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

About this trial

Last updated a year ago

Study ID

THYTECH1-2018-005

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Accepting

Up to 2 Years

All Sexes

Trial Timing

Started 6 years ago

What is this trial about?

The investigators developed a protocol to isolate Treg cells from thymic tissue (thyTreg) discarded in pediatric cardiac surgeries. After completing the pre-clinical studies, the investigators have initiated a phase I/II clinical trial to test the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children. Condition or disease: Heart Transplantation Intervention/treatment: Regulatory T Cell (Treg) Infusion

What are the participation requirements?

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