Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II)

この研究はハイインパクトの可能性があります。 OEのAI駆動型ハイインパクト指標は、論文が掲載されたジャーナルと論文自体の科学的内容の両方からのシグナルを統合することで、論文が持つ可能性の高い影響力を推定します。 最先端の自然言語処理を用いて開発されたOEハイインパクトモデルは、ジャーナルのインパクトファクターのみよりも、研究の将来の引用実績をより正確に予測します。 これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。

32 patients with Kellgren-Lawrence grade II-IV knee osteoarthritis were randomized to one of three injection groups: high-dose autologous bone marrow-derived mesenchymal stem cell injection and hyaluronic acid injection (high-dose MSC group), low-dose autologous bone marrow-derived mesenchymal stem cell injection and hyaluronic acid injection (low-dose MSC group), or hyaluronic acid injection alone (control group). Patients were assessed for safety and efficacy outcomes over 3, 6, and 12 month follow-up in this phase I/II study. Safety analysis reported no serious treatment-related adverse events in any group. Efficacy results demonstrated significant within-group improvement after 12 months in the high-dose MSC group for VAS pain, WOMAC pain, WOMAC stiffness, and WOMAC function, whereas within-group improvement in the low-dose MSC group was only noted for WOMAC stiffness after 6 and 12 months, and within-group improvement in the control group was only noted for WOMAC function at 3 and 6 months. Knee range of motion was significantly improved from baseline in the high-dose MSC group after 3, 6 and 12 months, and in the low-dose MSC group after 12 months; no significant change in knee range of motion was noted in the control group.