Three South Florida women suffered serious loss of vision soon after receiving stem cell treatments for age-related macular degeneration (AMD) at a Broward clinic in 2015, according to a study published today recently in the New England Journal of Medicine.
The retinal detachments, bleeding in the eyes and other blinding complications in these three patients raise concerns about stem cell clinics that charge patients for their services and that lack clinical data to support their practices, said Thomas Albini, MD, associate professor of clinical ophthalmology at Bascom Palmer Eye Institute and co-author of the study.
Albini said the three patients ages 72, 78 and 88 were concerned about losing their independence, including the ability to drive, due to AMD, a disorder that involves the gradual loss of the eyes photoreceptor cells and the leading cause of vision loss among elderly patients in the United States.
Patients seeking stem cell treatments for medical problems should only consider a carefully controlled clinical trial at an academic medical center, Albini said. Paying thousands of dollars to a local clinic for an unproven stem cell treatment as these patients did is extremely risky with a low probability of a successful outcome.
Five other Bascom Palmer physicians were co-authors of the study, Vision Loss after Intravitreal Injection of Autologous Stem Cells for AMD, in the journal: Ajay E. Kuriyan, MD; Justin H. Townsend, MD; Marianeli Rodriguez, MD, PhD; Philip J. Rosenfeld, MD, PhD; and Harry W. Flynn Jr., MD. Other co-authors were faculty members from the University of Rochester Medical Center; Dean McGee Eye Institute, University of Oklahoma; Center for Sight, Sarasota, and Byers Eye Institute, Stanford University.
In the study, the Bascom Palmer ophthalmologists discussed how the Broward clinic (its name was not disclosed) first harvested stem cells from the adipose fat tissues of the three patients and then injected the cells into both eyes of each patient.
Within 36 hours of their treatment at the Broward clinic, two of the three patients sought emergency care at Bascom Palmer for serious blinding conditions including ocular hypertension, vitreous hemorrhage, retinal detachment, and/or lens dislocation. Although the patients had suffered only moderate vision loss prior to their treatment, a year later their visual acuities ranged from 20/200 to total blindness.
While numerous stem cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem cell clinics are treating patients without that oversight and with potentially little concern for patient safety, Albin isaid. In this instance, these patients paid $5,000 each for a procedure that had never been studied in a clinical trial for possible improvement of vision.
Albini said the patients might have developed vision loss from retinal or optic nerve toxicity from the injected stem cells, enzymes or other materials, or from elevated intraocular pressure (IOP), which damages the optic nerve.
Several cellular therapy approaches are now being investigated by U.S. Food and Drug Administration (FDA) registered and Institutional Review Board (IRB) approved clinical trials, according to the study.
As of Nov. 2, 2016, at least 13 trials were registered on ClinicalTrials.gov studying the role of intravitreal injections of various stem cell populations. However, Albini cautioned that not every trial registered on the site has been approved by an IRB or the FDA.
Some clinics are claiming that treatments using the patients own stem cells dont require FDA oversight or clinical trials, even though there is no evidence the treatments are safe or effective, he said. Almost all legitimate research is funded by an institution or company with an established protocol, lots of pre-clinical data and extensive pre-trial and post-trial evaluations.
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