title: Intravenous autologous bone marrow mononuclear cells for ischemic stroke.
abstract: OBJECTIVE
  Cellular therapy is an investigational approach for stroke. Mononuclear cells (MNCs) from the bone marrow reduce neurological deficits in animal stroke models. We determined if autologous MNC infusion was feasible and safe in patients with ischemic stroke.
  
  
  METHODS
  We conducted an open-label prospective study of a bone marrow harvest followed by readministration of autologous MNCs in 10 patients, 18 to 80 years old, with acute middle cerebral artery ischemic stroke. Bone marrow was aspirated from the iliac crest, and MNCs were separated at a Good Manufacturing Practices facility and administered intravenously up to a maximum of 10 million cells/kg. The harvest and infusion had to occur between 24 and 72 hours after stroke. Patients were monitored for 6 months.
  
  
  RESULTS
  Bone marrow aspiration was successfully completed in all patients. Eight received 10 million cells/kg, and 2 received ≥7 million cells/kg. There were no significant adverse events related to harvest or infusion. Two patients had infarct expansion between enrollment and harvest and underwent hemicraniectomy after cell infusion. One patient died at 40 days due to a pulmonary embolism related to the stroke. There were no study-related severe adverse events. Median National Institutes of Health Stroke Scale score was 13 before harvest, 8 at 7 days, and 3 at 6 months. At 6 months, all surviving patients had shifted down by at least 1 point on the modified Rankin Scale compared to day 7. Seven of 10 patients achieved a Barthel Index ≥90.
  
  
  CONCLUSIONS
  This study suggests that a bone marrow harvest and reinfusion of autologous MNCs were safe and feasible in acute stroke patients.
authors.affiliation: Department of Neurology, University of Texas Medical School at Houston, Houston, TX, USA. Sean.I.Savitz@uth.tmc.edu
authors.forename: Sean I
authors.initials: SI
authors.lastname: Savitz
authors.forename: Vivek
authors.initials: V
authors.lastname: Misra
authors.forename: Mallik
authors.initials: M
authors.lastname: Kasam
authors.forename: Harrinder
authors.initials: H
authors.lastname: Juneja
authors.forename: Charles S
authors.initials: CS
authors.lastname: Cox
authors.forename: Susan
authors.initials: S
authors.lastname: Alderman
authors.forename: Imo
authors.initials: I
authors.lastname: Aisiku
authors.forename: Siddhartha
authors.initials: S
authors.lastname: Kar
authors.forename: Adrian
authors.initials: A
authors.lastname: Gee
authors.forename: James C
authors.initials: JC
authors.lastname: Grotta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016026:Bone Marrow Transplantation / Q000379:methods*; D002545:Brain Ischemia / Q000473:pathology / Q000601:surgery*; D049109:Cell Proliferation; D002478:Cells, Cultured; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D007963:Leukocytes, Mononuclear / Q000166:cytology / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020521:Stroke / Q000473:pathology / Q000601:surgery*; D014182:Transplantation, Autologous / Q000379:methods; D055815:Young Adult