Stroke is the main cause of adult health damage. 20% of stroke survivors need institutional care after 3 months, and up to 30% of them have severe or permanent disability. Stem cells are a kind of pluripotent cells with the ability of self replication. The self-renewal and differentiation characteristics of mesenchymal stem cells, as well as cytokine secretion effect and immune characteristics, provide the possibility for mesenchymal stem cells to treat ischemic stroke. After the infusion of mesenchymal stem cells, the secretion of soluble media including growth factors and cytokines may be the main mechanism of mesenchymal stem cells.
Stroke is the main cause of adult health damage. 20% of stroke survivors need institutional care after 3 months, and up to 30% of them have severe or permanent disability. Stem cells are a kind of pluripotent cells with the ability of self replication. The self-renewal and differentiation characteristics of mesenchymal stem cells, as well as cytokine secretion effect and immune characteristics, provide the possibility for mesenchymal stem cells to treat ischemic stroke. After the infusion of mesenchymal stem cells, the secretion of soluble media including growth factors and cytokines may be the main mechanism of mesenchymal stem cells. The main purpose of this study was to evaluate the safety and tolerance of intravenous injection of ischemia tolerant human allogeneic bone marrow mesenchymal stem cells in patients with ischemic stroke. The secondary objective was to evaluate the clinical efficacy of ischemic tolerant human allogeneic bone marrow mesenchymal stem cells in the treatment of ischemic stroke patients with neurological dysfunction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Different doses of it-hMSC
Peking University Third Hospital
Beijin, China
RECRUITINGAdverse events and serious adverse events rate
Safety and tolerability of it-hMSC treatment
Time frame: In 12 months
Rate of clinical significant changes in laboratory
Safety and tolerability of it-hMSC treatment
Time frame: In 12 months
Rate of abnormal neurological physical examination results
Safety and tolerability of it-hMSC treatment
Time frame: In 12 months
Rate of imaging changes
Safety and tolerability of it-hMSC treatment
Time frame: In 12 months
Change of NIHSS scores
The improvement of neurological function was evaluated by neurological
Time frame: 1、3、6、9、12 months after treatment
Change of BI scores
The improvement of neurological function was evaluated by neurological
Time frame: 1、3、6、9、12 months after treatment
Change of mRS scores
The improvement of neurological function was evaluated by neurological
Time frame: 1、3、6、9、12 months after treatment
Change of MMSE scores
The improvement of neurological function was evaluated by neurological
Time frame: 1、3、6、9、12 months after treatment
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Change of GDS scores
The improvement of neurological function was evaluated by neurological
Time frame: 1、3、6、9、12 months after treatment