This is a doble blind, placebo controlled clinical trial to assess safety and efficacy of intravenous administration of Umbilical cord-derived Mesenchymal Stem cells in patients with ischemic stroke within 6 months of onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million.
intravenous placebo solution with the same appearance as the treatment group.
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
Proportion of modified Rankin Scale (mRS) 0-2
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Time frame: 90 Days
Proportion of modified Rankin Scale (mRS) 0-2
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Time frame: 180,360 Days
changes in Fugl-Meyer scale
Fugl-Meyer Assessment Scale ranges from 0 to 100.
Time frame: 90days;180days;360days
changes in Purdue hand function test
The changes of fine motor function were evaluated by Purdue hand function test
Time frame: 90days;180days;360days
changes in box and block test
The changes of fine motor function were evaluated by box and block test
Time frame: 90days;180days;360days
Proportion of modified Rankin Scale (mRS) 0-1
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS
Time frame: 90days;180days;360days
changes in the national institutes of health stroke scale (NIHSS)
NIHSS ranges from 0-42, and high NIHSS means bad outcome
Time frame: 90days;180days;360days
changes in Mini-mental State Examination (MMSE) score
MMSE score ranges from 0 to 30.
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Time frame: 90days;180days;360days
changes in Montreal Cognitive Assessment (MoCA) score
MOCA score ranges from 0 to 30.
Time frame: 90days;180days;360days
The changes of head images
head images included flair, DTI
Time frame: 90days;180days;360days
changes in some serum biomarkers
serum biomarkers included CPEC, VEGF, BDNF, MMP-9
Time frame: 90days;180days;360days