摘要
We examined the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC)infusion for immune nonresponder(INR)patients with chronic HIV-1 infection,who represent an unmet medical need even in the era of efficient antiretroviral therapy(ART).Seventy-two INR patients with HIV were enrolled in this phase II randomized,double-blinded,multicenter,placebo-controlled,dose-determination trial(NCT01213186)from May 2013 to March 2016.They were assigned to receive high-dose(1.5 x 106/kg body weight)or low-dose(0.5 x 106/kg body weight)hUC-MSC,or placebo.Their clinical and immunological parameters were monitored during the 96-week follow-up study.We found that hUC-MSC treatment was safe and well-tolerated.Compared with baseline,there was a statistical increase in CD4+T counts in the high-dose(P<0.001)and low-dose(P<0.001)groups after 48-week treatment,but no change was observed in the control group.Kaplan-Meier analysis revealed a higher cumulative probability of achieving an immunological response in the low-dose group compared with the control group(95.8%vs.70.8%,P=0.00A).However,no significant changes in CD4/CD84-T counts and CD4/CD8 ratios were observed among the three groups.In summary,hUC-MSC treatment is safe.However,the therapeutic efficacy of hUC-MSC treatment to improve the immune reconstitution in INR patients still needs to be further investigated in a large cohort study.
基金
This work was supported by the National Science and Technology Major Project of the Ministry of Science and Technology of China(2017ZX10202102-004-002 and 2018ZX10302104-002)
the Innovative Research Team in the National Natural Science Foundation of China(81721002)
the National Key R&D Program of China(2017YFA0105703).
