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

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 corticosteroids within the prior 2 months
• •Scheduled knee arthroscopy or knee surgery in either knee within 12 weeks from enrollment
• •Known or suspected joint infection of either knee
• •History of knee ligament surgery in the past 12 months
• •Acute injury to the knee in the past 3 months resulting in difficulty walking for more than 24 hours
• •History of inflammatory joint diseases, crystalline diseases such as gout or pseudogout, systemic lupus, rheumatoid arthritis, autoimmune disease or Crohn's disease
• •Previous repair of a cruciate ligament, osteochondral autograft transfer, mosaicplasty, subchondral surgery (subchondroplasty) or previously diagnosed subchondral insufficiency fracture
• •Comorbid conditions that include the following: known other causes of arthritis (infectious arthritis, or psoriatic arthritis), osteomyelitis, cardiopulmonary disease that limits walking more than knee pain, bone metastases or Paget's disease involving the lower extremities.
• •Psoriasis or other acute or chronic inflammatory conditions or infection affecting the skin over the index knee
• •Symptoms of locking, intermittent block to range of motion or loose body sensation which could indicate meniscal displacement or an intraarticular loose body in the index knee
• •Use of anticoagulants (except for ≤ 81 mg of aspirin per day) or a history of any coagulopathy or bleeding disorder, sickle cell disease
• •History of substance abuse in the past 2 years
• •Prior or current use of systemic immunosuppressive medications (other than corticosteroids for arthritis), chemotherapy, or history of organ transplant (kidney, heart, lung)
• •Prior radiation therapy to the index knee
• •Prior treatment with CLARIX FLO, NEOX FLO, or injectable birth tissue products for any indication
• •Concurrent treatment, or treatment in the past 90 days, with any investigational agent
• •Severe concurrent illness which, in the view of the investigator, would interfere with this 52 week study
• •Any condition which, in the opinion of the investigator, would make a patient a poor candidate for this study
• •Positive blood pregnancy test or known pregnancy