Unproven Stem Cell-Based Interventions: Addressing Patients’ Unmet Needs or Causing Patient Harms?
Scholars began reporting about this marketplace in the mid-2000s; however, there is no sign of it dissipating despite efforts from regulators and scientific societies. While there have been periodic and repeated calls for a global approach to combat the unproven stem cell intervention (SCI) market, little action has been taken.
In this chapter, I will define unproven SCI, describe the marketplace, and discuss the risks to patients, clinical research, and regulatory authorities as well as the discontent between patients and regulators regarding what is safe to use in the clinic. I will also review current regulatory efforts to curb the market’s growth. Finally, I will argue for a series of strategies will be presented that can better inform patients and harmonize regulatory efforts between countries.
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