Pavel Neckar1, Hana Potockova2, Jaroslav Branis2, Vojtech Havlas3, Tomas Novotny4, Dominika Lykova2, Jana Gujski2, Ivana Drahoradova2, Katerina Ruzickova2, Jana Kaclova2, Petr Skala5, Peter O Bauer6. 1. Department of Sports Medicine, Masaryk Hospital, Krajska zdravotni, Usti nad Labem, Czech Republic. 2. Bioinova a.s., Prague, Czech Republic. 3. Department of Orthopaedics, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic. 4. Department of Orthopaedics, University of J.E. Purkyne in Usti Nad Labem, Masaryk Hospital, Krajska zdravotni, Usti nad Labem, Czech Republic. 5. Department of Orthopaedics and Traumatology, University Hospital Pilsen, Pilsen, Czech Republic. 6. Bioinova a.s., Prague, Czech Republic. peter.bauer@bioinova.cz.
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: EudraCT No.: 2018-004,067-31; October 18 2018.
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: EudraCT No.: 2018-004,067-31; October 18 2018.
Authors: Christoph Becher; Max Ettinger; Marco Ezechieli; Christian Kaps; Marc Ewig; Tomas Smith Journal: Arch Orthop Trauma Surg Date: 2015-05-08 Impact factor: 3.067
Authors: Aad A M Dhollander; Peter C M Verdonk; Stijn Lambrecht; René Verdonk; Dirk Elewaut; Gust Verbruggen; Karl Fredrik Almqvist Journal: Am J Sports Med Date: 2011-09-29 Impact factor: 6.202
Authors: Johannes Glasbrenner; Wolf Petersen; Michael J Raschke; Matthias Steiger; René Verdonk; Claudio C Castelli; Giorgio Zappalà; Daniel Fritschy; Mirco Herbort Journal: Orthop J Sports Med Date: 2020-05-29