FDA Warns About Stem Cell Therapies | FDA
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Researchers hope stem cells will one day be effective in the treatment of many medical conditions and diseases. But unproven stem cell treatments can be unsafeso get all of the facts if youre considering any treatment.
Stem cells have been called everything from cure-alls to miracle treatments. But dont believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous proceduresand confirm whats really being offered before you consider any treatment.
The facts: Stem cell therapies may offer the potential to treat diseases or conditions for which few treatments exist. Sometimes called the bodys master cells, stem cells are the cells that develop into blood, brain, bones, and all of the bodys organs. They have the potential to repair, restore, replace, and regenerate cells, and could possibly be used to treat many medical conditions and diseases.
But the U.S. Food and Drug Administration is concerned that some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful. And the FDA is increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics, while continuing to encourage innovation so that the medical industry can properly harness the potential of stem cell products.
To do your part to stay safe, make sure that any stem cell treatment you are considering is either:
And see the boxed section below for more advice.
The FDA has the authority to regulate stem cell products in the United States.
Today, doctors routinely use stem cells that come from bone marrow or blood in transplant procedures to treat patients with cancer and disorders of the blood and immune system.
With limited exceptions, investigational products must also go through a thorough FDA review process as investigators prepare to determine the safety and effectiveness of products in well-controlled human studies, called clinical trials. The FDA has reviewed many stem cell products for use in these studies.
As part of the FDAs 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 products safety, purity, and strength (potency). The FDA also requires sufficient data from animal studies to help evaluate any potential risks associated with product use. (You can learn more about clinical trials on the FDAs website.)
That said, some clinics may inappropriately advertise stem cell clinical trials without submitting an IND. Some clinics also may falsely advertise that FDA review and approval of the stem cell therapy is unnecessary. But when clinical trials are not conducted under an IND, it means that the FDA has not reviewed the experimental therapy to help make sure it is reasonably safe. So be cautious about these treatments.
About FDA-approved Products Derived from Stem Cells
The only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood.
These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood (called the hematopoietic system). These FDA-approved stem cell products are listed on the FDA website. Bone marrow also is used for these treatments but is generally not regulated by the FDA for this use.
All medical treatments have benefits and risks. But unproven stem cell therapies can be particularly unsafe.
For instance, attendees at a 2016 FDA public workshop discussed several cases of severe adverse events. One patient became blind due to an injection of stem cells into the eye. Another patient received a spinal cord injection that caused the growth of a spinal tumor.
Other potential safety concerns for unproven treatments include:
Note: Even if stem cells are your own cells, there are still safety risks such as those noted above. In addition, if cells are manipulated after removal, there is a risk of contamination of the cells.
When stem cell products are used in unapproved waysor when they are processed in ways that are more than minimally manipulated, which relates to the nature and degree of processingthe FDA may take (and has already taken) a variety of administrative and judicial actions, including criminal enforcement, depending on the violations involved.
In August 2017, the FDA announced increased enforcement of regulations and oversight of stem cell clinics. To learn more, see the statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA website.
And in March 2017, to further clarify the benefits and risks of stem cell therapy, the FDA published a perspective article in the New England Journal of Medicine.
The FDA will continue to help with the development and licensing of new stem cell therapies where the scientific evidence supports the products safety and effectiveness.
Know that the FDA plays a role in stem cell treatment oversight. You may be told that because these are your cells, the FDA does not need to review or approve the treatment. That is not true.
Stem cell products have the potential to treat many medical conditions and diseases. But for almost all of these products, it is not yet known whether the product has any benefitor if the product is safe to use.
If you're considering treatment in the United States:
If you're considering treatment in another country:
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FDA Warns About Stem Cell Therapies | FDA
