Last year, a 77-year-old woman traveled to a clinic in
Georgia to have stem cells injected in her eyes. She came in hope of a cure—or
at least something that could help her macular degeneration, which causes a
dark spot to appear in the center of vision.
The procedure was supposed to work like this: The clinic
would take fat from her belly, separate out stem cells that naturally occur in
fat, and inject them into her eyes to regenerate damaged tissue. The procedure
cost $8,900. It had not been approved by the Food and Drug Administration and
was not covered by insurance. To pay out of pocket, she had to raise money on a
crowdfunding site.
Her vision did not get better. It got much worse. Within
three months, her retinas—the eye’s layer of light-sensitive cells—had peeled
away from the rest of her eyes. As a result, she can only make out hand motions
in her right eye and light in the left, according to a recent case report. She
could no longer walk on her own.
In March, eye doctors based primarily at the Bascom Palmer
Eye Institute in Miami had published a widely covered report describing three
eerily similar cases: Three elderly women with macular degeneration got stem
cells derived from their own fat injected into their eyes at a different
stem-cell clinic in Florida. The same thing happened: Their retinas became detached,
and they went blind. The doctors ended up examining the 77-year-old woman too,
which led to the recent case report describing her condition.
And there are likely even more cases. Since writing the
first report, says Ajay Kuriyan, an author on the report and now a retinal
specialist at the University of Rochester, eye doctors around the country have
come forward with similar stories of stem-cell injections gone awry. They are
now preparing an article describing the additional cases.
Stem-cell clinics that offer seeming miracle cures for
everything from back pain to erectile dysfunction have proliferated in the
United States in the past decade. These cases of blindness now cropping up in
the medical literature point to the potential dangers of letting hundreds of
such clinics operate without oversight.
In August, the FDA moved toward a crackdown. It posted a
warning letter to the Florida clinic that had treated the first three women and
called the fat-derived stem cells an unapproved treatment. On the same day, the
agency announced that federal marshals had seized live-virus vaccines from a
California company that was injecting the viruses along with stem cells into
cancer patients. After the news broke, says Mark Berman, a plastic surgeon and
the California company’s director of stem-cell implantation,“I’ve actually had
patients call me up, cancel their surgery, demand their money back, and tell me
what a disgusting human being I am and I should be removed from this planet.”
He criticized the initial news reports as “classic leftist kind of propaganda,
fake news.”
Berman also cofounded the Cell Surgical Network, of which
the Georgia clinic that treated the 77-year-old woman is an affiliate. The
network trains affiliated doctors to use their equipment and follow their
stem-cell therapy protocols.
The case report does not name the Georgia clinic, but The
Atlantic has independently confirmed it is the Stem Cell Center of Georgia,
which operates within the Ageless Wellness Center in Peachtree City. The clinic
declined to comment for this story. A local news report from June 2016 quotes
the center’s doctor as saying, “We have an ophthalmologist who is going to
treat three people with macular degeneration with intraocular injections.”
Berman says that his network’s affiliates have performed
about 15 eye procedures total. They stopped offering it after the woman went
blind. (Cell Surgical Network and the Stem Cell Center of Georgia both still
list macular degeneration on their websites.) The injections, he says, were
part of a study approved by an institutional review board. At the clinic, the
77-year-old woman received injections into her two eyes one day apart. Berman
concedes that they should have waited longer to make sure there were no serious
side effects after the first eye. “That’s a pretty good lesson learned.
Unfortunately it was learned by doing them,” he says.
Others say the clinic should have known better. “It’s just
not a professional thing to take an unproven intervention and inject it in both
eyes,” says Leigh Turner, a bioethicist at the University of Minnesota, who
tracks stem-cell clinics. Kuriyan says that injecting both eyes and asking
patients to pay out of pocket for their treatment are both highly unusual for
clinical trials. “Those are all big red flags,” he says. A better approach, he
says, would have been to test the injections in animals for safety first.
It’s unclear exactly why the stem-cell injections caused
such a bad reaction in these women. Perhaps the stem cells had differentiated
into cells that formed a membrane and then contracted, peeling the retina away
from the rest of the eye. Or perhaps there was scarring caused by immune cells,
which are part of the mix of cells in fat that can be injected along with stem
cells into the eye.
Given the growing number of retinal detachments coming to
light, Turner wonders if there are other consequences of stem-cell injections
that have not been reported. Berman says that the Cell Surgical Network has
performed 7,000 stem-cell injections into various parts of the body, and the
77-year-old woman’s case is “the only real significant problem we’ve had.” A
FDA inspection report from July chastised his network for failing to
investigate and report four “serious adverse events” to the FDA, including the
77-year-old woman’s case as well as a hip infection, another “severe
infection,” and a case where a patient was hospitalized for confusion and
headache.
