The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cerebral Infarction

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Study the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
* Drug: Aspirin Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient within 2 weeks onset of symptoms. Symptoms and signs of clinically definite acute cerebral infarction patients. CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient. Signed informed consent after understanding all possible benefits and harm. Exclusion Criteria: allergic to basic drug with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis. tumor, injury, and parasites caused cerebral embolism rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism subject is processing thrombolytic therapy subject is pregnancy and of childbearing potential or breast feeding participate in any other clinical trial in last 3 months bleeding tendency patient; severe bleeding tendency in last 3 month with gastric duodenal ulcer participants with severe liver and kidney, hematopoietic, and metabolic diseases; Or with liver and kidney function examination abnormal participants are intolerance with Aspirin Enteric-coated Tablets, or need other antiplatelet drugs participants: alcoholism, drug addicted, or other situations may complicated the results under other therapy that possibly influence MSC security or efficacy investigator supposes not suitable to participate this clinical trail

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg | Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)<br>* 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.<br>Drug: Aspirin Tablet<br>* Drug: Aspirin Tablet, 100 mg/d<br>|
| Placebo Comparator: Group 2<br>Aspirin Tablet, 100mg/d; Placebo | Drug: Aspirin Tablet<br>* Drug: Aspirin Tablet, 100 mg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related-adverse events counting | patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute cerebral infarction, umbilical cord mesenchymal stem cells