FDA warns about stem cell therapiesStaff Writer | June 4, 2018
Stem cells have been called everything from cure-alls to miracle treatments. But don’t believe the hype, says FDA.
New methods Some unscrupulous providers offer unapproved stem cell products
The facts: Stem cell therapies may offer the potential to treat diseases or conditions for which few treatments exist.
Sometimes called the body’s “master cells,” stem cells are the cells that develop into blood, brain, bones, and all of the body’s 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.
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 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 (potency).
The FDA also requires sufficient data from animal studies to help evaluate any potential risks associated with product use.
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. ■