title: Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  www.clinicaltrials.gov. Unique identifier: NCT00761982.
authors: Department of Neurology, Hospital Universitario Virgen del Rocío, Seville, Spain. pmoniche@gmail.com
authors: Francisco
authors: F
authors: Moniche
authors: Alejandro
authors: A
authors: Gonzalez
authors: Jose-Ramon
authors: JR
authors: Gonzalez-Marcos
authors: Magdalena
authors: M
authors: Carmona
authors: Pilar
authors: P
authors: Piñero
authors: Ildefonso
authors: I
authors: Espigado
authors: David
authors: D
authors: Garcia-Solis
authors: Aurelio
authors: A
authors: Cayuela
authors: Joan
authors: J
authors: Montaner
authors: Cristina
authors: C
authors: Boada
authors: Anna
authors: A
authors: Rosell
authors: Maria-Dolores
authors: MD
authors: Jimenez
authors: Antonio
authors: A
authors: Mayol
authors: Alberto
authors: A
authors: Gil-Peralta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018952:Antigens, CD34; D016026:Bone Marrow Transplantation / Q000009:adverse effects / Q000379:methods*; D002545:Brain Ischemia / Q000628:therapy*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000097:blood; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D020244:Infarction, Middle Cerebral Artery / Q000150:complications / Q000628:therapy; D008297:Male; D008875:Middle Aged; D020932:Nerve Growth Factor / Q000097:blood; D009460:Neurologic Examination; D010865:Pilot Projects; D012449:Safety; D020521:Stroke / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor; D020932:Nerve Growth Factor