Effect of autologous bone marrow stem cells-scaffold transplantation on the ongoing pregnancy rate in intrauterine adhesion women: a randomized, controlled trial
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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DOI：
10.1007/s11427-023-2403-7
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发表时间：
2023-09
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通讯作者：
Hui Zhu;Taishun Li;Peizhen Xu;Li-jun Ding;Xianghong Zhu;Bin Wang;Xiaoqiu Tang;Juan Li;Pengfeng Zhu;Huiyan Wang;Chen-yan Dai;Haixiang Sun;Jianwu Dai;Yali Hu
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作者：
Hui Zhu;Taishun Li;Peizhen Xu;Li-jun Ding;Xianghong Zhu;Bin Wang;Xiaoqiu Tang;Juan Li;Pengfeng Zhu;Huiyan Wang;Chen-yan Dai;Haixiang Sun;Jianwu Dai;Yali Hu
宫腔粘连是女性生殖系统疾病的主要原因。虽然我们和其他非对照的初步研究表明，自体骨髓干细胞治疗使少数严重宫腔粘连患者获得活产，但迄今为止尚未报道这种治疗策略在此类患者中的大样本随机对照研究。为了验证自体骨髓干细胞-支架治疗中重度宫腔粘连患者在增加持续妊娠率方面是否上级传统治疗，我们进行了这项随机对照临床试验。2016年2月至2020年1月，共筛选了195例中重度宫腔粘连患者，其中152例按1：1的比例随机分配至自体骨髓干细胞-支架+Foley球囊导管组或仅Foley球囊导管组（对照组）。符合方案分析包括140名参与者：骨髓干细胞-支架组72名，对照组68名。骨髓干细胞支架组妊娠率为62.5%（45/72），明显高于对照组（41.2%）（RR=1.52，95%CI 1.08- 2.12，P =0.012）。活产率两组相似（骨髓干细胞支架组56.9%（41/72）vs对照组38.2%（26/68），RR=1.49，95%CI 1.04- 2.14，P =0.027）。与对照组相比，骨髓干细胞-支架组患者在宫腔镜粘连松解术后第3和第6周期月经量更多，第6周期子宫内膜厚度最大。骨髓干细胞-支架组轻度胎盘植入发生率增加，未见严重不良反应。总之，将骨髓干细胞支架移植到中度至重度子宫内粘连参与者的子宫腔中增加了他们的继续妊娠率和活产率，并且这种疗法相对安全。
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.