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.
