Preliminary results suggest that a single administration of this treatment is capable of restoring immune balance.
Researchers from the Immunoregulation Laboratory at Hospital General Universitario Gregorio Marañón have successfully treated seven infants who underwent heart transplantation with a treatment unique worldwide. The therapy is based on a cellular approach using thyTreg cells to prevent immune rejection and potentially extend the survival of the transplanted organ indefinitely, thereby prolonging the patient’s life.
To date, preliminary results suggest that a single administration of this therapy is capable of restoring immune balance and may prevent acute organ rejection in these children. In the first patient, a single infusion administered one week after transplantation has preserved proper immune balance for two years — the period associated with the highest incidence of rejection in this type of patient.
“We are witnessing an unprecedented medical advance that could establish a new paradigm in the treatment of various severe diseases,” explains Rafael Correa Rocha, Director of the Immunoregulation Laboratory at Hospital Gregorio Marañón, whose team has published the results in the Journal of Experimental Medicine.
This clinical trial is the first worldwide to administer Treg therapy in transplanted children and, notably, the first to use thymic-derived thyTreg cells in humans instead of blood-derived Tregs. This approach has enabled the production of a significantly higher number of cells of much greater quality, making advanced cell therapy feasible in pediatric patients.
Irene, the First Patient to Receive the Therapy
Six-month-old Irene was born with a congenital heart condition requiring heart transplantation and became the first patient worldwide to receive this innovative therapy following her transplant at Hospital Gregorio Marañón.
One week after transplantation, she received a single dose of her own thyTreg cells and has been closely monitored for two years to determine whether the therapy could reduce the risk of rejecting her new heart.
During this period, Irene has shown higher circulating levels of Treg cells compared to pediatric heart transplant recipients who did not receive thyTreg therapy. The presence of these cells has helped maintain control over the immunological mechanisms that could trigger rejection.
Importantly, no signs of rejection have been detected in this patient during the two-year post-transplant period, which is typically associated with the highest incidence of rejection in these children.
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