Introduction

Numerous clinics, in the United States and abroad, have publicized stem cell–based intervention (SCBI) to treat a variety of illnesses and injuries. Unfortunately, very few of these published “investigators” have conducted the clinical research necessary to ensure safety and efficacy. Unproven SCBIs pose serious problems for the public and for the field of regenerative medicine itself. These clinics prey on individuals who are desperate for treatments and cures—offering hope to people with autism, human immunodeficiency virus, multiple sclerosis, and Parkinson disease, to cite a few examples. Marketing their procedures on websites via videos and testimonials from patients, they play on emotions rather than clinical facts. Treatments cost from $3,500 to more than $400,000.

In the United States, unproven SCBI clinics typically use a patient’s own stem cells, moving cells from one location to another in the body (injecting adipose cells into an injured knee, for instance). Using high-quality cells and the optimal dosage for a specific treatment probably leads to the best clinical outcomes. Yet SCBI clinics often do not check the consistency, viability, or number of cells, nor do they use specific biological markers or physical metrics to measure outcomes. Moreover, they do not perform follow-up evaluations for prolonged periods of time, unless they are trying to get patients to return for regular treatments.

Scientists, regulators, patients, and patient advocates are all stakeholders. But because each perceives the risks, benefits, priorities, and goals differently, each promotes different SCBI practices and policies. To develop an effective policy for SCBIs, stakeholders must collaborate to distinguish between their different perspectives and to reach compromises that best meet competing demands and best respond to the growing number of unproven SCBI clinics.

Read the full article in Texas Heart Institute Journal.