Unapproved Stem Cell Treatments More Common in U.S. Than Previously Known

A map created by the authors of new research plots clinics offering stem-cell treatments unapproved by the FDA. Leigh Turner and Paul Knopfler

Depending on where you live in the United States, you might recently have noticed clinics advertising "stem cell treatments" popping up along your route to the grocery store. Stem cells are unspecialized cells in the body that have the potential to turn into a wide variety of different types of cells, depending on what's needed. The body uses them to repair damage, meaning that stem cell therapies have real potential to help a lot of sick people. The trouble is, not a lot of these therapies have been discovered yet, and even fewer have been proven effective by the United States Food and Drug Administration (FDA).

But the sad truth is, there's a lot of money to be made from people desperate for relief from illness. Until recently, people suffering from conditions ranging from erectile dysfunction to multiple sclerosis have been lured to countries like Mexico and India to undergo experimental stem cell "treatments" not approved in the United States. But according to new research on unapproved treatments in the U.S., since around 2009 Americans have been able to spend good money on that kind of untested medical quackery right here at home — and it's getting more common.

The paper, published today in the journal Cell Stem Cell, finds more and more businesses in U.S. are providing unapproved stem cell therapies for up to 40 different conditions, including everything from baldness to pulmonary disease.

"In almost every state now, people can go locally to get stem cell 'treatments,'" says author Paul Knoepfler, of the University of California Davis and Shriners Hospital for Children, in a press release.

Knoepfler and his co-author, bioethicist Leigh Turner of the University of Minnesota, used internet keyword searches and website analysis to establish the scope and size of the U.S. stem cell therapy marketplace. They found these clinics have been cropping up in some states more than others —California, Florida, Texas, Colorado, Arizona and New York lead the charge.

The researchers also discovered that while the majority of the more than 300 businesses found offered treatments for orthopedic conditions, other common "treatments" addressed chronic pain, sports injuries, neurological diseases, and immune disorders. Most of the stem cells used in the therapies were derived from either fat or bone marrow, and while some therapies may or may not be safe and approved by other countries, the FDA has yet to approve them as safe in the U.S.

"Brakes ought to exist in a marketplace like this, but where are the brakes?" asks Turner. "Where are the regulatory bodies? And how did this entire industry come into being in a country where stem cell-based interventions and the medical devices that produce them are supposed to be regulated by the FDA?"

Knoepfler, who also runs the stem-cell focused blog The Niche, adds, "Another serious consideration to think about is that over the years many people have begun to include these businesses in their overall impression of the stem cell field. There is a real risk that as clinics proliferate, if we don't address it in a more proactive way, as we see negative outcomes for patients grow and people get mixed bags of information about stem cells, then this could really negatively impact the public perception of this research."