Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS:a multicenter randomized controlled trial  

作　　者：Lifeng Wang Zheng Zhang Ruonan Xu Xicheng Wang Zhanjun Shu Xiejie Chen Siyu Wang Jiaye Liu Yuanyuan Li Li Wang Mi Zhang Wei Yang Ying Wang Huihuang Huang Bo Tu Zhiwei Liang Linghua Li Jingxin Li Yuying Hou Ming Shi Fu-Sheng Wang 

机构地区：[1]Treatment and Research Center for Infectious Diseases,Fifth Medical Center of Chinese PLA General Hospital,Beijing,China [2]lnstitute of Hepatology,National Clinical Research Center for Infectious Disease,Shenzhen Third Peopled Hospital,The Second Affiliated Hospital,School of Medicine,Southern University of Science and Technology,Shenzhen,Guangdong Province,China [3]Yunnan Provincial Hospital of Infectious Diseases,Kunming,China [4]Xinjiang Uygur Autonomous Regional the Sixth People's Hospital,Urumqi,China [5]Guangzhou Eighth Peopled Hospital,Guangzhou Medical University,Guangzhou,China [6]NHC Key Laboratory of Enteric Pathogenic Microbiology,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing,China

出　　处：《Signal Transduction and Targeted Therapy》2021年第7期2164-2171,共8页信号转导与靶向治疗（英文）

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).

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.

关 键 词：CD4/CD8 TRANSFUSION RANDOMIZED 

分 类 号：R329.2[医药卫生—人体解剖和组织胚胎学]