Izawa Hiromi, Xiang Charlie, Ogawa Seiji, Hisanaga Ichiro, Yoshimoto Takayuki
Jingu-Gaien Woman Life Clinic, Shibuya-ku, Tokyo, Japan.
Department of Immunoregulation, Institute of Medical Science, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.
Regen Ther. 2025 Mar 26;29:192-201. doi: 10.1016/j.reth.2025.03.009. eCollection 2025 Jun.
Menopausal syndrome is characterized by a wide range of physical and psychological symptoms in women aged 40s-50s as a result of hormonal fluctuations and age-related decline. Various treatments have been used to manage the symptoms, including hormone replacement therapy, but no effective causal therapies have yet been identified. Regenerative medicine has gained considerable attention as a promising approach to age-related problems, and mesenchymal stem cell therapies have been extensively studied. Recently, menstrual blood has emerged as a novel cell source of stem cells, called menstrual blood-derived stem cells (MenSCs), due to its non-invasive, regular and consistent collection from women. In this study, we have investigated the therapeutic potential of intravenous administration of autologous MenSCs on female menopausal syndromes.
Menstrual blood was collected from 15 patients aged 30s-60s with ovarian dysfunction using a menstrual cup, and MenSCs were isolated, cultured and expanded. Patients received either 3 × 10 cells or 1 × 10 cells intravenously 1 to 5 times at intervals of more than 1 month. Patient-reported symptoms were assessed using the Simplified Menopausal Index at pre-treatment and after 1, 3, 6, and 12 months, and safety assessments were performed. Serum estradiol and follicle-stimulating hormone levels were also measured by immunoassay.
Almost all patients who received MenSCs experienced a sharp reduction in menopausal symptoms, including vasomotor, neuropsychiatric, and motor symptoms, one month after the first administration, and these symptoms remained low for 6 months. The Simplified Menopausal Index score was significantly reduced after treatment. The reducing potency of 1 × 10 MenSCs was greater than that of 3 × 10 MenSCs. Patients who received a higher number of MenSCs showed an increasing trend in estradiol levels and a decreasing trend in follicle-stimulating hormone levels. When MenSCs were administered to postmenopausal patients, this trend was more pronounced. Overall, no apparent serious adverse events were observed during these treatments.
The present results suggest that the administration of MenSCs improved menopausal symptoms and regulated hormonal balance without any serious adverse events. This is the first report on the promising therapeutic potential of cell-based therapy using autologous MenSCs for female menopausal syndrome.
更年期综合征的特征是40多岁至50多岁的女性由于激素波动和年龄相关衰退而出现广泛的身体和心理症状。人们已经使用了各种治疗方法来管理这些症状，包括激素替代疗法，但尚未确定有效的因果疗法。再生医学作为一种解决与年龄相关问题的有前景的方法受到了广泛关注，间充质干细胞疗法也得到了广泛研究。最近，月经血已成为一种新型的干细胞来源，称为月经血源性干细胞（MenSCs），因为它可以从女性身上非侵入性、定期且持续地采集。在本研究中，我们研究了静脉注射自体MenSCs对女性更年期综合征的治疗潜力。
使用月经杯从15名30多岁至60多岁卵巢功能障碍患者中采集月经血，并分离、培养和扩增MenSCs。患者每隔1个月以上静脉注射3×10⁶个细胞或1×10⁶个细胞，注射1至5次。在治疗前以及治疗后1、3、6和12个月，使用简化更年期指数评估患者报告的症状，并进行安全性评估。还通过免疫测定法测量血清雌二醇和促卵泡激素水平。
几乎所有接受MenSCs治疗的患者在首次给药后1个月，更年期症状，包括血管舒缩症状、神经精神症状和运动症状，都急剧减轻，并且这些症状在6个月内一直保持较低水平。治疗后简化更年期指数评分显著降低。1×10⁶个MenSCs的减轻效力大于3×10⁶个MenSCs。接受更多MenSCs的患者雌二醇水平呈上升趋势，促卵泡激素水平呈下降趋势。当将MenSCs给予绝经后患者时，这种趋势更为明显。总体而言，在这些治疗过程中未观察到明显的严重不良事件。
目前的结果表明，MenSCs的给药改善了更年期症状并调节了激素平衡，且没有任何严重不良事件。这是关于使用自体MenSCs进行细胞治疗对女性更年期综合征具有潜在治疗潜力的首次报告。
