Identifying the Risks of Unproven Regenerative Medicine Therapies

Abstract

In the middle of the coronavirus disease 2019 (COVID-19) public health response, many priorities are currently competing for the attention of the US Food and Drug Administration (FDA). Some of these are directly related to the pandemic, but others have been challenging issues for years. Over the past several years, hundreds of clinics across the US have been offering unproven regenerative medicine therapies to patients for the treatment of conditions ranging from aging to arthritis to autism.^1,2 Some of these same clinics are now offering similar unproven products for the treatment of complications of COVID-19 and are making claims that are simply not supported by compelling clinical data. Overall, the safety and efficacy of regenerative medicine products outside a narrow range of indications have yet to be demonstrated.³ Identify all potential conflicts of interest that might be relevant to your comment. Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued. Err on the side of full disclosure. If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response. Not all submitted comments are published. Please see our commenting policy for details.