Treatment of knee osteoarthritis with multiple injections of human placenta-derived MSCs

Mesenchymal stem cells (MSCs) of different origin are the novel therapeutic agents that can slow down cartilage degeneration, improve reparation and ultimately prevent joint prosthetics. MSCs are capable to direct differentiation into chondrocytes, produce cytokines and growth factors with immunomodulatory and anti-inflammatory effects, stimulate angiogenesis, as well as induce chemotaxis of endogenous progenitors. Placenta-derived MSCs (PDMCs) can be considered the most promising source for cell therapy of joints disorders according to availability, safety, and expected therapeutic efficacy.

Study aim: to define the clinical effects of three intra-articular injections of allogenic PDMSCs for knee osteoarthritis

Methods: A total of 33 confirmed cases of patients with stage two OAs at the Kyiv City Clinical Hospital #6 and SI «The Institute of Traumatology and Orthopedics by NAMSU» were included in this non-randomized, open-label study registered on clinicaltrials.gov (NCT04453111). Ten patients who had undergone three intra-articular injections of HA during three weeks (one per 2 weeks) were enrolled in the Control group. Fifteen patients in MSC group undergone three intra-articular injections of HA with 20*106 of allogenic PDMSCs in normal saline during three weeks (one per 2 weeks). The visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, and magnetic resonance arthrography were evaluated for 1 year post-treatment. Blood laboratory tests were performed before and 6 months after treatment.

Quality of life of patients with knee osteoarthritis according to the WOMAC and VAS: 1-year follow-up; n(Control)=10, n(MSCs)=15; p≤0.01.

Results: All patients in the MSC group showed increased local pain, ten patients had knee swelling, five patients had function limitation. All of these adverse events were resolved safely within 3-7 days. In 2 weeks post-injection there was no serious adverse effect.

The bNeu count and the level of plasma IL-12 after 6 mo after beginnings of treatment; n(Control)=10, n(MSCs)=15; p≤0.05.

There was a significant knee VAS and WOMAC improvement 12 months after treatment. Chondral thickness was not improved in the different knee joint points in 6 months. Plasma level of IL-12 in MSC group was significant lower in compare to Control on 6 mo after treatment. The increasing of banded neutrophil count and percentage were observed in Control group. Conclusion: Multiple intra-articular allogenic placental MSC injection in knee OA is safe and can result in clinical improvements in 1 year follow-up.

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