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

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 background and points are discussed?

The US has federal regulations that classify different forms of treatments and dictate what procedures and reviews must occur before clinical trials are permitted to commence. Dr Turner’s investigation revealed numerous clinical studies listed on ClinicalTrials.gov that use stem cells (and other cell mixtures) generated by collecting and processing a patient’s own fat tissue, bone marrow, blood, or other bodily tissues. Representatives from several stem cell businesses claim that the stem cells administered in their studies meet specific criteria that exempt them from FDA oversight in the form of reviewed and cleared Investigational New Drug applications. However, Dr Turner provides an extensive list of references showing that the FDA classifies stem cells obtained using methods described in these studies as biological products or drugs. Therefore they should undergo review by the FDA before clinical trials begin. Numerous clinical studies listed on ClinicalTrials.gov were shown by Dr Turner to require patients to pay fees. Yet, these studies do not appear to have obtained permission from the FDA to charge study subjects, as federal regulations require. Some listings state that their study is ‘Patient-funded’, ‘patient-sponsored’ or ‘self-funded’ but many listings do not disclose on ClinicalTrials.gov that study subjects are charged fees to participate. Well-designed, scientifically sound clinical studies typically examine the effect of a new investigational agent on a specific disease or injury. Surprisingly, many pay-to-participate clinical studies include study subjects with a wide range of diseases and injuries. For example, one company cited by Dr Turner claims to be assessing the use of cells isolated from fat tissue to treat neurodegenerative diseases, erectile dysfunction, autoimmune diseases, cardiomyopathies, emphysema, lung conditions, Parkinson disease, ALS, and other diseases and injuries. This clinical study aims to enrol 3000 subjects, but doesn’t state on the ClinicalTrials.gov listing that it charges study subjects $6000 or more to enrol. All the businesses found by Dr Turner to be listing questionable clinical studies on ClinicalTrials.gov can be found in his paper “ClinicalTrials.gov, stem cells and ‘pay-to-participate’ clinical studies”.