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3.16.2017

Bascom Palmer Eye Institute Study Points to Dangers in Unproven Stem Cell Treatments

Three South Florida women suffered serious loss of vision soon after receiving stem cell treatments for age-related macular degeneration (AMD) at a Broward County clinic in 2015, according to a study published on March 15 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, M.D., co-author of the study and associate professor of clinical ophthalmology at Bascom Palmer Eye Institute, part of the University of Miami Health System and Miller School of Medicine.

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 eye’s 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,” said Albini. “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, M.D., voluntary assistant professor; Justin H. Townsend, M.D., assistant professor of clinical ophthalmology; Marianeli Rodriguez, M.D., Ph.D.; Philip J. Rosenfeld, M.D., Ph.D., professor of ophthalmology; and Harry W. Flynn, Jr., M.D., professor of ophthalmology. 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 (whose 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,” said Albini. “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 November 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 patient’s own stem cells don’t 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.”

About Bascom Palmer Eye Institute
Bascom Palmer Eye Institute is ranked the nation’s best in ophthalmology by U.S. News & World Report, an honor it has received for 13 consecutive years. In addition to its international reputation as one of the premier providers of eye care in the world, Bascom Palmer is the largest ophthalmic care, research and educational facility in the southeastern United States. Each year, more than 250,000 patients are treated with nearly every ophthalmic condition and more than 18,000 surgeries are performed. With five patient care facilities in Florida (Miami, Palm Beach Gardens, Naples, Plantation, and the Lennar Foundation Medical Center in Coral Gables), the Institute serves as the Department of Ophthalmology for the University of Miami Miller School of Medicine, part of UHealth-University of Miami Health System. Bascom Palmer faculty members also staff the Miami and West Palm Beach Veterans Affairs Medical Centers, Jackson Memorial Hospital and Miami Children’s Hospital. For information on Bascom Palmer Eye Institute, contact Marla Bercuson at (305) 326-6190 or mbercuson@med.miami.edu, or visit www.bascompalmer.org.

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