Factors that influence trust in non-standard stem cell therapies among patients with musculoskeletal conditions: a qualitative, constructivist grounded theory study.

AIMS: Stem cell interventions (SCIs) are an exciting area of regenerative medicine (RM) that may offer improved outcomes for many patients, including those suffering from musculoskeletal conditions. They can also raise regulatory tensions and policy challenges, including how to manage direct-to-consumer markets where nonstandard SCIs - those falling outside the standard of care and lacking sufficient evidence of safety or efficacy - are sold. Ongoing regulatory reform efforts in several countries, including Canada, to address these and other related issues would benefit from insights regarding what is important to patients for trust in SCIs and their providers. MATERIALS AND METHODS: Through interviews involving eight participants with musculoskeletal conditions, this qualitative, constructivist grounded theory study presents a preliminary model of factors that influence some patients' trust in nonstandard SCIs. RESULTS AND CONCLUSIONS: Participants' anticipated approaches to nonstandard SCIs were rooted in their lived experiences of pain and frustration, shaped through interactions with healthcare providers, and framed by assumptions about regulatory protection. Healthcare providers play a pivotal role in helping navigate and interpret information. These results highlight the importance of evidence-based approaches to governance that integrate patient voices, practitioner education, and regulatory accountability to protect patients and help advance responsible RM innovation.