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Stem cell therapies: Beware of unproven treatments and wild marketing claims

Posted at 6:00 PM, May 15, 2018
and last updated 2018-05-15 20:23:59-04

DENVER – When Eduardo Dominguez found himself dealing with crippling hip pain, he went to a surgeon who told him he needed to have his entire hip replaced.

But when a coworker recommended he instead get an injection of stem cells, Dominguez was intrigued, so he visited Downtown’s Healthcare in Denver and what staff there told him sounded too good to be true.

“The first thing they promised was that the cartilage would regenerate with their injection,” Dominguez’s son, Eduardo Dominguez Jr., said. “There was going to be no pain, ever.”

The clinic recommended canceling the surgery, which Dominguez did. Then he paid $6,000 for an injection that he was told would help eliminate his pain.

Three months later, the pain was only getting worse, so Dominguez returned to the clinic, where he was told he needed another injection. Again, Dominguez had an injection in his hip that offered no relief after several months.

At first, he said the clinic wanted to charge him $3,000 -- half off -- for the second injection, but after an argument, Dominguez said he received the injection for free.

“My dad was just getting worse day by day,” Dominguez Jr. said.

In the end, Dominguez went through with the hip replacement and got rid of his pain but not before handing over thousands of dollars for treatments that didn’t work.

Regenerative therapies – in particular, those that use stem cells – offer a great deal of promise for debilitating and chronic conditions that have long been incurable. But the field is operating in a sort of “Wild West” where patients can’t always be sure that what they’re paying for is what they’re getting.

Stem cells are the body’s so-called “master cells” that turn into skin cells, bone, organs and more. Because of their ability to grow into other types of tissue, scientists and doctors are eager to put them to use healing the body’s damaged tissues.

The field of stem cell therapy is quickly advancing but there’s still a lot of uncertainty. The science isn’t quite there yet on some treatments and conditions and that has left the door open for some clinics to take advantage of that uncertainty and make promises they can’t back up.

This past summer, the Federal Drug Administration said that it was ramping up enforcement around regenerative medicine and working to crack down on these so-called “bad actors” making false claims and sometimes operating outside of the law. The agency busted clinics in Florida and California that were providing experimental procedures that put their patients at risk, the agency said.

“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” said FDA Commissioner Scott Gottlieb.

In addition, the state of North Dakota recently settled with a clinic headquartered in Denver that was at the center of an investigation due to consumer complaints about alleged stem cell injections. That clinic, West 2 Medical Solutions, will have to repay nearly $20,000 to patients and will discontinue the injections in North Dakota.

A study published in 2016 identified 570 clinics across the country peddling “stem cell” treatments that are largely unproven and unregulated by the FDA. Though the study didn’t name any particular clinics or companies, Denver was identified as one of several cities with a relatively high concentration of such clinics scattered across the metro area.

Gottlieb wrote in August that these clinics and others like them cast a shadow on a promising field of medicine by not following established guidelines and regulations.

“These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses,” Gottlieb said. “This puts the entire field at risk.”

The presence of such “dishonest actors” also has created tension and conflict among physicians and others who work in the field of regenerative medicine.

Christopher Centeno, M.D., is a physician based in Broomfield, Colorado and is the founder of Regenexx, a nationwide network of doctors who offer stem cell treatments for orthopedic injuries. Centeno and several other doctors have joined together to raise similar concerns to those expressed by the FDA.

Centeno’s Orthobiologic Ethics Consortium claims that independent testing has shown some supposed “stem cell” treatments – many of them advertised as “amniotic” or “placental” stem cells -- don’t contain any live stem cells at all. And even if they did, they would most likely be considered drugs that would require FDA review before being used.

“Vulnerable elderly patients are being targeted through local seminars and are charged thousands of dollars for these injections delivered by non-physicians to treat knee, hip, shoulder, and low back arthritis,” the group warned.

“What we’re seeing is…elderly people being charged $5,000 a pop” for treatments that don’t really do anything, Centeno said. “Mostly just money down the drain.”

The FDA has approved a number of cord blood stem cell products for use in the United States, all of which are listed on the agency’s website. Some of these have been in use for years for the treatment of blood-related conditions like leukemia and other cancers but they haven’t been shown to be effective for other uses, the agency warned in 2014.

“Because cord blood contains stem cells, there have been stem cell fraud cases related to cord blood,” said Keith Wonnacott, Ph.D., Chief of the Cellular Therapies Branch in FDA’s Office of Cellular, Tissue, and Gene Therapies. “Consumers may think that stem cells can cure any disease, but science doesn’t show this to be the case. Patients should be skeptical if cord blood is being promoted for uses other than blood stem cell regeneration.”

One company that Centeno’s group has singled out for scrutiny is the Stem Cell Institute of America, which is a network of clinics with affiliates all over the country, including in Colorado. The company’s website says it uses placental cord blood stem cells, combined with growth factors and other ingredients, to treat a wide variety of ailments, such as arthritis, back pain and carpal tunnel -- with just one injection. The company routinely advertises its “educational seminars” on TV and in local newspapers.

A company spokesman told Denver7 that the Stem Cell Institute of America is well-versed in FDA guidelines and makes efforts to ensure that its affiliates are as well. And while the science around amniotic tissue injections is still developing, the company believes that regardless of whether the products actually contain any live stem cells, they’ve been shown to be beneficial to patients.

“Until we know definitively, we do not recommend that our clinic directors state that amniotic injectables contain live stem cells or that they don't, but that amniotic has a particular quality of cells and growth factors which create healing activity,” the company said in an emailed statement.

The organization rejects any arguments that it’s operating irresponsibly or that its clinics aren’t putting patients’ well-being first.

“[Centeno] tries to smear our clinics as if we are doing something wrong or are acting unprofessionally, when in truth our clinics are medically operated and have every right to determine what is best for their patients. We advocate that each of our clients become involved in the education of their communities about the wonderful advancements of regenerative medicine. These clinics are doing wonderful work and are achieving excellent results with their patients. We will continue to expand and help more and more people get out of pain.”

As the number of clinics offering regenerative therapies has grown in recent years, it’s become harder for the FDA to keep up and crack down on those operating outside the law.

“The FDA is playing whack-a-mole,” Centeno said. “In the last two to three years we’ve gone from two or three companies offering these products for sale to 50 or 60.”

In late 2017, the agency issued new guidance that’s meant to clear up some of the confusion and eliminate the gray area in which some clinics continue to operate. The new guidelines also make it easier and less expensive for manufacturers to gain FDA approval for their regenerative therapy products.  

“Going forward, the FDA will apply a risk-based approach to enforcement, taking into account how products are being administered as well as the diseases and conditions for which they are being used,” the agency said in a press release. “This risk-based approach allows product manufacturers time to engage with the FDA, as to determine if they need to submit a marketing authorization application and, if so, submit their application to the FDA for approval.”

In the meantime, Eduardo Dominguez Jr. hopes other people don’t fall for the same pie-in-the-sky marketing claims that led to his dad losing thousands of dollars.

“I just want people to be aware and go the right route and not waste money,” Dominguez said.

Downtown’s Healthcare declined to comment on Dominguez’s case but said he was informed about the possibility the injections wouldn’t work.

“While regenerative medicine helps many people there are those who do not respond to it just like other forms of healthcare,” said clinic representative Gary Rademacher. “All patients are made aware of this and sign a consent form before going forward.”

This is the first in a series of stories from Denver7 investigating stem cell therapy, the industry's rapid growth and concerns among medical professionals, particularly in Colorado.