In December 2019, Taliaferro et al published an article entitled “Cash-Based Stem-Cell Clinics: The Modern Day Snake Oil Salesman? A Report of Two Cases of Patients Harmed by Intra-articular Stem Cell Injections”. The article was published in the Journal of Bone & Journal of Surgery Case Connector, a journal that provides information to orthopedic surgeons for the discovery and reporting of unusual musculoskeletal problems, findings, treatments and outcomes in order to improve patient care.
Case 1 involved a patient who received an injection of an umbilical cord blood derived product and then developed septic arthritis. The patient was treated with antibiotics and then went on to receive a total hip arthroplasty. Case 2 involved a patient who received an injection of morselized human placenta allograft tissue and then developed what was considered to be a likely immune mediated reaction. Although these reported adverse events raise concern about safety, both are considered to be non-serious events as per the standard grading system used in research to classify the severity of adverse events and are relatively rare.
Septic arthritis is not just associated with stem cell injections. It has also been reported in intra-articular injections using common medications such as corticosteroids and hyaluronic acid.
In 2017, the center for disease control and prevention (CDC) reported an outbreak of 41 septic arthritis cases associated with intra-articular injections of pharmacy bulk packages products from a single outpatient clinic in New Jersey. An investigation identified multiple breaches of recommended infection prevention practices during the preparation and administration of pharmacy bulk packaged products. After the prevention recommendations were implemented within the clinic no additional septic arthritis cases were reported. The findings from this investigation highlight the importance of adhering to universal prevention protocols and sterile compounding standards. In 2011 Shemesh et al described six patients who developed septic arthritis of the knee following intra-articular injections of either a steroid preparation or hyaluronic acid in outpatient clinics. Albert et al reported two patients who developed septic arthritis of the knee after intra-articular injections of sodium hyaluronate alone or with corticosteroids. A single case of septic arthritis of the hip after an intra-articular injection of a steroid/lidocaine cocktail was reported by Nallamshetty et al in 2003.
Beyond reporting the two adverse events, the article by Taliaferro et al underlines that many cash based stem cell clinics use stem cell therapy in a non-FDA approved manner and are “touting stem cell injections to cure a myriad of conditions”. While there are such clinics that blatantly advertise curative effects without using human clinical data to support their claims, sweeping generalizations about stem cell therapy based on two cases does not accurately reflect the efficacy and safety shown in the majority of published research.
There also seems to be a palpable negative biasness towards stem cell therapy and those who offer this treatment by referring to them as “modern day snake oil salesman” in the title of their article.
In their conclusion, Taliaferro et al state that they report these cases in order to increase awareness of the potential danger of intra-articular stem cell injections from cash based clinics and to call for increased regulation of this therapy. This report adds to current body of evidence of potential adverse events of stem cell therapy and raises some concern about safety. However, this report only highlights relatively rare adverse events and does not reflect the safety and tolerability of intra-articular stem cell injections reported by most clinical trials.
Although all clinical interventions have the potential to cause adverse effects, the safety and tolerability of stem cell therapy has been clearly demonstrated in numerous studies involving large number of patients treated for various conditions including orthopedic conditions.
Please visit our Safety Research Archive for more information and clinical research on the safety of stem cell therapy.