Safety and Efficacy of Kartigen® in Treating Cartilage Defects: A Randomized, Controlled, Phase I Trial

Abstract

Here, we aimed to investigate the safety and preliminary efficacy of Kartigen®, a matrix with autologous bone marrow mesenchymal stem cell-derived chondrocyte precursors embedded in atelocollagen. As a surgical graft, Kartigen® was implanted onto the cartilage defects at the weight-bearing site of the medial femoral condyle of the knee. Fifteen patients were enrolled and stratified into two groups, undergoing either Kartigen® implantation (n = 10) or microfracture (control group, n = 5). The primary endpoint was to evaluate the safety of Kartigen® by monitoring the occurrence of adverse events through physician queries, physical examinations, laboratory tests, and radiological analyses for 2 years. There were no infections, inflammations, adhesions, loose body, or tumor formations in the Kartigen®-implanted knees. The preliminary efficacy was assessed using the International Knee Documentation Committee (IKDC) score, visual analog scale, and second-look arthroscopy. The postoperative IKDC scores of the Kartigen® group significantly improved in the 16th week (IKDC = 62.1 ± 12.8, p = 0.025), kept increasing in the first year (IKDC = 78.2 ± 15.4, p < 0.005), and remained satisfactory in the second year (IKDC = 73.6 ± 13.8, p < 0.005), compared to the preoperative condition (IKDC = 47.1 ± 17.0), while the postoperative IKDC scores of the control group also achieved significant improvement in the 28th week (IKDC = 68.5 ± 6.1, p = 0.032) versus preoperative state (IKDC = 54.0 ± 9.1). However, the IKDC scores decreased in the first year (IKDC = 63.5 ± 11.6) as well as in the second year (IKDC = 52.6 ± 16.4). Thirteen patients underwent second-look arthroscopy and biopsy one year after the operation. The Kartigen® group exhibited integration between Kartigen® and host tissue with a smooth appearance at the recipient site, whereas the microfracture group showed fibrillated surfaces. The histological and immunohistochemical analyses of biopsy specimens demonstrated the columnar structure of articular cartilage and existence of collagen type II and glycosaminoglycan mimic hyaline cartilage. This study indicates that Kartigen® is safe and effective in treating cartilage defects.

The Most Common Rehabilitation Protocol After Matrix-Assisted Autologous Chondrocyte Implantation Is Immediate Partial Weight-Bearing and Continuous Passive Motion

“…Table 5 shows the MCMS scores from the 25 included studies. Six studies 10 , 20 , 21 , 28 , 30 , 31 received an excellent score, 17 studies 8 , 9 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 22 , 23 , 24 , 27 , 29 , 32 received a good score, and 2 studies 25 , 26 received a fair score.…”

“…Twenty-two studies 8 , 10 , 12 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 reported on postoperative WB ( Table 2 ). All but 2 studies 16 , 17 allowed partial WB immediately after operation.…”

“…All but 2 studies 16 , 17 allowed partial WB immediately after operation. One study 29 allowed full WB at 4 weeks, 9 studies 10 , 12 , 15 , 18 , 25 , 26 , 28 , 30 , 32 allowed full WB at 6 weeks, 11 studies 10 , 16 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 27 , 31 allowed full WB at 8 weeks, and 10 studies 8 , 12 , 14 , 17 , 19 , 20 , 21 , 22 , 23 , 24 allowed full WB at 10 to 12 weeks’ postoperatively. Three studies 10 , 25 , 12 consisted of an initial 2-week period of WB at 20%, followed by a progressive increase to full WB at 6 weeks’ postoperatively.…”

“…Ten studies 10 , 17 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 28 described the use of a brace during rehabilitation. Thirteen studies 8 , 10 , 12 , 17 , 20 , 21 , 25 , 26 , 27 , 28 , 29 , 30 , 31 stated time to full knee ROM. Three studies 10 , 21 , 28 described the use of open-chain exercises.…”

Platelet Rich Plasma in the Repair of Articular Cartilage Injury: A Narrative Review

“…If not treated in time, it will cause joint pain and movement disorder, eventually lead to osteoarthritis. 3 It is reported that people with knee cartilage injury are 7.4 times more likely to suffer from osteoarthritis than those without cartilage injury. 4 So far, the treatment methods for articular cartilage injury mainly include conservative treatment and surgical treatment.…”