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 /L, Hgb ≥ 10 g/dL) * Adequate hepatic function (AST/ALT ≤ 1.5 × ULN, total bilirubin ≤ 1.2 × ULN) * Adequate renal function (creatinine ≤ 1.2 × ULN) * Negative urine test for opioids (including synthetic opioids) * If female and of child-bearing potential, willingness to use effective birth control during the study. Exclusion Criteria: * Cognitive impairment, mental illness, neuroses or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures * Non-ambulatory, bedridden, or with active fibromyalgia, radiculopathy, painful peripheral neuropathy, vascular insufficiency, hip OA or other joint disease severe enough to prevent assessment of knee pain or causing functional impairment * Current use of opioid analgesics, or positive urine laboratory test for opiates during the screening period * Hyaluronic acid, corticosteroid, platelet rich plasma or stem cells IA knee injections within the prior 3 months, oral or intramuscular corticosteroid…