Quality assurance and adverse event management in regenerative medicine for knee osteoarthritis: Current concepts.

The economic and human cost of knee osteoarthritis is forecast to increase. This will impact not only aging individuals, but also the working age members of emerging economies. The current treatment pathways are often costly, time-consuming, and insufficient to manage the degeneration of the knee over the ever-increasing lifespan of patients around the world. In response to the shortcomings of a focus on symptom management, international and high-impact regulators, researchers, clinicians, and most importantly patients, are increasingly interested in the possible management of knee osteoarthritis with novel therapies in the field of regenerative medicine treatments. Regenerative medicine is an emerging discipline whose adherents aim to use the tools of the human body to address underlying dysfunction, leading to lasting repair of damaged tissues and structures. The evidence base lacks consensus on issues related to safety, efficacy, cost-efficiency, and treatment specifications. In this current concepts review, we describe the potential impact of regenerative medicine for knee osteoarthritis and evaluate literature of the past decade for elements related to the quality of clinical research. Finally, we discuss strategies for improving the evidence base for the future. The results of the review reveal that the typical follow-up period for most clinical research into the area is between 6 and 12 months; local ethics board approval is commonly reported, and that Platelet-Rich Plasma is the most common option explored. However, several quality elements were lacking in this cohort of recent literature: cost efficacy data, long-term follow-up, and detailed adverse event reporting. In order to address these weaknesses in the literature, patient outcomes registries are needed, in order to satisfy the need for longer follow-up for individuals receiving regenerative treatments, in addition to further clinical trials which address larger and more diverse patient populations. Transparency will be of utmost importance in further research and clinical translation of regenerative medicine for knee osteoarthritis.