Regenerative medicine is a continually evolving field targeting human cells and tissues with the goal of restoring normal function. Orthopedics and sports medicine have emerged as leaders within this field. Stem cell presents an excellent example to demonstrate the regulation of regenerative medicine products both in the United States and worldwide. Much of stem cell research and products fall under the grouping of mesenchymal stem cells. These cells are present in nearly every tissue in the body and offer many properties that may help achieve the goals of regenerative medicine. Regulation of regenerative medicine products is diverse overall and specific to each country. The Food and Drug Administration is responsible for the regulation of these products in the United States. Regulation begins at the product development stage beginning with research. Products go through an extensive preclinical and clinical trial evaluation process. The overall process is quite rigorous and costly. To help accelerate the process, alternative pathways exist to expedite the approval process for products that meet certain criteria. Worldwide regulation is quite variable in terms of intensity with some countries mimicking or having more stringent policies than the United States whereas others have minimal to no regulation. Countries with less regulation have become hot spots for medical tourism seeking regenerative medicine products. However, these situations are not without risk not only with efficacy but with morbidity. Adverse events have been reported with regenerative medicine products in less tightly regulated countries. Although reduced regulation can help promote research in the field, it is not without risk to patients or to the public perception of the field. Overall, regenerative medicine offers significant potential to the field of orthopedics. It is critical for products to be used in a safe and appropriate manner as well as patients be properly informed for the continued growth of this field.