Intraarterial Stem Cells in Subacute Ischemic Stroke

Completed

Phase 1 Results N/A

Trial Description

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.

Conditions

Interventions

  • Standard Care Other
    ARM 1: Kind: Experimental
    Label: Stem cell group
    Description: autologous BMMNC stem cells with standard care
    ARM 2: Kind: Experimental
    Label: Control
    Description: Patients randomised in this group received standard care only
  • Autologous BMMNC stem cells Biological
    Intervention Desc: Autologous BMMNC injected in the ipsilateral MCA
    ARM 1: Kind: Experimental
    Label: Stem cell group
    Description: autologous BMMNC stem cells with standard care

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in National Institutes of Health Stroke Scale 6 month
Primary symptomatic intracranial hemorrhage 6 month
Primary new ischemic lesion 6 month
Primary Death 6 month
Secondary modified rankin score 6 months

Sponsors