Autologous cell therapy for osteoarthritis: an evaluation of the safety and efficacy of autologous transplantation of articular chondrocytes and/or bone marrow-derived stromal cells to repair chondral/osteochondral lesions of the knee
Symptomatic cartilage defects in the knee
According to the treatment allocation, trial participants will receive one of the three following cell therapy strategies: 1. Autologous chondrocytes: 1.1. One syringe containing resuspended autologous chondrocytes will be supplied, containing between 1 and 20 million cells depending on the cell kinetics of the individual patient 1.2. It is recommended that the full dose is used 2. Bone marrow-derived stromal cells (BMSCs): 2.1. One syringe containing resuspended autologous BMSCs will be supplied, containing between 1 and 20 million cells depending on the cell kinetics of the individual patient 2.2. It is recommended that the full dose is used 3. Autologous chondrocytes and BMSCs combined: 3.1. Two syringes will be supplied, one containing resuspended autologous chondrocytes and one containing resuspended BMSCs, each containing between 1 and 20 million cells, depending on the cell kinetics of the individual patient 3.2. It is recommended that half of each syringe will be used 3.3. Therefore the patient will receive a total cell population of between 1 and 20 million cells 3.4. This will prevent a bias of one group in the study having generally twice the number of cells in the other two groups 4. Each of the three groups will receive the intervention in two stages: 4.1. Cell harvesting stage 4.2. Cell implantation stage 5. There is approximately 3 weeks between the two stages 6. All participants will be followed up for 20 years after the second stage of treatment is complete
1. A symptomatic defect of the knee that extends to (Outerbridge grade 4) or into the subchondral bone 2. The patient will be aged between 18 and 80 years at the time of surgery 3. The defect is considered suitable for ACI 4. Surgical treatment has been performed on the same defect at least 6 months previously and has failed to relieve symptoms 5. The patient is able to provide written informed consent to participate in the trial
1. English is not the first language of the patient 2. Likely to show contraindications to autologous cell therapy: 2.1. Osteoarthritis 2.2. Inflammatory arthritis 2.3. Previous or current malignant tumour 2.4. Therapy with steroids or methotrexate 2.5. Bleeding tendency or known anaphylaxis to any product used in chondrocyte preparation 3. Low probability of compliance with physiotherapy or follow-up, including a major life threatening condition 4. A defect of greater than 20cm2 in total area 5. The patient is shown to be positive for serology tests required by the cell provider. This includes: 5.1. HIV 5.2. Hepatitis B and C 5.3. Syphilis 5.4. Human T cell lymphotrophic virus (HTLV) I & II 6. Pregnancy or lactation 7. Exclusion criteria (5) and (6) will not be confirmed until after written informed consent is obtained