Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.

Detailed Description
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Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage. To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.

Official Title
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Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage

Conditions
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Cerebral Hemorrhage

Intervention / Treatment
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* Biological: Human umbilical cord mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40-70 intracerebral hemorrhage patient With stroke history of more than 3 months, less than 60 months National Institutes of Health stroke scale(NIHSS) score of 7 or more points Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.) Exclusion Criteria: History of neurological disease, head injury or psychiatric disorder; Pregnant women; Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition; Progressive apoplexy; With malignant tumors.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hUC-MSC treatment<br>Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. | Biological: Human umbilical cord mesenchymal stem cells<br>* A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of infarct size measured by brain MRI |  | before the transplant and 1, 6, 12 months after transplantation | 
| Modified Barthel index |  | before and 1, 3, 6 and 12 months after transplantation | 
| National Institutes of Health stroke scale(NIHSS) score |  | before the transplant and after the transplant 1, 2 and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Cerebral hemorrhage