title: Autologous intravenous bone marrow mononuclear cell therapy for patients with subacute ischaemic stroke: a pilot study.
abstract: OBJECTIVE
  Bone marrow mononuclear cell therapy has emerged as one of the option for the treatment of Stroke. Several preclinical studies have shown that the treatment with mononuclear cell (MNCs) can reduce the infarct size and improve the functional outcome. We evaluated the feasibility, safety and clinical outcome of administering bone marrow mononuclear cell (MNCs) intravenously to patients with subacute ischaemic stroke.
  
  
  METHODS
  In a non-randomized phase-I clinical study, 11 consecutive, eligible and consenting patients, aged 30-70 yr with ischaemic stroke involving anterior circulation within 7 to 30 days of onset of stroke were included. Bone marrow was aspirated from iliac crest and the harvested mononuclear cells were infused into antecubital vein. Outcomes measured for safety included immediate reactions after cell infusion and evidence of tumour formation at one year in whole body PET scan. Patients were followed at week 1, 4-6, 24 and 52 to determine clinical progress using National Institute of Health Stroke Scale (NIHSS), Barthel Index (BI), modified Rankin Scale (mRS), MRI, EEG and PET. Feasibility outcomes included target-dose feasibility. Favourable clinical outcome was defined as mRS score of 2 or less or BI score of 75 to 100 at six months after stem cell therapy.
  
  
  RESULTS
  Between September 2006 and April 2007, 11 patients were infused with bone-marrow mononuclear cells (mean 80 million with CD-34 + mean 0.92 million). Protocol was target-dose feasible in 9 patients (82%). FDG-PET scan at 24 and 52 wk in nine patients did not reveal evidence of tumour formation. Seven patients had favourable clinical outcome.
  
  
  CONCLUSIONS
  Intravenous bone marrow mononuclear cell therapy appears feasible and safe in patients with subacute ischaemic stroke. Further, a randomized controlled trial to examine its efficacy is being conducted.
authors.affiliation: Department of Neurology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India. kp0704@gmail.com
authors.forename: Kameshwar
authors.initials: K
authors.lastname: Prasad
authors.forename: Sujata
authors.initials: S
authors.lastname: Mohanty
authors.forename: Rohit
authors.initials: R
authors.lastname: Bhatia
authors.forename: M V P
authors.initials: MV
authors.lastname: Srivastava
authors.forename: Ajay
authors.initials: A
authors.lastname: Garg
authors.forename: Achal
authors.initials: A
authors.lastname: Srivastava
authors.forename: Vinay
authors.initials: V
authors.lastname: Goyal
authors.forename: Manjari
authors.initials: M
authors.lastname: Tripathi
authors.forename: Amit
authors.initials: A
authors.lastname: Kumar
authors.forename: Chandrashekar
authors.initials: C
authors.lastname: Bal
authors.forename: Aarti
authors.initials: A
authors.lastname: Vij
authors.forename: Nalini Kant
authors.initials: NK
authors.lastname: Mishra
mesh_terms: D000328:Adult; D000368:Aged; D016026:Bone Marrow Transplantation; D002545:Brain Ischemia / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D064987:Cell- and Tissue-Based Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000637:transplantation*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011859:Radiography; D020521:Stroke / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D014182:Transplantation, Autologous; D016896:Treatment Outcome