Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Biological: Allogeneic umbilical cord mesenchymal stem cell
* Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: proved cerebral infarction by CT or MRI. no cerebrovascular disease before signed informed consent form Exclusion Criteria: serious body and intracranial lesions (tumor, infection, etc.) patients repeated cerebral infarction attacks multi-foci of cerebral infarction history of drug dependence and mental disease disturbance of consciousness and non-compliance patients subjects who are HIV positive pregnant or lactation donor: HIV infected, Active hepatitis B/C infected, Syphilis antibody positive subjects/ donor: alcoholism, drug addicts or mental disease

Ages Eligible for Study
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Minimum Age: 20 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: Experimental group<br>Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells | Biological: Allogeneic umbilical cord mesenchymal stem cell<br>* Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)<br>Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium<br>* Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.<br>|
| Placebo Comparator: Control group<br>Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo：saline | Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium<br>* Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 6 months | 

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