Investigating the Efficacy of Autologous, Adipose-derived Mesenchymal Stem Cell Therapy for the Treatment of Sexual Function Impairment in Women Aged 40-50

Launched by VINMEC RESEARCH INSTITUTE OF STEM CELL AND GENE TECHNOLOGY · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for women aged 40 to 50 who experience sexual dysfunction, which can affect their overall well-being. The study is testing a therapy that uses stem cells taken from the patient’s own fat, called autologous adipose-derived mesenchymal stem cells. These stem cells are thought to help improve sexual function by promoting healing and reducing inflammation in the body. Women who are eligible to participate must be between 40 and 50 years old, have not yet gone through menopause, and meet specific health criteria.

Participants in the trial will receive two infusions of stem cells over a six-month period and will be monitored for changes in their sexual function and overall quality of life. They will undergo various evaluations, including blood tests and questionnaires, to assess the treatment’s effectiveness. This study is particularly important as it aims to find a safer alternative to existing treatments, which can have risks. If you or someone you know fits the eligibility criteria, this trial may provide an opportunity to explore a promising new therapy while contributing to research in women's health.

Gender

FEMALE

Eligibility 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