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<p>Regulatory T cells (Tregs) play a pivotal role in promoting immune tolerance during organ transplantations, prompting a critical shift from conventional immunosuppression to active immune regulation in therapeutic paradigms. This review synthesizes recent advances in Treg-based therapies for liver, kidney, and heart transplantations, highlighting their capacity to modulate immune responses and prevent allograft rejection, with preclinical studies and early-phase clinical trials demonstrating the safety and feasibility of autologous polyclonal Treg therapy for enhancing graft survival. Despite these promising results, widespread clinical application faces challenges including complex manufacturing, cellular stability in inflammatory environments, and lack of standardized potency assays. Therefore, this review critically assesses emerging strategies, such as antigen-specific chimeric antigen receptor (CAR)-Tregs for precise immune targeting and gene-edited, “off-the-shelf” allogeneic Tregs, aimed at improving scalability and accessibility. By providing a comprehensive overview of current progress and remaining obstacles, this review guides future research and supports the clinical translation of Treg-based therapies to ultimately improve long-term outcomes for transplant recipients.</p>

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From immunosuppression to active tolerance induction: an evolving paradigm of regulatory T cell-based therapy in organ transplantation

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月30日

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  • Shao-Wei Li,
  • Xin-Yu Fu,
  • Hao-Ting Li,
  • Hao Liu,
  • Masayuki Fujino,
  • Xiao-Kang Li

摘要

Regulatory T cells (Tregs) play a pivotal role in promoting immune tolerance during organ transplantations, prompting a critical shift from conventional immunosuppression to active immune regulation in therapeutic paradigms. This review synthesizes recent advances in Treg-based therapies for liver, kidney, and heart transplantations, highlighting their capacity to modulate immune responses and prevent allograft rejection, with preclinical studies and early-phase clinical trials demonstrating the safety and feasibility of autologous polyclonal Treg therapy for enhancing graft survival. Despite these promising results, widespread clinical application faces challenges including complex manufacturing, cellular stability in inflammatory environments, and lack of standardized potency assays. Therefore, this review critically assesses emerging strategies, such as antigen-specific chimeric antigen receptor (CAR)-Tregs for precise immune targeting and gene-edited, “off-the-shelf” allogeneic Tregs, aimed at improving scalability and accessibility. By providing a comprehensive overview of current progress and remaining obstacles, this review guides future research and supports the clinical translation of Treg-based therapies to ultimately improve long-term outcomes for transplant recipients.