Efficacy and Safety of Stem Cell Combination Therapy for Osteonecrosis of the Femoral Head: A Systematic Review and Meta-Analysis

BACKGROUND: The treatment results of core decompression (CD) and biomechanical support are not always satisfactory in osteonecrosis of the femoral head (ONFH). Stem cell therapy has been incorporated into traditional treatment in order to promote bone regeneration. The efficacy and safety of stem cell therapy combined with CD or biomechanical support on advanced and long-term patients with ONFH were unknown. The aim of this study was to assess whether stem cell combination therapy is superior to single CD or porous tantalum rod implantation treatment in ONFH. METHODS: A systematic search of the literature was performed to evaluate all included randomized controlled trials (RCTs) on stem cell combination therapy for patients with ONFH in PubMed, Cochrane Library, Web of Science, and Embase sites. We assessed the quality and risk of bias for the included studies. And the outcomes of Harris hip score (HHS), visual analogue scale (VAS), and adverse events were statistically analyzed. RESULTS: We included 10 randomized controlled trials, containing a total of 498 patients with 719 hips. Stem cell therapy combined with CD versus CD alone for HHS of ONFH was different (MD = 8.87, 95% CI = [5.53, 12.22], P < 0.00001). The combination of stem cell therapy and CD can effectively improve HHS. Similarly, the VAS of the stem cell combination therapy group also differed compared with the control group (MD = −14.07, 95% CI = [−18.32, −9.82], P < 0.00001). The result showed that stem cell combination therapy can relieve the pain of patients with ONFH. There was no significant difference in adverse response outcome events between the combination therapy group and the control group (RR = 1.57, 95% CI = [0.62, 3.97], P = 0.34). CONCLUSIONS: Stem cell therapy combined with core decompression is an effective and feasible method with few complications in the clinical treatment of early-stage ONFH. Even in the combination of porous tantalum rod implantation and peripheral blood stem cells, stem cell combination therapy is superior to single biomechanical support treatment. But high-quality, large-sample, multicenter, and long-term follow-up RCTs are still needed to corroborate the efficacy and safety of stem cell combination therapy in ONFH treatment.