University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Culture and expand mesenchymal stromal cells (MSC)
研究概览
简要总结
The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.
详细描述
Cell banks will be manufactured and cellular products used for future translational or clinical research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 35 years
- •Willingness to provide written informed consent
排除标准
- •Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum,
- •Presence of communicable disease risk associated with xenotransplantation.
- •Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum.
- •Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device.
- •History of malignancy.
- •Pregnancy
- •In the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide BM donation.
结局指标
主要结局
Culture and expand mesenchymal stromal cells (MSC)
时间窗: Day 1- cells are counted within 24 hours of bone marrow aspirate collection
Cell viability, proliferation profile, and expression characteristics will be evaluated.
次要结局
- Characterization profile of MSC during and after expansion will be assessed(Examine the cell surface marker profile of MSC using standard flow cytometry)