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.
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Availability of Data and Materials
The data support the findings of this study are included in this article. Unpublished data are available from the corresponding author upon reasonable request and with permission from the Ethics Committee of Vinmec International Hospital.
mesenchymal stem cell
adipose tissue-derived mesenchymal stem/stromal cell
Follicle stimulating hormone
Serious adverse event
International Index of Erectile Function
Female Sexual Functioning Index
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We thank the patients for their trust and willingness to participate in this clinical trial. We acknowledge the support of Vinmec International Hospital.
This work was supported by Vingroup Joint Stock Company.
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.
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Nguyen Thanh, L., Dam, P.T.M., Nguyen, H . et al. Can Autologous Adipose-Derived Mesenchymal Stem Cell Transplantation Improve Sexual Function in People with Sexual Functional Deficiency?. Stem Cell Rev and Rep 17, 2153–2163 (2021). https://doi.org/10.1007/s12015-021-10196-w