A study comparing the efficacy of current products utilizing participant’s adipose tissue (Lipogems technique), and blood extracts (Orthokine or Platelet-Rich-Plasma (PRP)) in combination with peptide injections for the treatment of moderate to severe knee osteoarthritis.

INTERVENTION: For the treatment of moderate to severe knee osteoarthritis, this study aims to compare the efficacy of treatment combinations. If eligible, all participant treatment groups are prescribed proprietary peptides; dosage – Commencing 3 weeks prior to liposuction procedure, 3 self‐injections of up to 0.2 ml, 5 days/week and continuing for 5 to 10 weeks after procedure (i.e. total duration = 8 to 13 weeks). The peptides are derived from those that are present naturally throughout the body and are critical to cellular processes particularly growth and regeneration. The ongoing maintenance dose of the peptides via injection is necessary due to their short half‐life and most effective circulation and absorption. Participants are randomly divided into three treatment groups receiving either (Group 1) A novel commercial product, Lipogems which uses extracts from the participant’s own adipose tissue (Lipogems are produced by a gradual size reduction of the adipose clusters immersed in saline solution within a single use, sealed, sterile device also eliminating oily and hematic residues); (Group 2) Lipogems and Platelet‐Rich‐Plasma (PRP is extracted from the patient’s blood via two steps of centrifugation and coagulation. PRP contains growth factors released from platelets and endogenous fibrin scaffold); (Group 3) Lipogems and Orthokine (produced by incubation of blood within a sealed device for 9 hours which induces increased amounts of the protective IL‐1RA proteins. Serum ready for injection is subsequently extracted via centrifugation). The clinical procedure (Day 1) uses the Lipogems technique which involves a mini‐Liposuction procedure using local anaesthesia and syringe collection from the waist region to collect the adipose tissue specimen (30 gm) for subsequent processing to extract the adipose tissue fraction. Lipogems (15 gm) are injected directly into the joint guided by ultrasound. For Group (3), whole blood (10 ml) is extracted followed by preparation of Orthokine. The duration of the liposuction procedure including extraction, processing and injection is CONDITION: Osteoarthritis PRIMARY OUTCOME: Assessment of Quality of Life (AQoL) compared to baseline score. Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline score. pain intensity numeric rating scale (NRS) compared to baseline score. SECONDARY OUTCOME: Changes in Analgesic and Anti‐inflammatory Use as reported by participants at data collection points compared to baseline medication. The safety of protocol will be evaluated by assessment of the number, time‐frame of occurrence and severity of Adverse Events (Adverse Events will be graded by the Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) and coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Adverse events monitoring will consist of measurement of signs at injection site such as inflammation, infection, and stiffness of the joint and vital signs (temperature, heart rate, blood pressure, respiration). X‐ray analysis knee joint structure compared to baseline. INCLUSION CRITERIA: Patients who give written consent to participate in the study. Radiological diagnosis of knee osteoarthritis with Kellgren‐Lawrence grades 3 ‐ 4 (Patients will need to have imaging findings (radiography or magnetic resonance imaging) that show degenerative changes). Concurrent disease medically stable 7 hours. The liposuction procedure occurs only once. Following the procedure, standard supportive measures including antimicrobial prophylaxis are followed as per clinic protocols. On Day 8, whole blood (10 ml) is extracted followed by preparation of PRP for Group (2). On the same day, groups (2) and (3) receive either PRP (10 ml) or Orthokine (10 ml) which are injected directly into the joint (30 min). Any adverse events are monitored at procedures and as reported throughout the trial. Participants are responsible for monitoring adherence to the peptide treatments in a personal log or calendar. Condition specific validated questionnaires are applied at subsequent interviews at 3, 6, and 12 months via telephone. Data will be compared with previous medical history and baseline measurements taken before procedure.