Regulatory Aspects of Regenerative Therapy and Stem Cell Therapy: Current Perspectives

This chapter outlines the current regulatory landscape of regenerative medicine germane to orthopedics, spine and pain management; It includes relevant legislation and guidelines set forth by governing bodies such as the United States Food and Drug Administration (FDA), Federal Trade Commission, and Federation of State Medical Boards. We define important terminology and aim to elucidate prior gray areas concerning government compliance and good practice as more information has become available and the federal discretionary period has ended (meaning consequences will be effective where they were not previously for non-compliance). This text highlights appropriate steps to take based on various factors including the type of drug or biologic product to be used, how it is processed (minimally manipulated, etc.), tissue or cell of origin, etc. We also discuss ethical guidelines and recommendations for appropriate marketing in regenerative medicine. The ultimate goal of this chapter is to provide key information enabling clinicians to provide the best care for their patients adhering to current safety standards, legislation, ethics, and marketing practices outlined by the government, hence, staying off of the FDA’s radar.