Safety and efficacy of engineered tissue composed of silk fibroin/collagen and autologous chondrocytes in two patients with cartilage defects: A pilot clinical trial study

The objective of this pilot clinical trial study was to evaluate safety and effectiveness of the newly engineered tissue composed of autologous chondrocytes and collagen/fibroin scaffold in repair of osteochondral defects. We implemented a pilot clinical study in two patients with knee osteochondral lesions using engineered tissue composed of scaffold and autologous chondrocytes. Patients were clinically evaluated using the International Repair Cartilage Society score and magnetic resonance imaging (MRI) for one year. Improved clinical outcomes and objective scores indicated a normal or nearly normal knee in both patients. International Knee Documentation Committee score was upgraded from 34.5 at baseline to 72.4 in the first patient, and 28.7 to 81.6 in the second patient. Visual analogue scale, showing the suffering pain score, was lowered from 8 to 0 in both patients, Western Ontario and McMaster Universities Osteoarthritis Index score representing the physical ability of the patients was changed from 68.1 to 87.1 in Patient 1 and 58.3 to 87.1 in Patient 2, the knee function score, related to the functional ability of the knee, was improved from 70 to 100 in the first patient and from 45 to 91 in the second patient. MRI showed great coverage and integration of the graft in patients, with no effusion, decreased edema and cartilage formation signals. The functional and clinical outcomes alongside MRI data showed promising results for regenerating osteochondral defects. A randomized clinical trial study is required to confirm feasibility of this novel engineered tissue in repair of osteochondral defects.