Actively Recruiting
Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female
Led by Vinmec Research Institute of Stem Cell and Gene Technology · Updated on 2024-06-04
130
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hormones are a chemical substance synthesized and secreted by endocrine gland. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function.- Hormone therapy is used to treat female hormone deficiency and results in a significant improvement, but long-term use increases cardiovascular disease or cancer risk. Other treatments do not give apparent results. Therefore, it is necessary to develop new and effective treatments to achieve the requirements of improving health in general and sexual health in particularly in women. AD-MSCs have been widely used as autologous and allogeneic stem cell sources to treat numerous disease recently, and they have been proven to be safe. The phase I trial showed that administration of autologous AD-MSCs at the dose of 1.0 x 10\^6 cells/kg patient bodyweight was safe for patients with sex hormone deficiency. The therapy introduced potential improvement in sexual and general quality of life indicating by the increased FSFI. Therefore, this phase II trial to evaluate efficiency of autologous adipose tissue-derived mesenchymal stem cells therapy in treatment of female patients with sexual function impairment.
CONDITIONS
Official 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 according to STRAW 2011
- Last menstrual period was at least 2 months before study entry
- Follicle-stimulating hormone (FSH) level above 40 mIU/mL and Estradiol below 30 pg/mL tested between days 2 to 4 of menstrual cycle
- Female Sexual Function Index (FSFI) score below 26.55 with signs of sexual or reproductive decline such as hot flashes, excessive sweating, or headaches
- Normal liver function
- Normal kidney function
- Normal cardiovascular function
- No active bacterial, fungal, or viral infections including HIV, HBV, HCV, or syphilis
- Provided written informed consent
You will not qualify if you...
- Previous surgery to remove gonads
- No sexual activity
- Diagnosed with cancer and currently untreated or undergoing treatment
- History of organ transplant
- Congenital malformations related to the gonads
- Chronic diseases such as diabetes, hypopituitarism, adrenal insufficiency, or uncontrolled blood pressure
- Active autoimmune diseases
- Diagnosed with heart failure, kidney failure, liver failure, respiratory failure, cerebral infarction, myocardial infarction, or Alzheimer's disease
- Hypothyroidism or hyperthyroidism
- Clinically significant blood coagulation disorders
- History of allergic reactions to anesthetic agents or antibiotics
- Used hormone therapy within the last 2 weeks or plans to use during the study
- Planning to become pregnant during the study
- Using hormonal contraceptives
- Absence of menstruation for at least 12 months
- Mental illness or inability to communicate or answer interview questions correctly
AI-Screening
AI-Powered Screening
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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
CONTACT
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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