Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients

Completed

Phase 1 Results

Trial Description

The purpose of this research study is to find out if bone marrow treatment (bone marrow aspiration and infusion of stem cells) can be safely used in adults who have recently (within 24-72 hours)suffered an acute ischemic stroke.

Detailed Description

Our primary hypothesis is that autologous bone marrow mononuclear cell transplantation by intravenous administration is feasible and safe after acute ischemic stroke. Our secondary hypothesis is that autologous transplantation is associated with improved outcome after acute stroke.

Conditions

Interventions

  • Autologous stem cell Biological
    Intervention Desc: Peripheral IV infusion of autologous stem cell
    ARM 1: Kind: Experimental
    Label: 1
  • Autologous bone marrow mononuclear cell transfusion Biological
    Other Names: mononuclear cells
    Intervention Desc: the full amount of autologous mononuclear cells derived from 30 cc of bone marrow
  • Autologous bone marrow mononuclear cells Biological
    Intervention Desc: Harvest of bone marrow from ischemic stroke patients, isolation of bone marrow mono-nuclear cells, and peripheral IV infusion of autologous bone marrow mono-nuclear cells
    ARM 1: Kind: Experimental
    Label: Autologous Bone Marrow Mononuclear Cells
    Description: Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Patients will under go autologous stem cell transplant using a peripheral IV infusion of autologous stem cells. Approximately 3-6 hours after aspiration, subjects receive cells by intravenous infusion. Patients are being followed for at least 2 years to ascertain long term outcome as part of secondary exploratory safety analysis. Functional assessment is also being measured on the NIHSS, modified Rankin and Barthel Index scales. Multimodal MRI with DTI is being serially performed over two years to investigate any structural changes.

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety and feasibility of bone marrow mononuclear cell autologous (stem cell) transplantation in patients with acute stroke
Secondary Functional outcome
Primary Study Related Serious Adverse Events (SR-SAE) 2 Years Yes

Sponsors