Actively Recruiting
Evaluation of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Therapy for Female Sexual Function Impairment
Led by Vinmec Research Institute of Stem Cell and Gene Technology · Updated on 2024-06-04
130
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of autologous adipose tissue-derived mesenchymal stem cells (AD-MSCs) to improve sexual function in women with hormone deficiency and sexual function impairment. This phase II trial follows earlier findings that AD-MSC therapy was safe and showed potential to enhance sexual quality of life, as indicated by improvements in the Female Sexual Function Index (FSFI). The study focuses on hormone levels such as follicle-stimulating hormone (FSH) and estradiol (E2), which are important in female sexual health. Participants are randomly assigned to one of two groups receiving two intravenous infusions of their own AD-MSCs. Group A receives infusions on day 0 and day 90 (plus or minus 7 days), while group B receives infusions on day 180 (plus or minus 14 days) and day 270 (plus or minus 14 days). The dose is 1.0 x 10^6 cells per kilogram of body weight, and cells are prepared and infused over 30 minutes. During the study, participants will have their hormone levels (FSH and E2) and quality of life measured using FSFI and The Utian Quality of Life Scale at 1, 3, 6, and 12 months after the first infusion. Safety will also be monitored at these times. The trial runs until December 2025, with ongoing assessment to understand the therapy's impact on sexual function and overall quality of life in women aged 40 to 65 years.
CONDITIONS
Brief Title
Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 40 to 50 years or older who have not reached menopause based on STRAW 2011 criteria
- Last menstrual period at least 2 months ago
- Follicle-stimulating hormone (FSH) level above 40 mIU/mL
- Estradiol (E2) level below 30 pg/mL tested between days 2 and 4 of menstrual cycle
- Female Sexual Function Index (FSFI) score below 26.55 with signs of decline in sexual or reproductive functions
- Normal liver, kidney, and cardiovascular function
- No active bacterial, fungal, or viral infections (including HIV, HBV, HCV, syphilis)
- Provide written informed consent
You will not qualify if you...
- Previous surgery to remove gonads
- No sexual activity
- Diagnosed with untreated or ongoing cancer
- History of organ transplant
- Congenital malformations related to gonads
- Chronic diseases such as diabetes, hypopituitarism, adrenal insufficiency, uncontrolled blood pressure
- Active autoimmune diseases
- Diagnosed heart failure, kidney failure, liver failure, respiratory failure, history of stroke or myocardial infarction, Alzheimer's disease
- Thyroid disorders (hypothyroidism or hyperthyroidism)
- Clinically significant blood coagulation disorders
- History of allergic reactions to anesthetic agents or antibiotics
- Use of hormone therapy within last 2 weeks or planned use during study
- Planning pregnancy during study
- Use of hormonal contraceptives
- Absence of menstruation for at least 12 months
- Mental illness or inability to communicate or answer interview questions correctly
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months for two infusions per group, with timing depending on group assignment
Participants receive two intravenous infusions of autologous adipose-derived mesenchymal stem cells to treat sexual function impairment.
2 infusions administered on Day 0 and Day 90 ± 7 days for group A; or on Day 180 ± 14 and Day 270 ± 14 for group B
Duration - 12 months after the first infusion
Participants are monitored for safety and changes in hormone levels and quality of life up to 12 months after their first infusion.
Visits at 1 month, 3 months, 6 months, and 12 months after first infusion
Trial Site Locations
Total: 1 location
1
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 100000
Actively Recruiting
Research Team
P
Phuong Nguyen, MSC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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