Divergent Approaches To Stem Cell Regulation

By James Akers, Akers Kennedy & Associates

Stem cells and other regenerative medicine products offer considerable benefits to patients as well as potential financial rewards for companies. At the same time, cell-based therapies present challenges to regulators because, in many cases, they involve withdrawing cells from a patient’s bone marrow, blood or adipose tissue, growing cells in vitro with minimal to extensive manipulation, and then administering in some form the expanded (and possibly modified) cells population back into the patient.