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

内容摘要

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. 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. 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. Many people suffer from musculoskeletal conditions like osteoarthritis, a joint disease where cartilage wears down over time. Unfortunately, current treatments are not always effective in reducing pain and helping maintain quality of life. Regenerative medicine, which includes stem cell interventions, is a promising area of biomedicine. It may produce better treatments for different issues, including musculoskeletal conditions, but there are many unknowns that need further study. Nonetheless, there are stem cell-related treatments available on a direct-to-consumer basis that are still unproven, or “non-standard.” These practices raise concerns including regarding risks to patients. Policy and regulatory efforts are underway in countries, including Canada, to address these concerns and to encourage innovation in regenerative medicine and related fields, while protecting patients. This study offers evidence to inform this important work. Drawing on interviews with eight Canadians with musculoskeletal conditions, this research sheds light on what is important to them for developing trust in nonstandard stem cell treatments and in the healthcare professionals who provide them. Participants’ experiences of pain and frustration with their condition(s) were key in prompting interest in nonstandard stem cell treatments. They also looked to diverse healthcare providers to help navigate and interpret information about treatment options. While not overly familiar with oversight of health products or providers in Canada, our participants discussed their assumptions about the protection regulation offers. More research is needed, but these findings highlight the value of accounting for patients’ perspectives and of prioritizing provider education and oversight in efforts to strengthen regenerative medicine governance.