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

Ischemic Stroke Clinical Trial

Official title:
Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke. A Phase II, Open-label, Multicenter, Randomized and Controlled Clinical Trial.

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02178657
Study type Interventional
Source Andalusian Initiative for Advanced Therapies
Contact
Status Completed
Phase Phase 2
Start date April 2015
Completion date April 12, 2023
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