Using stem cells to improve sexual function in women
Evaluation of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Efficacy for the Treatment of Sexual Function Impairment in Female
This study is testing whether using stem cells from fat can help women aged 40 to 50 improve their sexual function and quality of life before menopause.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Vinmec Research Institute of Stem Cell and Gene Technology Academic / other |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT05329662 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of adipose tissue-derived mesenchymal stem cells (AD-MSCs) to treat sexual dysfunction in women aged 40 to 50 who have not yet reached menopause. The study aims to assess the safety and efficacy of this therapy, building on previous findings that suggest AD-MSCs can enhance sexual quality of life and hormone levels. Participants will receive autologous AD-MSC administration, and their sexual function will be evaluated over a 12-month period. The trial seeks to provide a new treatment option for women experiencing hormone deficiency-related sexual dysfunction.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 to 50 who have not undergone menopause and exhibit signs of sexual dysfunction due to hormone deficiency.
Not a fit: Patients who have undergone gonad removal surgery or have active infections or chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve sexual function and quality of life for women suffering from hormone deficiencies.
How similar studies have performed: Previous studies have shown promising results with AD-MSC therapy in improving sexual function, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Hanoi
- Vinmec Research Institute of Stem Cell and Gene Technology — Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Tan Sinh Nguyen, PhD — Vinmec Times City International Hospital
- Study coordinator: Phuong Nguyen, MSC
- Email: v.phuongnh9@vinmec.com
- Phone: 0914740683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.