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Intra-Arterial Infusion of Autologous Bone-Marrow Mononuclear Cells in Patients with Moderate to Severe Middle-Cerebral-Artery Acute Ischemic Stroke
Authors: Maurício A. G. Friedrich, Maurer P. Martins, Mariana D. Araújo, Charles Klamt, Leonardo Vedolin, Bernardo Garicochea, Eduardo F. Raupp, Jeber Sartori El Ammar, Denise Cantarelli Machado, Jaderson C da Costa, Raul G Nogueira, Paulo Henrique Rosado-de-Castro, Rosalia Mendez-Otero, Gabriel R. de Freitas
Source: Cell Transplantation
Publisher: Cognizant Communication Corporation
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Abstract:
Transplantation of autologous bone-marrow mononuclear cells has been proven safe in animal and human studies. However, there are very few studies in stroke patients. In this study, intra-arterial autologous bone-marrow mononuclear cells were infused in patients with moderate to severe acute middle-cerebral-artery infarcts. The subjects of this study included 20 patients with early or late spontaneous recanalization but with persistent deficits, in whom treatment could be initiated between 3 and 7 days after stroke onset. Mononuclear cells were isolated from bone-marrow aspirates and infused at the proximal middle cerebral artery of the affected hemisphere. Safety analysis (primary endpoint) during the 6-month follow-up assessed death, any serious clinical events, neurological worsening with ≥4-point increase in National Institutes of Health Stroke Scale (NIHSS) scores, seizures, epileptogenic activity on electroencephalogram, and neuroimaging complications including new ischemic, hemorrhagic, or neoplastic lesions. Satisfactory clinical improvement (secondary endpoint) at 90 days was defined according to the pretreatment NIHSS scores as follows: modified Rankin Scale score of 0 in patients with NIHSS < 8, modified Rankin Scale scores of 0-1 in patients with NIHSS 8-14, or modified Rankin Scale scores 0-2 in patients with NIHSS >14 . Good clinical outcome was defined as mRS ≤2 at 90 days. Serial clinical, laboratory, electroencephalogram, and imaging evaluations showed no procedure-related adverse events. Satisfactory clinical improvement occurred in 6/20 (30%) patients at 90 days. Eight patients (40%) showed a good clinical outcome. Intra-arterial autologous bone-marrow mononuclear cells infusion appears to be safe in patients with moderate to severe acute middle-cerebral-artery strokes. No cases of intra-hospital mortality were seen in this pilot trial. Larger prospective randomized trials are warranted to assess the efficacy of this treatment approach.Document Type:
DOI: http://dx.doi.org/10.3727/096368911X612512
Appeared or available online: December 14, 2011
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