Intraarterial Stem Cells in Subacute Ischemic Stroke

Phase 1

Completed

• Conditions: Ischemic Stroke; MCA Infarction
• Interventions: Biological: autologous BMMNC stem cells; Other: standard care

• Registration Number: NCT03080571
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Study First Posted: 2017-03-15
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stem cell group	standard care	autologous BMMNC stem cells with standard care
Control	standard care	Patients randomised in this group received standard care only
Stem cell group	autologous BMMNC stem cells	autologous BMMNC stem cells with standard care

Primary Outcome Measures

Name	Time	Method
new ischemic lesion	6 month
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
Death	6 month

Secondary Outcome Measures

Name	Time	Method
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.