Editorial Commentary: Amniotic Orthopaedic Biologics: There's Hope If We Avoid Hype.

Amniotic products donated from mothers having live births have been in use for wound care and other medical uses for many years. Recent developments in regenerative sciences have suggested these products in solution or lyophilized forms may be useful for the treatment of inflammatory diseases such as chronic tendinopathies and osteoarthritis of joints. These products for these indications, however, are deemed human cells, tissues, or cellular or tissue-based products (otherwise known as HCTPs) in the "351" category, meaning that they need to have a biologic license to be marketed and sold in the United States, and to gain this license, one needs to go through the usual rigor of investigational new drug filing and phase 1, 2, and 3 trials to prove safety and efficacy. Although current clinical use of amniotic solution and lyophilized products is on hold through this study period, both basic science and clinical trial studies are building a convincing set of data that suggest broad possibilities for their uses in the future. To date, both animal and human studies have shown that a single injection of amniotic suspension allograft is safe, has not elicited any significant immune response, and has been shown to be effective in several prospective studies and at least one well-controlled randomized controlled human study for knee osteoarthritis when compared with both hyaluronic acid and placebo saline. Proteins in these harvested and processed tissue allografts are anti-inflammatory, anticatabolic, and proanabolic. Appropriate caution by the Food and Drug Administration in granting licenses for these indications should not dissuade basic scientists and physicians from pursuing further research into these interesting products.