The purpose of this study is to determine the safety of injecting mesenchymal stem cells through intraspinal delivery for the treatment of ALS.
A single patient safety study for harvesting, expanding ex vivo and injecting autologous mesenchymal stem cells (MSC's) into the subarachnoid space of a patient with amyotrophic lateral sclerosis (ALS). Cells will be isolated from adipose tissue by subcutaneous biopsy and expanded using an FDA-approved protocol. They will then be injected by lumbar puncture into the cerebrospinal fluid. Injection will be completed in the in- patient clinical research unit (CRU). the patient will be followed for two years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
single intrathecal dose of 10x6 cells by lumbar puncture.
Mayo Clinic
Rochester, Minnesota, United States
Safety
Clinical monitoring of possible reaction to intrathecal MSC delivery including blood pressure, temperature and pain score.
Time frame: 2 year follow-up
Neurologic disability score
Quantitative, summated, manual muscle testing
Time frame: Two year follow-up
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