A White Paper published yesterday in Transplantation (co-authored by ITN Deputy Director Larry Turka, MD) outlines recommendations from an international workshop convened by The Transplantation Society (TTS) to determine the necessary steps to make tolerance protocols a standard of care for transplant over the next decade. To date three academic centers have employed successful tolerance-inducing protocols in kidney transplant recipients (Stanford University, Northwestern University, and Massachusetts General Hospital – the MGH studies were funded by the ITN), with the results of the ACCEPTOR kidney transplant study at Johns Hopkins yet to be determined. The combined efforts of these centers have resulted in 45 subjects off immunosuppression for variable lengths of time.
Implementing standardized tolerance protocols more broadly has a number of challenges which were discussed at length by the ~50 workshop participants who represented academia, industry, and funding organizations. Based on these identified challenges, the workshop recommended the following steps to help advance tolerance protocols in kidney transplantation:
1) Establish a registry of results for patients enrolled in tolerance trials;
2) Establish standardized protocols for sample collection and storage;
3) Establish standardized biomarkers and assays;
4) Include children 12 years and older in protocols that have been validated in adults; and
5) Establish a task force to engage third party payers in discussions of how to fund tolerance trials.
Having expertise in tolerance trials and sample management, as well as access to hundreds of tolerant transplant study participants, the ITN is in a unique position to help facilitate efforts to standardize tolerance protocols for more widespread adoption. Progress is underway to implement these recommendations, and the next TTS workshop is scheduled for the fall of 2015.