Cash-Based Stem-Cell Clinics

Abstract

Update This article was updated on January 14, 2020, because of a previous error. On page 1, in the Abstract and the section entitled “Case Reports,” the word that had read “Genentech“ now reads “Genetech.” An erratum has been published: JBJS Case Connect. 2020 Feb 5;10(1):e0363ER. Case: The use of biologics is rapidly expanding. Over the past decade, there has been a significant increase in the number of cash-based “stem cell”/regenerative medicine clinics in the United States. These clinics provide cash-based services touting stem cell injections to cure a myriad of conditions. Largely, these clinics are unregulated and using injections in a non–Food and Drug Administration–approved manner. We report on 2 patients who presented with symptoms suggestive of septic arthritis following stem cell injections by cash-based local stem cell clinics. Case 1 involved a patient who developed septic arthritis following an injection of umbilical cord blood–derived cellular products (Genetech) and required an antibiotic spacer followed by a total hip arthroplasty. Case 2 involved a patient who developed a likely immune-mediated reaction following an injection of morselized human placental allograft tissue by a local chiropractic office at a cost of approximately $8,000. Conclusions: We present these cases to bring increased awareness to the issue and call for increased regulation of this practice.

Colony Forming Potential and Protein Composition of Commercial Umbilical Cord Allograft Products in Comparison With Autologous Orthobiologics

“…43,44 Further, multiple cases of localized and systemic infections have been attributed to bacterially contaminated commercial UC allograft products, resulting in lengthy hospitalizations and prompting a nationwide recall notification. 28,36 The FDA has recently issued regulatory actions, in the form of untitled letters (Chara Biologics Inc and Rich-Source Stem Cells Inc) 41,42 and warning letters (Liveyon Labs Inc and Stemell Inc), 43,44 against the suppliers of most UC allograft products tested in this study, reiterating that they should be regulated as 351 HCT/P drugs for their nonhomologous use and claims of metabolically active cells rather than as 361 HCT/Ps, the position these tissue product manufacturers had previously taken. To date, the only FDA-approved stem cell drugs are intended for hematopoietic and immunologic reconstitution.…”

Untitled

“…Concerns have been raised about the impact of stem cell research on the public by scientific societies, the research community, and regulatory authorities 67 . The scientific enthusiasm surrounding these treatment modalities has given rise to some unproven therapies which are often expensive 44,68,69 . The number of stem cell clinics has grown five-fold in the last 5 years.…”

JBJS Case Connector

“…Although those recommendations were appropriate at the time, more recently, the use of web-based communication and more flexible search tools, allowing greater accessibility to aggregated content, has allowed Case Connector to broaden the scope of publishable case reports 2 . Illustrative examples of the types of orthopedic problems published in Case Connector include unexpected experience with a new drug or device 3,4 , exceptional presentation of a disorder that itself may not be rare 5,6 , unexpected revelation related to new technology 7,8 , early experience with a new procedure 9 , unexpected complications 10,11 , rare neoplasm or genetic disorder 12,13 , and exceptionally long follow-up of an unusual event 14 . The increasing use and evolution of the search capabilities on jbjs.org have brought continued efficiency to discovering cases of use to clinicians.…”