Non-autologous Biologics

Non-autologous biologics are obtained from donor-derived tissue sources, including cord blood, amniotic fluid, placental tissues (amnion, chorion), umbilical cord tissue, and cells cultured from these tissues. There has been significant effort made in commercializing non-autologous biologics over the past 15 years. Starting with dehydrated amnion/chorion membrane sheets, and extending to more recent innovative products like exosomes, there has been an expanding commitment to perform Level 1 clinical studies in order to obtain clinical data to support Pre-market Applications to the United States Food and Drug Administration (USFDA) for approval of these products. On the other hand, some of the donor tissue-derived products that have demonstrated preliminary clinical benefit in in vitro studies or pre-clinical studies have been placed on the market without appropriate regulatory approval, which makes it imperative for clinicians to ensure that they are working with approved products and not experimental drugs outside of an Institutional Review Board-approved clinical study. The pace of innovation in the field of non-autologous biologics remains strong. Intriguing clinical results have been published that point potentially to an expanded scope of use of non-autologous biologics to treat chronic conditions like rheumatoid arthritis (RA) in a combination therapy with drug management in order to relieve the musculoskeletal sequalae.