TregCel
Autologous Regulatory T Cell Therapy for Transplant Immunomodulation
Problem
For solid organ transplant recipients, preventing immune rejection remains a lifelong challenge. Although immunosuppressive drugs have significantly improved transplant outcomes, they must often be taken indefinitely and can increase the risk of infection, cancer, cardiovascular disease, and other serious complications. Because these therapies suppress the immune system broadly rather than addressing the underlying cause of rejection, patients remain dependent on chronic medication and ongoing monitoring.
A longstanding goal in transplantation medicine has been the development of therapies that promote immune tolerance to the transplanted organ, reducing or eliminating the need for lifelong immunosuppression while preserving graft function.
Solution
TregCel™ is Tract Therapeutics’ proprietary adoptive regulatory T cell (Treg) therapy designed to promote immune tolerance in transplant recipients. The treatment begins with the collection of a patient’s own regulatory T cells through leukapheresis. These cells are then expanded ex vivo under GMP conditions and re-infused into the patient.
Once administered, TregCel™ is designed to restore immune balance through multiple mechanisms. The therapy suppresses effector T cell activity, promotes the generation of additional regulatory T cells through a process known as infectious tolerance, and influences other immune cell populations to reduce inflammation and support long-term immune regulation.
By harnessing the body’s natural tolerance mechanisms, TregCel™ aims to provide a more targeted approach to transplant immune management and has the potential to reduce reliance on lifelong immunosuppressive therapy while supporting long-term graft health.
By harnessing the power of regulatory T cells, we can provide our patients with the potential for long-term, rejection-free transplant success while minimizing the adverse effects associated with traditional immunosuppression.”
— Joseph Leventhal, MD, PhD
Professor, Feinberg School of Medicine
Benefits
- Autologous Therapy: Uses the patient’s own cells, minimizing risk of rejection.
- Immune Tolerance: Promotes long-term acceptance of transplanted organs.
- Reduced Drug Burden: Could lower or eliminate dependence on immunosuppressants.
- Improved Outcomes: Enhances graft survival and patient quality of life.
Technology & Commercialization Status
TregCel™ is based on regulatory T cell (Treg) immunotherapy developed by Feinberg's transplant surgeon and researcher Dr. Joseph Leventhal, whose pioneering clinical work demonstrated the potential of regulatory T cells to promote immune tolerance in organ transplantation. Building on this Northwestern-originated research, Tract Therapeutics developed the TregCel™ platform to translate these advances into a scalable cell therapy for transplant patients.
The therapy has progressed through early clinical development and is being advanced for Phase II clinical evaluation in living donor kidney transplant recipients. To support future clinical studies and commercialization, Tract Therapeutics expanded its manufacturing capabilities through the transfer of the TregCel™ production platform to Taiwan Bio Therapeutics’ GMP facility in 2024, establishing the infrastructure needed for larger-scale manufacturing and international clinical development.
A significant commercialization milestone followed in 2025, when Tract Therapeutics was acquired by Taiwan Bio Therapeutics. The acquisition brought TregCel™ under Taiwan Bio’s leadership, providing additional resources to support continued clinical development, manufacturing scale-up, and global regulatory activities.
Northwestern Innovator
Joseph R. Leventhal, MD, PhD
Fowler McCormick Professor of Surgery
Feinberg School of Medicine