We are always learning from Data and in this Blog, I will let you learn with me. Please note that the results reproduced below are very preliminary and not to confused with the indications or results of our Bone Marrow Aspirate Concentrate/Stem cell interventions and outcomes. Because of the American Academy of Orthopedic withdrawal of support for visco-supplementaion (Hyaluronic Acid)in the arthritic knee, the orthopedic world is seeking something to fill that void, hence the interest in Amniotic Fluid Concentrate. Cortisone injections expanded with local anesthetics has been the mainstay but recent data indicates that local anesthetics kill cartilage and several cortisone injections are equally toxic to cartilage in animal models.

Interim Analysis of Prospective, Multi-Center Outcome Observational Cohort Registry of Amniotic Fluid Treatment for Osteoarthritis of the Knee Douglas Beall, MD,* Sri Nalamachu MD, **

Introduction Osteoarthritis (OA) of the knee is one of the leading causes of functional limitations and poor quality of life. Nonsurgical treatment of OA of knee includes oral medications and injection. Corticosteroid or hyaluronic acid (HA) injections to alleviate pain and/or improve function are common techniques but recently HA effectiveness has been questioned for the treatment of OA of knee in the Medicare population as well as for its overall efficacy. Alternatives are sought to provide pain relief and improve functional outcomes. Allograft amniotic tissues have a long history of clinical use. The use of amniotic fluid in the treatment of knee OA was initially reported by Shimberg  who demonstrated that injections of the fluid improved knee function and pain relief without any significant adverse events in 68 patients. Amniotic fluid is a homologue to synovial fluid which acts as a cushion to protect and lubricate the contents in a closed environment. This study measures the safety and efficacy of processed allograft amniotic fluid in treating osteoarthritic knees using common, validated instruments.

Summary of methods This is a protocol-driven, single arm post-market Registry reviewed and approved by the Western Institutional Review Board (Olympia, WA). Patients with Kellgren Lawrence Grade 1-3 OA via radiologic examination were eligible for enrollment. Excluded patients were < 35 years, had BMI > 45 or had received Hyaluronic Acid injections in the previous six months, or steroid or PRP injection in the last three months. There were no threshold pain inclusion or exclusion criteria. Eligible patients were injected with 4cc of minimally processed amniotic fluid (AmnioClear LCT; Liventa Bioscience, West Conshohocken, PA) into the affected knee. Primary efficacy endpoints are VAS scores and WOMAC overall and Pain, Stiffness and Difficulty (function) subscore scales, measured during office visits at baseline and at 30, 90 and 180 days. Enrollees also filled out weekly Pain Diaries to report WOMAC Pain subscore (5 questions) at weeks 1-4 post-treatment. Results To date over 420 of an anticipated 470 Registry enrollees have been treated. This is an interim analysis of the first 181 patients to attain 30 day follow up and the first 51 to attain 90 day follow up visits, with 15 of 23 investigational sites reporting. WOMAC Pain subscore average improvement over baseline was 62.1 percent (150.9 mm) and 62.3 percent (151.2 mm), respectively at 30 days and at 90 days. VAS average improvement over baseline was 58.9 percent (37.7mm) and 62.5 percent (40 mm) at 30 and 90 days, respectively. All other WOMAC scores showed similar improvement.

OMEGA Statistics, Murieta, CA On average, patient outcomes improved significantly compared to basel

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