Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female
Evaluation of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Efficacy for the Treatment of Sexual Function Impairment in Female
Vinmec Research Institute of Stem Cell and Gene Technology
130 participants
May 1, 2023
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria12
- 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 Criteria17
- 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
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Interventions
* Patients in the two groups will receive two autologous AD-MSC administrations: the group A on day 0 and day 90 ± 7; the group B on day 180 ± 14 and day 270 ± 14. * Dose: 1.0 x 106 cells/kg patient bodyweight. * Route: intravenous infusion ADSCs were collected after the third passage. On the day of transplantation, the ADSCs were harvested, washed twice with NaCl 0.9%, counted and resuspended in NaCl 0.9% in a total volume of 20 ml. Each participant received a dose of 1x10\^6 cells/kg body weight infused through the intravenous route within 30 minutes before being discharged after 24 hours
Locations(1)
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NCT05329662