Abstract
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 Notably, a quarter of cell therapy clinical trials for stroke have been withdrawn (15.2%) or terminated (6.8%) to date.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.
Highlights
BackgroundStroke has a devastating effect on the society worldwide
A stroke results in a complex interplay of inflammation and repair with effects on neural, vascular, and connective tissue in and around the affected areas of the brain [3]
For example in the US clinical trials are regulated by the Food and Drug Administration (FDA) whereas in Australia Therapeutic Goods Administration (TGA) and in the UK it is The Medicines and Healthcare Products Regulatory Agency (MHRA)
Summary
Stroke has a devastating effect on the society worldwide. In addition to its significant mortality rate of 50% as reported in 5-year survival studies [1], it affects as many as 1 in 6 people in their lifetimes, and is the leading cause of disability worldwide [2]. Mainly targeted at small cohorts of patients with chronic stroke, completed in the 2000s, showed satisfactory safety profiles and suggestions of efficacy [10] Current treatments such as tPA and EVT only have a narrow therapeutic window, limited efficacy in severe stroke and may be accompanied by severe side effects. Stem cells have been postulated to significantly extend the period of intervention and target subacute as well as the chronic phase of stroke Numerous neurological disorders such as Parkinson’s disease [12, 28], Alzheimer’s disease [29], agerelated macular degeneration [30], traumatic brain injury [31], and malignant gliomas [32] have been investigated for the applicability of stem cell therapy. - Low yield - Heterogenous populations with difference in potential and efficacy
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