Can Autologous Adipose-Derived Mesenchymal Stem Cell Transplantation Improve Sexual Function in People with Sexual Functional Deficiency?

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.

Abstract

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,

Citation

Nguyen Thanh, L., Dam, P. T., Nguyen, H. P., Nguyen, T. S. T., To, H. M., Nguyen, H. B., Luu, N. A., & Hoang, D. M. (2021). Can Autologous Adipose-Derived Mesenchymal Stem Cell Transplantation Improve Sexual Function in People with Sexual Functional Deficiency?. Stem Cell Reviews and Reports, 17(6), 2153-2163. https://doi.org/10.1007/s12015-021-10196-w

• Journal Article Type: Article
• Acceptance Date: Jun 2, 2021
• Online Publication Date: Jun 15, 2021
• Publication Date: 2021-12
• Deposit Date: Oct 19, 2024
• Journal: Stem Cell Reviews and Reports
• Print ISSN: 1550-8943
• Electronic ISSN: 1558-6804
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 17
• Issue: 6
• Pages: 2153-2163
• DOI: https://doi.org/10.1007/s12015-021-10196-w
• Keywords: Sexual dysfunction · Adipose mesenchymal stem/stromal cell · Reproductive hormones
• Public URL: https://nottingham-repository.worktribe.com/output/40563052
• Publisher URL: https://link.springer.com/article/10.1007/s12015-021-10196-w
• Additional Information: Accepted: 2 June 2021; First Online: 15 June 2021; : ; : This study was approved by The Clinical Research Ethics Committee of Vietnam Ministry of Health (November 30th, 2017). Written informed consent was obtained from each participant. This trial was registered witNoth ClinicalTrials.gov (NCT03346967). Participants waived any hospital fees for screening and treatment-related interventions.