Investigating the Efficacy of Autologous, Adipose-derived Mesenchymal Stem Cell Therapy for the Treatment of Sexual Function Impairment in Women Aged 40-50

Summary

Female Sexual Dysfunction (FSD) represents a critical public health challenge, significantly impacting women's physical, psychological, and social well-being. Despite its prevalence, cultural barriers in Vietnam and other Asian countries often limit awareness and research on FSD. Existing treatments, such as hormone therapy, carry risks like cardiovascular complications and cancer, emphasizing the need for innovative interventions. This study investigates FSD-related factors and evaluates the efficacy of autologous adipose-derived mesenchymal stem cell (MSC) therapy as a novel approach. In this phase 2 clinical trial, MSCs are intravenously administered at a dose of 10\^6 cells/kg. These autologous cells, which are non-immunogenic, survive for approximately 8 weeks and release growth factors and cytokines to enhance vascular supply, reduce harmful inflammation, and counteract cellular aging. The study enrolls 50 female participants randomized into two groups: Group A receives MSC infusions at months 0 and 3, while Group B acts as a control for 6 months. Outcomes are assessed through clinical evaluations, blood tests for hormonal levels, molecular analyses, and internationally validated quality-of-life and sexual function scales. Evaluations are conducted at baseline, 3, and 6 months post-infusion. This research seeks to provide robust evidence for the safety and efficacy of MSC therapy, offering a promising alternative to conventional treatments while addressing a critical gap in women's health.

Timeline

Start

2023-10-01

Primary completion

2025-12-30

Completion

2026-01-01

Drugs

Indications