FYI ALL!
On Friday, March 17, 2017 8:43 AM, Sarah Moyer <smoyer@xxxxxxxxx> wrote:
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 AwayWednesday, 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 of these
three patients were published as a brief report today in theNew 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 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., 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@ ;
freelists.org]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.
