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

Phase 1

Recruiting

• Conditions: Female Sexual Dysfunction
• Interventions: Biological: Intravenous administration of Autologous, adipose-derived mesenchymal stem cells

• Registration Number: NCT06726538
• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

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.

Detailed Description

Female Sexual Dysfunction (FSD) is a significant public health concern. FSD can lead to various health issues and increase the risk of developing other conditions such as osteoporosis, cardiovascular diseases, and cancer. Although hormone therapy is commonly used to treat FSD, its long-term use may have adverse effects on cardiovascular health and raise the risk of cancer. Therefore, exploring new, safe, and effective treatment methods is essential. In 2015, the FDA approved the use of flibanserin (Addyi® Sprout Pharmaceuticals, USA) for premenopausal women with reduced sexual desire. However, this therapy remains controversial due to its potential side effects and limited efficacy. Current treatments for Female Sexual Dysfunction (FSD) mainly involve hormone replacement therapy, gonadotropin therapy, dietary supplements, or lifestyle modifications. While hormone therapy is commonly used to address hormonal decline in women, long-term use may lead to cardiovascular issues or cancer. Therefore, exploring psychological therapies and researching new potential treatments to meet patients' needs is essential.

Recent studies suggest that mesenchymal stem cells (MSCs) offer a safe approach to restoring hormone deficiencies. Clinical trials have investigated the use of MSC transplants to treat conditions like premature ovarian failure and ovarian cancer. Numerous trials have employed MSCs derived from bone marrow, umbilical cords, adipose tissue, or menstrual blood to address ovarian and uterine dysfunctions. Edessy et al. reported using autologous stem cells to treat 10 participants with premature ovarian failure. Following transplantation, two participants resumed menstruation within three months, one of whom became pregnant after 11 months and delivered a healthy full-term baby. Hormonal tests in the pregnant case revealed restored levels of FSH, LH, E2, and AMH to normal ranges. Although these studies are limited by small sample sizes and the lack of control groups, they highlight the potential of MSC transplantation as a treatment for FSD.

A study by Mashayekhi et al. demonstrated the safety of autologous adipose-derived mesenchymal stem cell (MSC) therapy for premature ovarian failure, with no adverse effects reported among nine participants receiving different cell doses. Menstruation resumed in two participants in both the high-dose (15x10\^6 cells/kg) and lower-dose (5x10\^6 and 10x10\^6 cells/kg) groups, while serum FSH levels improved in four participants. Despite small sample size and lack of a control group, the study supports the safety of MSC infusion into the ovaries. Another ongoing trial (NCT01853501) aims to further investigate MSC therapy for ovarian failure, though results are pending. In Vietnam, the Vinmec Institute of Stem Cell and Gene Technology conducted a study on Female Sexual Dysfunction (FSD), using intravenous MSC infusions for 16 women. The trial reported no adverse effects, with participants reporting improved satisfaction with sexual health, though hormone levels (AMH, FSH, and E2) showed no significant changes.

This study aims to address the need for a novel and more effective approach to treating hormonal decline in women, not only improving sexual function but also enhancing their quality of life. Based on this rationale, we have decided to conduct the study titled "Investigating the efficacy of autologous, adipose-derived mesenchymal stem cell therapy for the treatment of sexual function impairment in women aged 40-50," with the following objective: Evaluate the improvement in sexual function among women aged 40-50 years who received autologous adipose-derived mesenchymal stem cell (MSC) therapy.

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-02-28
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSC infusion group (Group A)	Intravenous administration of Autologous, adipose-derived mesenchymal stem cells	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.

Primary Outcome Measures

Name	Time	Method
The safety of autologous, adipose-derived mesenchymal stem cell therapy based on The number of adverse events (AEs) and serious adverse events (SAEs)	at baseline, 3, and 6 months post-infusion	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.
Changes in sexual functions of participants based on the Female Sexual Function Index	at baseline, 3, and 6 months post-infusion	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.
Changes in sexual functions of participants based on the AMS Diagnosing Menopause	at baseline, 3, and 6 months post-infusion	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
Changes in sexual functions of participants based on the UTIAN Quality of Life Scale (UQOL)	at baseline, 3, and 6 months post-infusion	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

Trial Locations

Locations (2)

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam

Vinmec Times City International Hospital; 🇻🇳 Hanoi, Vietnam