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

ConditionHeart Transplantation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorRafael Correa-Rocha

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.

Patients without contraindication to immunosuppressive drugs.

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

Disqualifiers

Patients with DiGeorge Syndrome, since their thymic function is affected.

Human immunodeficiency virus positive serology

Epstein-Barr virus active infection

Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous thyTreg

    Biological/Vaccine

    Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)

Treatment groups

11 Participants
are divided into 2 treatment groups
Group A: 10.000.000 thyTreg /kgExperimental treatment 1 intervention
Group B: 20.000.000 thyTreg /kgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Repopulation of Treg cells in the patient, determined as the increase of Treg values in peripheral blood with respect to pre-transplant values or in comparison with a control cohort of non-treated patients.

Time frame
24 months

Secondary outcomes

1

Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography) that require treatment in the 2 years post-transplant

Time frame
24 months
2

Number of Treg cells in peripheral blood

Time frame
24 months
3

Change in the number of naive and memory Treg cells, and the production/levels of interferon gamma and interleukins (IL-4, IL-17A and IL-10).

Time frame
24 months
4

Decrease of cell subsets related with rejection (CD8 T cells subsets, activated T cells, antibody-secreting B cells) during the post-transplant follow-up period.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rafael Correa-Rocha

Lead sponsor

Hospital General Universitario Gregorio Marañon

Sponsor institution

Instituto de Salud Carlos III

Collaborator

Source ClinicalTrials.gov
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