Clinical efficacy and safety of somatic cell therapy for chronic low back pain: evidence from the pooled randomized controlled trials

Chronic low back pain (CLBP) is a highly prevalent and burdensome musculoskeletal disorder globally, significantly impacting individuals' health and quality of life. This study aimed to evaluate the efficacy and safety of the somatic cell therapies in treating CLBP. All relevant randomized controlled trials (RCTs) in the Cochrane, Embase, PubMed, and Web of Science databases were systematically searched for the meta-analysis. The outcomes consisted of Visual Analogue Scale (VAS) scores, Oswestry Disability Index (ODI) scores, and the incidence of serious adverse events (SAE). Dichotomous outcomes were described as odds ratios (OR) with 95% confidence intervals (CIs), while continuous data were presented as mean difference (MD) with 95% CIs. Statistical analysis was performed with RevMan 5.4 and stata 17 software. A total of seven RCTs involving 518 patients were included in the meta-analysis. The results showed that somatic cell therapies were effective in terms of VAS scores [MD = -12.04 (-17.35,-6.72)] and ODI scores [MD = -8.03 (-12.84,-3.22)], while not increasing risk of SAE [OR = 0.70 (0.19, 2.64)]. Our findings suggested that somatic cell therapy demonstrated significant therapeutic efficacy in the management of CLBP. Future large-scale, multicenter RCTs with extended follow-up durations are warranted to confirm the optimal somatic cell type and dosage regimen for maximal therapeutic benefit.