The study is to determine the safety of human neural stem cell transplantation for the treatment of paralysis and related symptoms due to chronic motor stroke and to determine the maximum tolerated dose.
This is a Phase I study of human neural stem cell transplantation for the treatment of chronic motor stroke. This single-site, Phase I, open-label study may enroll up to 18 patients across 5 cohorts of ascending doses of human neural stem cells to define maximal tolerated dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Dosing will consist of a one-time stereotactic, intracranial injection of a hNSC line, NSI-566, ranging from 1.2×107 cells to 8×107 cells, as tolerated.
Ba Yi Brain Hospital
Beijing, China
Adverse Events
Time frame: 24 months
Clinical improvement using NIH Stroke Scale
Time frame: 12 months
Clinical improvement using Modified Rankin Scale
Time frame: 12 months
Clinical improvement using Fugl-Meyer Motor Score
Time frame: 12 months
Clinical Improvement using Mini-mental State Examination
Time frame: 12 months
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