The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of single injection of it-hMSC in patients with ischemic stroke in a multicenter, blind, randomized, placebo controlled trial
Stroke is a leading cause of disability. According to the comprehensive standardized prevalence estimation in 2016, 12.42 million people older than 40 years in China are currently suffering from stroke or have ever suffered from stroke. The overall prevalence rate of stroke in China was 1,596 per 100,000 people in 2016, 4.6 times higher than the rate of 345.1 per 100,000 people in 2013 and 70% of the survivors have disabilities in varying degrees. In addition to rehabilitation therapy, there is no therapeutic drugs of remarkable curative effect for the treatment of ischemic stroke patients. The latest data show that the annual recurrence rate of ischemic stroke in China is as high as 17.7%. Allogeneic mesenchymal stem cells have been used in many clinical studies for different diseases. In addition to differentiating into multiple cell types and promoting the recovery and repair of the brain by replacing damaged cells, mesenchymal stem cells also secrete cytokines and neurotrophic factors to support and stimulate the growth of other endogenous cells. Meanwhile, mesenchymal stem cells also have anti-inflammatory and immunomodulatory functions. These characteristics of mesenchymal stem cells provide a new therapy for the treatment of stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
RECRUITINGIncidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after it-hMSC infusion.
Time frame: 12 months
Modified Rankin Scale
The change from the baseline in Modified Rankin Scale will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available. The scale is divided into 7 degrees, from 0 (no deficit) to 6 (dead).
Time frame: month 1, month 3, month 6, month 9, month 12
National Institute of Health stroke scale
The change from the baseline in National Institute of Health stroke scale will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available. The range of scores is from 0 (normal) to 42.
Time frame: month 1, month 3, month 6, month 9, month 12
Mini-mental State Examination
The change from the baseline in Mini-mental State Examination will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available. The range of scores is from 0 to 30 (normal).
Time frame: month 1, month 3, month 6, month 9, month 12
Barthel Index
The change from the baseline in Barthel Index will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available. The range of scores is from 0 to 100 (normal).
Time frame: month 1, month 3, month 6, month 9, month 12
Geriatric Depression Scale
The change from the baseline in Geriatric Depression Scale will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available. The range of scores is from 0 (normal) to 10.
Time frame: month 1, month 3, month 6, month 9, month 12
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