These Women Went Blind After A Florida Clinic Injected Fat Cells Into Their Eyeballs


Elizabeth Noble enjoyed a full and active life, and is
nobody’s fool. For more than a quarter-century, she taught
statistics in the School of Education at the University of
Missouri-Kansas City. In retirement, she continued to work as a
consultant, and travelled widely in Europe and Asia.

When Noble was diagnosed with Age-Related
Macular Degeneration, which slowly blurs the sharp central
vision that we rely on to read, drive, and identify faces, she
wanted to do something about it. And she thought she had found
an answer — a research
study described on ClinicalTrials.gov, a website run by the
National Institutes of Health (NIH), the US government’s
premier biomedical research agency.

It seemed scientifically legitimate, so in June 2015 Noble went
to a clinic in Sunrise, Florida, where staff sucked a small
quantity of fat from around her belly button, treated it with
enzymes to extract the cells it contained, and mixed those
cells with a sample of Noble’s blood plasma. They injected the
mixture into Noble’s eyeballs, charged her $5,000, and told her
to avoid strenuous activity for the next three days.

Three days later, when the 72-year-old was seen by doctors at
the University of Miami’s Bascom Palmer Eye Institute,
strenuous activity was out of the question. Noble’s eyes hurt
and she was nauseous. Her retinas were bleeding and she could
just make out a hand being waved in front of her face.

Noble’s sight continued to deteriorate and one year later she
couldn’t tell the difference between night and day. “That’s as
bad as it gets,” Thomas Albini, an ophthalmologist at the
Bascom Palmer Eye Institute, told BuzzFeed News, describing the
condition of the woman he identified only as Patient 1.

In the latest issue of the New England Journal of
Medicine
, Albini and his colleagues describe
the cases of three women treated by the same stem cell company,
each of whom became legally blind. The doctors don’t name the
women involved, but BuzzFeed News established the identities of
two of them from
court
filings and other public documents.

This isn’t the first time that people have been harmed by
clinics offering unproven treatments purportedly involving stem
cells. In 2010, for example, a woman with the autoimmune
disease lupus
died after her own bone marrow cells were injected into her
kidneys at a clinic in Thailand. And in 2013, the Florida
Department of Health
revoked the medical license of Zannos Grekos over the death
of a 69-year-old woman. He had extracted material from her bone
marrow, filtered it, and then infused it into the arteries
feeding her brain. The woman had a stroke, and died shortly
afterwards.

But the latest tragic cautionary tale has a disturbing twist,
as two of the women who were blinded contacted the company
involved, now called US Stem Cells but
formerly known as
Bioheart, only after reading about its macular degeneration
study on ClinicalTrials.gov.

The site was
launched in 2000 after Congress
passed a law demanding that the NIH keep a registry of
clinical trials — experiments with new drugs on volunteer
patients — so that drug companies couldn’t sweep negative
results under the carpet. ClinicalTrials.gov has since grown to
include some 290,000 studies run in countries across the globe.

But with only minimal screening of the listings, experts who
track the
burgeoning and loosely regulated landscape of stem cell
clinics fear that the website is being abused to claim spurious
legitimacy for unproven therapies that are being sold for
profit.

“It’s very easy to register studies on ClinicalTrials.gov and
essentially use a government website as a marketing device,”
Leigh Turner, a bioethicist at the University of Minnesota,
told BuzzFeed News.

Noble told the doctors at the Bascom Palmer Eye Institute that
she thought her treatment was part of a clinical trial.
Patients are not usually charged to take part in research. Yet
each of the three women described in the case reports were
charged $5,000, and Albini said that the consent paperwork made
no mention of a study.

“I think it was presented as a clinical trial and documented as
a fee-for-service procedure,” Albini said. In September 2015,
shortly after the three women were treated, the
ClinicalTrials.gov listing was amended to say the study had
been “withdrawn prior to enrollment.”

Before that change was made, it is easy to see why Noble and
Patsy Bade, who also decided to seek treatment after finding
the ClinicalTrials.gov listing, might have found it convincing.
It includes an long list of conditions that could exclude
people from participating, and indicates that patients would be
studied 6 months after their treatment, to record their field
of view and the sharpness of their vision.

Neither Noble nor Bade had severe sight loss before their
eyeballs were injected with material extracted from their
abdominal fat. Noble still had 20/30 vision in her left eye,
which is barely different from normal. “It’s good enough to
read newspaper print,” Albini said. “It’s very functional
vision.” Bade, who was 78 when she was treated and lives in
Venice, Florida, struggled to read fine print and had problems
driving at night. But otherwise, she could function normally.

