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TREG02 is an autologous cell therapy product consisting of ex vivo expanded polyclonal regulatory T cells (Tregs), developed by Charité - Universitätsmedizin Berlin. It is primarily indicated for the prevention of organ rejection in solid organ transplantation, with current clinical development focused on liver transplant recipients. The therapy involves isolating CD4+ CD25+ Tregs from the patient's own blood, expanding them to therapeutic doses under GMP conditions, and re-infusing them to promote immunological tolerance. By suppressing the activation and proliferation of effector T cells, TREG02 aims to reduce the patient's reliance on long-term pharmacological immunosuppression, thereby mitigating associated side effects such as kidney damage and increased infection risk.
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