Evaluation of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Efficacy for the Treatment of Sexual Function Impairment in Female
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change of Estradiol (E2) hormone level
研究概览
简要总结
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.
详细描述
Hormones are a chemical substance synthesized and secreted by endocrine gland. They are used by multicellular organism to organize, coordinate, and regulate multiple functions of cells and tissues in the body. They are considered as chemical messenger molecules that send signals from one cell to another within or between various body parts. Hormones are responsible for regulating many physiological processes and behavioral activities such as growth and development of the body, metabolism, homeostasis of intracellular and extracellular fluid, and reproduction. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function. The phase I clinical study named " Single-group, open-label clinical trial, evaluating the safety and efficacy of adipose tissue-derived mesenchymal stem cell therapy for early sex hormone deficiency in middle-aged people" showed that AD-MSC therapy for patients with hormone deficiency is safe, can improve the sexual quality of life in both men and women. A significant statistical increase of testosterone levels was observed in male patients at 3-month, 6-month and 12-month. In female patients, the FSFI was 20.70 at baseline and increased to 27.1 at 12 months after AD-MSC infusion (p<0.05). There were no significant changes in AMH, FSH, or E2 infusion compared to baseline in the 16 enrolled patients. Within those under 45 years old, FSH and E2 tended to increase at 3 months after ADSC infusion and decreased at the follow-up after 6 and 12 months. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change of Estradiol (E2) hormone level
时间窗: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
Estrogen is a steroid hormone associated with the female reproductive organs and is responsible for the development of female sexual characteristics.
Change in Quality of life using Female Sexual Function Index - FSFI questionaires
时间窗: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
The FSFI questionnaire consists of 19 close-ended questions related to sexual activity within the 4 weeks prior to the examination. Points are assigned for each answer (1-5 and 0-5 for questions 1-2 and questions 3-19, respectively), the sum of the scores for the domain is multiplied by the domain factor, the six domain scores are added up, and the total score may vary from 2.0 to 36.0 points.
Change of Follicle-stimulating hormone (FSH) hormone level
时间窗: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
FSH stimulates granulosa cells in the ovarian follicles to synthesize aromatase, which converts androgens produced by the thecal cells to estradiol. FSH peaks at the same time as the LH surge that causes ovulation. FSH then remains low throughout the luteal phase, preventing the development of new follicles. FSH levels is measured in the serum sample.
Change in Quality of life using The Utian Quality of life Scale
时间窗: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
The UQOL is the first pure QOL measure of this new generation of instruments that can be applied to a menopausal population. Items are scaled using a Likert-type 1 to 5 rating.
次要结局
- The safety of AD MSC therapy in the treatment of sexual function impairment in female(1 month, 3 months, 6 months, 12 months after the first UCMSC infusion)