The treatment uses thymus-derived regulatory T cells (Treg) to regulate the immune system’s response and prevent rejection.
Researchers at Hospital General Universitario Gregorio Marañón have developed a world-pioneering therapy to prevent immune rejection in organ transplantation. The approach is based on thyTreg cells, as explained by the hospital.
Over six years, the hospital’s Immunoregulation Laboratory, directed by Rafael Correa Rocha, developed a new strategy to manufacture therapeutic doses of Treg cells. These cells control and reduce inappropriate inflammatory responses of the immune system that lead to serious conditions such as autoimmune diseases or transplant rejection.
Organ rejection is one of the most feared complications of transplantation, as it can endanger the patient’s life. In adults, rejection may occur within the first three months after surgery. In children, transplanted organs are often eventually rejected by the body, making a second transplant necessary.
“Thymus-derived Treg cells (thyTreg) possess unique properties and an exceptionally high regulatory capacity,” the hospital states.
Until now, immunosuppressive drugs used to reduce inflammation have been non-specific and may suppress the entire immune response. Previous attempts using blood-derived Treg cell therapies did not achieve strong therapeutic efficacy in adults and were not feasible in children.
The Gregorio Marañón team developed a new strategy to produce therapeutic doses of Treg cells from the thymus — a tissue located near the heart that is routinely removed and discarded during pediatric cardiac surgery. According to the researchers, thyTreg cells have unique qualities and a very high regulatory capacity.
This therapy can restore proper immune balance and may completely inhibit or significantly reduce immune responses responsible for rejection. “We are witnessing an unprecedented medical advance that could establish a new paradigm in the treatment of severe diseases. Our cell therapy harnesses and enhances the body’s intrinsic immune mechanisms to restore immunological tolerance and proper immune balance — without the use of drugs,” explains Rafael Correa, Director of the Immunoregulation Laboratory.
In the months following therapy, the presence of these cells appears to keep inflammatory mechanisms and immune cell proliferation that could trigger rejection under control.
The research has been supported by the Instituto de Salud Carlos III (ISCIII), the Fundación Familia Alonso, and the Organización Nacional de Trasplantes (ONT). It has also received international recognition, including from Professor Lori West, Scientific Director of the Canadian Donation and Transplantation Research Program.
The first human trial was conducted in a six-month-old girl with a congenital heart defect. She is currently progressing favorably. In the months after therapy, she has shown higher-than-usual levels of Treg cells compared to similar patients who did not receive cell therapy, and these cells appear to be controlling inflammatory mechanisms that could lead to rejection.
“We are fully confident that this therapy could represent a true revolution and enable effective treatment of serious conditions such as transplant rejection, autoimmune diseases, Crohn’s disease, graft-versus-host disease, and even immune hyperactivation processes that are a major cause of mortality in severe COVID-19 cases,” Correa concludes.
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