Shapiro, Shane

Introduction The unproven stem cell intervention (SCI) industry markets stem cell products to patients navigating chronic and serious conditions who seek alternative options when conventional treatments no longer offer relief or improvement. This market is often characterized by providers using deceptive advertising to misinform potential consumers to seek stem cells that have not been shown to be safe and/or effective through clinical studies. Objective This study examines how patients describe interpersonal and institutional trust in relation to their interest in and decisions about unproven SCIs among two distinct and divergent chronic disease patient groups: patients with little or no interest in unproven SCIs (low seekers) and those with high interest or have undertaken an unproven SCI (high seekers). Methods A semi-structured interview guide was developed deductively and modified inductively based on the Unified Theory of Health Behavior. Qualitative interviews among 36 patients and carers were conduct and transcripts were analyzed using constant comparison based on the principles of grounded theory. Results Trust varies across social contexts as low seekers expressed strong reservations about the commercialization elements of the SCI industry placing greater confidence in conventional medicine. In contrast, high seekers questioned the advice of conventional providers and motives of medical regulators. Across both, personal relationships were commonly described as influential in how participants evaluated unproven SCIs. Conclusion These findings suggest that communication efforts in clinical settings should account for the relational and emotional dimensions of trust. Interventions aimed at countering misleading information and promoting informed choices should engage trusted messengers and address the broader social and psychological contexts in which patients may seek unproven SCIs.

Abstract Background Osteoarthritis is a leading cause of disability worldwide, and cell‐based treatments including adipose‐derived and bone marrow aspirate have been sought by the lay and medical community as treatment options. Objective To perform a scoping review of published literature on cell‐based injections allowed by the U.S. Food and Drug Administration for the treatment of osteoarthritis to synthesize existing evidence and identify research gaps for future evaluation. Methods A comprehensive search of five databases was executed from inception through January 2, 2025. Studies that met the inclusion criteria were original research studies written in English on Food and Drug Administration‐allowed cell‐based treatments in adults with osteoarthritis of any joint. Results The database search yielded 4257 unique records. After screening, 84 studies met the inclusion criteria, encompassing 9996 patients and a total of 10,508 procedures. The primary research study designs were cohort studies ( n = 62), focused on treatment of knee osteoarthritis ( n = 63), and described bone marrow aspirate ( n = 42) and adipose‐derived ( n = 42) treatments. Postprocedure monitoring ranged from 6 weeks to 5 years, with most studies ≤1 year ( n = 59). Patient‐reported outcomes were reported in 83 of 84 studies; few provided imaging outcomes including magnetic resonance imaging ( n = 9) or radiographs ( n = 2). Conclusion This review identified limited randomized controlled trials, limited studies outside the knee, limited description of cell‐based treatments, and treatment protocols, along with inconsistent patient‐reported outcomes limited to 1 year in most studies. We propose establishing reporting guidelines in research on cell‐based therapies.