Status:
RECRUITING
Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female
Lead Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Conditions:
Sexual Dysfunction Female
Eligibility:
FEMALE
40-65 years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
Hormones are a chemical substance synthesized and secreted by endocrine gland. They are used by multicellular organism to organize, coordinate, and regulate multiple functions of cells and tissues in ...
Eligibility Criteria
Inclusion
- Women who are 40 - 50 years of age or older and have not gone through menopause according to Stages of Reproductive Aging Workshop (STRAW) 2011
- The last menstrual period before participating in the study at least 2 months or more
- FSH, Estrogen above the menopause:
- \+ FSH \> 40 mIU/mL
- \+ Estradiol \< 30 pg/mL
- (tested between the 2nd and the 4th day of the menstrual cycle)
- 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
- No active bacterial, fungal and viral (HIV, HBV, HCV, syphilis) infections
- Provide written informed consent
Exclusion
- Previous surgery to remove gonads
- No sexual activity
- Diagnosed with cancer and is being or has not been treated
- Had an organ transplant
- Has congenital malformations related to the gonads
- Chronic disease such as: Diabetes, hypopituitarism, adrenal insufficiency, blood pressure unresponsive to treatment, etc
- Any active autoimmune diseases
- Being diagnosed with heart failure, kidney failure, liver failure, respiratory failure, history of cerebral infarction, myocardial infarction, Alzheimer's
- Hypothyroidism or hyperthyroidism
- Any active autoimmune diseases
- Any clinically significant blood coagulation disorders.
- History of allergic reaction to anesthetic agents and antibiotics
- Using hormone therapy within the last 2 weeks or want to use these drugs during the study period
- Planning to become pregnant during the study period
- using hormonal contraceptives
- Absence of menstruation for at least 12 months
- Mental illness, inability to communicate, inability to answer the interview questions correctly
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05329662
Start Date
May 1 2023
End Date
December 30 2025
Last Update
June 4 2024
Active Locations (1)
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1
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 100000