Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery Infarct

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the efficacy of intravenous transplantation of autologous bone marrow-derived mesenchymal stem cells in patients with acute middle cerebral artery infarct.

Official Title
-----------------
An Open Lable, Phase II Exploratory Study Assessing the Efficacy of Intravenous Autologous Mesenchymal Stem Cells in Patients With Middle Cerebral Artery Infarct

Conditions
-----------------
Middle Cerebral Artery Infarction

Intervention / Treatment
-----------------
* Other: Standard medical care
* Biological: Autologous bone marrow-derived mesenchymal stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experiences stroke onset within 2 weeks to 2 months NIHSS score of >10-35 Never received or failed thrombolysis Evidence of unilateral middle cerebral artery infarct on brain MRI Exclusion Criteria: Medically unfit (eg. those are unstable haemodynamically despite treatment, with worsening conscious level and with other serious medical co-morbidity) Evidence of any tumor or other space-occupying lesion on brain MRI Evidence of hemorrhagic stroke on brain CT or MRI Experiences transient ischemic attack or lacunar infarct Has any acute or chronic infections such as Hepatitis B, Hepatitis C and HIV Is diagnosed with concurrent malignancy or primary hematological disorders Renal impairment indicated with serum creatinine greater than 200 umol/l or creatinine clearance less than 30 ml/min Liver impairment indicated with serum aspartate transaminase and serum alanine transaminase greater than 4 times upper limit of the normal range Any contraindication to stem cell transplantation or bone marrow biopsy Any co-morbidity which will compromise the ability to obtain adequate stem cells (eg. chronic debilitating diseases, frail patients and patients with known osteoporosis) Any contraindication to brain MRI (eg. metal implants, pacemaker, joint implants and ocular implants)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard medical care<br>This is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke | Other: Standard medical care<br>* Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.<br>|
| Experimental: BM-MSCs<br>Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs) | Other: Standard medical care<br>* Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.<br>Biological: Autologous bone marrow-derived mesenchymal stem cells<br>* Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NIH Stroke Scale |  | 1 year | 
| Change in Barthel Index |  | 1 year | 
| Change in modified Rankin Scale |  | 1 year | 
| Change in size of infarct based on brain MRI stroke sequences |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Stroke Specific Quality of Life Scale |  | 1 year | 
| Change in Stroke Impact Scale |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone marrow, Autologous, Mesenchymal stem cells, Unilateral middle cerebral artery infarct