BENITIONSClinical Trial Intelligence

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

Phase 2 Active, not recruiting NCT03268603

ConditionALS, Amyotrophic Lateral Sclerosis
PhasePhase 2
SponsorMayo Clinic
StatusActive, not recruiting
Enrollment75 participants
InterventionsAutologous Adipose-derived Mesenchymal Stromal Cells
Start dateOct 10, 2017
Completion dateJan 31, 2024
Results postedApr 2, 2025

Summary

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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