NCT03181087撤回1 期
A Phase I, Single-arm, Open Study of the Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
Maternal and Child Health Hospital of Foshan1 个研究点 分布在 1 个国家开始时间: 2021年12月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Safety evaluation through vital signs, the results of clinical lab tests and adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous women receiving cesarean delivery
- •Ages between 21-35 years
- •Gestation ages ≥ 37 weeks and < 42 weeks
- •Willing to comply with study dosing and completed the entire course of the study
- •Willing to give and sign an informed consent form and a photographic release form
排除标准
- •Placenta previa
- •Placenta abruption
- •Multiple gestation
- •Antepartum hemorrhage
- •Preeclampsia/Eclampsia
- •Hepatic or renal dysfunction
- •Any systemic uncontrolled disease
- •Inability to provide consent
结局指标
主要结局
Safety evaluation through vital signs, the results of clinical lab tests and adverse events
时间窗: 6 months post treatment
Safety evaluation through vital signs, the results of clinical lab tests and adverse events.
次要结局
- Change of uterine scar thickness(6 weeks, 3 and 6 months post treatment)
- Change of uterine scar area(6 weeks, 3 and 6 months post treatment)
- Number of participants with uterine niche(6 months post treatment)
- Number of participants with wound infection(6 months post treatment)
- Immunoglobulin concentrations in breast milk and serum(6 weeks, 3 and 6 months post treatment)
- Adverse events occurrence(6 months post treatment)
- Number of participants with endometritis(6 months post treatment)
研究者
Zhengping Liu, MD
Director
Maternal and Child Health Hospital of Foshan
研究点 (1)
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