Evaluation of mesenchymal stem cells in the treatment of knee osteoarthritis – A randomised Controlled Trial

INTERVENTION: This study will look to assess the response of symptomatic medial knee compartment osteoarthritis to different dosing and injection protocols of mesenchymal stem cells in comparison to accepted conservative management. 30 participants will be enrolled in the study and randomly separated into 3 study groups. ‐ Group 1. Single intra‐articular injecton of 100million stem cells at 0months. ‐ Group 2. Intra‐articular injection of 100million stem cells at 0 and 6 months (total of 200million cells) ‐ Group 3. Control Group ‐ conservative management. Autologous adipose derived mesenchymal stem cells will be used due to the ease of harvest (liposuction) and safety in comparison to allogeneic cells. CONDITION: Osteoarthritis PRIMARY OUTCOME: 0‐10 Numerical Pain Rating Scale (NPRS) ‐ The NPRS has been validated for use in people with knee osteoarthritis Knee Injury and Osteoarthritis Outcome Score ‐ ; consists of 5 subscales being pain, other symptoms, function in daily living, function in sport and recreation and knee related quality of life. It is reliable and valid for the population of people with osteoarthritis. MRI quantitative data including mapping of cartilage volume. ; SECONDARY OUTCOME: Global perceived effect scale. Measures of global effect are a recommended outcome measure for clinical trials Pain Treatment Satisfaction Scale ‐ a validated questionnaire The Orebro Musculoskeletal Pain Questionnaire will also be completed. This questionnaire has been to shown to be reliable and valid for detecting individuals at risk of developing persistent pain. This questionnaire will be used in the current study to assess the potential impact of psychosocial factors on participants’ outcome. INCLUSION CRITERIA: 1. Radiological diagnosis of osteoarthritis using the American College of Rheumatology criteria (Altman, 1986). 2. Radiological grading of Grade II‐III OA of the knee as determined by a qualified radiologist using the Kellgren and Lawrence system (Kellgren and Lawrence 1957). 3. Medial Compartment OA as determined above. 4. Primary OA treatment already undertaken defined as: analgesia/anti‐inflammatory medication, supplements approved by the treating clinician (eg glucosamine sulphate), an attempted exercise program prescribed by a physiotherapist or medical practitioner for at least 8 weeks (Petrella 2000), weight loss and nutritional management as prescribed by a dietitian or medical practitioner for at least 8 weeks, and biomechanical management including bracing if appropriate as prescribed by a physiotherapist, podiatrist or medical practitioner. Autologous MSC is an invasive treatment and guidelines recommend trialling conservative measures a