Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke

Recruiting

Phase 2 Results N/A

Trial Description

This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.

Detailed Description

This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent. 76 patients will randomize in proportion 2:1:1 in a group control that will receive only medical conventional treatment and in two groups of intervention that will receive an unique intra-arterial infusion of mononuclear autologous bone marrow stem cells (one group of dose of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC for kilogram of weight). The three groups of patients will be followed for 24 months. The randomization will be stratified depending on the NHSS score. This clinical trial has a voluntary substudy to obtain information on plasma biomarkers.

Conditions

Interventions

  • No intervention Behavioral
    Intervention Desc: The patients will receive conventional treatment
    ARM 1: Kind: Experimental
    Label: Medical conventional treatment
    Description: No interventions
  • Autologous bone marrow mononuclear cell intra-arterial injection Drug
    ARM 1: Kind: Experimental
    Label: Bone marrow transplantation low dose
    Description: Intra-arterial autologous bone marrow mononuclear cells injection (dose 2x10^6 per kilogram)
    ARM 2: Kind: Experimental
    Label: Bone marrow transplantation high dose
    Description: Intra-arterial autologous bone marrow mononuclear cells injection (dose 5x10^6 per kilogram)
  • Mononuclear autologous bone marrow stem cells Drug
    Intervention Desc: Unique intra-arterial infusion of BMSC/Kg
    ARM 1: Kind: Experimental
    Label: 2 millions of BMSC/Kg
    Description: Unique intra-arterial infusion of Mononuclear autologous bone marrow stem cells, dose of 2 millions for kilogram of weight
    ARM 2: Kind: Experimental
    Label: 5 millions of BMSC/Kg
    Description: Unique intra-arterial infusion of Mononuclear autologous bone marrow stem cells, dose of 5 millions for kilogram of weight
  • Autologous bone marrow mononuclear stem cells Drug
    Intervention Desc: Unique intra-arterial infusion of BMSC/Kg
    ARM 1: Kind: Experimental
    Label: 2 millions of BMSC/Kg
    Description: Unique intra-arterial infusion of autologous bone marrow mononuclear stem cells, dose of 2 millions per kilogram.
    ARM 2: Kind: Experimental
    Label: 5 millions of BMSC/Kg
    Description: Unique intra-arterial infusion of autologous bone marrow mononuclear stem cells, dose of 5 millions per kilogram.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary The rate of the patients that will reach the functional independence (scale modified of Rankin 0-2) 6 months No
Secondary Improvement in NIHSS's scale 6 months No
Secondary Independence in Barthel's scale (Barthel> 90) 6 months No
Secondary Mortality 24 months Yes
Secondary Tumorigenesis 24 months Yes
Primary Disability 6 months No
Secondary Functional outcomes 6 months No
Secondary Infarct volume 6 months No
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability 24 months Yes
Secondary Number of Participants with new-onset seizures as a Measure of Safety and Tolerability 24 months Yes

Sponsors