Resources and Insights

In an effort to improve awareness and increase patient access to credible trials in regenerative medicine across a range of indications, True Trials has created a user-friendly, interactive map with a list of target diseases. This map identifies the locations of only those clinics with FDA-authorized regulatory status. Using this resource, patients will readily find and consider participation in regulated clinical trials. Such a tool will - for the first time - help patients specifically concentrate their interest and exploration on regenerative medicine clinical programs that have the data requisite to qualify for and conduct a clinical trial with FDA authorization.

The listings on clinicaltrials.gov are not screened with respect to FDA authorization, so having a listing on clinicaltrials.gov does not in any way mean that it is an FDA-authorized trial. For example, of the 207 results for a search of “mesenchymal stem cell” on clinicaltrials.gov, 86 list that they are studying an FDA-regulated drug or device, however, these do not actually indicate that they possess FDA-authorization via IND or IDE. Prospective patients are often unaware of this distinction.

The US Food and Drug Administration (FDA) has the authority to regulate regenerative medicine products, including stem cell products and exosome products. There is a lot of misleading information on the internet about these products, including statements about the conditions they can be used to treat. The FDA is concerned that many patients seeking cures and remedies may be misled by information about products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues that put patients at risk. The FDA wants to help consumers be informed about how these products are regulated when considering treatment. Stem cell products are regulated by the FDA, and all stem cell products require FDA authorization. Patients should be cautious of any clinics, including regenerative medicine clinics or healthcare providers, including physicians, chiropractors, or nurses, that advertise or offer such products commercially outside of an authorized clinical trial setting at a trusted institution or hospital.

Several high-visibility publications have provided maps and expositions of clinics with uncertain ethical and safety standards, advising people where not to go for treatment. The TrueTrials team believes that patients in need are particularly well-served by a more positive approach that shows them where they can and should go for treatment. TrueTrials uniquely features FDA-authorized clinical studies in regenerative medicine, including FDA-authorization numbers, targeted diseases, test agent identities, locations and contact information. This information is provided to the public using the optimized, accessible TrueTrials map. The map links a geographic site locator with the disease targets based on medical need, site location, and other key features.

We believe that this approach will serve the mutual interests of a wide range of stakeholders in the field. Patient education about trial existence will facilitate accelerated trial enrollment and maximize efficiency of resource utilization. The availability of this information will provide a safeguard for patients when selecting providers, limiting exposure to clinics that are not using an FDA-authorized approach and instead increasing access to clinics with known FDA-compliant regulatory status.