PERSPECTIVES: Stroke survivors' views on the design of an early‐phase cell therapy trial for patients with chronic ischaemic stroke.

STROKE treatment; ACTION research; ATTITUDE (Psychology); CELLULAR therapy; CLINICAL trials; DENTAL pulp; EXPERIMENTAL design; INFORMED consent (Medical law); INTERVIEWING; RESEARCH methodology; RESEARCH funding; RISK perception; STEM cells; PATIENT participation; QUALITATIVE research; STEM cell research; JUDGMENT sampling; THEMATIC analysis; HUMAN research subjects; PATIENT selection; DATA analysis software; PATIENTS' attitudes; STROKE patients

Background: Stem cell research holds the potential for a paradigm shift in the management of diseases such as stroke. Patient and public involvement in research (PPIR) can bring a focus to issues of clinical relevance and accelerate translation to real‐world clinical practice. Objective: A qualitative thematic analysis of the perspectives of stroke survivors regarding the conduct and design aspects of a proposed phase I clinical cell therapy study in stroke. Design: Twelve stroke survivors were purposively recruited in July 2016–August 2017 and participated in semi‐structured, face‐to‐face interviews for input into the design of a proposed phase I clinical study of autologous dental pulp stem cells. Concurrent thematic analysis was conducted until data saturation was achieved. Discussion and conclusions: Participants conveyed that the most relevant outcomes to them were regaining participation, decreased dependence on caregivers and improvement in cognition, memory, mood, pain and fatigue. The perception of risk vs. benefit was likely influenced by the time elapsed since stroke, with participants being more willing to accept a higher level of risk early in the post‐stroke disease course. They believed that all stroke survivors should be given an opportunity to participate in research, irrespective of their cognitive capacity. A relatively small sample population of 12 stroke survivors was studied as thematic saturation was achieved. PERSPECTIVES study applied principles of PPIR to early‐phase cell research. Incorporation of outcomes relevant to patients' need within the study design is critical to generate data that will enable personalized application of regenerative medicine in stroke. [ABSTRACT FROM AUTHOR]