U.S. Businesses using ClinicalTrials.gov to market unproven and unlicensed stem cell interventions

Written by Regenerative Medicine

To further public understanding of regenerative medicine, EuroStemCell has published lay summaries for all articles from the latest Regenerative Medicine special focus issue.

EuroStemCell have launched a digital platform to accompany the publication of the Regenerative Medicine two-part Special Focus Issue entitled “Regenerative Medicine in Society: Interdisciplinary Perspectives”. The platform presents lay summaries of each article in the issue which are freely available to all in order to engage and educate non-experts on the key issues surrounding regenerative medicine.

You can now read the lay summary for the article entitled, “ClinicalTrials.gov, stem cells and ‘pay-to-participate’ clinical studies” from Leigh Turner [1].

Businesses in the US are registering pay-to-participate stem cell studies on ClinicalTrials.gov. A recent examination of clinical studies registered on ClinicalTrials.gov revealed multiple study listings that have not been appropriately reviewed and cleared by the FDA and are being conducted by businesses that charge study participants. To avoid the erosion of public trust in the database, studies submitted to ClinicalTrials.gov need to be properly screened before being registered and listed.

What questions & challenges are raised? What insight and direction does this give for research policies? To find out, read the full lay summary on the EuroStemCell website here: https://www.eurostemcell.org/regenerative-medicine-society/us-businesses-using-clinicaltrialsgov-market-unproven-and-unlicensed

The full original article can be accessed here: https://www.futuremedicine.com/doi/10.2217/rme-2017-0015

Read an interview with Leigh Turner on what prompted him to write the paper here: https://www.regmednet.com/users/1122-regenerative-medicine/posts/18659-pay-to-participate-stem-cells-studies-an-interview-with-leigh-turner

References

[1] Turner L. ClinicalTrials.gov, stem cells, and pay-to-participate clinical studies. Regen. Med. 12(6), 705—719 (2017).