Patients left blind after
paying for experimental stem cell treatment
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[March 16, 2017] By
NEW YORK (Reuters Health) - Researchers are
warning consumers to be wary of doctors who claim to be able to cure
illness using stem cells after three women, at least two who thought
they were enrolling in a government-registered trial, were left legally
blind when the unproven therapy failed.
"The patients paid for a procedure that had never been studied in a
clinical trial, lacked sufficient safety data, and was performed in
both eyes on the same day," said the research team, led by Dr. Ajay
Kuriyan, assistant professor of ophthalmology at the University of
Rochester Medical Center in New York. Experimental injections into
both eyes at the same time "are both atypical and unsafe."
"We don't mean to say all stem cell clinical studies are dangerous,"
coauthor Dr. Thomas Albini of the University of Miami told Reuters
Health in a telephone interview. "There is solid clinical data
backing up its use for a number of conditions. But the studies need
to be done in traditional fashion with FDA (Food and Drug
Administration) oversight so we can know whether these treatments
actually work and are safe."
An estimated 600 clinics around the country are claiming to use stem
cells to treat a wide variety of disorders, sometimes without
"In this case these women participated in a clinical enterprise that
was off-the-charts dangerous,” said Dr. Albini, an associate
professor of clinical ophthalmology.
The unnamed women ages 72 to 88 were slowly losing their eyesight
through age-related macular degeneration, the leading cause of
blindness in the elderly. They sought treatment at a Florida clinic
that had announced a study to treat the condition on
clinicaltrials.gov, a federal database of research studies.
The analysis of their cases, published in Thursday's New England
Journal of Medicine, does not name the treatment clinic. The
announcement says it was sponsored by Bioheart Inc. of Sunrise,
Florida. The company is now known as U.S. Stem Cell Inc.
It released a statement Wednesday saying it no longer treats eye
patients and would not comment on specific cases "due to patient
confidentiality or legal confidentiality obligations."
Dr. Albini said at least two of the three women sued and their cases
were settled out of court.
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Each woman paid Bioheart $5,000 to have fat removed from their body
through liposuction. Extracted cells and blood plasma were then
injected into each eye during the same visit.
Legitimate medical research seldom requires patients to pay and, in
the case of eye treatments, only one eye is treated at a time so
doctors can gauge its effectiveness, the Kuriyan team said.
All three women ended up with detached retinas that left them blind
or virtually blind.
"Although numerous stem-cell therapies for medical disorders are
being investigated at research institutions with appropriate
regulatory oversight, many stem-cell clinics are treating patients
with little oversight and with no proof of efficacy," Dr. Albini and
his colleagues warned.
The fact that the doctors giving the injections were not eye
specialists and the study group was not affiliated with an academic
medical center should also have been warning flags for the patients,
Such clinics charge between $5,000 and $50,000 per treatment,
something that is never done in a major research study.
SOURCE: http://bit.ly/2mtwnWU New England Journal of Medicine,
online March 15, 2017.
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