None listed
Conditions
Brief summary
Osteoarthritis is a major cause of pain and disability world wide. This study aims to explore the effectiveness of arthroscopic microfracture in combination autologous mesenchymal stem cell (MSC) injections in the treatment of full thickness cartilage lesions of the hip. 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, and improve cartilage quality post micro fracture - thus supporting their potential in the treatment of hip osteoarthritis.
Interventions
This study will look to prospectively assess the response of symptomatic hip full thickness cartilage lesions to arthroscopic microfracture combined with post operative mesenchymal stem cell therapy.
Arthroscopic microfracture is an accepted technique to treat areas of full thickness cartilage loss and encourage scar cartilage formation. This is performed as a day procedure within an orthopaedic hospital.
2 intra-articular hip joint injections of 100 × 10*6 autologous MSC will occur at 0 and
This study will look to prospectively assess the response of symptomatic hip full thickness cartilage lesions to arthroscopic microfracture combined with post operative mesenchymal stem cell therapy. Arthroscopic microfracture is an accepted technique to treat areas of full thickness cartilage loss and encourage scar cartilage formation. This is performed as a day procedure within an orthopaedic hospital. 2 intra-articular hip joint injections of 100 × 10*6 autologous MSC will occur at 0 and 6months. Subjects will receive a total of 200 × 10*6 MSCs. The initial injection will be performed between 1-4weeks post arthroscopy and this timing will be determined by the treating physician. This will be a single treatment group uncontrolled case series. Autologous adipose derived mesenchymal stem cells will be used due to the ease of harvest (liposuction) and safety.
Sponsors
Magellan Stem Cells
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria : 1. Radiological diagnosis of a hip cartilage lesion. 2. Primary 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 dietician 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 (Thompson, Gordon et al. 2009). 3. 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
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 ankle symptoms suspected to be due to serious pathology such as tumour or referral from the lumbar spine. These conditions are not under investigation within the current project. 5. Current cancer. 6. History of significant organ impairment/failure (ie. renal failure). 7. History of allergy to any substances used within the treatments. 8. Bovine allergy
Outcome results
None listed