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自体经血来源间充质干细胞卵巢内注射改善卵巢低反应患者妊娠率及活产率:Ⅰ/Ⅱ期临床试验。

Improvement of Pregnancy Rate and Live Birth Rate in Poor Ovarian Responders by Intraovarian Administration of Autologous Menstrual Blood Derived- Mesenchymal Stromal Cells: Phase I/II Clinical Trial.

机构信息

Nanobiotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, P.O. Box 19615-1177, Islamic Republic of Iran.

出版信息

Stem Cell Rev Rep. 2020 Aug;16(4):755-763. doi: 10.1007/s12015-020-09969-6.

DOI:10.1007/s12015-020-09969-6
PMID:32198596
Abstract

The study was aimed to evaluate the safety and efficacy of cell therapy using autologous menstrual blood derived- mesenchymal stromal cells (Men-MSCs) in fertility potential of poor ovarian responders (PORs). POR women were divided into mesenchymal stroma cell (MSC) therapy (n = 15) and routine ICSI (n = 16) groups. The cultured Men-MSCs were autologously injected into left ovary of MSC group after approval by flow cytometry, karyotyping, endotoxin, sterility and mycoplasma tests. Changes in anti-Mullerian hormone (AMH), antral follicles count (AFC), oocytes and embryos number, clinical pregnancy rate and live birth rate were followed in both groups up to one year after treatment. 4 of 15 participants in MSC group got naturally pregnant during 3 months after cell administration, in contrast to no natural conception in control group (P = 0.04). The mean AMH level did not significantly differ with that of previous cycle or control group. Although mean AFC and oocytes number in MSC group did not indicate considerable difference with those of control group, raise of these parameters in comparison with previous cycle was significant (both P = 0.01). Nonetheless, oocyte fertilization rate and embryo number in MSC group were higher than control group (P = 0.04 and P = 0.008, respectively). Altogether, 7 of 15 women in MSC group and 2 of 16 women in routine ICSI group had clinical pregnancy that resulted in 5 live births in main group and one birth in control group. In conclusion, cell therapy using Men-MSCs could be considered as a potential treatment to restore fertility capability of POR women.The trial registration number (TRN): IRCT20180619040147N2.Date of registration: 2018-08-21.

摘要

该研究旨在评估使用自体月经血衍生的间充质基质细胞(Men-MSCs)进行细胞治疗对卵巢低反应(POR)患者生育潜力的安全性和有效性。POR 患者分为间充质基质细胞(MSC)治疗组(n=15)和常规 ICSI 组(n=16)。经过流式细胞术、核型分析、内毒素、无菌和支原体检测后,将培养的 Men-MSCs 自体注射到 MSC 组的左侧卵巢。在治疗后 1 年内,对两组的抗苗勒管激素(AMH)、窦卵泡计数(AFC)、卵子和胚胎数量、临床妊娠率和活产率进行了随访。在细胞给药后 3 个月内,MSC 组有 4 名参与者自然怀孕,而对照组则没有自然受孕(P=0.04)。与前一周期或对照组相比,MSC 组的平均 AMH 水平没有显著差异。尽管 MSC 组的平均 AFC 和卵子数量与对照组没有显著差异,但与前一周期相比,这些参数有所增加(均 P=0.01)。尽管如此,MSC 组的卵母细胞受精率和胚胎数量高于对照组(分别为 P=0.04 和 P=0.008)。总的来说,MSC 组的 15 名女性中有 7 名和常规 ICSI 组的 16 名女性中有 2 名出现了临床妊娠,主要组有 5 名活产,对照组有 1 名活产。总之,使用 Men-MSCs 的细胞治疗可以被认为是一种潜在的治疗方法,可以恢复 POR 患者的生育能力。试验注册号(TRN):IRCT20180619040147N2。注册日期:2018 年 8 月 21 日。

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