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Effect of autologous bone marrow stem cells-scaffold transplantation on the ongoing pregnancy rate in intrauterine adhesion women:a randomized,controlled trial

查看全文 作　　者：Hui [1]Zhu;Taishun [2]Li;Peizhen [3]Xu;Lijun [1]Ding;Xianghong [1]Zhu;Bin [4]Wang;Xiaoqiu [1]Tang;Juan [5]Li;Pengfeng [3]Zhu;Huiyan [1]Wang;Chenyan [1]Dai;Haixiang [1]Sun;Jianwu [6]Dai;Yali [1]Hu 高影响力作者 机构地区：[1]Department of Obstetrics and Gynecology,Nanjing Drum Tower Hospital,Affiliated Hospital of Medical School,Nanjing University,Nanjing 210008,China;[2]Department of Biostatistics,Nanjing Drum Tower Hospital,Affiliated Hospital of Medical School,Nanjing University,Nanjing 210008,China;[3]Department of Gynecology,Changzhou Maternal and Child Health Care Hospital,Changzhou Medical Center,Nanjing Medical University,Changzhou 213004,China;[4]Clinical Center for Stem Cell Research,Nanjing Drum Tower Hospital,Affiliated Hospital of Medical School,Nanjing University,Nanjing 210008,China;[5]Department of Hematology,Nanjing Drum Tower Hospital,Affiliated Hospital of Medical School,Nanjing University,Nanjing 210008,China;[6]Institute of Genetics and Developmental Biology,Chinese Academy of Sciences,Beijing 100190,China高影响力机构 出　　处：《Science China(Life Sciences)》索引2024年第67卷第1期,共9页高影响力期刊 基　　金：This work was supported by the Strategic Priority Research Program of the Chinese Academy of Sciences(XDA16040302,XDA01030505);the National Natural Science Foundation of China(81971336);Jiangsu Provincial Key Medical Center(YXZXB2016004);Jiangsu Provincial Obstetrics and Gynecology Innovation Center(CXZX202229)。 摘　　要：Intrauterine adhesion is a major cause of female reproductive disorders.Although we and others uncontrolled pilot studies showed that treatment with autologous bone marrow stem cells made a few patients with severe intrauterine adhesion obtain live birth,no large sample randomized controlled studies on this therapeutic strategy in such patients have been reported so far.To verify if the therapy of autologous bone marrow stem cells-scaffold is superior to traditional treatment in moderate to severe intrauterine adhesion patients in increasing their ongoing pregnancy rate,we conducted this randomized controlled clinical trial.Totally 195 participants with moderate to severe intrauterine adhesion were screened and 152 of them were randomly assigned in a 1:1 ratio to either group with autologous bone marrow stem cells-scaffold plus Foley balloon catheter or group with only Foley balloon catheter(control group)from February 2016 to January 2020.The per-protocol analysis included 140 participants:72 in bone marrow stem cells-scaffold group and 68 in control group.The ongoing pregnancy occurred in 45/72(62.5%)participants in the bone marrow stem cells-scaffold group which was significantly higher than that in the control group(28/68,41.2%)(RR=1.52,95%CI 1.08–2.12,P=0.012).The situation was similar in live birth rate(bone marrow stem cells-scaffold group 56.9%(41/72)vs.control group 38.2%(26/68),RR=1.49,95%CI 1.04–2.14,P=0.027).Compared with control group,participants in bone marrow stem cells-scaffold group showed more menstrual blood volume in the 3rd and 6th cycles and maximal endometrial thickness in the 6th cycle after hysteroscopic adhesiolysis.The incidence of mild placenta accrete was increased in bone marrow stem cells-scaffold group and no severe adverse effects were observed.In conclusion,transplantation of bone marrow stem cells-scaffold into uterine cavities of the participants with moderate to severe intrauterine adhesion increased their ongoing pregnancy and live birth rates,and this therapy was relatively safe. 关 键 词：intrauterine adhesion Asherman’s syndrome uterine infertility autologous bone marrow stem cells transplantation endometrial regeneration ongoing pregnancy rate
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