Intraarterial Stem Cells in Subacute Ischemic Stroke

Study Overview
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Brief Summary
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Stroke is a leading cause of morbidity and mortality.Acute ischemia causes irreversible damage to neurons and glial cells, leading to functional deficits and chronic sequelae with variable degrees of spontaneous recovery of function. Stem cells have been shown to enhance recovery through multiple immunomodulatory effects, neoangiogenesis and neurogenesis. We conducted a prospective randomised end observer blinded study to evaluate primarily the safety of intraarterial autologous stem cells delivered to ipsilateral middle cerebral artery in acute and subacute stroke patients (0-15 days post ictus).Secondarily we aimed to evaluate the outcome on the basis of clinical evaluation and follow up imaging

Detailed Description
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This study was done over a period of one and a half years from July 2015 to December 2016. A total of 229 patients who presented with acute middle cerebral artery stroke and admitted at Post graduate institute of medical education and research were evaluated for recruitment into this study. Participants who satisfied the inclusion criteria were randomized at 1 week into control and stem cell infusion test group within 15 days of stroke onset. Investigators evaluated 20 patients, with 10 each in control and stem cell infusion test group. Participants in the test group were infused autologous bone marrow mononuclear cells through intraarterial route using a microcatheter which was placed in proximal ipsilateral M1 segment of MCA. Participants in the control group did not receive stem cell therapy. Rest of the pharmacological treatment and physiotherapy were similar in both groups for the period of 6 months. 5,Participants were evaluated with clinical and radiological follow up at 6 months.

Official Title
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To Evaluate the Safety, Feasibility and Clinical Outcome of Intraarterial Infusion of Bone Marrow Derived Mononuclear Cells in Subacute Ischaemic Stroke Patients

Conditions
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Ischemic Stroke, MCA Infarction

Intervention / Treatment
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* Biological: autologous BMMNC stem cells
* Other: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requires presence of all of the following Age range 20-80 years symptoms Signs of clinically definite MCA stroke (0 to 14 days post ictus) National Institute of Health Stroke Scale (NIHSS)> 7, Stroke clinically and on imaging conforming to the MCA territory, Recanalization/patency of involved M1 segment of MCA on imaging Patency of carotid arteries for intra-arterial access of cerebral circulation Exclusion Criteria: Requires presence of any of the following cerebral hemorrhage on CT/MRI Imaging evidence of M1-MCA segment complete occlusion Hemodynamic instability Known defect of clotting or platelet function Severe co-morbidity precluding intra-arterial intervention Hepatic or renal dysfunction Pregnant patients Patient likely to be unavailable for follow-up Patients with evidence of chronic illness or advanced cancer Patient already dependent in activities of daily living before the present acute stroke i.e. pre stroke mRS >3 Refusal to give informed consent

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: test group :Stem cell plus standard care control group : standard care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell group<br>autologous BMMNC stem cells with standard care | Biological: autologous BMMNC stem cells<br>* Autologous BMMNC injected in the ipsilateral MCA<br>Other: standard care<br> <br> |
| Active Comparator: Control<br>Patients randomised in this group received standard care only | Other: standard care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in National Institutes of Health Stroke Scale | increase in National Institutes of Health Stroke Scale more than / equal to 4 points | 6 month | 
| symptomatic intracranial hemorrhage |  | 6 month | 
| new ischemic lesion |  | 6 month | 
| Death |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified rankin score | A modified rankin score of 0-1 in patients with National Institutes of Health Stroke Scale of 8-14 at the admission and modified rankin score of 0-2 in patients with National Institutes of Health Stroke Scale >14 at the admission. | 6 months |