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Allogeneic Mesenchymal Bone Marrow Cells in Ischemic Stroke

NCT01297413Phase 2

Key facts

Status: Completed
Start: Feb 2011
Primary completion: Sep 2017
Countries: 1
Sponsor: Stemedica Cell Technologies
Modality: Mesenchymal Stem Cells

Drugs: ischemia-tolerant mesenchymal stem cells
Conditions: ischemic stroke

Overview

Phase 2, open-label, single-arm trial of ischemia-tolerant mesenchymal stem cells in ischemic stroke, sponsored by Stemedica Cell Technologies. Primary endpoint: Safety of treatment with aMBMC at 12 months. Started Feb 2011; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Stem cells
All subjects receive a single IV dose of allogeneic adult mesenchymal bone marrow stem cells.

Who it enrols

Adult patients with chronic ischemic stroke (>6 months) and stable neurological deficits (NIHSS 6-20).

Endpoints

Primary

Safety of treatment with aMBMC12 months

Secondary

National Institutes of Health Stroke Scale12 months
Mini Mental Status Exam12 months
Barthel Index12 months
Geriatric Depression Scale12 months

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