Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
2期
进行中(已停止招募)
NCT03268603
| 适应症 | ALS, Amyotrophic Lateral Sclerosis |
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| 分期 | 2期 |
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| 申办方 | Mayo Clinic |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 75 人 |
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| 干预(药物) | Autologous Adipose-derived Mesenchymal Stromal Cells |
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| 开始日期 | 2017年10月10日 |
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| 完成日期 | 2024年1月31日 |
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| 结果公布日 | 2025年4月2日 |
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摘要
The purpose of this study is to determine the safety and efficacy of intrathecal treatment delivered to the cerebrospinal fluid (CSF) of mesenchymal stem cells in ALS patients every 3 months for a total of 4 injections over 12 months. Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown into a number of different kinds of cells. In this study, MSCs will be taken from the subject's body fat and grown. CSF is the fluid surrounding the spine. The use of mesenchymal stem cells is considered investigational, which means it has not been approved by the Food and Drug Administration (FDA) for routine clinical use. However, the FDA has allowed the use of mesenchymal stem cells in this research study.
Adverse Events
12-months · Number of Adverse Events
| Mesenchymal Stromal Cells | 668 Number of Adverse Events |
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Unexpected Severe Adverse Events
12-months · Number of unexpected severe adverse eve
| Mesenchymal Stromal Cells | 41 Number of unexpected severe adverse eve |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。