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

NCT06726538 | Completed Phase 1 DMC

• 1 other identifier: ISC.01230086
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

female sexual dysfunction; sexual function impairment; adipose-derived mesenchymal stem cell therapy

Outcome Measures

Primary Outcomes (4)

• The safety of autologous, adipose-derived mesenchymal stem cell therapy based on The number of adverse events (AEs) and serious adverse events (SAEs)

  Adverse Events (AEs): refer to any unfavorable or unintended signs, symptoms, or diseases that occur in a participant during a study or treatment, regardless of whether they are causally related to the intervention. Serious Adverse Events (SAEs): Events are a subset of adverse events that meet specific criteria (e.g., hospitalization, life-threatening situations) indicating a higher level of severity.

  at baseline, 3, and 6 months post-infusion

• Changes in sexual functions of participants based on the Female Sexual Function Index

  based on the Self-Assessment Questionnaires: the Vietnamese versions of Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item questionnaire scored on a 5-point Likert scale, designed to assess six key domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 36, with higher scores indicating better sexual function, while scores below 26.55 suggest a risk of dysfunction.

  at baseline, 3, and 6 months post-infusion

• Changes in sexual functions of participants based on the AMS Diagnosing Menopause

  The Self-Assessment Questionnaires: the AMS Diagnosing Menopause (AMS): the severity of problem is scored as follows score: None =0; Mild =1; Moderate =2; Severe =3. The symptoms are grouped into 4 categories, vasomotor, psychological, locomotor and urogenital. A score of 15 or over usually indicates lower sexual function

  at baseline, 3, and 6 months post-infusion

• Changes in sexual functions of participants based on the UTIAN Quality of Life Scale (UQOL)

  The Utian QOL scale (UQOL) that is strongly based on perception of sense of well-being as distinct from menopausal symptoms. The UQOL contains 23 items divided into four domains: Occupational (7 items); Health (7 items); Emotional (6 items); Sexual (3 items). Total Score: 23-115. Higher scores indicate a better quality of life

  at baseline, 3, and 6 months post-infusion

Study Arms (2)

MSC infusion group (Group A)

EXPERIMENTAL

This clinical trial involves intravenous administration of MSCs at a dose of 10\^6 cells/kg, offering a non-rejection approach due to the autologous nature of the cells. These cells, surviving approximately 8 weeks in the body, secrete growth factors and cytokines to nourish cells, enhance vascular supply, and mitigate harmful inflammation, thereby countering cellular aging. Fifty female participants will be randomly assigned to two groups. Group A will receive mesenchymal stem cell (MSC) infusions twice: once at baseline and a second time three months later.

Biological: Intravenous administration of Autologous, adipose-derived mesenchymal stem cells

Control group (Group B)

NO INTERVENTION

25 participants in Group B will act as controls for 6 months.

Interventions

Intravenous administration of Autologous, adipose-derived mesenchymal stem cells BIOLOGICAL

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.

MSC infusion group (Group A)

Eligibility Criteria

• Age: 40 Years - 50 Years
• Gender Eligibility Details: This study is open to individuals who self-identify as female. Participants must be biologically female and within the age range of the study criteria, as the research focuses on addressing Female Sexual Dysfunction (FSD) and related factors specific to women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 40 - 50 years of age and have not gone through menopause
• The last menstrual period before participating in the study at least 2 months or more
• FSH before the menopause (tested on 2nd - 7th day of the menstrual cycle): FSH ≤ 29.8 mIU/mL
• FSFI \< 26.55 ± signs of decline in sexual or reproductive functions such as symptoms of premenopausal such as hot flashes, excessive sweating, headaches
• Normal liver function
• Normal kidney function
• Normal cardiovascular function

You may not qualify if:

• Previous surgery to remove gonads
• Diagnosed with cancer
• Had an organ transplant
• Has congenital malformations related to the gonads
• Diagnosed with chronic diseases such as diabetes, hypopituitarism, adrenal insufficiency, and blood pressure unresponsive to treatment
• Diagnosis of active autoimmune diseases

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (2)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

Location

Vinmec Times City International Hospital

Hanoi, 100000, Vietnam

Location

Study Officials

• Liem Thanh Nguyen, PhD

  Vinmec Research Insitute of Stem Cell and Gene Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 10, 2024
• Study Start: October 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: January 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-12

Locations

VN (2)