Terry- Thank you for sharing. "If you are asked to pay, walk away" is good
advice regardless of the research and should be helpful for patients trying
to identify genuine studies.
Sarah
On Fri, Mar 17, 2017 at 8:23 AM, Schaefer, Terrance <
Terrance_Schaefer@xxxxxxxxxxxxxxxxxx> wrote:
This was just in our University of Rochester’s daily news.
I think it is worth sharing with all of you.
Terry
Commentary on Stem Cell Therapies: If You’re Asked to Pay, Walk Away
Wednesday, March 15, 2017
Ajay E. Kuriyan, M.D., M.S.
Stem cell clinics around the country are offering experimental treatments
to cure a myriad of ailments - from multiple sclerosis and paralysis to
vision loss. However, these unproven treatments can cost patients thousands
of dollars and potentially cause devastating side effects.
While serving as chief resident and co-director of Ocular Trauma at Bascom
Palmer Eye Institute in Miami, FL, I was part of a team that took care of a
patient who had blinding complications after receiving injections into her
eyes at a stem cell clinic. She was charged $5,000 for the injection of
stem cells that were isolated from her own body fat into both of her eyes,
in hopes of halting the progressive vision loss caused by age-related
macular degeneration.
Within days of the stem cell injections she was nearly blind and
ultimately progressed to complete blindness. Two other patients who
underwent similar treatments at the same clinic are also now legally blind
after complications of the injections. Case studies
<http://www.nejm.org/doi/full/10.1056/NEJMoa1609583> of these three
patients were published as a brief report today in the *New England
Journal of Medicine. *
These patients provide an unfortunate example of what can go wrong when
stem cell procedures are not appropriately regulated. Stem cell clinics
have cropped up all over the US in recent years and are operating in a
self-perceived regulatory loophole. They argue that deriving stem cells
from a patient’s own body and minimizing manipulation of those cells should
excuse them from the level of Food and Drug Administration (FDA) oversight
used to vet traditional drugs.
The FDA, however, has stated
<https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm> that
stem cells ought to be held to the same regulatory standard as any other
drug, citing the complexity of mammalian cells, the manipulation needed to
isolate stem cells, and the difficulty of predicting how these cells will
react to different environments (i.e. different tissues of the body).
Without regulation of stem cell isolation and delivery processes at stem
cell clinics, it’s hard to know whether their cocktails contain harmful
chemicals leftover from the isolation process – or whether they contain
stem cells at all. The stem cell clinic mentioned above committed a breach
of standard clinical protocol by injecting an unproven experimental
treatment into both eyes of a patient on the same day. Oversight from the
FDA, would have prevented this.
The unregulated use of stem cells at these clinics is in stark contrast to
the very responsible and appropriately regulated stem cell clinical trials
being conducted at academic centers across the country. The actions of
these stem cell clinics not only pose a risk to patients but also have the
potential to erode trust in these legitimate stem cell studies. For
patients, it’s hard to know the difference between a legitimate clinical
trial and an unregulated experimental therapy that might put them at risk.
My best advice for all patients is to consult your physician about any
experimental stem cell treatment that asks you to pay out-of-pocket; that
is a huge red flag. Regulated clinical trials performed at academic
medical centers are fully funded and do not require patients to pay for
treatment.
In short, if you are asked to pay, walk away.
*Ajay E. Kuriyan, M.D., M.S.*
<https://www.urmc.rochester.edu/people/22549839-ajay-kuriyan>*, is a
retinal specialist certified by the American Board of Ophthalmology and an
assistant professor of Ophthalmology at the University of Rochester Medical
Center. *
*From:* optimal-bounce@xxxxxxxxxxxxx [mailto:optimal-bounce@xxxxxxxxxxxxx]
*On Behalf Of *Sarah Moyer
*Sent:* Thursday, March 16, 2017 2:18 PM
*To:* optimal@xxxxxxxxxxxxx
*Subject:* [optimal] Stem Cell Clinics
Today I learned about adverse reactions happening at stem-cell clinics
from the attached paper (summary below). I haven't seen any of these cases
myself. Have any of you seen other cases of this? I was oblivious to these
clinics even existing until today...
Sarah
Paper Summary: Adipose tissue–derived “stem cells” have been increasingly
used by “stem-cell clinics” in the United States and elsewhere to treat a
variety of disorders. We evaluated three patients in whom severe bilateral
visual loss developed after they received intravitreal injections of
autologous adipose tissue–derived “stem cells” at one such clinic in the
United States. In these three patients, the last documented visual acuity
on the Snellen eye chart before the injection ranged from 20/30 to 20/200.
The patients’ severe visual loss after the injection was associated with
ocular hypertension, hemorrhagic retinopathy, vitreous hemorrhage, combined
traction and rhegmatogenous retinal detachment, or lens dislocation. After
1 year, the patients’ visual acuity ranged from 20/200 to no light
perception.
