Single-dose, Phase 1 Clinical Trial to Evaluate the Safety, and Tolerability of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cell Therapy in Patients With Premature Ovarian Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Abnormality cases in lab test results
研究概览
简要总结
This clinical study will evaluate the safety and tolerability of CordSTEM-ST after administering a single dose in patients with premature ovarian insufficiency (POI), as well as identify the maximum tolerated dose (MTD) and evaluate the potential therapeutic effects.
详细描述
3 or 6 subjects will be enrolled sequentially by applying the "traditional 3+3 design" to evaluate the dose limiting toxicities (DLTs) for 28 days from the first administration date of the investigational product according to the protocol. A DLT is defined as the occurrence of a grade 3 or higher adverse drug reaction (ADR) according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
First three subjects will be enrolled in Study Group 1 (low dose group) to be evaluated for DLTs up to 28 days after IP administration. If none of three subjects develope DLT, three subjects for Study Group 2 (high dose group) will be recruited. If one out of three subjects in Study Group 1 develop DLT, additional three subjects in Study Group 1 will be enrolled to be evaluated for DLT. If two or more subjects develop DLT in initial three subjects, the study will be terminated.
This study will be followed up by a long-term follow-up study under the separate protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged ≥ 25 years and < 40 years
- •Individuals diagnosed with premature ovarian insufficiency: Individuals who have a follicle stimulating hormone (FSH) level of 40 IU/L or higher in the results of two tests conducted at least 4 weeks apart and are amenorrheic for at least 4 months
- •Individuals who voluntarily decide to participate and provide written consent
排除标准
- •Individuals diagnosed with primary amenorrhea*
- •* No secondary sex characteristics by age 13, Absence of menarche for 5 years after initial breast development, or Absence of menstruation by age 15
- •Individuals diagnosed with polycystic ovary syndrome
- •Individuals with any other conditions that may affect the result of this study.
研究组 & 干预措施
Study Group 1 (Low dose CordSTEM-ST)
Low dose CordSTEM-ST, 1 (single) administration
干预措施: umbilical cord-derived mesenchymal stem cell (Biological)
Study Group 2 (High dose CordSTEM-ST)
High dose CordSTM-ST, 1 (single) administration
干预措施: umbilical cord-derived mesenchymal stem cell (Biological)
结局指标
主要结局
Abnormality cases in lab test results
时间窗: up to 6 months after the IP administration
Number of clinically significant abnormalities found in lab test results.
Abnormality cases in vital signs
时间窗: up to 6 months after the IP administration
Number of clinically significant abnormalities found in vital signs
Number of adverse events
时间窗: up to 6 months after the IP administration
Number of adverse event cases reported
Abnormality cases physical exam results
时间窗: up to 6 months after the IP administration
Number of clinically significant abnormalities found in physical exam results
次要结局
- Percent change from baseline in blood Follicle Stimulating Hormone (FSH) level(up to 6 months after the IP administration)
- Percent change from baseline in blood Anti-Mullerian Hormone (AMH) level(up to 6 months after the IP administration)
- Percent change from baseline blood Estradiaol (E2) level(up to 6 months after the IP administration)
- Percent change from baseline in number of mature follicles(up to 6 months after the IP administration)
- Percent change from baseline in endometrial thickness(up to 6 months after the IP administration)
- Percent change from baseline in number of antral follicles(up to 6 months after the IP administration)
- Status of menstruation resumption(up to 6 months after the IP administration)