Definition

A biologic product that consists of undifferentiated stem cells, obtained from adult bone marrow or other non-embryonic tissue sources, that are expanded in vitro and deposited in master cell banks for “off-the-shelf” use, with potential hematopoiesis-inducing and immunomodulating activities. Allogeneic multipotent adult progenitor cells (MAPCs) are non-immunogenic due to the lack of major histocompatibility (MHC) molecule expression, and so elicit no immune response upon administration. In vivo, bone marrow-derived adult stem cells are capable of maturing into a broad range of cell types and may help restore the immune system by producing multiple therapeutic molecules in response to inflammation and tissue damage.