Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.

Completed

Phase 1/2 Results N/A

Trial Description

The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.

Detailed Description

The proposed trial will involve the recruitment of a total of 20 patients.
The cells will be collected from ten subject recruited as cases, via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, which will be resuspended in heparinized isotonic saline for infusion into the area of the stroke intra-arterially using the middle cerebral artery.
The investigators will monitor each case and control for a period of 6 months post-stem cell infusion. Initially, they will be subjected to a review after one month,three months and finally 6 months.
Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.

Conditions

Interventions

  • Infusion on autologous CD34+ stem cells into middle cerebral artery Procedure
    Intervention Desc: Intraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients
    ARM 1: Kind: Experimental
    Label: bone marrow stem cells
    Description: Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Absence of new neurological deficits and adverse effects during the timeframe. Duration of study Yes
Secondary Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale. Duration of study Yes

Sponsors