Complications from “Stem Cell Tourism” in Neurology

Abstract

Stem cell tourism," the practice of offering unproven cellular preparations to patients as approved therapy, is rising in neurology. Currently, the experiences of patients and reported complications from these procedures are unknown in the United States. We evaluate academic neurologists' experiences with stem cell tourism and assess perceived competency on discussing this topic with patients. We found a lack of neurologist preparedness to discuss stem cell therapies with patients and an alarming list of unreported complications from these unregulated procedures. We also identified an urgent need for neurologist education and the creation of a national registry for reporting patient complications resulting from experimental stem cell interventions.

A Global Study of Haematopoietic Stem Cell Transplantation in Multiple Sclerosis and Other Neurodegenerative Disorders

“…The correct timing of HSCT has not been investigated. [13] The therapy has been discredited for early or mild disease, and there is no evidence that HSCT will help in progressive MS. [13] Greater research is needed into this area [14] to elucidate the effectiveness and timing in order to establish it as a proven therapy as MS patients are paying with their lives.…”

Inclusivity and diversity: Integrating international perspectives on stem cell challenges and potential

“…In this era of increasing pressure for international competitiveness, where some medicines regulatory frameworks become increasingly permissive, it is important that countries do not lower their regulatory thresholds without fully considering the consequences for patient safety, health care budgets, and public trust in science, and without ensuring that commitments on post-marketing studies are respected. Undesirable practices inherent in stem cell tourism in some countries (e.g., Skeen et al., 2019 ; Julian et al., 2020 ) are one consequence of the relative laxity in some national regulatory frameworks.…”

ISSCR’s Guidelines for Stem Cell Research and Clinical Translation: Supporting development of safe and efficacious stem cell-based interventions

“…Patients are drawn to such clinics by misleading advertising claims; widespread “hype” that assigns near-magical properties to stem cells; the sense of fear and desperation that sometimes accompanies being diagnosed with life-threatening or life-altering medical conditions; hope that they can receive effective treatments for their diseases, injuries, and painful symptoms; and other factors. The marketing and administration of unlicensed and unproven stem cell products sold on a direct-to-consumer basis has resulted in fatal outcomes, serious injuries, substantial loss of personal savings, and other significant harms to patients ( Berkowitz et al., 2016 ; Julian et al., 2020 ). Widespread marketing of purported stem cell treatments has also generated considerable public confusion concerning how to distinguish between cell-based products backed by substantial evidence of safety and efficacy and unproven stem cell-based interventions.…”