The FDA has drafted guidelines on how to oversee stem-cell
clinics. The agency says stem cells do not have to be regulated as drugs as
long as clinics follow certain standards, like if they only minimally
manipulate the cells and don’t change their purpose in the body. For example,
transferring fat from the belly to breasts would not fall under FDA purview
because the fat is still acting as fat. But if stem cells are being separated
from fat and then injected to treat a disease, then the FDA may have reason to
step in.
“The question to me is, ‘Will the FDA really dedicate the
resources that are needed?’” says Turner. The FDA very publicly criticized a
couple stem-cell clinics in August as a warning shot, but there are hundreds of
such clinics in the United States, and overseeing them all would require a
significant investment. In just the five years Turner has been closely tracking
the stem-cell industry, he says, business seems to have been booming.
Courtesy of a colleague
Nirwan RS, Albini TA, Sridhar J, Flynn HW Jr, Kuriyan AE.
Assessing "Cell Therapy" Clinics Offering Treatments of Ocular
Conditions using Direct-to-Consumer Marketing Websites in the United States.
Ophthalmology. 2019 Mar 21. pii: S0161-6420(18)32630-7. doi:
10.1016/j.ophtha.2019.03.019. [Epub ahead of print]
Abstract
PURPOSE:
"Cell therapy" is becoming increasingly available
to the public via online direct-to-consumer advertisement within the United States
(U.S.). The current study investigates the scope of "cell therapy"
clinics across the U.S. that advertise and offer "cell therapy" for
ocular conditions based on information provided on their websites.
DESIGN:
Cross-sectional study.
PARTICIPANTS:
The study included companies that are U.S.-based,
participate in direct-to-consumer online marketing, have websites that can be
data-mined with content analysis, and advertise therapy for ocular conditions.
METHODS:
Using a systematic, extensive keyword-based Internet search,
content analysis of company websites was utilized to identify, document, and
analyze U.S. businesses marketing "cell therapy" for ocular
conditions as of September 16, 2017.
MAIN OUTCOME MEASURES:
Clinic locations, source of stem cells used, route of
administration, marketed ocular conditions, and cost of treatment.
RESULTS:
Forty companies with 76 clinics use "cell therapy"
to treat ocular conditions. California (23), Florida (12), and Illinois (10)
contain the most clinics. All 40 companies specified sources of cells, which
included autologous adipose-derived stem cells (35; 67%), autologous bone
marrow-derived stem cells (8; 15%), amniotic stem cells (2; 4%), peripheral
blood-derived stem cells (2; 4%), umbilical cord blood stem cells (2; 4%),
allogenic bone marrow-derived stem cells (1; 2%), placental stem cells (1; 2%),
and xenocells (1; 2%). The most commonly marketed ocular conditions included
macular degeneration (35), optic neuritis (18), retinitis pigmentosa (17), and
diabetic retinopathy (16). The most common routes of administration were
intravenous (22) and "unspecified" (12); however, other companies
listed more ocular-specific routes such as intravitreal injections (2),
retrobulbar injections (2), eye injections (2), retrofundal injection (1),
sub-Tenon injection (1), intraocular injection with vitrectomy (1), and eye
drops (1). The cost of advertised "cell therapy" ranged from $4000 to
$10 500.
CONCLUSIONS:
"Cell therapy" for ocular conditions is readily
available via direct-to-consumer marketing strategies across the United States.
The "cells" are harvested from numerous sources and administered
through different methods for multiple ocular conditions at these "cell
therapy" clinics. Limited data for these treatments necessitates
advocating caution to physicians and patients about treatments offered at
commercial "cell therapy" clinics.
Hussain RM, Dubovy SR, Kuriyan AE, Zhou XY, Flynn HW Jr,
Albini TA. Clinicopathologic Correlations of Retinal Membranes
Associated With Intravitreal 'Stem Cell' Injections. Ophthalmic Surg Lasers Imaging
Retina. 2019 Feb 1;50(2):125-131.
Abstract
The histologic findings of a subretinal band and epiretinal
membrane (ERM) excised from two patients who developed retinal detachments
(RDs) after non-U.S. Food and Drug Administration-regulated intravitreal
"stem cell" injections are reported. Both membranes were composed of
fibrocellular tissue that stained positively with Smooth Muscle Actin and
Masson's trichrome, consistent with collagenous and smooth muscle composition.
CD34 immunostain (for hematopoietic cells) was negative for the subretinal band
and minimally positive for the ERM. The authors speculate that the "stem
cells" may cause RDs by differentiation into myofibroblasts that cause
tractional membranes, though further studies are warranted.
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