Evaluation of autologous adipose-derived mesenchymal stem cells (AD-MSCs) therapy on sexual hormone deficiency in the middle-aged patients: an open-label, single-group clinical trial

Principle Investigator: Prof. PhD. MD. Nguyen Thanh Liem

Time: 2017 - 2018

Hormones play an integral role in your overal health. In women, hormonal imbalance results in many negative symptoms such as: heavy or irregular periods, stopped period, or frequent period, hirsutism, weight gain or trouble losing weight, vaginal dryness, pain during sex, and other symptoms. Androgen excess leads to the development of hirsutism, androgenic alopecia, acne, ovulatory dysfunction... Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in premenopausal women (incidence 5-10%). In men, testosterone is essential for the development and maintenance of secondary male characteristics. If you aren’t producing enough testosterone, it can cause a variety of symptoms: physical and psychological effects which can compromise their general well-being, sexuality and fertility.

There are many possible causes for a hormonal imbalance such as diabetes, hypothyroidism, hyperthyroidism, hypogonadism, cushing syndrome, hormone therapy, thyroiditis, hyperfunctioning thyroid nodules, tumors (benign or cancerous), congenital adrenal hyperplasia, eating disorders, medications, stress, adrenal insufficiency, pitutary tumor, injury or trauma. Many causes of hormonal imbalance in women are related to reproductive hormones including: menopause, pregnancy, breastfeeding, PCOS, premature menopause, hormone drugs, primary ovarian insufficiency. Age is also a factor in reduced levels of hormones.

Commone treatment options include: estrogen therapy, vaginal estrogen, hormonal birth control, anti-androgen medications, metformin, testosterone therapy, thyroid hormone therapy, flibanserin, eflornithine, natural remedies and supplements. However, these therapies have negative side effects. Androgen therapy causes weight gain, the development of oedema, gynecomastia and polycythaemia with an increased risk of thrombosis. Furthermore, androgens may increase triglycerides with a reduction in HDL cholesterol, thereby increasing the risk for cardiovascular events.

Mesenchymal stem/stromal cells (MSCs) are the adult stem cells that have been studied in recent years and used to treat many type of diseases. MSCs can be isolated from a variety of tissues such as bone marrow, adipose tissue, human placenta, umbilical cord. Due to their unlimited source, high differentiation potential and secrete a great variety of factors, MSCs are considered as potentially new therapeutic agents for the treatment of hormone imbalance.