Stroke is the second leading cause of death and physical disability, with a global lifetime incidence rate of 1 in 6. Currently, the only FDA approved treatment for
ischemic stroke is the administration of
tissue plasminogen activator (tPA). Stem cell clinical trials for
stroke have been underway for close to two decades, with data suggesting that cell
therapies are safe, feasible, and potentially efficacious. However, clinical trials for
stroke account for <1% of all stem cell trials. Nevertheless, the resources devoted to clinical research to identify new treatments for
stroke is still significant (53-64 million US$, Phase 1-4). Notably, a quarter of
cell therapy clinical trials for
stroke have been withdrawn (15.2%) or terminated (6.8%) to date. This review discusses the bottlenecks in delivering a successful
cell therapy for
stroke, and the cost-to-benefit ratio necessary to justify these expensive trials. Further, this review will critically assess the currently available data from completed
stroke trials, the importance of standardization in outcome reporting, and the role of industry-led research in the development of cell
therapies for
stroke.