BridgeMD
Phase I / II clinical trial, randomized, exploratory and prospective to evaluate the safety and efficacy of the transfusion of autologous TREG cells obtained from thymic tissue in the prevention of rejection in heart transplanted children
EU CTIS ID: 2024-519845-30-00
What this study is testing
The main objective is to evaluate the feasibility, safety and efficacy of the infusion of autologous thyTreg cells in the prevention of acute rejection in children transplanted from the heart.
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient under two years of age, who meets all the requirements necessary 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. 2) HIV positive
- HIV positive serology.
- Active infection by EBV
- Patients hyperimmunized with cytotoxic anti-HLA antibodies
- Patients with a history of prior malignancy
- Patients who have received induction therapy with Basiliximab or Thymoglobulin
See the full eligibility criteria
- Patient under two years of age, who meets all the requirements necessary 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. 2) HIV positive
- HIV positive serology.
- Active infection by EBV
- Patients hyperimmunized with cytotoxic anti-HLA antibodies
- Patients with a history of prior malignancy
- Patients who have received induction therapy with Basiliximab or Thymoglobulin
- Patients who have been previously timectomized or transplanted.
- Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
- Patiens who have to receive a heart in asystolia
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.