In early 2017, I was shocked – along with the rest of the world – to hear that three AMD patients had suffered permanent vision loss after receiving an unapproved stem cell therapy at a clinic in Florida (1). Disturbingly, the story got murkier: the patients had paid $5,000 each to receive the autologous-derived stem cell injections (AASCIs). And despite a clinical trial being registered at the clinic (NCT02024269; withdrawn in September 2015 – three months after the experimental ‘treatments’), none of the patients actually knew that they were participants. Further investigative journalism revealed that two of the physicians on the approving ethical board had troubled disciplinary histories (2).
At the beginning of 2018, I was even more shocked to discover that the above incident was not isolated. In a case report published in the January issue of JAMA Ophthalmology, Andrew Rong and colleagues described a male patient who presented with poor visual acuity (hand motion in the right eye and 20/30 in the left eye), and a pupillary defect and extensive proliferative vitreoretinopathy in the right eye (3). Six months prior, the patient had received AASCIs for retinitis pigmentosa – and paid $4,000 for the privilege. Lured to a stem cell clinic in Florida by a television commercial, the patient had been referred to an office in the Dominican Republic for the ‘treatment’, but received no follow-up care despite experiencing visual problems. It had happened again – and it wasn’t the only case described.
It’s been playing on my mind ever since. Could this be a growing problem in the US with more patients at risk? Rong certainly thinks so, blaming the rise of profiteering stem cell clinics who peddle promising research rather than proven therapies. The fact that autologous cell procedures sit in a regulatory ‘gray area’ depending on how they’re prepared also plays a role – especially when unscrupulous individuals seek to evade oversight by downplaying the extent to which the cells are manipulated.
So who is ultimately responsible for protecting these sometimes-desperate patients? Do ophthalmologists need to shout louder or should regulatory agencies take charge? It seems to me that an ‘all hands on deck’ approach might be the best way to tackle the rising tide – not only to save sight but also to preserve public trust in stem cell therapies of the future.
Ruth Steer
Managing Editor
- AE Kuriyan et al., “Vision loss after intravitreal injection of autologous ‘stem cells’ for AMD”, N Engl J Med, 376, 1047–1053 (2017). PMID: 28296617.
- P Aldhous, BuzzFeed News (2017). “An experiment that blinded three women unearths the murky world of stem cell clinics”, Available at: bit.ly/AldhousBuzz. Accessed January 25, 2018.
- AJ Rong et al., “Vision loss secondary to autologous adipose stem cell injections: a rising problem”, JAMA Ophthalmol, 136, 97–99 (2018). PMID: 29192301.
