Using stem cells to improve sexual function in women aged 40-50
Investigating the Efficacy of Autologous, Adipose-derived Mesenchymal Stem Cell Therapy in Women Aged 40-50
This study is testing whether using stem cells from women's own fat can improve sexual function in women aged 40-50 who are experiencing sexual dysfunction.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 50 Years |
| Sex | Female |
| Sponsor | Vinmec Research Institute of Stem Cell and Gene Technology Academic / other |
| Locations | 2 sites (Hanoi and 1 other locations) |
| Trial ID | NCT06726538 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of autologous adipose-derived mesenchymal stem cell therapy for treating female sexual dysfunction in women aged 40-50. Participants will receive intravenous administration of stem cells derived from their own adipose tissue, which are believed to enhance vascular supply and reduce inflammation. The study aims to evaluate the safety and efficacy of this innovative treatment compared to standard therapies, addressing a significant public health issue in Vietnam and beyond. A total of 50 women will be enrolled and randomized into treatment groups to assess outcomes related to sexual function.
Who should consider this trial
Good fit: Ideal candidates are women aged 40-50 who have not yet gone through menopause and exhibit signs of sexual function impairment.
Not a fit: Patients who have undergone gonad removal surgery, have cancer, or suffer from chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel and safer treatment option for women experiencing sexual dysfunction.
How similar studies have performed: While there have been studies exploring the use of mesenchymal stem cells for various conditions, this specific application for female sexual dysfunction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women between 40 - 50 years of age and have not gone through menopause * The last menstrual period before participating in the study at least 2 months or more * FSH before the menopause (tested on 2nd - 7th day of the menstrual cycle): FSH ≤ 29.8 mIU/mL * 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 Exclusion Criteria: * Previous surgery to remove gonads * Diagnosed with cancer * Had an organ transplant * Has congenital malformations related to the gonads * Diagnosed with chronic diseases such as diabetes, hypopituitarism, adrenal insufficiency, and blood pressure unresponsive to treatment * Diagnosis of active autoimmune diseases
Where this trial is running
Hanoi and 1 other locations
- Vinmec Research Institute of Stem Cell and Gene Technology — Hanoi, Vietnam (Recruiting)
- Vinmec Times City International Hospital — Hanoi, Vietnam (Recruiting)
Study contacts
- Study coordinator: Hoang - Phuong Nguyen, MPH
- Email: hoangphuonghsph@gmail.com
- Phone: + 84 914740683
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.