Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell and Mesenchymal Stem Cell Lyophilisate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- anti-Müllerian hormone (AMH) serum levels
研究概览
简要总结
This is a multi-centers of long term safety and efficacy follow up study for patients with premature ovarian failure (the women aged younger than 40 years, who present with amenorrhoea, hypergonadotropic hypogonadism, and infertility) who have been treated with ex vivo gene therapy drug product in Institute of Bio-Stem Cell Rehabilitation UAB - sponsored clinical studies. After completing the parent clinical study (approximately 6 month), eligible subject will be followed for additional 2 years for total of 2 years and 6 month post drug product infusion. No investigation drug product will be administered in the study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent for this study by subjects or as applicable parent legal guardian. Treated with drug product for therapy of premature ovarian insufficiency in a Institute Bio-Stem Cell Rehabilitation UAB clinical study.
- •Diagnosed of premature ovarian insufficiency ESHRE:
- •Women age of 18 to 40 years
- •Have experienced 4 months of oligo/amenorrhea
- •Two serum follicle-stimulating hormone (FSH was >40 mIU/ml levels in the menopausal range, obtained at least a month apart
- •lower FSH levels ( 25 mIU/ml)
- •anti-Müllerian hormone (AMH) serum levels ( 3.0 ng/ml)
排除标准
- •There are no exclusion criteria for this study
结局指标
主要结局
anti-Müllerian hormone (AMH) serum levels
时间窗: 2 years
AMH \<0.5-1.1 ng/ml
Antral follicular count (AFC) serum levels
时间窗: 2 years
Antral follicular count (AFC) \<5-7 follicles
次要结局
- Regular menstruation and/or pregnancy(2 years)