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Stroke. 2012 Aug;43(8):2242-4. doi: 10.1161/STROKEAHA.112.659409. Epub 2012 Jul 3.

Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial.

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  • 1Department of Neurology, Hospital Universitario Virgen del Rocío, Seville, Spain. pmoniche@gmail.com

Abstract

BACKGROUND AND PURPOSE:

Bone marrow mononuclear cell (BM-MNC) intra-arterial transplantation improves recovery in experimental models of ischemic stroke. We aimed to assess the safety, feasibility, and biological effects of autologous BM-MNC transplantation in patients with stroke.

METHODS:

A single-blind (outcomes assessor) controlled Phase I/II trial was conducted in patients with middle cerebral artery stroke. Autologous BM-MNCs were injected intra-arterially between 5 and 9 days after stroke. Follow-up was done for up to 6 months and blood samples were collected for biological markers. The primary outcome was safety and feasibility of the procedure. The secondary outcome was improvement in neurological function.

RESULTS:

Ten cases (BM-MNC-treated) and 10 control subjects (BM-MNC-nontreated) were consecutively included. Mean National Institutes of Health Stroke Scale before the procedure was 15.6. Mean BM-MNCs injected were 1.59×10(8). There was no death, stroke recurrence, or tumor formation during follow-up, although 2 cases had an isolate partial seizure at 3 months. After transplantation, higher plasma levels of beta nerve growth factor (β-nerve growth factor) were found compared with control subjects (P=0.02). There were no significant differences in neurological function at 180 days. A trend to positive correlation between number of CD34+ cells injected and Barthel Index was found (r=0.56, P=0.09).

CONCLUSIONS:

Intra-arterial BM-MNC transplantation in subacute ischemic stroke is feasible and seems to be safe. Larger randomized trials are needed to confirm the safety and elucidate the efficacy of BM-MNC transplantation.

CLINICAL TRIAL REGISTRATION URL:

www.clinicaltrials.gov. Unique identifier: NCT00761982.

[PubMed - indexed for MEDLINE]
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