplant patients. The approach involves isolating Treg cells from discarded thymic tissue during cardiac surgeries, which allows for a higher yield and purity of Tregs compared to traditional methods. The trial aims to assess the safety and efficacy of these autologous thyTreg infusions in children under two years of age who are undergoing heart transplantation. By enhancing the immune system's regulatory capabilities, the study seeks to improve transplant outcomes and patient longevity.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital General Universitario Gregorio Marañon
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Rafael Correa-Rocha, PhD — Hospital General Universitario Gregorio Marañon
• Study coordinator: Rafael Correa-Rocha, PhD
• Email: rafael.correa@iisgm.com
• Phone: 34 915866455

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nationwide Swedish program testing donor-derived cell-free DNA to monitor rejection after heart transplant

  This project tests whether a blood test measuring donor-derived cell-free DNA can help monitor rejection in adults who have had a heart transplant.

  Recruiting Karolinska Institutet · Stockholm · NCT07531784

• Metabolic deterioration after heart transplant determines outcomes

  We'll test whether worsening cardiac and systemic metabolism after a heart transplant predicts heart function and long-term survival in adult transplant recipients.

  Recruiting Heinrich-Heine University, Duesseldorf · Düsseldorf, North Rhine-Westphalia · NCT07372820

• Mapping fat-cell sizes around the coronary arteries to trace inflammation

  This project will test whether differences in fat-cell size next to the coronary arteries can show how inflammation spreads in people having a heart transplant for advanced heart failure.

  Recruiting Institute for Clinical and Experimental Medicine · Prague · NCT07360925

• Multimodal analysis of heart biopsy samples

  This project will take one extra small heart biopsy during a clinically needed procedure to test whether detailed molecular and immune analyses can find disease-specific signatures in adults with cardiomyopathies, myocarditis, cardiac amyloidosis, or after heart transplant.

  Recruiting University Hospital, Essen · Essen, North Rhine-Westphalia · NCT07359690

• Long-term health of children born to mothers who had a solid organ transplant

  This project will look for long-term heart, kidney, and immune system problems in people aged 16 and older who were born to mothers who had a kidney, liver, pancreas, heart, or lung transplant.

  Recruiting University Medical Center Groningen · Groningen, Provincie Groningen · NCT07291258

• Cardiac rehabilitation cohort at Medicine Campus Davos to explore recovery

  This project will follow adults coming to Hochgebirgsklinik Davos for cardiac rehabilitation to see how their heart health and recovery progress over time.

  Recruiting Hochgebirgsklinik Davos · Davos, Kanton Graubünden · NCT07096973

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.