Intra-Arterial Bone Marrow Mononuclear Cells in Ischemic Stroke A Pilot Clinical Trial

• Published in: Stroke (1970) 2012-08, Vol.43 (8), p.2242-2244
• Main Authors: MONICHE, Francisco, GONZALEZ, Alejandro, ROSELL, Anna, JIMENEZ, Maria-Dolores, MAYOL, Antonio, GIL-PERALTA, Alberto, GONZALEZ-MARCOS, Jose-Ramon, CARMONA, Magdalena, PINERO, Pilar, ESPIGADO, Ildefonso, GARCIA-SOLIS, David, CAYUELA, Aurelio, MONTANER, Joan, BOADA, Cristina
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antigens, CD34; Biological and medical sciences; Blood. Blood coagulation. Reticuloendothelial system; Bone Marrow Transplantation - adverse effects; Bone Marrow Transplantation - methods; Brain Ischemia - therapy; Female; Granulocyte Colony-Stimulating Factor - blood; Hemodynamics - physiology; Humans; Infarction, Middle Cerebral Artery - complications; Infarction, Middle Cerebral Artery - therapy; Male; Medical sciences; Middle Aged; Nerve Growth Factor - blood; Neurologic Examination; Neurology; Pharmacology. Drug treatments; Pilot Projects; Safety; Stroke - therapy; Treatment Outcome; Vascular diseases and vascular malformations of the nervous system; Young Adult
• ISSN: 0039-2499; 1524-4628
• DOI: 10.1161/STROKEAHA.112.659409

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. 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. 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). 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. www.clinicaltrials.gov. Unique identifier: NCT00761982.