The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).
This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, evaluate the security and efficacy of hUC-MSC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Allogeneic umbilical cord mesenchymal stem cells will transfusion into by forearm intravenous transplantation, 0.5 - 1 \*10\^6/kg. once a month, total 3 times.
Drug: Aspirin Tablet, 100 mg/d
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, China
Treatment related-adverse events counting
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
Time frame: 26 weeks
Modified Rankin Scale
After the first time transplantation, follow-up visit for 26 weeks. Based on Modified Rankin Scale, counting the percentage of different symptom changes to evaluate MSC efficacy: * the percentage of participants run from 0-1, no symptom or no significant disability. * the percentage of participants run from 0-2, no symptom or slight disability. * the percentage of participants decline 2 scales compare to baseline. * the percentage of participants decline 1 scale compares to baseline.
Time frame: 26 weeks
Barthel activities of daily living (ADL) Index
Based on Activity of Daily Living Scale (ADL) to counting the percentage of patients in following condition: * the percentage of patients with score \> 75 * the decline of Barthel ADL Index range compares to baseline. Evaluate the efficacy of MSCs treatment
Time frame: 26 weeks
NIH stroke scale (NIHSS)
According to NIHSS changes after the treatment, evaluate MSCs efficacy by counting the percentage of patients in following condition: * the percentage of patients with score 0-1; * the percentage of patients with score declined 7 compare to baseline; * the percentage of patients with score declined 50% compare to baseline; * the declined ranges compare to baseline
Time frame: 26 weeks
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