Trial intelligence / Profile preview

Autologous BM-MSCs in Middle Cerebral Artery Infarct

NCT01461720Phase 2

Key facts

Status: Unknown
Start: Mar 2012
Primary completion: Dec 2015
Countries: 1
Sponsor: Universiti Kebangsaan Malaysia
Modality: Stem Cell Therapies

Drugs: autologous bone marrow derived mesenchymal stromal cells
Conditions: middle cerebral artery infarction

Overview

Phase 2, randomised, open-label trial of autologous bone marrow derived mesenchymal stromal cells in middle cerebral artery infarction (2 arms), sponsored by Universiti Kebangsaan Malaysia. Primary endpoints: Change in NIH Stroke Scale at 1 year, Change in Barthel Index at 1 year and 2 more. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

BM-MSCs
Autologous bone marrow-derived mesenchymal stem cells + Standard medical care
Standard medical care
Standard medical care alone

Who it enrols

Patients with acute middle cerebral artery infarct (onset 2 weeks to 2 months), NIHSS 10-35, who never received or failed thrombolysis. Excludes hemorrhagic stroke, tumors, infections (Hep B/C, HIV), and severe renal/liver impairment.

Endpoints

Primary

Change in NIH Stroke Scale1 year
Change in Barthel Index1 year
Change in modified Rankin Scale1 year
Change in size of infarct based on brain MRI stroke sequences1 year

Secondary

Change in Stroke Specific Quality of Life Scale1 year
Change in Stroke Impact Scale1 year

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