Stem cell therapy isn't approved to treat heart failure in the U.S., but dozens of clinics nationwide advertise the treatments anyway, often charging thousands of dollars for procedures that may not be safe or effective, a new study suggests.
Researchers found 61 centers offering stem cell therapies for heart failure as of last year in the U.S. alone, including five that claimed to have performed more than 100 procedures. Only nine centers required copies of patients' medical records and just one facility said it had a board certified cardiologist on staff.
"We simply do not know anything about the quality of the treatment delivered at these centers," said senior study author Dr. Paul Hauptman director of heart failure at Saint Louis University Hospital.
"These centers are not regulated in any way," Hauptman said by email.
Almost 6 million Americans have heart failure, and it's one of the most common reasons older adults go to the hospital, according to the American Heart Association.
It happens when the heart muscle is too weak to effectively pump enough blood through the body. Symptoms can include fatigue, weight gain from fluid retention, shortness of breath and coughing or wheezing. Medications can help strengthen the heart and minimize fluid buildup in the body.
While some experimental stem cell therapies for heart failure are currently being tested in late-stage human trials, none have won approval from the U.S. Food and Drug Administration.
In theory, after a transplant, stem cells could permanently become part of the diseased heart and either help grow new healthy heart tissue or tell existing cells to work better, said Paul Knoepfler, a cell biology researcher at the University of California Davis School of Medicine in Sacramento who wasn't involved in the study.
It's also possible stem cells could temporarily visit the heart and stimulate a positive response in cells already there, he said.
Even though there's no conclusive proof yet that any stem cell treatments are safe and effective for heart failure, centers contacted for the study charge an average of $7,694 for each treatment using patient's own stem cells and $6,038 for each procedure with donor stem cells.
In one instance, though, a clinic staff member said, "If you have a million dollars to spend we will set you up with weekly infusions."
Hauptman's team had used a standard script when contacting each center, asking about the stem cell treatment itself, medical exams before and afterward and pricing.
Among the other responses they received from clinic staff were remarks such as, "If you know anyone that can start an IV, a neighbor that is a nurse for example, we can send you the stem cells and that person can administer them to you" and "We hope you don't believe your doctor when they tell you there is nothing they can do, you were smart to call us."
None of the sites in the study discussed what methods they used to isolate or identify stem cells, though most claimed to use patients' cells and 24 said they got cells from fat tissue.
Most centers claimed to deliver cells intravenously, researchers report in JAMA Internal Medicine.
"This approach has been associated with complications such as stroke, in which infused cells block blood vessels in the brain," said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasn't involved in the study.
"The biggest risk is that patients will waste their money, time and hopes on an unnecessary and useless invasive procedure," Sipp said by email.
If any stem cell treatment did ultimately prove safe and effective enough to win FDA approval, it would likely offer a significant improvement over the limited treatment options currently available, said Leigh Turner, a researcher at the University of Minnesota Center for Bioethics who wasn't involved in the study.
But it's impossible to say what patients would get at unregulated clinics offering unapproved stem cell therapies, Turner said by email. In at least two cases unrelated to the current study, patients died after getting stem cell procedures at a clinic in Florida, and in another case at a different Florida clinic, a woman went blind, Turner noted.
"Clinics marketing stem cell treatments to patients suffering from heart failure might be administering anything from slurries of mixed cells, some of which might be stem cells, to nothing more than cellular debris," Turner said. "Often one can only speculate."