Nguyen Thanh Liem, Dam Phuong T M, Nguyen Hoang-Phuong, Nguyen Tan-Sinh Thi, To Huong Minh, Nguyen Hung Ba, Luu Ngoc-Anh, Hoang Duc M
Vinmec Research Institute of Stem Cell and Gene Technology (VRISG), Vinmec Health Care System, Hanoi, Vietnam.
Vinmec Hightech Center, Vinmec Healthcare System, Hanoi, Vietnam.
Stem Cell Rev Rep. 2021 Dec;17(6):2153-2163. doi: 10.1007/s12015-021-10196-w. Epub 2021 Jun 15.
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.
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.
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.
Autologous ADSC infusion is a potential therapeutic option for patients with reduced sexual activity, especially for male patients.
ClinicalTrials.gov. NCT03346967, Registered November 20, 2017.
性功能缺陷在人生的某个阶段会出现，并成为中年期的一个问题。再生医学，尤其是间充质干细胞（MSC）移植，已经得到广泛发展，临床前和临床试验都强调了干细胞疗法对恢复性功能缺陷的益处。本研究旨在开发一种针对性功能缺陷患者的新型治疗性干细胞疗法。
31名患者，包括15名男性和16名有性活动减少病史的女性，符合纳入标准并被纳入该研究，这是一项为期12个月随访的I/IIa期临床试验。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），并在符合ISO 14644-1标准的干细胞核心设施中培养。每位参与者通过静脉途径接受每公斤体重100万个细胞。通过评估不良事件或严重不良事件的发生情况来评估安全性。在男性中，通过监测睾酮水平和发放国际勃起功能指数（IIEF）问卷来评估疗效；在女性中，通过在基线以及移植后3个月、6个月和12个月监测抗苗勒管激素（AMH）、雌二醇（E2）和促卵泡激素（FSH）水平以及发放女性性功能指数（FSFI）问卷来评估疗效。
在我们的研究中，ADSC给药后未发生严重不良事件。本研究纳入的所有患者在移植后均观察到性满意度。男性患者的睾酮水平在移植后很快升高，并在高水平维持长达6个月，然后在12个月随访时再次下降。女性患者的AMH、FSH或E2水平未记录到显著变化。
自体ADSC输注是性活动减少患者，尤其是男性患者的一种潜在治疗选择。
ClinicalTrials.gov。NCT03346967，2017年11月20日注册。
