None listed
Conditions
Brief summary
Osteoarthritis is a major cause of pain and disability world wide. This study aims to explore the effectiveness of autologous mesenchymal stem cell (MSC) injections in treating OA. This study involves the use of autologous MSC, autologous meaning that the cells are taken from and injected back into the same person. Based on previous animal studies and initial human patients, these MSCs are expected reduce pain and assist in bone and cartilage tissue repair, supporting their potential in the treatment of osteoarthritis.
Interventions
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)
- G
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.
Sponsors
Magellan Stem Cells
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 as the first line of treatment in knee OA (Thompson, Gordon et al. 2009). 5. A minimum pain score of 5 on an 11-point numerical rating scale. 6. Single symptomatic knee osteoarthritis. 8. Less than 5 degrees varus or valgus knee deformity as measured by the long mechanical axis of the knee on X-Ray. 9. Sufficient English skills to complete the questionnaires required for the study, as well as to understand the instructions given by the study doctors. This is required as no funding is available for translation or interpreters, and the outcome questionnaires to be used have only been validated in English language.
Exclusion criteria
1. Age <18yrs. OA does not commonly occur in people under 18. 2. Pregnancy (accepted contra-indication as no safety data on this population). 3. Breastfeeding (accepted contra-indication as no safety data on this population). 4. Have other causes of their knee symptoms suspected to be due to serious pathology such as tumour or referral from the hip or lumbar spine. These conditions are not under investigation within the current project. 5. Blood disorder (accepted contra-indication as no safety data on this population) 6. Anti-coagulant therapy that cannot safely be ceased. 7. MRI confirmed displaced meniscial tear. 8. MRI Confirmed Grade IV chondral loss 9. Previous meniscectomy/significant partial meniscectomy or other knee related surgery within the last 12 months. 10. Previous intra-articular injectable therapies within the last 6months. 11. Lateral Compartment and/or Patellofemoral compartment Grade 2-4 osteoarthritis. 12. History of cancer. 13. History of systemic illness or significant organ impairment/failure (ie. renal failure). 14. History of an atypical pain syndrome. 15. History of infective or inflammatory joint disorders, or suspected infective or inflammatory joint disease 16. Plans at the time of enrolment to undergo surgery in the following 12 months. This criterion is aimed at avoiding co-interventions that may confound the results of the study. While involvement in the project will not strictly prevent participants from undertaking such interventions if required, we will exclude volunteers who already have such procedures scheduled. 17. History of allergy to any substances used within the treatments. 18. History of other musculoskeletal or neurological condition that effects lower limb function. 19. Patients may not participate in any other clinical study of an investigational drug or investigational treatment at any time while participating in this study
Outcome results
None listed