Randomized Assessment of the Safety and Efficacy of Intra-Arterial Infusion of Autologous Stem Cells in Subacute Ischemic Stroke

Abstract

Background and purpose: Stroke is a debilitating illness for which treatment window is limited. Most patients present to the healthcare facility beyond that window. Autologous stem cells have shown some promise for this group of patients. This study was performed to evaluate the safety and the efficacy of intra-arterial infusion of bone marrow-derived mononuclear cells in patients with middle cerebral artery ischemic stroke.

Materials and methods: A prospective, randomized, open-label, blinded-end point study was performed from July 2015 to June 2016. Of 229 patients with acute stroke who presented to the hospital during this period, 20 patients who satisfied the inclusion/exclusion criteria were included and randomized into the control and intervention groups. Intra-arterial stem cell infusion into the ipsilateral MCA was performed in the patients in the intervention group at 8-15 days post-stroke ictus. Final analysis at 6 months was performed for primary (safety) and secondary outcomes (efficacy).

Results: When we compared the primary end point of the study, no procedure-related mortality, complication, new infarct, or symptomatic intracranial hemorrhage was seen in the intervention group. When we compared the secondary end point of good clinical outcome, 8 (80%) patients in the intervention group showed good clinical outcome (modified Rankin Scale score < 2) with 4 (40%) patients in the control group achieving this (95% confidence interval for good outcome in patients with stem cell infusion, 49.03-94.3, and without stem cell infusion, 16.82-68.73; P = .068).

Conclusions: Intra-arterial infusion of stem cells can be carried out safely in the subacute stage of ischemic stroke. Improved clinical outcomes were observed with intra-arterial stem cell therapy; however, studies with larger cohorts are needed to validate the results.

Fig 1.

A 70-year-old man with left hemiparesis and a baseline NIHSS score of 10 (intervention group). Axial FLAIR image (A) shows an infarct in the right periventricular and posterior limb of the internal capsule, showing diffusion restriction on diffusion-weighted image (B). MR angiogram shows no evidence of any major branch occlusion (C). Preprocedural right ICA diagnostic run (D) shows normal opacification of the MCA branches. Post–stem cell infusion right ICA run (E) shows similar findings, with normal opacification of all the branches. Axial FLAIR MR imaging at 6-month follow-up shows a reduction in infarct size. This patient had an mRS score of 1 at 6-month follow-up, and his outcome was considered good.

Fig 2.

A 50-year-old man with right hemiparesis and an NIHSS score of 7 (intervention group). Axial FLAIR image (A) shows an infarct in the right cortical subcortical location showing diffusion restriction on DWI (B). MR angiogram shows no evidence of any major branch occlusion. Axial FLAIR MR imaging at 6-month follow-up shows a reduction in infarct size. This patient had an mRS score of zero at 6-month follow-up, and his outcome was considered good.