A phase 2 randomized, sham controlled trial of internal carotid artery infusion of autologous bone marrow derived ALD-401 cells in patients with recent stable ischemic stroke (RECOVER-stroke)
Circulation Dec 05, 2018
Savitz SI, et al. - Researchers performed this trial with the primary objective to determine the safety of internal carotid artery, intra arterially- delivered autologous bone marrow derived ALD-401 in patients with disabling middle cerebral artery stroke (MCA) compared to sham-harvest with sham-infusion. They randomized patients (3:2) to bone-marrow harvest at 11-17 days after stroke followed 2 days later by intracarotid infusion of ALD-401 vs sham-harvest and then sham-infusion in the same time-fame. Based on modified Rankin scale (mRS) change, they assessed efficacy at 90 days. The proportions of patients experiencing adverse events, disability by Barthel index, quality of life using EQ-5D, rehabilitation utilization, disability at 1 year and MRI evidence of complications were included as other secondary outcomes. Outcomes revealed no clinical adverse events with intra-carotid infusion of ALD-401 although there was a higher incidence of small lesions on MRI in the treatment group. The groups were not significantly different in the primary efficacy endpoint.
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