Unapproved stem-cell treatments touted on federal database ClinicalTrials.gov, study says
Stem cell clinics offering unapproved treatments for ailments from hip pains to autism to erectile dysfunction increasingly are using a federal clinical-trials database as a marketing tool — a strategy that confuses patients and exposes them to “unjustifiable” safety risks and high costs, according to a new study.
At least 18 purported clinical trials — all of which involve unregulated therapies and require patients to pay to enroll — are listed on ClinicalTrials.gov, the comprehensive registry for public and private clinical trials that is run by the National Institutes of Health, according to an article published Wednesday in the journal Regenerative Medicine.
Leigh Turner, who authored the study and is an associate professor at the University of Minnesota's Center for Bioethics and School of Public Health, said NIH should use much tougher screening tools to exclude from its database unapproved treatments, especially trials that require patients to pay to participate. [...]clinical research health law policy human subjects research medical safety public health regulation stem cells