Typically, when
patients go to a doctor they are seeking for a problem to either be improved or
resolved; unfortunately, this is not always the outcome. According to an article in The New York
Times, three elderly women with macular degeneration went to a vision clinic in
Florida possessing at least partial vision.
However, after treating at this clinic, one of the women went blind and
the other two lost a considerable amount of their eyesight. Before the procedures, the women had vision
deficiencies, but they could at least drive a car. The ladies underwent stem cell injections in
2015 at a clinic that is now called U.S. Stem Cell, and at this clinic, fat is
taken out of the women’s stomachs and then stem cells are extracted from this
and put into their eyes. The company
claimed that they did not require FDA approval as the patients were being
treated with their own stem cells, which aren’t classified as a drug.
Stem cells don’t
require FDA approval
According this same New
York Times Article, regulations state that stem cells don’t require FDA
approval if they are the patient’s stem cells and those stem cells are only “minimally
manipulated”, but the question becomes: what qualifies as minimally
manipulated? Troublingly, it appears
that at the time, this company had found some sort of legal loophole, as they
haven’t had any other penalties aside from being sued by two of the eye
patients.
There are multiple
different avenues to take to find companies that perform stem-cell treatments,
and some of them are misleading. All
three women discovered U.S. Stem Cell because one of their studies was on
clinicaltrials.gov. According to the New
York Times article, clinical trials don’t need to be approved by the government
to be listed on their website. The chief
science officer of U.S. Stem Cell, Kristin Comella, has announced that the
company is no longer treating eyes, but they continue to treat people for other
ailments. Hundreds of similar clinics
are appearing all over the country, and concerned researchers have been warning
people against these types of facilities with poor regulations and big
promises.
A wide array of
injuries
Some other ailments
that people are claiming to treat with stem cells include: injured knees,
arthritis, heart failure and damaged spinal discs. Frighteningly, an article in The New England
Journal of Medicine proposes that negative events transpiring from stem-cell
treatments are “probably much more common than is appreciated, because there is
no reporting requirement when these therapies are administered outside clinical
investigations”. According to an
article in Healthline, other negative outcomes that could result from stem-cell
treatments include tumors and lesions, and this can even occur with less
extreme procedures, such as therapy for anti-aging.
A new, unproven technology coupled with a lack of reporting requirements is
generally a mishap waiting to happen. If
you or a loved one have suffered from a negative outcome because of stem-cell
treatment(s), please call my office for a free consultation.
SOURCES:
http://www.healthline.com/health-news/stem-cell-treatments-offer-hope-also-severe-risks#3
New
York Times- March 16, 2017, A16 of the New York edition with the headline: After Stem Cell
Shots in Their Eyes, 3 Patients in Florida Lose Vision.
