Intraarterial Stem Cells in Subacute Ischemic Stroke
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03080571|
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : March 15, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke MCA Infarction||Biological: autologous BMMNC stem cells Other: standard care||Phase 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||test group :Stem cell plus standard care control group : standard care|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||PROBE design|
|Official Title:||To Evaluate the Safety, Feasibility and Clinical Outcome of Intraarterial Infusion of Bone Marrow Derived Mononuclear Cells in Subacute Ischaemic Stroke Patients|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Stem cell group
autologous BMMNC stem cells with standard care
Biological: autologous BMMNC stem cells
Autologous BMMNC injected in the ipsilateral MCA
Other: standard care
Active Comparator: Control
Patients randomised in this group received standard care only
Other: standard care
- 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 ]
- new ischemic lesion [ Time Frame: 6 month ]
- Death [ Time Frame: 6 month ]
- modified rankin score [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080571
|Study Director:||Vivek Gupta, DM||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||Vikas Bhatia, DM||Postgraduate Institute of Medical Education and Research|