Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
第2相
実施中(募集終了)
NCT03268603
| 対象疾患 | ALS, Amyotrophic Lateral Sclerosis |
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| 相 | 第2相 |
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| スポンサー | Mayo Clinic |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 75 名 |
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| 介入(薬剤) | Autologous Adipose-derived Mesenchymal Stromal Cells |
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| 開始日 | 2017年10月10日 |
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| 完了日 | 2024年1月31日 |
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| 結果公開日 | 2025年4月2日 |
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概要
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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