Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions

Abstract

The promise of stem cell (SC) therapies to restore functions of damaged tissues and organs brings enormous hope to patients, their families, loved ones, and caregivers. However, limits may exist for which indications SC therapies might be useful, efficacious, and safe. Applications of innovative therapies within regulatory boundaries and within the framework of controlled clinical trials are the norm in the scientific and medical community; such a system minimizes patient risk by setting a clear and acceptable safety and efficacy profile for new therapeutics before marketing authorization. This careful clinical validation approach often takes time, which patients suffering from terminal or debilitating diseases do not have. Not validated, unproven stem cell interventions (SCI) that promise a working treatment or cure for severe diseases have therefore found their way into the patient community, and providers of such treatments often take advantage of the public's willingness to pay large amounts of money for the misguided hope of a reliable recovery from their illnesses. We conducted a review of scientific publications, clinical case reports, and mass media publications to assess the reported cases and safety incidents associated with unproven SCI. The review also analyzes the main factors that were identified as contributing to the emergence and global rise of the “stem cell tourism” phenomenon. stem cells translational medicine 2018;1–10

Glioneuronal Growth Infiltrating Lumbosacral Nerve Roots Following Intrathecal Stem Cell Injections Highlighting Perils of Stem Cell Tourism

“…Stem cell tourism has become popular for the treatment of neurological disorders, but the safety of a wide variety of the associated stem cell therapies remains a concern. Few reports illustrate the potential complications of intrathecal a neural stem cell injection, including cauda equina syndrome due to glioproliferative lesions of the spinal cord . In the current paper, we report a case of growth of glioneuronal tissue on lumbosacral nerve roots causing polyradiculopathies following serial intrathecal stem cell injections from an international stem cell clinic with the intention to “cure” Parkinson's disease.…”

“…Few reports illustrate the potential complications of intrathecal a neural stem cell injection, including cauda equina syndrome due to glioproliferative lesions of the spinal cord. [1][2][3][4] In the current paper, we report a case of growth of glioneuronal tissue on lumbosacral nerve roots causing polyradiculopathies following serial intrathecal stem cell injections from an international stem cell clinic with the intention to "cure" Parkinson's disease. This case underscores the serious concern regarding potential complications of stem cell transplantation at these unregulated international stem cell clinics.…”

Medical Crowdfunding for Unproven Medical Treatments: Should Gofundme Become a Gatekeeper?

“…In some cases, access can provide individuals with hope or a continued sense of purpose that may have psychological benefits or, at least, a placebo effect that improves the quality of recipients’ lives, even if these interventions do not provide any direct medical benefit. However, people have been directly harmed by unproven treatments whose safety has not been demonstrated, as in cases of individuals who died or suffered significant negative health impacts from unproven stem cell interventions . In other cases, individuals may substitute proven effective treatments with unproven treatments or forgo palliative care in favor of pursuing ineffective interventions.…”

Designer Stem Cells: Genome Engineering and the Next Generation of Cell‐Based Therapies

“…[22][23][24] Despite the lack of clear evidence to support these "stem cell" therapies, numerous clinics continue to offer unproven procedures in the United States, with an unknown number of such clinics outside the United States offering various cell therapies as medical tourism. Not only do many of these procedures not involve actual stem cells, there have been a number of serious adverse effects that have been documented due to unproven stem cell therapies, 25 including growth of a mucus-producing nose in the spine, 26 tumor formation, 27 blindness, 28 and infection. 29 Indeed, the results of less than half of the stem cell clinical trials are published, suggesting that many negative findings in the stem cell field go unreported.…”