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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of adipose derived mesenchymal stem cells (AD-MSCs) therapy on sexual hormone deficiency in the middle-aged patients
详细描述
The purpose of this study is to evaluate the safety and efficiency of adipose-derived mesenchymal stem cells in 30 patients with sexual hormone deficiency at Vinmec International Hospital, Hanoi, Vietnam
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 35 years to 70 years (Male) and from 35 years to menopause age (Female)
- •Male: decrease in libido, decrease in intercourse frequency, erectile dysfunction, Difficulty in concentration, testosterone level ≤ 12 nMol/dL
- •Female: reduced or absent menstruation after radiation exposure or chemotherapy; Hot flushes, excessive sweating, and anxiety, together with other symptoms associated with the menopause, AMH level ≤ 2 ng/ml and/or FSH level ≥ 10 mIU/ml.
- •Patients signed the informed consent form
排除标准
- •Surgery removal of endocrine glands
- •Abnormalities in the endrocrine glands
- •Hormone deficiency due to diabetes and other metabolic disorders
- •Active autoimmune diseases
- •Current usage of immunosuppressive drugs
- •Coagulation disorders
- •Allergy to anesthetic agents
- •Severe health conditions such as cancer, failure of heart, lung, liver or kidney
- •Active infections
研究组 & 干预措施
Stem cell Administration for female patients
Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for female patients
干预措施: adipose-derived mesenchymal stem cells (Combination Product)
Stem cell Administration for male patients
Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for male patients
干预措施: adipose-derived mesenchymal stem cells (Combination Product)
结局指标
主要结局
Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male
时间窗: up to the 12-month period following treatment
Comparison between Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male at pre and post AD-MSCs therapy
次要结局
未报告次要终点