The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) With Injectable Collagen Scaffold Transplantation in Woman With Premature Ovarian Failure (POF)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Safety and Tolerability assessed by Adverse Events
研究概览
简要总结
Cellular therapies are rapidly progressing fields and have shown immense promise in the treatment of damaged ovarian function. The purpose of this study is to determine safety and efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.
详细描述
The purpose of this study was to explore the therapeutic potency of the HUC-MSCs with injectable collagen scaffold transvaginal injection for POF women. The serum of each patient was kept and sent for laboratory test before the surgery. HUC-MSCs were isolated and cultured in vitro and the biomarkers of HUC-MSCs were detected using Flow cytometry detection. The HUC-MSCs with injectable collagen scaffold were then injected directly into bilateral ovaries. The outcomes of patients were examined after the injection. The patients are monitored for signs of follicle growth and growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and In Vitro Fertilization (IVF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Premature Ovarian Failure.
- •Patients show no response to drug treatment
- •Women between 20 and 39 years.
- •Willing to sign the Informed Consent Form.
排除标准
- •Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome).
- •Congenital ovarian malformation.
- •Severe endometriosis.
- •Thyroid dysfunction.
- •Contraindications for pregnancy.
- •Contraindications for hormone replacement therapy.
- •Prior personal history of ovarian cancer or after radiotherapy.
- •Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period.
结局指标
主要结局
Safety and Tolerability assessed by Adverse Events
时间窗: Up to 6 months
Proportion of patients with postoperative infections and serious adverse events (SAEs) were assessed by long term follow-up.
次要结局
- Follicle Stimulating Hormone (FSH) serum level(Once a week within 3 months after the surgery)
- Number of Antral follicle development(Once a week within 3 months after the surgery)
- Estradiol (E2) serum level(Once a week within 3 months after the surgery)
- Anti-Mullerian Hormone (AMH) serum level(Once a week within 3 months after the surgery)
- Pregnancy rate(2 weeks after embryo implantation)
研究者
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences