Understanding potential barriers and enablers to a perioperative early phase cell therapy trial

Cytotherapy. 2022 Jun;24(6):629-638. doi: 10.1016/j.jcyt.2021.08.008. Epub 2022 Apr 6.


Background aims: Early-phase cell therapy clinical trials depend on patient and physician involvement, yet barriers can impede their participation.

Methods: To optimize engagement for a planned cell therapy trial to prevent perioperative cardiac complications, the authors conducted semi-structured interviews with at-risk patients and physicians who could potentially be involved in the study. The authors used the theoretical domains framework to systematically identify potential barriers and enablers.

Results: Forty-one interviews were conducted to reach data saturation, and four overall potential barriers to participation (themes) were identified. Theme 1 emphasizes that patients and physicians need accessible information to better understand the benefits and risks of the novel therapy and trial procedures and to address misconceptions. Theme 2 underscores the need for clarity on whether the trial's primary purpose is safety or efficacy, as this may influence patient and physician decisions. Theme 3 recognizes the resource and logistic realities for patients (e.g., convenient follow-up appointments) and physicians (e.g., personnel to assist in trial procedures, competing priorities). Theme 4 describes the importance of social influences (e.g., physicians and family, peers/colleagues) that may affect decisions to participate and the importance of patient preferences (e.g., availability of physicians to discuss the trial, including caregivers in discussions).

Conclusions: Prospectively addressing these issues may help optimize feasibility prior to conducting an expensive, resource-intensive trial.

Keywords: cellular therapy; clinical trials; mesenchymal stromal cells (MSCs); perioperative myocardial infarction; stromal cells; theoretical domains framework.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cell- and Tissue-Based Therapy
  • Humans
  • Physicians*