跳至主要内容
临床试验/NCT04675970
NCT04675970已完成不适用

Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell and Mesenchymal Stem Cell Lyophilisate

Ukraine Association of Biobank1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2020年9月1日最近更新:
适应症

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

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)

研究者

发起方
Ukraine Association of Biobank
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验