Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

Completed

Phase 1/2 Results N/A

Trial Description

The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.

Conditions

Interventions

  • Autologous bone marrow mononuclear cells Biological
    Intervention Desc: intravenous administration of autologous bone marrow derived mononuclear cells obtained from 50ml of bone marrow on day 7-10 after stroke (only once in that period)
    ARM 1: Kind: Experimental
    Label: autologous bone marrow mononuclear cell
    Description: On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.
    ARM 2: Kind: Experimental
    Label: autologous bone marrow mononuclear cells
    Description: On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement of NIHSS(National Institute of Health Stroke Scale) 30 days after treatment No
Primary Frequency of change for the worse in NIHSS 30 days aftrer treatment Yes
Secondary Mean level of mRS (modified Rankin Scale) 30 days after treatment No
Secondary Frequency of death day 30 after treatment Yes

Sponsors