Ischemic Stroke, MCA Infarction
Conditions
Brief summary
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
1. 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. 2. 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. 3. Investigators evaluated 20 patients, with 10 each in control and stem cell infusion test group. 4. 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.
Interventions
BIOLOGICALautologous BMMNC stem cells
Autologous BMMNC injected in the ipsilateral MCA
OTHERstandard care
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
PROBE design
Intervention model description
test group :Stem cell plus standard care control group : standard care
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Requires presence of all of the following 1. Age range 20-80 years symptoms 2. Signs of clinically definite MCA stroke (0 to 14 days post ictus) 3. National Institute of Health Stroke Scale (NIHSS)\> 7, 4. Stroke clinically and on imaging conforming to the MCA territory, 5. Recanalization/patency of involved M1 segment of MCA on imaging 6. Patency of carotid arteries for intra-arterial access of cerebral circulation
Exclusion criteria
Requires presence of any of the following 1. cerebral hemorrhage on CT/MRI 2. Imaging evidence of M1-MCA segment complete occlusion 3. Hemodynamic instability 4. Known defect of clotting or platelet function 5. Severe co-morbidity precluding intra-arterial intervention 6. Hepatic or renal dysfunction 7. Pregnant patients 8. Patient likely to be unavailable for follow-up 9. Patients with evidence of chronic illness or advanced cancer 10. Patient already dependent in activities of daily living before the present acute stroke i.e. pre stroke mRS \>3 11. Refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in National Institutes of Health Stroke Scale | 6 month | increase in National Institutes of Health Stroke Scale more than / equal to 4 points |
| symptomatic intracranial hemorrhage | 6 month | — |
| new ischemic lesion | 6 month | — |
| Death | 6 month | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified rankin score | 6 months | 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. |
Outcome results
None listed