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

NCT06726538 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • Female Sexual Dysfunction

Interventions

BIOLOGICAL

Intravenous administration of Autologous, adipose-derived mesenchymal stem cells

Patients in group A will receive two infusions of autologous, adipose-derived mesenchymal stem cells at day 0 and day 90 ± 14 at a dose of 10\^6 cells/kg. Autologous, adipose-derived mesenchymal stem cells used in this study were harvested from autologous fat tissue through an enzyme method and expanded using our in-house optimized serum-free and xeno-free culture under a physiological oxygen concentration of 5%. For clinical use, cells at passage 3 will be harvested in 100 mL Ringer's lactate. Therapeutic ASC products must pass the following releasing criteria: (1) negative for bacteria, fungi and mycoplasma; (2) more than 90% viability; (3) expression of more than 95% positivity for CD105, CD73, and CD90 and less than 2% positivity for CD45, CD34, CD11b, CD19, and HLA-DR; and (4) endotoxin \<5 EU/kg. The patient will be infused with 1x106 cells/kg body weight within 60 minutes via the intravenous route.

Sponsors & Collaborators

  • Vinmec Research Institute of Stem Cell and Gene Technology

    lead OTHER

Principal Investigators

  • Liem Thanh Nguyen, PhD · Vinmec Research Insitute of Stem Cell and Gene Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-12-30
Completion
2026-01-01

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06726538 on ClinicalTrials.gov