Researchers Question Safety, Value Of Untested Stem Cell Treatments

Sep 5, 2016
Originally published on September 5, 2016 9:27 am

Hundreds of clinics around the country are offering to treat a long list of health problems with stem cells.

The clinics claim that stem cells found in fat tissue, blood, bone marrow and even placentas can help people suffering from arthritic joints and torn tendons to more serious medical problems, including spinal cord injuries, Parkinson's disease and strokes. Some even claim the cells can help children with autism.

But leading stem cell researchers say there's not enough evidence to support the clinics' claims.

Doctors have long used stem cells from bone marrow and blood to treat some types of cancer, such as leukemia and lymphoma. And stem cells are being widely studied as potential treatments for other health problems. Researchers hope stem cells may someday make it possible to repair or replace damaged cells, tissues and even entire organs — but there are very few treatments currently available that have been proven safe and effective.

"There's a lot of sketchy stuff going on," says George Daley, a Harvard stem cell researcher.

"You've got clinics springing up, taking a patient's own cells and then injecting these cells into arthritic joints, into spinal cords, into the brain. And there's really no evidence this is going to work," says Daley. "In fact, there are major concerns about safety."

The treatments could cause life-threatening infections, create tumors or trigger dangerous reactions by a patient's immune system, says Daley and other stem cell researchers.

So far the Food and Drug Administration has not aggressively regulated stem cell clinics. The reason is the stem cells being used typically come from the patient's own body — an autologous transplant. And the clinics don't process the cells much before injecting them.

But now that the treatments are being offered so much more widely, the FDA is considering more aggressive regulation. As part of that process, the agency will hold a workshop this Thursday, followed by a two-day hearing next week.

Another issue is cost. Patients are paying thousands of dollars for these treatments, which are not covered by insurance.

"We're talking about really big bucks here," says Paul Knoepfler, a stem cell scientist at the University of California, Davis, who monitors health and safety issues with stem cell clinics in his blog.

The treatments can cost from $5,000 to as much as $100,000, Knoepfler reports in an article recently published in the journal Cell Stem Cell. He estimates that there are more than 500 stem cell clinics treating as many as 100,000 patients a year in the United States.

Knoepfler hopes the FDA will crack down on the clinics.

"The FDA needs to step up its game on this, because otherwise this could continue to grow as an industry, and it's just going to put more and more people at risk," he says.

The clinics defend what they're doing.

"Patients should have access to their own body tissue," says Kristin Comella, chief scientific officer at the U.S. Stem Cell clinic, which is based in Sunrise, Fla. Comella also serves as president of the Academy of Regenerative Practices, which represents the clinics.

If patients "are able to provide and give informed consent to move forward with these treatments, that is their right," Comella says. "In particular for diseases where they have not had much success with traditional medicine."

Comella acknowledges that two of her clinic's patients suffered detached retinas after getting stem cells injected into their eyes. As a result, the clinic has stopped treating eye conditions. But otherwise, Comella says, the clinic has had no serious problems. It offers stem cell treatments for a host of conditions including diabetes, spinal cord injuries and congestive heart failure.

"There are always risks no matter what you're doing. That being said, our group has treated more than 6,000 cases and we've had very few safety events associated with these treatments," she says.

The clinics point out that the cells they are using are not human embryonic stem cells, which are controversial because embryos are destroyed to get them. And they're not induced pluripotent stem cells, which scientists create in the lab.

The FDA has no timetable for when it expects to make any decisions on regulation. In the meantime, the FDA website suggests patients carefully research any stem cell treatment before going ahead with it.

Copyright 2018 NPR. To see more, visit http://www.npr.org/.

RENEE MONTAGNE, HOST:

First, we explore stem cell treatments. Hundreds of clinics in the United States are using them to treat medical conditions. The questions are whether stem cell treatments work and whether they work safely.

STEVE INSKEEP, HOST:

This week, the Food and Drug Administration will start considering how to regulate those clinics. NPR's Rob Stein reports.

ROB STEIN, BYLINE: If you search the web, you'll find clinics all over the country like this one in Sunrise, Fla. They offer stem cell treatments for all sorts of health problems, from arthritic joints and torn tendons to spinal cord injuries, multiple sclerosis and stroke.

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED WOMAN: At the U.S. Stem Cell Clinic, we're utilizing what are called adipose derived stem cells, or fat-derived stem cells.

STEIN: As this promotional video makes clear, these aren't human embryonic stem cells, which are controversial because embryos are destroyed to get them. And they're not the type of stem cells that scientists create in the lab.

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED WOMAN: These are considered autologous stem cells, which means you're utilizing stem cells from your own body.

STEIN: And, the clinic claims, have amazing healing powers.

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED WOMAN: All of these cells have different growth factors and can help to promote healing.

STEIN: And other clinics are using other kinds of stem cells from bone marrow, blood and even placentas. But there are big questions about all this.

GEORGE DALEY: There's a lot of sketchy stuff going on.

STEIN: George Daley is a stem cell researcher at Harvard. He says stem cells are really promising and someday could revolutionize medicine by providing healthy cells and tissues for damaged parts of the body. But he says we're still years away from that.

DALEY: You've got clinics springing up, taking a patient's own cells. And practitioners are then injecting these cells into arthritic joints, into spinal cords, into the brain. And there's really no evidence that this is going to work. And in fact, there are major concerns about safety.

STEIN: The procedures could cause life-threatening infections. The cells could turn into tumors or trigger dangerous reactions by patients' immune systems. And these supposed treatments don't come cheap. Paul Knoepfler is a stem cell scientist at the University of California Davis. He estimates there are more than 500 of these clinics treating as many as 100,000 patients a year in the United States.

PAUL KNOEPFLER: We're talking about really big bucks here. The therapies can run anywhere from five to $100,000 a shot.

STEIN: And they're not covered by insurance. Knoepfler thinks the Food and Drug Administration should crack down on these clinics.

KNOEPFLER: The FDA needs to step up its game on this because otherwise, this could continue to grow as an industry. And it's just going to put more and more people at risk.

STEIN: For their part, the stem cell clinics defend what they're doing. Kristin Comella is the chief scientific officer of the Florida clinic we heard about at the beginning of the story. She says they're helping a lot of sick people.

KRISTIN COMELLA: Patients should have access to their own body tissue, in particular for diseases where they have not had much success with traditional medicine. And if they are able to provide and give informed consent to move forward with these treatments, that is their right.

STEIN: Comella acknowledges that two of her clinic's patients suffered detached retinas when they had stem cells injected into their eyes. So the clinic has stopped treating eye conditions. But otherwise, Comella says, they've had no serious problems.

COMELLA: There are always risks, no matter what you're doing. Now, that being said, our group has treated more than 6,000 cases. And we've had very few safety events associated with these treatments.

STEIN: The FDA's first hearing about how best to regulate these stem cell clinics is scheduled for Thursday, followed by another two-day hearing next week. Rob Stein, NPR News. Transcript provided by NPR, Copyright NPR.