Clinical trials are under way to test the safety and efficacy of different types of cell therapies in patients with ischemic stroke. The informed consent process for recruitment of patients with stroke in cell therapy trials is complex and requires extensive discussions on multiple aspects.
Various issues in approaching patients with stroke and their families and discussing participation in cell therapy studies are described, including participation in clinical trials, clarifying the perception of stem cell therapy and the risks of bone marrow harvest, and discussing risks vs benefits, cell-based therapies for chronic stroke, and consent for minority and immigrant populations.
Conclusions and Relevance
Informed consent for cell therapy studies in patients with stroke requires lengthy discussions about several issues unique to clinical trials in stroke patients. Careful thought is needed to create an informative consent process.