NCT02118740Unknown不适用
Bone Marrow Collection in Healthy Volunteers
Amarna Stem Cells BV1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL
研究概览
简要总结
This is a observational study in which healthy found volunteers are recruited to donate 50 ml of bone marrow aspirate to enable preclinical studies to obtain proof of concept and safety of a bone marrow derived stem cell preparation named AMARCELL. The prepared AMARCELL is only for animal studies and after completion of the preclinical program, the intention of AMARCELL is to treat humans with a traumatic Spinal cord injury.
详细描述
Coded anonymized patient data
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men in the age range of 21-30 years and/or women in the age range of 21-30 years and taking birth control medication to prevent pregnancy
- •Written informed consent
- •Healthy as concluded by the answers given to questions in a short health questionnaire
排除标准
- •Pregnancy or lactation period
- •Volunteers who are unable to comply with the rules of this project. Important is if the volunteer can not follow the schedule of the appointments.
- •Abuse of alcohol, medicines or illicit drugs.
- •Legally protected people
结局指标
主要结局
Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL
时间窗: 3 days
Important is to have more than 2 million mononuclear cells (MNCs) include hematopoietic stem and progenitor cells in the end product AMARCELL
次要结局
- Absence of contamination with infectious agents especially bacteria and pseudomonas(3 days)
研究者
研究点 (1)
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