Novel biomarkers and functional assays to monitor cell-therapy-induced tolerance in organ transplantation.

ABSTRACT

PURPOSE OF REVIEW Cell-based immunotherapy offers a novel approach to minimize the need for immunosuppressive drugs and to promote a state of immunological tolerance to a transplanted organ. We review the most promising biomarkers and functional assays able to identify patients tolerant to their graft. Such a signature of tolerance is essential in the assessment of the efficacy with which trials of cellular therapies promote immunoregulation and minimize graft rejection. RECENT FINDINGS: A multitude of novel cellular therapies have entered early-phase clinical trials in solid-organ transplant patients. Recent multicentre collaborations have enabled the determination of distinct tolerance profiles for both liver and kidney transplant recipients. These have been shown to be highly predictive of tolerance in certain settings and show utility in identifying patients in whom immunosuppressive drugs can be weaned or discontinued. SUMMARY: In order to become a viable treatment option in solid-organ transplantation, the latest large, multicentre clinical trials of cellular therapies must utilize, validate and discover the biomarkers with the capacity to reliably identify a signature of immune tolerance.