None listed
Conditions
Brief summary
The treatment of isolated knee cartilage defects remains difficult. Research indicates that these isolated lesions lead to later development of generalised osteoarthritis. Traditional and accepted arthroscopic microfracture of these lesions leads to formation of fibrocartilage which unfortunately only causes short to medium term improvement. Use of mesenchymal stem cells injections post micro fracture has shown promise in pre-clinical animal studies and also in initial human trials. We wish to explore the potential of autologous adipose derived mesenchymal stem cell injections post surgery to improve the quality of cartilage repair and prevent later onset development of osteoarthritis.
Interventions
This study will determine the efficacy of autologous adipose derived mesenchymal stem cell injections post arthroscopic microfracture for isolated knee cartilage defects versus arthroscopic microfracture alone. The arthroscopic microfracture will not form part of the study as this is accepted surgical management. The post operative stem cell injections are the sole intervention. 40 participants will be recruited and randomally allocated to a treatment arm/group of 20 participants who receive ste
This study will determine the efficacy of autologous adipose derived mesenchymal stem cell injections post arthroscopic microfracture for isolated knee cartilage defects versus arthroscopic microfracture alone. The arthroscopic microfracture will not form part of the study as this is accepted surgical management. The post operative stem cell injections are the sole intervention. 40 participants will be recruited and randomally allocated to a treatment arm/group of 20 participants who receive stem cell injections and a control arm/group of 20 particpants who have no intervention post microfracture. The treatment arm/group will receive injections of 100million mesenchymal stem cells at 1week post microfracture and a 2nd injection of 100Million stem cells at 6months totalling 200Million 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 50 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 – 50 (inclusive). As isolated full thickness chondral defects are often traumatic in nature it is likely that this age restriction represents the majority of patients who undergo microfracture. 2. Pre-operative radiological diagnosis of an isolated full thickness knee cartilage defect of the medial or lateral femoral condyle 3. Planned arthroscopic microfracture/osteoplasty 4. Sufficient English skills to complete the questionnaires required for the study, as well as to understand the instructions given by the study doctors. 5. No plans at the time of enrolment to undergo surgery in the following three 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
Exclusion criteria
1. Pregnancy (accepted contra-indication as no safety data on this population). 2. 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; 3. Blood disorder (accepted contra-indication as no safety data on this population) 4. MRI confirmed displaced meniscial tear. 5. MRI confirmed Grade II-IV degenerative osteoarthritis 6. History of cancer 7. History of atypical chronic pain syndrome
Outcome results
None listed