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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

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Abstract

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.

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Acknowledgement

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), and Jiangsu Provincial Obstetrics and Gynecology Innovation Center (CXZX202229). The funding sources had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. We thank Yaling Li from Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University for assistance in participants care, Biyun Xu from Department of Biostatistics Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University for her help in randomization, Jian Dai from Clinical Trial Institution Office of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University for monitoring the process of the clinical trial, Yihua Zhou from Departments of Laboratory Medicine and Infectious Diseases, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University for his help in polishing the language, and all the dedicated staff in the group and participants included.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210008, China

    Hui Zhu, Lijun Ding, Xianghong Zhu, Xiaoqiu Tang, Huiyan Wang, Chenyan Dai, Haixiang Sun & Yali Hu

  2. Department of Biostatistics, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210008, China

    Taishun Li

  3. Department of Gynecology, Changzhou Maternal and Child Health Care Hospital, Changzhou Medical Center, Nanjing Medical University, Changzhou, 213004, China

    Peizhen Xu & Pengfeng Zhu

  4. Clinical Center for Stem Cell Research, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210008, China

    Bin Wang

  5. Department of Hematology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210008, China

    Juan Li

  6. Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, 100190, China

    Jianwu Dai

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  1. Hui Zhu
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Correspondence to Haixiang Sun, Jianwu Dai or Yali Hu.

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The author(s) declare that they have no conflict of interest. For studies of human participants, we conformed with the Helsinki Declaration of 1975 (as revised in 2008) concerning Human Rights, and that we followed out policy concerning Informed Consent as shown on Springer.com.

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Zhu, H., Li, T., Xu, P. et al. Effect of autologous bone marrow stem cells-scaffold transplantation on the ongoing pregnancy rate in intrauterine adhesion women: a randomized, controlled trial. Sci. China Life Sci. 67, 113–121 (2024). https://doi.org/10.1007/s11427-023-2403-7

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