NCT03762512招募中不适用
Collection of Donated Placenta for Isolation of Mitochondria for Research and for Future Use in Mitochondrial Augmentation Therapies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Placenta donated
研究概览
简要总结
Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant females between the age of 18-45, judged to be medically eligible by the Investigator and the Sponsor's Medical Monitor.
- •Planned elective C-section at weeks 36-41 of pregnancy.
- •Uncomplicated pregnancy as determined by the Investigator.
- •Available Medical History of the donor (diagnosis, diseases, medication etc...)
排除标准
- •Donor is positive for a communicable disease, such as: HBV, HCV, HIV 1&2, WNV, HTLV 1&2, Treponema pallidum, CMV, Chagas, Chlamydia Trachomatis, Neisseria Gonorrhea, or any other tests required by the medical facility, IMoH, FDA, EMA or the Sponsor.
- •Donor is at risk for a communicable disease as assessed by medical history, medical records, physical exam, and the Donor Screening Questionnaire.
- •Donor is at risk for COVID-19 as assessed by medical history, medical records, physical exam, and the COVID-19 Screening Questionnaire.
- •Donor smokes more than one pack of cigarettes a day or drinks more than one alcoholic beverage a day.
- •Donor has taken a medication with potential mitochondrial effects within 2 weeks prior to placental donation, such as valproic acid, aminoglycoside antibiotics, neuromuscular blocking drugs (See Appendix 3).
- •Donor has current or history of malignancy.
- •Donor has current or history of insulin dependent diabetes
- •Donor has current gestational diabetes treated with insulin, or pre-eclampsia.
- •Donor is known to be a carrier of a primary mitochondrial disease.
结局指标
主要结局
Placenta donated
时间窗: immediate
The purpose of this study is to collect placenta for the production of mitochondria. Therefore, only general measurements are taken such as placenta weight and health of mother during pregnancy. No further intervention or interaction with the mother will occur, and she does not receive any drug product or treatment prior to or after placenta donation.
次要结局
未报告次要终点
研究者
研究点 (1)
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