Characterizing Dangerous, Unregulated Stem Cell Therapy for Ocular Disease


Though cell therapies have gained FDA approval to treat any ocular disease, companies have marketed predominately to patients with AMD, with procedures that could lead to blindness.

Direct-to-consumer marketing has put US patients at a heightened risk of falling for misleading or scam promotion of inefficient—or even dangerous—medicine. In particular, the promotion of advertised ‘cell therapies’ for patients of retinal conditions has become a major issue in the field.

A new study from researchers at the University of Rochester Medical Center has found that patients are susceptible to various online marketing strategies that could eventually cause them to spend up to $10,000 for falsely-advertised ‘cell therapy.’

After presenting the study’s findings at the American Society of Retina Specialists (ASRS) Annual Meeting in Vancouver, BC, author Ajay E. Kuriyan, MD, MS, assistant professor at the Flame Eye Institute and Strong Memorial Hospital at the medical center, explained the severe implications that may come from such marketing strategies to MD Magazine®.

“There’s no FDA- (US Food and Drug Administration) approved cell therapies for retinal disease at this point,” Kuriyan said. “However, patients have access to them through these clinics, and unfortunately, there have been some patients who have developed blinding conditions after treatment at these clinics.”

Kuriyan and colleagues sought out to better characterize the sites that market ‘cell therapy’ for retinal disease. By identifying US-based companies that have a history of participating in direct-to-consumer online marketing, as well as data-accessible websites and advertisements that include ocular condition therapy promotion, they were able to distinguish 37 companies that advertised ‘cell therapy’ for retinal disease.

Among US states, California (n= 20) had the most identified clinics, followed by Florida (11) and Illinois (9). Businesses with offices in the US but international practices were noted by researchers, but excluded from analysis.

Researchers analyzed companies for their source of cells used according to advertisement, the route by which cells were administered to patients, the ocular conditions advertised as being treated by the therapy, and the cost of care.

A majority of the companies (n= 33; 89.1%) reported as using autologous adipose derived stem cells, followed by marrow-derived stem cells (9; 24.3%). Other companies advertised as using placental stem cells (2; 5.4%), amniotic stem cells (2; 5.4%), peripheral blood-derived stem cells (2; 5.4%), and umbilical cord stem cells (2; 5.4%). Among all the companies, 8 (21.6%) offered to administer multiple cell types.

Nearly all the companies (34) marketed to patients with macular degeneration, and the most common routes of administration were intravenous (21) and “targeted injections” (16). Researchers noted the remaining routes of care were very specific: intravitreal injection (2), retrobulbar injection (2), retrofundal injection (1), and eye drops (1).

Advertised costs for these procedures ranged from $4000 to $10,500.

Having found distinct and consistent characteristics of these companies, Kuriyan advocated for a promotion of facts. The first line of advice he has for patients is also his simplest: if a company solely offers cell therapy for ocular conditions, don’t believe it.

“We know there are some legitimate cell therapy studies going on right now, and they can be at universities or even at private practices,” Kuriyan said. “But those private practices and universities offer other treatments.”

As the average age of patients with ocular conditions is commonly older, they could be more susceptible to false online advertisement, unless otherwise informed. The cost of what these unreliable therapies should not be an indication of their value. On the contrary, it’s another simple indication that the company is not to be trusted.

“Right now, since it’s not FDA-approved, the studies going on right now are funded and cover the costs for the patients,” Kuriyan said. “If you’re being asked to pay out of pocket, that’s a big red flag that you’re at one of these cell therapy clinics.”

The study, "Direct-to-Consumer Marketing by US “Cell Therapy” Clinics for Retinal Conditions," was presented at ASRS 2018 on Saturday.

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