Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES)

Inclusion Criteria: * Age greater or equal to 40 but less than or equal to 70 years old * Males and females * Recent knee radiograph of the targeted knee (standing anteroposterior (AP) lateral and sunrise view) * Diagnosis of OA in the targeted knee (radiographic evidence of OA in the medial and/or lateral tibiofemoral compartment, which would include one or more osteophytes on a standard radiograph taken within 3 months) * Continued OA pain in the targeted knee despite conservative measures (per treating provider's discretion) * Average daily Visual Analog Scale (VAS) ≥3 * Kellgren-Lawrence system of Grade II, III, or IV * Subjects may have concomitant patellofemoral but they must have stage II or higher generalized knee OA * Females of childbearing potential only, must have a negative pregnancy test done at screening prior to enrollment in the study * Women and men of child-producing potential must agree to use acceptable contraception methods for the duration of the trial such as birth control pills or condoms with spermicide Exclusion Criteria: * Clinically apparent tense effusion of the targeted knee * Significant valgus/varus deformities (+/- 10 degrees) * Viscosupplementation within 6 months in the targeted knee * Other biologic injection (PRP or stem cell) within 1 year in the targeted knee * Surgery in the targeted knee within the past 6 months (either open or scope) * Systemic or intra-articular injection of corticosteroids in any joint within 3 months before scr…