People suffering from diseases or other medical conditions that currently have no cure may be desperate to seek some kind of medical treatment. And while stem cell therapies may sound promising and offer hope, many of those currently being advertised are not proven to be safe or even successful. It’s important to be cautious and understand all of the facts before considering any kind of stem cell therapy.
What Diseases Stem Cells Can Treat
While stem cell therapies have the potential to treat various diseases such as multiple sclerosis, type 1 diabetes, Parkinson’s disease and Alzheimer’s disease, so far only a few have proven to be safe and effective. The U.S Food and Drug Administration (FDA) is responsible for regulating stem cell products. Currently, the only FDA-approved stem cell therapies in the U.S. are stem cell transplants.
Since stem cells have the ability to develop into a wide range of specialized cell types, such as muscle, skin and brain cells they can be used to produce new tissue and replace damaged cells. In a stem cell transplant, stem cells are taken from a donor’s cord blood or bone marrow. The donated stem cells replace the cells damaged by chemotherapy or disease and they help fight cancers and blood-related diseases, such as leukemia, lymphoma, neuroblastoma and multiple myeloma.
Stem Cell Therapy Safety Concerns
The FDA has approved a very limited number of stem cell treatments, but you wouldn’t know it by the amount of advertising and clinics around the U.S. offering stem cell therapies. Unfortunately, many of these advertised therapies have never been approved by the FDA and are considered unsafe and can cause more health issues. According to the FDA, some of the adverse effects of unapproved stem cell treatments include:
- Administration site reactions
- The ability of cells to move from placement sites and change into inappropriate cell types or multiply
- Failure of cells to work as expected
- The growth of tumors
Why Stem Cell Therapies Should Be Approved by the FDA
Having stem cell therapies go through the FDA review process means the products are investigated through clinical trials to determine if they are safe and effective. As part of the FDA’s review, investigators must show how each product will be manufactured so the FDA can make sure appropriate steps are being taken to help assure the product’s safety, purity and strength. You must be cautious of any stem cell treatments that haven’t gone through the FDA, or if they are being offered in different countries. It’s important to understand both the benefits and risks of stem cell therapies.
When exploring stem cell treatments, the FDA recommends people to consider the following:
- Ask if the FDA has reviewed the treatment. Ask your health care provider to confirm this information. Ask for this information before getting treatment—even if the stem cells are your own
- Learn about regulations that cover stem cell products in other countries
- Know that the FDA does not have oversight of treatments done in other countries.
- If you’re considering a stem cell-based product in a country that may not require a regulatory review of clinical studies, it may be hard to know if the experimental treatment is reasonably safe.
While the list of approved stem cell treatments is short, many therapies are making their way through clinical trials. But until then any unapproved treatments should be considered highly experimental. If something sounds too good to be true, it probably is.
Both an Emory School of Law graduate and MBA graduate of Goizueta Business School at Emory, Chris Nace focuses his practice on areas of medical malpractice, drug and product liability, motor vehicle accidents, wrongful death, employment discrimination and other negligence and personal injury matters.
A. Rahman Ford, JD, PhD
Dear Mr. Nace,
As an advocate for stem cell therapy, I thank you for giving voice to such an important topic. Stem cells represent a revolutionary, paradigm-shifting medical modality that can cure - not simply treat - many conditions that conventional medicine currently has no answer for. I applaud you for privileging the safety and well-being of the patient.
That being said, the potential of stem cell therapy is neither speculative nor experimental. It TODAY and it is NOW, as evidenced by the countless patients around the world who have been able to forego dangerous, addictive pharmaceuticals and painful, expensive surgeries. A robust body of published research, as well as clinical data compiled by stem cell practitioners, has demonstrated both the safety and efficacy of a variety of stem cell therapies for a wide array of indications.
The landscape of medicine has shifted toward regenerative medicine, and stem cell therapy is playing a central role in this shift. The stem cell tipping point among the American populace has long been reached. Fear-based overtures about the specious "dangers" of "unproven," "expensive" stem cell therapies no longer resonate. Instead, the American people have elevated their expectations and seek a brighter health future, with more medical freedom, fewer crippling medical bills and less federal government restriction.
If so inclined, please read some of my writing on stem cell therapy. My work can be found at my online portfolio. Specifically, my own experience with stem cell therapy can be found there. My general opinion on FDA stem cell regulations can also be found there . Finally, a perspective from a stem cell practitioner who runs a clinic in California can be found there.
Mr. Nace, we must look forward, not backward. The safeguarding of Americans' health requires change and a recognition that previous methods - which may have at one time proven useful - have become, counter-productive, antiquated and anachronistic. If we are to envision a modern model of medical ethics that transcends even that of Hippocrates, then institutional rigidity, attachment to ideology and habitual intransigence can have no place.
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