“Hey Doc, I saw an advertisement for stem cells to regenerate joints, since nothing has worked, is it time for me to have this done on my bum knee?”

Stem cell therapy has drawn interest as a novel approach to treat difficult medical conditions. Hematopoietic stem cells retrieved from the bone marrow or blood are being used successfully to replace bone marrow damaged by chemotherapy regimens. These treatment regimens continue to be studied and refined and are now a widely-accepted treatment option.

Successfully replacing bone marrow damaged by chemotherapy regimens used to treat leukemia, lymphoma and multiple myeloma is one type of stem cell treatment. Does medicine support the use of stem cells for orthopedic conditions? Has research and science confirmed that these treatments are ready for prime time?

The demand for this type of stem cell treatment is referred to as “regenerative medicine.” Regenerative medicine clinics have sprung up as a response to the interest, offering hope to those desperate to treat difficult conditions. They have commercialized therapies that are not FDA approved and are offering “patient-funded research” using adult mesenchymal stem cells.¹ This type of stem cell can be harvested from the bone marrow or by liposuction from adipose fat tissue in the flank or abdomen.

Stem cells are multipotent cells with the potential for maturing and differentiating into more complex cells and tissues. The underlying hope is after removal and isolation of one‘s own stem cells they may be reintroduced into a diseased joint or tissue where they will sense the underlying disease process. They hopefully will differentiate, grow and mature resulting in curing the disease with no secondary adverse effects.  Interest in this treatment has included applications for hard to treat conditions such as cancer, autoimmune disorders, heart failure, blindness, arthritis, neurodegenerative diseases, paralysis and even autism.

Is it possible that these cells can release chemicals or alter the immune response to help pain and other symptoms? Is it possible that these cells can develop and replace cartilage that has been damaged over time from repetitive wear and tear? These are questions that have not yet been answered by clinical studies, yet the regenerative medicine clinics have gone forward with the treatments.²

One local clinic has even included case reports with claims on their website suggesting benefits for Parkinson’s disease and preventing the need of liver transplant in a man suffering from sclerosing cholangitis.

The providers and practitioners of these unproven treatments are reimbursed handsomely and justify their approach with anecdotes. They charge thousands or tens of thousands of dollars for this “patient-funded research.” Rather than supporting treatment with evidence from peer reviewed research they provide celebrity videos, blogs or stories relating patients’ experiences or recommendations for others. It is not at all clear if the treatment is beneficial or if after investing large sums of money for these treatments patients report improvement rather than admitting they were taken advantage of by a hoax.

The literature is full of complications related to stem cell therapies. Recently blindness related to treating macular degeneration and paralysis related to treating stroke have been described.³ Fewer adverse effects related to orthopedic applications have been reported, but this may be due to no reporting requirements. The adverse effects of stem cells are not known.

I would strongly advise against orthopedic applications of stem cell therapy and regenerative medicine based on the current evidence.  Let the buyer beware.

These treatments have not been proven to be effective and can be costly. BCBSKS considers regenerative medicine techniques experimental/investigational, a contract exclusion, and does not provide reimbursement. Additionally, any complications relative to such an excluded service would be excluded and not covered. Anyone with a bum knee should discuss available time tested treatment options with their physician.

Kent Haverkamp, M.D., is board certified in both internal medicine and pediatrics. Prior to joining BCBSKS in 2013 as a medical director, Haverkamp worked for Cotton-O’Neil Clinic from 1993 to 2013 as a primary care provider for adult and pediatric patients.

¹ Peter W. Marks, M.D., Ph.D., Celia M. Witten, Ph.D., M.D., and Robert M. Califf, M.D.N Engl J Med 2017; 376:1007-1009

² Hermes Taylor-Weiner, Ph.D., and Joshua Graff Zivin, Ph.D.N Engl J Med 2015; 373:985-98

³ Kuriyan AE, Albini TA, Townsend JH, et al. Vision loss after intravitreal injection of autologous “stem cells” for AMD. N Engl J Med 2017;376:1047-1053