The Evaluation of Cartilage Regeneration Efficacy of Three-Dimensionally Biofabricated Human-Derived Biomaterials on Knee Osteoarthritis: A Single-Arm, Open Label Study in Egypt

Abstract

Full thickness cartilage defects in cases of knee osteoarthritis are challenging in nature and are difficult to treat. The implantation of three-dimensional (3D) biofabricated grafts into the defect site can be a promising biological one-stage solution for such lesions that can avoid different disadvantages of the alternative surgical treatment options. In this study, the short-term clinical outcome of a novel surgical technique that uses a 3D bioprinted micronized adipose tissue (MAT) graft for knee cartilage defects is assessed and the degree of incorporation of such graft types is evaluated via arthroscopic and radiological analyses. Ten patients received 3D bioprinted grafts consisting of MAT with an allogenic hyaline cartilage matrix on a mold of polycaprolactone, with or without adjunct high tibial osteotomy, and they were monitored until 12 months postoperatively. Clinical outcomes were examined with patient-reported scoring instruments that consisted of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score and the Knee Injury and Osteoarthritis Outcome Score (KOOS). The graft incorporation was assessed using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score. At 12 months follow-up, cartilage tissue biopsy samples were taken from patients and underwent histopathological examination. In the results, at final follow-up, the WOMAC and KOOS scores were 22.39 ± 7.7 and 79.16 ± 5.49, respectively. All scores were significantly increased at final follow-up (p < 0.0001). MOCART scores were also improved to a mean of 82.85 ± 11.49, 12 months after operation, and we observed a complete incorporation of the grafts with the surrounding cartilage. Together, this study suggests a novel regeneration technique for the treatment of knee osteoarthritis patients, with less rejection response and better efficacy.

Protecting the regenerative environment: selecting the optimal delivery vehicle for cartilage repair—a narrative review

“…Clinical studies on focal cartilage defects ( Buda et al, 2013 ; Saw et al, 2013 ; Akgun et al, 2015 ; Koh et al, 2016 ; de Windt et al, 2017 ; Kamei et al, 2018 ; Shimomura et al, 2018 ; de Girolamo et al, 2019 ; Gobbi and Whyte, 2019 ; Hashimoto et al, 2019 ; Monckeberg et al, 2019 ; Pipino et al, 2019 ; Kyriakidis et al, 2020 ; Neckar et al, 2022 ; Shetty et al, 2022 ; Venosa et al, 2022 ; Abdelhamid et al, 2023 ; Song et al, 2023 ) ( Table 4 ) often included individuals with isolated cartilage lesions of International Cartilage Repair Society (ICRS) grades 3–4 or equivalent (severely abnormal cartilage with loss of ≥50% cartilage depth). Vehicles included liquid delivery systems such as saline ( Kamei et al, 2018 ; Shimomura et al, 2018 ), HA ( Buda et al, 2013 ; Saw et al, 2013 ; Hashimoto et al, 2019 ; Shetty et al, 2022 ; Song et al, 2023 ), and PRP ( Monckeberg et al, 2019 ; Venosa et al, 2022 ).…”

“…Vehicles included liquid delivery systems such as saline ( Kamei et al, 2018 ; Shimomura et al, 2018 ), HA ( Buda et al, 2013 ; Saw et al, 2013 ; Hashimoto et al, 2019 ; Shetty et al, 2022 ; Song et al, 2023 ), and PRP ( Monckeberg et al, 2019 ; Venosa et al, 2022 ). Scaffolds included HA- or collagen-based membranes ( Buda et al, 2013 ; Akgun et al, 2015 ), fibrin glue ( Koh et al, 2016 ; de Windt et al, 2017 ; de Girolamo et al, 2019 ), or tissue-engineered materials ( Gobbi and Whyte, 2019 ; Pipino et al, 2019 ; Kyriakidis et al, 2020 ; Neckar et al, 2022 ; Abdelhamid et al, 2023 ) ( Figure 1 ). Fluid-based vehicles were often injected under arthroscopic guidance, while scaffolds shaped to match the focal cartilage defect were often placed using mini arthrotomy ( Table 4 ).…”

“…Synovial fluid-derived MSCs contained within 3D spheroids reduced the sizes of OCDs in an equine model as seen on MRI and the histology-based ICRS scale ( Murata et al, 2022 ). This technology has been piloted in clinical studies of OCD ( Abdelhamid et al, 2023 ), with positive structural results ( Jiang et al, 2021 ; Lv et al, 2023 ). Given the large number of individuals affected by OCD, the research advances represent an important step forward ( Mandelbaum et al, 1998 ; Ding et al, 2007 ; Everhart et al, 2019 ; Liu et al, 2022 ).…”