View this image ›

The back of Patsy Bade’s left
eye after the stem cell treatment. Dark patches show
bleeding in the retina. Thomas
Albini

ID: 10705950

“These ladies who were both independent were rendered blind,”
their attorney, Andrew Yaffa of Grossman Roth Yaffa Cohen in
Coral Gables, Florida, told BuzzFeed News. The women sued US
Stem Cell, the affiliated US Stem Cell Clinic,
and two medical professionals who were involved in the
procedures.

The suits were settled for undisclosed sums, with a
confidentiality agreement that prevents Yaffa from naming the
women or the company involved. Noble and Bade also told
BuzzFeed News that they were not allowed to discuss their
cases.

“This litigation has been resolved to the mutual satisfaction
of the parties,” Yaffa said.

A couple of days after her injections, Bade turned up at the
Bascom Palmer Eye Institute with bleeding retinas. Again, her
eyesight rapidly deteriorated. A year later, she could just
detect a hand waving in front of her face with her right eye,
and had 20/200 vision in her left. That is the legal threshold
for blindness, and means
she could read an eye chart at 20 feet only as well as a person
with normal vision standing 200 feet away.

Both women’s eyesight would likely still be fairly good had
they not been given the injections. Macular degeneration
typically proceeds “pretty slowly,” Albini said.

Neither Mike Tomás, US Stem Cell’s CEO, nor Kristin Comella,
the company’s chief science officer, returned emails and phone
calls from BuzzFeed News. Comella is described on the company’s
website as a “world renowned expert on regenerative medicine.”
She is not a medical doctor, and is enrolled as a PhD student
in biomedical engineering at Florida International University
in Miami.

Kristin Comella, US Stem Cell’s
chief science officer, in a promotional video.
youtube.com

ID: 10708284

The company responded instead with a statement from its PR
firm, Becker Public Relations, which said: “Since 2001, our
clinics have successfully conducted more than 7,000 stem cell
procedures with less than 0.01% adverse reactions reported. We
are unable to comment further on specific cases due to patient
confidentiality or legal confidentiality obligations. Neither
US Stem Cell nor US Stem Cell Clinic currently treats eye
patients.”

On its website, US Stem Cell Clinic says it offers treatments
for conditions from Parkinson’s disease to congestive heart
failure. US Stem Cell’s PR company would not say how many of
the 7,000 procedures the company claims to have performed
involved patients with eye diseases.

While the blinding of three patients is an extreme example,
experts who follow the stem cell industry worry that other
people may have been harmed by clinics offering unproven
treatments, without their cases coming to public attention.

“What I’m most worried about is that this may be the tip of the
iceberg,” Paul Knoepfler, a stem cell biologist at the
University of California, Davis, told Buzzfeed News. Last year,
he and Turner of the University of Minnesota published a
survey that identified
570 clinics offering unproven stem-cell treatments across
the US.

Most of these clinics argue that their treatments do not need
to be regulated by the Food and Drug Administration (FDA)
because they are merely injecting people’s own stem cells back
into their bodies. The FDA maintains that these cells count as
drugs, which it must approve for clinical use, if they are more
than “minimally
manipulated” and are not replacing cells with the “same
basic function.”

Last September, the FDA held a
two-day hearing on treatments based on human cells. “The
FDA is evaluating the feedback we received at the hearing,
along with the written comments, as we work to finalize our
guidance,” agency spokesperson Andrea Fischer told BuzzFeed
News by email.

It’s unclear whether that will to lead to a crackdown on
clinics offering unproven stem-cell treatments — especially as
President Donald Trump’s
nominee for FDA commissioner, Scott Gottlieb, in 2012
co-wrote an
Op-Ed for the Wall Street Journal criticizing the
agency’s efforts to regulate cells as drugs.

“The FDA is perennially complaining to Congress that it lacks
the resources to do its day job of regulating products that
fall squarely in its purview,” Gottlieb and his co-author
wrote. “Yet in chorus, the agency is always seeking novel
authority to insert itself into new areas of science where its
mandate is shaky.”

Whatever the FDA does next, Turner argues that the NIH should
do more to screen the listings posted on ClinicalTrials.gov.

“The information on ClinicalTrials.gov is provided by the study
sponsor or principal investigator and posting on
ClinicalTrials.gov does not necessarily reflect endorsement by
the NIH,” Renate Myles, an NIH spokeswoman, told BuzzFeed News
by email.

Earlier today, the NIH added a similarly-worded disclaimer
to the website. Myles said that the change was made because of
the concerns raised by Alibini’s paper.

“It is time NIH representatives stopped giving boilerplate
responses,” Turner said. “They should have addressed this
problem before patients were harmed.”



Source link