Regenerative medicine and the utilization of stem cells to treat countless diseases have expanded rapidly over the past several years. Although the science and purpose seem promising, proving the efficacy and determining what types of cells to utilize for particular diseases remain challenging. Although many physicians perform autologous cell transfers for patients, most would agree that this practice is less controversial than nonautologous (e.g., umbilical cord blood) transfers.
Over the past year and a half, while serving on the AAOS Board of Councilors (BOC), I heard countless stories of colleagues reporting nonautologous stem cell injections. I’ve also witnessed recent similar activity in my state of North Dakota and wanted to share our experience in helping curtail the practice.
The story is a familiar one. A nonphysician practitioner, not licensed in the state, opened a clinic in early November 2017 in one of North Dakota’s larger communities. Managed by a nonmedical provider, the clinic held free seminars during which participants were given information about failure rates of multiple orthopaedic procedures and were aggressively sold nonautologous injections as a nonsurgical option. Participants also were shown radiographs that illustrated improvement following stem cell injections.
The injections patients received were derivatives of umbilical cord tissue and blood. The website for this product specifically states that it is not approved by the Food and Drug Administration, and the website does not claim treatment with the product as a cure for any condition, disease, or injury. The patients were injected by advanced practitioners employed by the clinic. The cost of the injections was variable and based on how much the patient could afford, ranging from around $5,000 for a knee injection to upwards of $20,000 for a series of injections in multiple areas. If a patient said he or she could not afford a specific amount, the clinic would drop the price so as not to lose the business.
Our orthopaedic practice—the Bone & Joint Center in Bismarck, N.D.—started to receive an increasing number of questions from patients about the use of stem cells, which prompted our further inquiry into the clinic. When our patients asked why we didn’t perform nonautologous stem cell injections, we educated them on stem cell science, indications, and efficacy. We also explained that, as surgeons, we get paid less for a total knee arthroplasty than the cost of a knee injection at the stem cell clinic.
Realizing that this was a patient safety issue, the Bone & Joint Center, along with the North Dakota Medical Association, contacted the North Dakota Attorney General’s (NDAG) Consumer Protection Division in late November 2017. The NDAG also had received inquiries from consumers about the clinic and its ads, so the office had already started an investigation in mid-November 2017. As time went by, more patients contacted NDAG to file formal complaints against the stem cell clinic. NDAG was in communication with multiple medical entities in the state throughout the process. During a meeting with the affected medical boards, it was confirmed that NDAG would proceed with legal action, if necessary, to resolve the matter.
The focus of the investigation was to assess whether the efficacy of the nonautologous stem cell injections was based on sound scientific principles and data. The stem cell clinic was unable to provide documentation to support their use of the injections. In addition, the clinic could not provide any supporting documentation that substantiated many of the comments made to the patients, such as “end your pain now” and “we can literally regenerate any cell in your body.”
Upon conclusion of its investigation, NDAG settled with the clinic in May. The state district court issued a court order enjoining the clinic from engaging in nonautologous stem cell injections, and the clinic was required to pay civil penalties to the state and give refunds to some patients.
The NDAG Consumer Protection Division also approached the clinic’s two nonphysician practitioners with similar concerns. The NDAG obtained separate agreements with the nonphysician practitioners and filed with the state district court, and a court order was entered that enjoined them from administering the stem cell injections and making any misrepresentations, as well as required them to pay civil penalties to the state.
Our experience in North Dakota appears to be one of the few successes in this arena thus far. I believe that we, as physicians, need to be our patients’ advocates and protect them from significant financial loss and possible physical harm. If you hear from a patient with a problem or bad experience, encourage him or her to report the issue to the state’s attorney general. It is incumbent on physicians to ensure that state governments are aware of both patient complaints and medical community concerns.
To learn more about these cases, visit the NDAG website at https://attorneygeneral.nd.gov/consumer-resources/recent-enforcement-actions.
Duncan Ackerman, MD, practices at the Bone & Joint Center in Bismarck, N.D., and is a member of the AAOS BOC.