Proliferation of
Unapproved Stem Cell Therapy as a Cure-all
Stem cell therapy, drawn from infant umbilical cord blood or
from an adults’s own cells is the new snake oil cure-all. In the United States
the only FDA approved use of stem cell therapy is for treatment of blood
disorders like leukemia or hemophilia. (US Food and Drug Administration,
n.d.)
Here is the link to approved stem cell products in the US. https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/default.htm
Any other use is experimental and has
not received the rigor of the Federal Drug Agency investigation for patient
safety and efficacy. Unfortunately, thanks to unscrupulous direct-to-consumer
marketing, stem cell therapy is nearly as ubiquitous as Botox treatment. This article
highlights some of the dangers of unapproved treatment, what the FDA has done
to protect consumers, and resources for further investigation.
Are Stem Cell
Treatments Drugs?
The FDA considers stem cell treatment to be an injectable
drug therapy and as such is under the purview of the agency. Many of these high
profit stem cell clinics offering the treatment disagree with the FDA
classification and have been flouting the rules.
Risks of Stem Cell
Treatment
- Stem cell products are being manufactured in
facilities that are not inspected or run by FDA patient safety standards.
Injectables that are created in an unsterile environment run a high risk of
infection for patients. Timothy Lunceford of Texas was injected with stem cells
for joint pain and was hospitalized for 58 days with a blood infection and E.
coli.
- Nonscientists are creating stem cell products which
means they do not assess, test, or control for unintended consequences the way
a controlled scientific experiment does. Three people lost their sight after
being injected with stem cells as a treatment for macular degeneration.
- Umbilical cord blood containing stem cells, billed
as the miracle of life, can have different reactions in people. At least 17
people have been hospitalized after being injected with products containing
umbilical cord blood.
- Site infections from injection of stem cell
products is also common and can require hospitalization. John Herzog, MD
injected himself as a test of safety before he would recommend the product to
his patients and he ended up in the hospital with a bone infection and a blood
clot.
- People promoting stem cell treatments often have
no scientific or medical background and their only motive is to make money. Liveyon
products sold as stem cell therapy were tested by Lisa Fortier, a Cornell
University regenerative medicine researcher and she found that nine of the
products did not contain stem cells or even a single live cell.
- Two people died in Florida after receiving stem
cell injections in 2012.
Centers for Disease Control and Prevention tested and found
that bacterial contamination occurred at the manufacturing level prior to
clinical use of the stem cell products distributed by Liveyon of Yorba Linda,
California. A product recall for Liveyon ReGen treatment vials occurred 4
months after the company’s product tested positive for e coli. Most worrisome
is Liveyon has opened an operation in Cancun, Mexico so American patients can
receive treatment without the oversight of the FDA. (McGinley,
2019)
The FDA has the authority to regulate drug, cosmetic, and
scientific treatments in the US. New drugs or treatments are supposed to apply
for an Investigational New Drug (IND)application. The agency has reviewed 5,322
stem cell products in clinical trials. To learn more about stem cell products
which have been reviewed in a clinical trial follow this link: https://clinicaltrials.gov/ct2/results?term=stem+cell+therapies
The FDA sued the US Stem Cell Clinic, LLC in Florida for failure to respond to their inspection concerns. The agency also took action against StemImmune, Inc in California to prevent the use of a dangerous and unproven treatment. In 2017, US marshals seized vials of smallpox which were being used to create stem cells and given to cancer patients in California. In November 2017, the FDA published 4 guidance documents on risk and regulatory compliance for regenerative medicine products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm
The FDA sued the US Stem Cell Clinic, LLC in Florida for failure to respond to their inspection concerns. The agency also took action against StemImmune, Inc in California to prevent the use of a dangerous and unproven treatment. In 2017, US marshals seized vials of smallpox which were being used to create stem cells and given to cancer patients in California. In November 2017, the FDA published 4 guidance documents on risk and regulatory compliance for regenerative medicine products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm
So, it’s quite simple you should not be using any stem cell therapy which has not been in a clinical trial under the auspices of the FDA. And you should definitely avoid companies which promote stem cell treatments despite being found to have contaminated products by the CDC. These opportunists do not sign a hippocratic oath like physicians for patient care.
This is the healthpolicymaven signing off encouraging you
not to sign blanket release forms when you check into a treatment center. Do
specify that for why you consent and that for which you decline.
Roberta Winter is a freelance journalist and health policy
analyst whom has published under the trademark healthpolicymaven since 2007.
This article does not give medical advice, but is an advisory on health policy.
She is the author of Unraveling U.S. Healthcare-A Personal Guide, published in
2013.
References
alpha1.org. (2018, May 16). FDA Files Lawsuits to
Stop Unapproved Stem Cell Therapies. alpha1.org. Retrieved March 24,
2019, from
https://www.alpha1.org/Alphas-Friends-Family/Resources/News/ArtMID/5952/ArticleID/7860/FDA-files-lawsuits-to-stop-unapproved-stem-cell-therapies
McGinley, W. W. (2019, February 27). Miraculous Stem
Cell Therapy Has Sickened People in Five States. The Washington Post,
pp. 1-10. Retrieved March 9, 2019, from
https://www.washingtonpost.com/national/health-science/miraculous-stem-cell-therapy-has-sickened-people-in-five-states/2019/02/26/c04b23a4-3539-11e9-854a-7a14d7fec96a_story.html?utm_term=.0a2ea7b69b72
US Food and Drug Administration. (n.d.). FDA
Consumer Updates. doi:ucm286155
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