Matsushita Takehiko, Matsumoto Tomoyuki, Araki Daisuke, Nagai Kanto, Hoshino Yuichi, Niikura Takahiro, Kawamoto Atsuhiko, Go Masahiro J, Kawamata Shin, Fukushima Masanori, Kuroda Ryosuke
Department of Orthopedic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.
Foundation for Biomedical Research and Innovation at Kobe, Japan.
Asia Pac J Sports Med Arthrosc Rehabil Technol. 2022 Mar 28;28:6-12. doi: 10.1016/j.asmart.2022.03.004. eCollection 2022 Apr.
BACKGROUND/OBJECTIVE: The purpose of this study was to report the outcomes of a clinical trial conducted in Japan to assess the safety and effectiveness of third-generation autologous chondrocyte implantation (ACI) using IK-01 (CaReS™), which does not require flap coverage, in the treatment of patients with focal cartilage injury of the knee.
This was an open label, exploratory clinical trial. Patients were enrolled between June 2012 and September 2016. The primary endpoint of the study was the International Knee Documentation Committee (IKDC) score at 52 weeks after implantation. The IKDC, Lysholm, and visual analog scale (VAS) scores were evaluated at the time of screening and at 4, 12, 24, 36, and 52 weeks after implantation. Improvements from the baseline scores were evaluated using the equation "(postoperative score) - (preoperative score)." Magnetic resonance imaging (MRI) was performed at 2, 12, 24, and 52 weeks after implantation, and MRI measurements were evaluated using T1 rho and T2 mapping.
Nine patients were enrolled in this study and were examined for safety. Product quality did not satisfy the specification in one patient, and bacterial joint infection occurred in one patient. As a result, seven patients were included in the outcome analyses. The mean IKDC score significantly improved from 36.4 preoperatively to 74.1% at 52 weeks after implantation (p < 0.0001). The mean Lysholm and VAS scores also significantly improved from 39.6 to 57.4 to 89.6 and 22.9, respectively, after surgery. In the MRI evaluation, the T1 rho and T2 values of the implanted area were similar to those of the surrounding cartilage at 52 weeks after implantation.
Third generation ACI (IK-01) can be an effective treatment option for focal cartilage defects of the knee; however, surgeons must pay careful attention to the risk of postoperative joint infection.
背景/目的：本研究旨在报告在日本进行的一项临床试验的结果，该试验旨在评估使用无需皮瓣覆盖的IK-01（CaReS™）进行第三代自体软骨细胞植入（ACI）治疗膝关节局灶性软骨损伤患者的安全性和有效性。
这是一项开放标签的探索性临床试验。患者于2012年6月至2016年9月入组。该研究的主要终点是植入后52周时的国际膝关节文献委员会（IKDC）评分。在筛查时以及植入后4、12、24、36和52周对IKDC、Lysholm和视觉模拟量表（VAS）评分进行评估。使用公式“（术后评分）-（术前评分）”评估相对于基线评分的改善情况。在植入后2、12、24和52周进行磁共振成像（MRI），并使用T1 rho和T2映射评估MRI测量结果。
本研究共纳入9例患者并进行安全性检查。1例患者的产品质量不符合规格，1例患者发生细菌性关节感染。因此，7例患者纳入结果分析。平均IKDC评分从术前的36.4显著提高到植入后52周时的74.1%（p<0.0001）。术后平均Lysholm和VAS评分也分别从39.6显著提高到57.4和从22.9提高到89.6。在MRI评估中，植入区域的T1 rho和T2值在植入后52周时与周围软骨相似。
第三代ACI（IK-01）可以成为治疗膝关节局灶性软骨缺损的有效选择；然而，外科医生必须密切关注术后关节感染的风险。
