A Phase I, Prospective, Randomized, Open-label, Active-Controlled Clinical Trial for Safety Evaluation of Intra-articular Injection of RegenoGel-SP for the Treatment of Moderate to Severe Osteoarthritis

Inclusion Criteria: * Subject has signed and dated the informed consent form * Subject is experiencing pain in the intended study knee with a VAS score of ≥ 5 * Subject with degenerative changes in the intended study knee that can be categorized as grade III-IV Kellgren Lawrence based upon standing posterior-anterior and lateral radiographs of the knee and is a candidate for TKR * Subject has a Body Mass Index (BMI) between 18.5 and 35 * Subject has failed conservative treatments to the intended study knee, including such measures as weight reduction, physical therapy, hydrotherapy, analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and/or intra-articular injections Exclusion Criteria: * Subjects with history of significant knee trauma to the intended study knee or with previous arthroscopic surgery of the intended study knee within the last 3 months preceding screening * Subject had any intra-articular injections to the intended study knee within 6 months prior to Screening * Subject is unable to stop chronic administration of pain medications (including paracetamol), from the day before each study visit through completion of the study visit. * Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis,or any other inflammatory condition associated with arthritis * Subject has a superficial wound in the area of the intended study knee * Subject has known sensitivity to any of the treatment components, egg, rubber or latex * Subject has a history of anaphylactic shock or other severe systemic response or other adverse event to human blood products * Subject has a clinically significant abnormal finding (e.g., laboratory result or ECG) on screening * Subject has clinically significant abnormal INR or aPTT coagulation result. * Subject has a hemoglobin concentration below 10.5 * Subject is positive for Human Immunodeficiency Virus / Aquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B or C viral infections, or acute or chronic liver disease * Subject has ever had cellulitis of the lower extremities, a superficial or deep vein thrombosis, or a family history of a clotting disorders * Subject has had cancer in the past 5 years or surgery involving the chest, abdomen, pelvis, or lower extremities in the past year * Subject receives any investigational device or product within 30 days of Visit l * Subject has any recent (acute) or chronic medical, psychiatric, or social problem that might: 1) interfere with the Subject's performance or completion of the trial; 2) obfuscate the Subject's study data; or 3) render the Subject unable to understand the nature, scope, and possible consequences of the study * Subject is receiving an oral or injected anticoagulant * Subject ever abused drugs or alcohol (self-reported) * Subject received a blood transfusion within 6 months prior to Visit 1. * Subject donated blood or blood products within 3 months prior to Visit 1. * Subject has any elective surgery of any kind to the lower extremities or elective surgery requiring general anesthesia scheduled during the course of the trial