Category: Clinical

Month: 17 Mar 2017

Issue: not yet available

Three patients are reported to have suffered significant vision loss following “stem cell” treatment in a Florida clinic

A brief report, published in the New England Journal of Medicine (NEJM 2017;376:1047-53), has highlighted three cases of severe vision loss in elderly female patients following autologous “stem cell” treatment. The report, from the Bascom Palmer Eye Institute, University of Miami, Florida, follows the management of three cases of vision loss in patients with age-related macular degeneration (AMD) who had presented following a “treatment” of bilateral intravitreal injections of autologous adipose tissue–derived stem cells at a “stem-cell clinic” in Florida. Following the “stem cell” procedure, in June 2015, the patients were referred to two separate university ophthalmic practices and evaluated by experienced qualified ophthalmic specialists.

 

According to the NEJM report, each of the patients had been treated in a clinic in which adipose autologous tissue was taken from the abdomen by liposuction and was then processed to obtain supposed stem cells. The liposuction aspirate underwent laboratory preparation before being suspended in the patient’s own platelet-rich plasma prior to immediate intravitreal injection into both eyes. Prior to the so-called stem cell procedure, patient 1, a 72 year old woman, had best-corrected Snellen visual acuity of 20/60 in the right eye and 20/30 in the left eye; in patient 2, a 78 year old woman, previously diagnosed with quiescent neovascular AMD, best-corrected Snellen visual acuity was 20/50 in the right eye and 20/100 in the left eye, and; in patient 3, an 88-year-old woman, visual acuity was 20/40 in the right eye and 20/200 in the left eye. Within a year of the treatment, patient 1 had no light perception in either eyes, patient 2 only had perception of hand motion in the right eye and 20/200 in the left eye, while patient 3’s visual acuity was reduced to perception of hand motion in the right eye and light perception only in the left eye.

 

The authors of the NEJM report stated that at least one of the patients had found the

stem-cell clinic through its listing on Clinical-Trials.gov (NCT02024269). The patients are understood to have paid $5,000 for the bilateral procedure and, while the clinic responsible was not named in the NEJM report, the New York Times identified the location of the clinic to be in Sunrise, Florida and that the clinic was part of a company previously called Bioheart, but presently called U.S. Stem Cell. A10K filing at the SEC for US Stem Cell confirms the origins of the company in Bioheart Inc, incorporated in August 1999, and refers shareholders to a website (http://usstemcellclinic.com/en/about-us/) which lists details of several stem cell procedures, including patient testimonials. The company’s SEC 10K filing additionally reports that at least one of its trials with adipose stem cells resulted in 100% of patients experiencing improvement, or no change, in their condition within 3 months of treatment. The same SEC filing states that Institutional Review Board submissions for treatment of dry macular degeneration, originating in 2013, are now discontinued. The company listed recognized revenues in FY2016 of $3,083,261 “generated from the sale of test kits and equipment, training services, patient treatments and laboratory services, and cell banking”. The top two executives had recorded remuneration in excess of $2.5M between them for FY2016 while, at time of writing, the company had a market cap of <$2M.

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