Recruiting patients with stroke into cell therapy trials a review

Vivek Misra; William J. Hicks; Farhaan S. Vahidy; Susan Alderman; Sean I. Savitz

doi:10.1001/jamaneurol.2016.0940

Recruiting patients with stroke into cell therapy trials a review

Vivek Misra, William J. Hicks, Farhaan S. Vahidy, Susan Alderman, Sean I. Savitz

Research output: Contribution to journal › Review article › peer-review

1 Scopus citations

Abstract

IMPORTANCE 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. OBSERVATIONS 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.

Original language	English (US)
Pages (from-to)	1141-1144
Number of pages	4
Journal	JAMA Neurology
Volume	73
Issue number	9
DOIs	https://doi.org/10.1001/jamaneurol.2016.0940
State	Published - Sep 1 2016

ASJC Scopus subject areas

Clinical Neurology

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10.1001/jamaneurol.2016.0940

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title = "Recruiting patients with stroke into cell therapy trials a review",

abstract = "IMPORTANCE 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. OBSERVATIONS 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.",

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AU - Misra, Vivek

AU - Hicks, William J.

AU - Vahidy, Farhaan S.

AU - Alderman, Susan

AU - Savitz, Sean I.

PY - 2016/9/1

Y1 - 2016/9/1

N2 - IMPORTANCE 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. OBSERVATIONS 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.

AB - IMPORTANCE 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. OBSERVATIONS 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.

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Recruiting patients with stroke into cell therapy trials a review

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