In short
THYTREG is an investigational cell therapy made from a child's own thymus tissue, being studied to prevent rejection after heart transplantation. One authorised Phase 1 clinical trial is testing this approach in 11 children. The therapy uses regulatory T cells (Tregs) expanded with IL-2, given as an intravenous infusion. It has no marketing authorisation and is supplied by Fundación para la Investigación Biomédica del Hospital Gregorio Marañón.
Key points
- THYTREG is an investigational cell therapy made from a child's own thymus tissue.
- It is being studied in one Phase 1 trial for preventing heart transplant rejection in children.
- The trial plans to enrol 11 participants and is currently authorised.
- The therapy is given as a solution for infusion into a vein.
- The main measure is the repopulation of Treg cells and recovery of the Treg to T-effector cell ratio.
- THYTREG has no marketing authorisation and remains an experimental treatment.
What is THYTREG?
THYTREG is an investigational cell therapy. It consists of autologous regulatory T cells (Tregs) that are differentiated from a child's own thymic tissue, expanded, and stimulated with interleukin-2 (IL-2). The cells are prepared as a solution for infusion and given intravenously. The product is supplied by Fundación para la Investigación Biomédica del Hospital Gregorio Marañón. THYTREG has no marketing authorisation in the product records and remains an experimental substance.
How does THYTREG work?
Regulatory T cells are a type of immune cell that helps control the immune system and prevent it from attacking the body's own tissues. In heart transplantation, the recipient's immune system can recognise the donor heart as foreign and attack it, causing rejection. THYTREG is designed to increase the number of Treg cells in the patient, which may help restore the balance between regulatory T cells and effector T cells. This balance is measured as the Treg / T-effector cell ratio. The trial's primary outcome is the repopulation of Treg cells in the patient, determined as the increase of their blood values and the recovery of this ratio compared to values before transplantation.
Which conditions is THYTREG studied for?
- Heart transplant rejection in children — the trial investigates whether THYTREG can help prevent acute rejection after heart transplantation in paediatric patients.
How is THYTREG given?
THYTREG is prepared as a solution for infusion and is administered intravenously. The cells are obtained from the child's own thymus tissue, which is typically removed during cardiac surgery in young children. The tissue is processed to isolate and expand the regulatory T cells before they are given back to the patient.
What do the clinical trials show?
One clinical trial is registered for THYTREG. It is a Phase 1/2, randomised, exploratory and prospective trial. The trial is authorised and plans to enrol 11 children who have received a heart transplant. The main objective is to evaluate the feasibility, safety and efficacy of infusing autologous thyTreg cells in preventing acute rejection. The primary outcome measures the repopulation of Treg cells in the blood and the recovery of the Treg / T-effector cell ratio compared to pre-transplant values.
The trial is interventional and randomised, meaning participants are assigned to different groups. The study is exploratory and prospective, following participants over time. It is registered in the EU Clinical Trials Information System with the identifier 2024-519845-30-00.
What side effects are known?
No side effect information is available from the provided sources.