Neckar Pavel, Potockova Hana, Branis Jaroslav, Havlas Vojtech, Novotny Tomas, Lykova Dominika, Gujski Jana, Drahoradova Ivana, Ruzickova Katerina, Kaclova Jana, Skala Petr, Bauer Peter O
Department of Sports Medicine, Masaryk Hospital, Krajska zdravotni, Usti nad Labem, Czech Republic.
Bioinova a.s., Prague, Czech Republic.
Int Orthop. 2023 Oct;47(10):2375-2382. doi: 10.1007/s00264-022-05505-y. Epub 2022 Jul 19.
Damage of the knee cartilage is a common condition manifesting itself mainly by pain and/or swelling that may substantially reduce the quality of life while ultimately leading to osteoarthritis in affected patients. Here, we aimed to evaluate the safety and efficacy of cultured autologous bone marrow mesenchymal stem cells (BM-MSCs) attached to the 3D Chondrotissue® scaffold by autologous blood plasma coagulation (BiCure® ortho MSCp) in the treatment of knee cartilage defects.
The primary endpoint of this phase I/IIa clinical trial was to evaluate the safety of the treatment. The secondary objective was to determine the short-to-medium-term therapeutic outcomes by standardized scoring questionnaires including Lysholm Knee Scoring Scale (Lysholm score), Knee Injury and Osteoarthritis Outcome Score (KOOS), and pain Visual Analogue Scale (VAS) systems and imaging (X-ray and magnetic resonance imaging, MRI). A total of six patients were included and followed for 12 months after the surgery.
BiCure® ortho MSCp was well tolerated with no adverse events associated with the investigational medicinal product. Significant improvements were observed in Lysholm scores and KOOS while X-ray showed no deterioration of the arthritis and MRI revealed a persistent filling of the chondral defects by the implant.
Overall, our data demonstrate the safety of the tested investigational medicinal product. The function of the treated knee improved within one year after surgery in all enrolled patients.
EudraCT No.: 2018-004,067-31; October 18 2018.
膝关节软骨损伤是一种常见病症，主要表现为疼痛和/或肿胀，这可能会显著降低生活质量，并最终导致受影响患者患骨关节炎。在此，我们旨在评估通过自体血浆凝固（BiCure® ortho MSCp）附着于3D Chondrotissue®支架上的培养自体骨髓间充质干细胞（BM-MSCs）治疗膝关节软骨缺损的安全性和有效性。
这项I/IIa期临床试验的主要终点是评估治疗的安全性。次要目标是通过标准化评分问卷确定短期至中期的治疗结果，这些问卷包括Lysholm膝关节评分量表（Lysholm评分）、膝关节损伤和骨关节炎疗效评分（KOOS）以及疼痛视觉模拟量表（VAS）系统和影像学检查（X射线和磁共振成像，MRI）。总共纳入了6名患者，并在术后随访12个月。
BiCure® ortho MSCp耐受性良好，未出现与研究用药品相关的不良事件。Lysholm评分和KOOS均有显著改善，而X射线显示关节炎未恶化，MRI显示植入物持续填充软骨缺损。
总体而言，我们的数据证明了所测试研究用药品的安全性。所有入组患者在术后一年内治疗膝关节的功能均有改善。
欧洲临床试验数据库编号：2018-004,067-31；2018年10月18日。
