, stem cells and 'pay-to-participate' clinical studies

Research output: Contribution to journalReview articlepeer-review

31 Scopus citations


Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.

Original languageEnglish (US)
Pages (from-to)705-719
Number of pages15
JournalRegenerative Medicine
Issue number6
StatePublished - Sep 2017


  • FDA
  • NIH
  • clinical studies
  • pay-to-participate
  • regulations
  • stem cells

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