Intraarterial Stem Cells in Subacute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-12-31

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

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Detailed Description

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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.

Conditions

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Ischemic Stroke MCA Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

test group :Stem cell plus standard care control group : standard care

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

PROBE design

Study Groups

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Stem cell group

autologous BMMNC stem cells with standard care

Group Type EXPERIMENTAL

autologous BMMNC stem cells

Intervention Type BIOLOGICAL

Autologous BMMNC injected in the ipsilateral MCA

standard care

Intervention Type OTHER

Control

Patients randomised in this group received standard care only

Group Type ACTIVE_COMPARATOR

standard care

Intervention Type OTHER

Interventions

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autologous BMMNC stem cells

Autologous BMMNC injected in the ipsilateral MCA

Intervention Type BIOLOGICAL

standard care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No