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New treatment option for Heart Transplantation
Official title Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
ClinicalTrials.gov ID: NCT04924491
What this study is testing
What is Autologous thyTreg?
Autologous thyTreg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for heart transplantation.
Also referred to as thyTreg cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 2
You may be able to join if
- 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
You likely can't join if
- 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
- Patients with a history of previous malignancy
- Patients who have participated in other intervention studies in the last month.
See the full eligibility criteria
- 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
- 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
- Patients with a history of previous malignancy
- Patients who have participated in other intervention studies in the last month.
- Patients who have received induction therapy with Basiliximab or Thymoglobulin.
- Patients who have previously been thymectomized or transplanted.
- Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
- Patients who will receive an asystole heart
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 2 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.