Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord (TTAX03) for KL Grade 3-4 Knee OA

Inclusion Criteria: * Able and willing to provide written informed consent * ≥ 35 and ≤ 85 years of age (until a cap of 30 subjects \< 50 years of age is reached, at which point this will convert to ≥ 50 and ≤ 85 years of age) * Able to reliably complete the KOOS self-administered questionnaire * Clinical diagnosis of OA of the index knee, with pain onset more than one year prior to screening according to subject recall * KL grade 3 or 4 in the index knee * Pain score (KOOS) over the past week ≥ 70 in the index knee at Screening (the index knee will be the more painful knee by ≥ 20 in the case of bilateral disease) * A ≥ 3 months history of insufficient pain relief from IA hyaluronic acid or a ≥ 3 months history of insufficient pain relief from IA corticosteroids, unless they are medically contraindicated for the subject * A ≥ 3 months history of insufficient pain relief from other currently recommended treatments, including weight loss and physical therapy * Any two of the following: * Severe knee pain or stiffness that limits everyday activities, including walking, climbing stairs, and getting in and out of chairs. Finding it hard to walk more than a few blocks without significant pain and need to use a cane or walker * Moderate or severe knee pain while resting, either day or night * Chronic knee inflammation and swelling that does not improve with rest or medications * BMI ≤ 40 kg/m2 * Adequate bone marrow function (ANC \> 1000 × 109 /L, platelets ≥ 100,000 × 109 …