BENITIONSClinical Trial Intelligence

Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)

2상 진행 중(모집 완료) NCT03268603

대상 질환ALS, Amyotrophic Lateral Sclerosis
임상 단계2상
스폰서Mayo Clinic
상태진행 중(모집 완료)
참여자 수75 명
중재(약물)Autologous Adipose-derived Mesenchymal Stromal Cells
시작일2017년 10월 10일
완료일2024년 1월 31일
결과 공개일2025년 4월 2일

요약

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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