A Randomized, Open-label, Parallel-controlled Clinical Study of Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Temperature
研究概览
简要总结
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of human Amniotic mesenchymal stem cells (hA-MSCs) therapy in women suffering from POI.
详细描述
This clinical trial is designed to understand the safety and effectiveness of human amniotic membrane mesenchymal stem cells (hA-MSCs) in the treatment of primary ovarian insufficiency (POI). Human amniotic MSCs were infused back into the patients by intravenous injection. The trial was designed with two groups, 1) the control group by conventional hormone replacement therapy with oral Climen and 2) the stem cell treatment group by intravenous infusion of human amniotic membrane mesenchymal stem cells (hA-MSCs) combined with oral Climen hormone therapy. Patients were followed up every 2 weeks after the post-injection stem cells to observe their outcomes. The investigators focused on safety indicators, but also monitored hormone levels and signs of follicular growth to initially assess the effectiveness of the stem cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The intention of pregnant women aged >= 20 and < 40, with normal karyotype;
- •Oligo/amenorrhea for at least 4 months;
- •Elevated FSH level >25 IU/l on two occasions >4 weeks apart;
- •Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;
- •Voluntary participation in the study with signed informed consent;
排除标准
- •Unable to follow the treatment observation process required by the trial;
- •Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;
- •With breast, uterine, ovarian tumors, or any other benign or malignant tumors;
- •Allergic history to drugs or any other things;
- •Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.
- •Have undergone ovariectomy or have organic gynaecological diseases.
- •Presence of other gynaecological endocrine diseases such as polycystic ovary syndrome.
- •Severe functional impairment of vital organs.
- •High risk factors for venous thromboembolism and abnormalities in coagulation mechanisms.
- •Attending doctor considers inappropriate to take part in.
研究组 & 干预措施
Climen
Hormone replacement therapy (HRT): Take the drug Climen. Each box has 21 tablets. The first 11 tablets contain 2 milligrams of estradiol valerate each. The last 10 tablets contain 2 milligrams of estradiol valerate and 1 milligram of cyproterone acetate each. Begin taking it on the fifth day of your menstrual cycle. Take one tablet every day for seven days. Then, stop taking the medicine for seven days. After that, continue for two cycles in a row.
干预措施: Climen 21 Tablets (Drug)
hA-MSCs+Climen
The stem cell treatment group will be administered Climen, with the dosage and method of administration to be determined based on the control group. Concurrently, patients will receive the initial infusion of amniotic MSCs intravenously on the third day after the onset of menstruation, with a subsequent infusion administered after one month. The number of stem cells infused was calculated according to 1 million cells per kilogram of body weight.
干预措施: Climen 21 Tablets (Drug)
hA-MSCs+Climen
The stem cell treatment group will be administered Climen, with the dosage and method of administration to be determined based on the control group. Concurrently, patients will receive the initial infusion of amniotic MSCs intravenously on the third day after the onset of menstruation, with a subsequent infusion administered after one month. The number of stem cells infused was calculated according to 1 million cells per kilogram of body weight.
干预措施: hA-MSCs (Biological)
结局指标
主要结局
Temperature
时间窗: Up to 24 weeks
Body temperature of the participants will be measured fortnightly after injection.
Pulse
时间窗: up to 24 weeks
Pulse of the participants will be measured fortnightly after injection.
Breaths per minute
时间窗: up to 24 weeks
Breathing rate of the participants will be measured fortnightly after injection.
Blood pressure
时间窗: 0-24 weeks
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
次要结局
- Follicle-stimulating hormone (FSH) serum level(Up to 24 weeks)
- Estradiol (E2) serum level(Up to 24 weeks)
- Anti-Mullerian hormone (AMH) serum level(up to 24 weeks)
- Number of antral follicle(up to 24 weeks)
- Achievement of pregnancy(up to 12 months)
研究者
Yan Hongli
Professor of Reproductive Medicine
Changhai Hospital