Abstract 3369: Intravenous Autologous Bone Marrow Derived Stem Cell Therapy for Patients with Subacute Ischemic Stroke (InVeST): A Multi-Centric Randomized Controlled Trial

Abstract

Background & Objective We have completed a randomized controlled clinical trial (CTRI-PROVCTRI/2008/091/00046) to evaluate the safety and efficacy of administering bone marrow mononuclear cells intravenously to patients with subacute ischemic stroke. Methods A total 120 consecutive, eligible and consenting patients, aged 18 to 75 years with ischemic stroke involving MCA or ACA territory infarct between 7 to <30 days of onset of stroke with moderate severity in stable condition were recruited from 31 January 2009 to 16 June 2010. Patients were randomly allocated by central telephone/fax/email. For stem cell arm, bone marrow has been aspirated from iliac crest and the harvested mononuclear cells infused into antecubital vein. Outcome measures for safety are immediate reactions after cell infusion and evidence of tumor formation at one year in whole body FDG-PET scan. Efficacy measurement time points are 7 (±2 days), 90(-7 to +14 days), 180 (-7 to +28 days) and 365 (-7 to +28 days) NIHSS, BI, mRS, MRI, PET scan and EEG. BI and mRS were measured by blinded assessors centrally on telephone. Primary outcome is modified BI score at six months post-randomisation. Results Stem cell arm has been administered bone marrow mononuclear cells (mean 280.73 million with CD34+ mean 2.85 million). Central telephonic follow up has been completed in 117 patients. Data on SAEs, clinical outcome (mRS, BI, NIHSS), cerebral infarct volume, whole body FDG-PET scan and EEG will be presented. Conclusion Intravenous bone marrow MNC therapy is safe in patients of subacute stroke. Further results will be presented.