This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.
40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)
Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, China
Motor function analysis
Based on Activity of Daily Living Scale (ADL) to analysis efficacy of cell treatment.The score of patient with upper limb \>60, and total score \>90 is considered good recovery.
Time frame: 6 months
Neurological deficits analysis
According to Chinese scale of clinical neurologic deficit to analysis, the result as follow: * Excellent: after treatment, patient with consciousness, and clinical symptoms improved; * Effective: vital signs and main symptoms in remission; * Inefficient: no obvious improvement or condition worsened.
Time frame: 6 months
Limb motor function analysis
Using fugl-meyer assessment evaluate motor function. Mild movement disorder: 96 - 99; Moderate movement disorder: 85 - 95; Obvious movement disorder: 50 - 84; Serious movement disorder: \< 50
Time frame: 6 months
Barthel Index analysis
Obvious effective: Barthel Index score between 96 - 99, patient with self care ability. Effective:Barthel Index score between 70 - 89, patient with condition improved. Invalid: The effect do not meet above standards.
Time frame: 6 months
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