Objective To evaluate the effectiveness and safety of mesenchymal stem cells(MSCs)in the treatment of knee osteoarthritis(KOA).Methods The databases PubMed,OVID,Web of Science,CNKI,Wanfang,were systematically searched from inception to May 2023 to collect randomized control trials(RCTs)of MSCs in the treatment of KOA.The literature was selected according to the inclusion and exclusion criteria,and relevant data was extracted.Meta-analysis was conducted using RevMan 5.4 software.Heterogeneity was assessed using the I2 statistic,with the fixed effects model applied when P was less than 50％,and the random effects model utilized otherwise.The combined effect size and 95％confidence interval(CI)were calculated using the inverse-variance method.Sensitivity analysis and assessment of publication bias were performed using Stata 14.0 software.Results A total of 29 RCTs involving 1 402 participants were included.The outcomes showed that at the 12 month follow-up,MSCs reduced pain[WOMAC pain:MD(95％CI)=-4.38(-7.22,-1.55),P＜0.001;VAS:MD(95％CI)=-2.00(-2.67,-1.33),P＜0.001].And WOMAC stiffness[WOMAC stiffness:MD(95％CI)=-1.21(-2.32,-0.10),P＜0.001];moreover,MSCs reduced KOA severity and Restored joint function,[WOMAC:MD(95％CI)=-9.40(-15.87,-2.93),P＜0.001;Lequesne:MD(95％CI)=-10.57(-15.89,-5.24),P＜0.001].And the effect lasted for at least 4 years.MRI analysis showed no significant difference between the MSC group and the control group[MD(95％CI)=-6.68(-18.45,5.09),P=0.270].Subgroup analysis showed that there was no significant difference in the effects of the tissue source and dosage of MSC on osteoarthritis pain and joint function.Using WOMRS for subgroup analysis,we found that adipose tissue was the best MSCs source for cartilage repair in osteoarthritis[MD(95％CI)=-30.94(-43.87,-18.01),P＜0.001].For the occurrence of adverse events,no study had reported the occurrence of serious adverse events.Most of the adverse events were self-limited pain and discomfort,such as transient joint swelling and back pain.Conclusion Based on current evidence,MSCs may be a safety therapy that have a good effect for OA,and the time to maintain the curative effect is no less than 4 years.There is currently no reliable evidence to address the issue of which tissue source and injection cell dosage yield the best therapeutic effect.High-quality clinical trials are needed.
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