Intra-arterial ALD401 Cell Therapy Is Associated with Reduction in Stroke Volume at 90 Days in a Subset of the RECOVER-Stroke Trial (P6.004)

Objective: To evaluate stroke volume changes in ischemic stroke patients receiving ALD-401 cell therapy Background: Stroke is a leading cause of major long-term disability worldwide. Despite availability of IV tPA and mechanical thrombectomy,over half of treated patients have significant disability. Cell based therapy is a promising in pre-clinical studies in improving stroke recovery. Brain infarct volume is a major predictor of stroke outcome and may decrease with this treatment. We hypothesized that patients treated with intra-arterial stem cell therapy will have a significant reduction in stroke volume compared to non-treated patients. Methods: The RECOVER-Stroke trial is a randomized,sham-controlled study to determine the safety and efficacy of processed autologous bone marrow cells (ALD-401) injection via intracarotid infusion in ischemic stroke patients. Anterior circulation ischemic stroke patients were double-blind randomized into 2 groups, receiving ALD-401 injection or sham procedure between 9-19days post stroke. All enrolled patients at 1 of 8 sites were included. Two blinded physicians used OSIRIX software to analyze stroke volume on DWI/24h CT brain and MRI at 90,180,365 days post intervention. Volumes were compared between the 2 groups at these timepoints. Results: Total of 11 patients at our center(out of 48 multicenter patients) were included,6 patients receiving sham procedure and 5 patients receiving ALD-401. There was no significant difference in baseline variables. Mean baseline stroke volumes were not significantly different between ALD-401(103.9±96.2ml) and sham groups(70.2±46ml),p=0.53. Stroke volume reduction in the ALD-401 was 22.9±15.5ml vs. 4.04±12.5ml in the sham group(p=0.046). On day 180 and 365, both groups did not show any further significant stroke volume reduction from day 90. Conclusions: In this exploratory analysis from one center in the multi-center RECOVER-Stroke trial, intra-arterial stem cell injection with ALD-401 was associated with significant reduction in stroke volume at 90 days post therapy compared to sham procedure in subacute ischemic stroke patients. Disclosure: Dr. Atchaneeyasakul has nothing to disclose. Dr. Dharmadhikari has nothing to disclose. Dr. Sidani has nothing to disclose. Dr. Ramdas has nothing to disclose. Dr. Delgado has nothing to disclose. Dr. Pafford has nothing to disclose. Dr. Huang has received personal compensation for activities with Aldagen/Cytomedix and Dart Neuroscience as a consultant. Dr. Hinson has nothing to disclose. Dr. Savitz has received research support from NIH T32 grant. Dr. Yavagal has received personal compensation for activities with Covidien/evV3 as a consultant and Steering Committee Member.