BENITIONSClinical Trial Intelligence

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
第2相
スポンサーMayo Clinic
ステータス実施中(募集終了)
参加者数75 名
介入(薬剤)Autologous Adipose-derived Mesenchymal Stromal Cells
開始日2017年10月10日
完了日2024年1月31日
結果公開日2025年4月2日

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 Cells668 Number of Adverse Events

Unexpected Severe Adverse Events

12-months · Number of unexpected severe adverse eve

Mesenchymal Stromal Cells41 Number of unexpected severe adverse eve

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