NANOVAE to Treat Knee Osteoarthritis (KOA)

A total of 24 subjects meeting all inclusion/exclusion criteria will be divided into two groups. Group 1 will be an open-label lead-in phase. Group 2 will be a randomized, double-blinded, placebo-controlled cohort. Group 1 will receive one dose of 2ml of NANOVAE, and Group 2, in a randomized and double-blinded fashion, will receive two doses of 2ml NANOVAE. Neither the patients nor the researchers will know who is getting the placebo and who is getting the NANOVAE; only the product manufacturing staff will be unblinded. The ratio of placebo to NANOVAE is 1:1 for a total of 16 subjects in Group 2. Only the knee with the more severe symptoms of OA will be treated. The allogenic-HAF

In lieu of AF, the saline for injection will be used as a placebo. Vials acquired from the manufacturer is pipetted into glass vials, stoppered, capped, placed in labeled header foil pouches, and sealed. These are transferred to a quarantine freezer to await post-production testing.