Abstract 34: Cognitive Outcomes Following Intracranial Injection of SB623 Cells in Patients with Stable Ischemic Strokes
Background: Ischemic stroke remains a major cause of disability with 90% of patients achieving no improvement after 90 days. The primary objective of this study was to evaluate the safety and feasibility of intraparenchymal administration of SB623 cells in chronic stroke. SB623 cells are adult bone-marrow-derived cells transfected with a plasmid encoding the intracellular domain of Notch-1 and have been shown to secrete factors that protect neurons in animal models.
Methods: Patients with hemiparesis from stable subcortical ischemic stroke and NIHSS > 7 received intracranial injection of 2.5, 5 or 10 million SB623 cells. Clinical outcome measures including NIHSS, MRS, ESS, FMA and cognitive testing including Rey verbal learning and figure copy, digit vigilance, digit-symbol coding, trails, logical memory, word association, Stroop interference and letter-number sequencing were recorded at baseline and then repeated at 6 and 12 months.
Results: 18 patients were enrolled, 11 had complete data available for analysis. There was improvement from 0-12 months in Rey verbal learning (p = 0.033); and from 0-6 months in categorical word association (p = 0.014), which was affected by cell dose (p = 0.043). Patients with cortical versus deep infarcts showed more improvement on Rey figure immediate (p = 0.01) and delayed recall (p = 0.014), and digit-symbol coding (p = 0.042). Patients with left-sided infarcts showed more improvement on logical memory (T1 p = 0.038, T2 p = 0.008), but worsened performance on letter number sequencing (p = 0.046).
Conclusions: Intraparenchymal injection of SB623 cells in chronic ischemic strokes resulted in improvement of some measures of cognitive function. Further investigation of cognitive function in stem cell therapy for stroke is warranted.
Author Disclosures: C.L. Kenmuir: None. V.K. Reddy: None. C. Stilley: None. P. Zeifert: None. G.K. Steinberg: Consultant/Advisory Board; Modest; Medtronic. Research Grant; Significant; NIH NINDS, CIRM. D.S. Kondziolka: None. L.D. Lunsford: None. N.E. Schwartz: None. E. Yankee: Ownership Interest; Significant; Executive Vice President of Development & Regulatory Affairs at SanBio Inc. L.R. Wechsler: None.
- © 2015 by American Heart Association, Inc.