Background

Sexual functional deficiency occurs at some point in life and becomes a problematic issue in middle-aged adulthood. Regenerative medicine, especially mesenchymal stem cell (MSC) transplantation, has developed extensively, with preclinical and clinical trials emphasizing the benefits of stem cell therapy for restoration of sexual deficiency. This study was designed to develop a new therapeutic stem cell treatment for people with sexual functional deficiency.

Methods

Thirty-one patients, including 15 males and 16 females with a medical history of reduced sexual activity, met the inclusion criteria and were enrolled in the study, phase I/IIa clinical trial with a 12-month follow-up. Adipose tissue-derived mesenchymal stem/stromal cells (ADSC) were isolated by type I collagenase digestion and cultured at the Stem Cell Core Facility under ISO 14644-1. Each participant received 1 million cells/kg of body weight via the intravenous route. Safety was evaluated by assessing the occurrence of adverse events or severe adverse events. Efficacy was assessed in males by monitoring testosterone levels and administering the International Index of Erectile Function (IIEF) questionnaire and in females by monitoring anti-Mullerian hormone (AMH), estradiol (E2), and follicle-stimulating hormone (FSH) levels and administering the Female Sexual Functioning Index (FSFI) questionnaire at baseline and 3-, 6-, and 12-months post-transplantation.

Results

There was no occurrence of severe adverse events after ADSC administration in our study. Post-transplantation sexual satisfaction was observed in all patients enrolled in this study. Testosterone levels in males increased soon after transplantation and were maintained at high levels for up to 6 months before decreasing again at the 12-month follow-up. No significant changes in AMH, FSH or E2 levels were recorded in female patients.

Conclusions

Autologous ADSC infusion is a potential therapeutic option for patients with reduced sexual activity, especially for male patients.

Trial Registration

ClinicalTrials.gov. NCT03346967, Registered November 20, 2017.

中文翻译：

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自体脂肪来源的间充质干细胞移植能否改善性功能障碍患者的性功能？

背景

性功能缺陷发生在生活中的某个阶段，并成为中年成人的一个问题。再生医学，尤其是间充质干细胞 (MSC) 移植，已经得到了广泛的发展，临床前和临床试验强调了干细胞治疗对恢复性缺陷的益处。这项研究旨在为性功能障碍患者开发一种新的治疗性干细胞疗法。

方法

31 名患者，包括 15 名男性和 16 名女性，有性活动减少的病史，符合纳入标准，并被纳入研究，I/IIa 期临床试验，随访 12 个月。通过 I 型胶原酶消化分离脂肪组织来源的间充质干/基质细胞 (ADSC)，并在 ISO 14644-1 下在干细胞核心设施中培养。每个参与者通过静脉途径接受 100 万个细胞/公斤体重。通过评估不良事件或严重不良事件的发生来评估安全性。通过监测睾酮水平和管理国际勃起功能指数 (IIEF) 问卷评估男性的疗效，通过监测抗苗勒管激素 (AMH)、雌二醇 (E2)、

结果

在我们的研究中，ADSC 给药后没有发生严重的不良事件。在参加本研究的所有患者中观察到移植后的性满意度。男性的睾酮水平在移植后很快增加，并在 6 个月内保持高水平，然后在 12 个月的随访中再次下降。女性患者的 AMH、FSH 或 E2 水平没有显着变化。

结论

对于性活动减少的患者，尤其是男性患者，自体 ADSC 输注是一种潜在的治疗选择。

试用注册

ClinicalTrials.gov. NCT03346967，2017 年 11 月 20 日注册。