Related Experiment Video
Updated: Dec 25, 2025
Electrically Conductive Scaffold to Modulate and Deliver Stem Cells
Published on: April 13, 2018
What are potential barriers and enablers to patient and physician participation in Canadian cell therapy trials for
Manoj M Lalu1,2, Madison Foster2, Justin Presseau2,3
1Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
Objectives:
Early 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.
Design:
Semistructured interview study.
Setting:
Patients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling.
Participants:
Thirteen 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.
Methods:
Interview guides and directed content analysis were based on the Theoretical Domains Framework (TDF). Interviews were coded, and relevant themes were identified.
Results:
Most 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.
Conclusions:
This 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.
Insights
Patient and physician views on mesenchymal stem cell (MSC) therapy for stroke trials reveal key participation factors. Optimizing trial design requires understanding patient preferences for cell administration and trial goals, alongside physician concerns about time and resources.
Area of Science:
- Neuroscience
- Regenerative Medicine
- Clinical Trials
Background:
- Early phase cell therapy trials, particularly for chronic stroke, face significant challenges impacting completion.
- Mesenchymal stem cell (MSC) therapy is a promising treatment for stroke, but its clinical trial implementation requires careful consideration of participant perspectives.
Purpose of the Study:
- To identify potential barriers and enablers influencing patient and physician participation in a planned clinical trial of MSC therapy for chronic stroke.
- To gather insights to optimize the design and conduct of early-phase cell therapy trials.
Main Methods:
- A qualitative study employing semistructured interviews with chronic stroke patients and physicians across Canada.
- The Theoretical Domains Framework (TDF) guided interview content and data analysis through directed content analysis.
Main Results:
- Patients expressed optimism and willingness to participate, with preferences for intravascular administration and efficacy-focused trials.
- Physicians were interested in screening patients but showed less motivation for safety-focused trials and highlighted time constraints and resource needs.
- Key factors influencing participation included cell administration method, trial objectives (efficacy vs. safety), and logistical considerations for physicians.
Conclusions:
- The Theoretical Domains Framework effectively identified critical barriers and enablers for MSC therapy trials in stroke.
- These findings will inform the refinement of the current clinical trial design and execution.
- This approach offers a valuable model for other investigators planning early-phase cell therapy trials.
Related Concept Videos
01:21Barriers to Effective Communication II
Cultural barriers:
Differences in values, beliefs, religion, knowledge, and tradition can significantly impact communication. Awareness of nonverbal cues is critical, especially when conversing with a patient from a different culture. What appears appropriate in one culture may be inappropriate in another.
Semantic barriers:
As a result of their tendency to use...
01:21EPS and iPS Cells in Disease Research