High- and low-dose BM-MSC injection versus control for treatment of knee osteoarthritis .
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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)
J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-232 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.
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