This study is a non-randomized, open-label, partially blinded, sequential cohort, dose-escalation study designed to obtain preliminary data on the safety, tolerability, and early efficacy of Q-Cells® transplantation in subjects with ALS. Following an initial cohort receiving cell transplants unilaterally in the lumbar spinal cord, subsequent cohorts will receive escalating doses transplanted unilaterally in cervical spinal cord. Subjects and outcome measure assessors will be blinded to side of treatment. The study will be conducted at sites with extensive clinical experience with the care of patients with ALS.
Subject has the ability to understand the purpose and risks of the study and provide a signed and dated informed consent and authorization to collect and use protected health information (PHI) in accordance with national and local subject privacy regulations.
Subject lives within reasonable driving distance of study center (approximately 3 hours).
Subject has a caregiver willing/able to assist in the transportation and care required by study participation.
Subject is 18 - 80 years of age (inclusive) on the first day of the Screening Period.
Subject in whom causes of neuromuscular weakness other than ALS have not been practically excluded.
Subject with a diagnosis of significant cognitive impairment, clinical dementia, or major psychiatric illness including psychosis, bipolar disease, major depression, as determined by the DSM-V.
Subject with a diagnosis of other neurodegenerative disease (e.g., Parkinson's disease, Alzheimer's disease).
Subject with a diagnosis of any medical condition that impairs nerve or muscle function (e.g., notable peripheral neuropathy, metabolic muscle disease).
Parallel
Q-Cells
Biological/Vaccinecellular therapeutic comprised of human cells of the glial lineage
6
Treatment groupsSee each treatment group below.
Safety of human glial restricted progenitor cell transplantation in patients with Amyotrophic Lateral Sclerosis. (adverse events)
Safety will be measured by the number of therapy related adverse events.
Score on the amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Quantitative muscle strength values from a hand held dynamometer (HHD) will be tested bilaterally
Hand grip (bilateral) values from a grip dynamometer
Forced vital capacity (FVC)
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