To Evaluate the Safety, Feasibility and Clinical Outcome of Intraarterial Infusion of Bone Marrow Derived Mononuclear Cells in Subacute Ischaemic Stroke Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Enrollment
- 20
- Primary Endpoint
- new ischemic lesion
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Vikas Bhatia
Principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
Eligibility Criteria
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
Outcomes
Primary Outcomes
new ischemic lesion
Time Frame: 6 month
Change in National Institutes of Health Stroke Scale
Time Frame: 6 month
increase in National Institutes of Health Stroke Scale more than / equal to 4 points
symptomatic intracranial hemorrhage
Time Frame: 6 month
Death
Time Frame: 6 month
Secondary Outcomes
- modified rankin score(6 months)