The legal and policy considerations of transplanting pediatric thymus regulatory T cells as an immunotherapy in Canada

Abstract

Regulatory T cells (Tregs) hold promise for cell-based therapies for autoimmunity and transplant rejection. In Canada, the potential collection, short-term banking, and transplantation of pediatric Tregs left over from surgery raise legal and policy concerns. Tregs likely fall under the definitions of “tissue” found in most provincial donation and transplantation statutes. With the exception of Alberta’s Human Tissue and Organ Donation Act, the fundamental distinction between donation of tissue primarily for transplantation and secondary donation of by-products of a medical intervention undertaken for the benefit of the donor is inadequately addressed in Canadian law. Most statutes prohibit transplantation except in accordance with their provisions and do not contemplate living donation by minors under a specific age. Provinces could amend their legislation in order to properly enable the transplantation of by-products like Tregs from infant donors. This process is relatively ethically uncontroversial, so if common research ethics and privacy concerns can be addressed, it should likely be permitted.