Recruiting Patients With Stroke Into Cell Therapy Trials

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

doi:10.1001/jamaneurol.2016.0940

Cited by 2 publications

(4 citation statements)

References 34 publications

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“…Study findings also showed us that participant barriers should not be assumed and that rather patients should be asked and involved. Despite researchers suggesting potential concerns, 11 we found that patients did not have ethical concerns surrounding the use of stem cells, nor would a placebo necessarily deter them from participating. We encourage other investigators to take this approach when developing future trials to identify barriers and enablers a priori, as this will help to improve the design of the trial to better meet the needs of both patients and physicians.…”

Section: Discussioncontrasting

confidence: 64%

“…This is in contrast to a previous retrospective narrative that detailed encountered barriers to cell therapy trials for stroke. 11 We detail key findings and potential implications for future clinical trials. There has been little work assessing potential barriers and enablers to both patient participation and physician involvement in early phase clinical trials.…”

Section: Discussionmentioning

confidence: 99%

“…A recent review on the use of cell therapy for treatment of stroke highlighted that patients sometimes have ethical concerns with 'stem cells'. 11 Patients may mistakenly believe that stem cells can only be procured from embryos, 11 while in reality they can be collected from other sources (eg, bone marrow). Counter to this, our interview study found that only one patient voiced ethical concerns over the use of stem cell therapy.…”

Section: Discussionmentioning

confidence: 99%

“…Open access experience in recruitment for cell therapy for stroke trials identified several potential patient barriers, including misconceptions regarding stem cells and a preference for single arm designs 11 ; however, a formal assessment of barriers was not performed. In preparation for a new clinical study of MSC therapy for chronic stroke, we sought to prospectively identify potential barriers and enablers using the Theoretical Domains Framework (TDF).…”

mentioning

confidence: 99%

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What are potential barriers and enablers to patient and physician participation in Canadian cell therapy trials for stroke? A stakeholder interview study

et al. 2020

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ObjectivesEarly phase cell therapy trials face many barriers to successful, timely completion. To optimise the conduct of a planned clinical trial of mesenchymal stem cell (MSC) therapy for chronic stroke, we sought patient and physician views on possible barriers and enablers that may influence their participation.DesignSemistructured interview study.SettingPatients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling.ParticipantsThirteen chronic stroke patients (patients who had experienced a stroke at least 3 months prior; 10 male, 3 female) and 15 physicians (stroke physiatrists; 9 male, 6 female) participated in our interview study. Data adequacy was reached after 13 patient interviews and 13 physician interviews.MethodsInterview guides and directed content analysis were based on the Theoretical Domains Framework (TDF). Interviews were coded, and relevant themes were identified.ResultsMost patients were optimistic about participating in an MSC therapy clinical trial, and many expressed interest in participating, even if it was a randomised controlled trial with the possibility of being allocated to a placebo group. However, the method of administration of cells (intravascular preferred to intracerebral) and goal of the trial (efficacy preferred to safety) may influence their intention to participate. All physicians expressed interest in screening for the trial, though many stated they were less motivated to contribute to a safety trial. Physicians also identified several time-related barriers and the need for resources to ensure feasibility.ConclusionsThis novel application of the TDF helped identify key potential barriers and enablers prior to conducting a clinical trial of MSC therapy for stroke. This will be used to refine the design and conduct of our trial. A similar approach may be adopted by other investigators considering early phase cell therapy trials.

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Section: Discussioncontrasting

confidence: 64%

Section: Discussionmentioning

confidence: 99%