Stem cell business booms, but state fails to regulate unproven, potentially harmful treatments

Selling Hope: The Stem Cell Sales Pitch

Blank checks

Stem cells are your body’s own specialized cells offering the hope of healing chronic injuries and treating incurable diseases.

“Stem cells are basically blank checks,” said Dr. Insoo Hyun, a professor of bioethics at Case Western Reserve University’s School of Medicine and director of the CWRU Stem Cell Ethics Center. “They can eventually become any kind of cell in the human body." 

Scientists are studying ways to transform stem cells into effective therapies and treatments.

 “There’s a lot of hope we can learn to use…various stem cells that we have,” said Dr. Jaime Imitola, a neurologist and stem cell researcher.

Inside his lab at Ohio State Wexner Medical Center in Columbus, he is working to figure out how brain inflammation alters patients’ stem cells to find treatments for multiple sclerosis, a devastating autoimmune disease.

 “We have indeed shown we can improve neurological conditions,” he said. “However, there is a lot of work to do, and there is a lot of hype of in the potential of this.”

He said the same is true for stem cell therapy for almost any condition, apart from a handful of blood diseases.

“Right now, there’s no therapy,” Imitola said. “It’s all experimental research.”

"If it worked today, we would all know about it,” Hyun said.

He said treatments could also be harmful.

“Just because they’re your own cells doesn’t mean it’s good for you,” he added. “Cancer cells are actually your own cells, so just because something is your own cell doesn’t mean it’s necessarily going to help you. It might actually hurt you.” 

The sales pitch

However, despite scant scientific evidence, our exclusive 5 On Your Side hidden camera investigation captured Ohio chiropractors selling stem cell treatments.

Inside rooms and restaurants, we found chiropractors pitching stem cell therapies to crowds of mostly senior citizens at four different events across Northeast Ohio.

Each sales pitch was similar.

First, the chiropractors described stem cells.

“They [stem cells] are preprogrammed by the creator to create tissues in your body,” said Dr. Keith Ungar, of Functional Endocrinology of Ohio. “They know exactly where to go…and that’s what they actually do.” 

Then, the chiropractors’ claimed their treatments can improve joint problems, including issues affecting shoulders, hips and knees.

“We treat a lot of shoulder pain with regenerative medicine,” said Dr. Brandon Blood, founder and clinical director of Apex Physical Medicine in Canton. “It’s a really unique, and in my opinion, very awesome non-surgical way to help manage symptoms.” 

The chiropractors said their stem cell treatments can even help patients avoid surgery.

 “See that little space right there,” said Dr. Matt Walker, Superior Healthcare Group, as he pointed to an x-ray of a knee. “We can get an injection in there and stem cells can save this knee.”

Finally, as participants finished free meals provided at the seminars, chiropractors offered discounts to pay for their treatments, which can cost thousands of dollars out of pocket. Health insurance companies will not cover most therapies.

“If you do one injection, it’s 10 percent off,” said Dr. Brandon Bupp, of Advanced Health and Wellness Center. “There’s maybe been three people that we have had to do it more than once – one wasn’t enough.”

“I called around…the average stem cell treatment costs $4,500 to $7,500,” Ungar said.  “Why do I do it for $3,750? Because I try to help as many people as possible.”

We reached out to the four chiropractors we captured on hidden camera to give them an opportunity to respond to our report.

Ungar and Walker did not respond to our emails.

Bupp provided this statement:

To clarify, I am the owner of the clinic functioning in the role of patient educator in this program. The lecture I gave was over an hour in length. I have not seen the report but I am guessing the entire lecture was not shown. Our medical staff does an excellent job of examining, evaluating and qualifying appropriate candidates for treatment. Part of the reason we have a very good success rate is because not everyone that comes to the clinic receives treatment. Our medical providers have very specific qualifications for treatment. The expectations for care are fully explained. Not everyone has successful outcomes with treatment and our clinic does not make claims as such but it is true that a very high percentage do have great responses. Additionally, the product we use with patients is human umbilical allograft tissue that contains amino acids, proteins, hyaluronic acid, and growth factors. This tissue has been found to contain stem cells as well. The lab we use is FDA regulated and approved as a tissue bank for umbilical allograft tissue. This treatment has been beneficial for many people to relieve pain and the burden of prescription pain medications that we know have detrimental effects for some people. In the time that we have used this therapy, we have had no infections or reported negative effects from treatment.

Blood provided a statement which reads, in part:

Apex Physical Medicine offers medical and chiropractic programs with two priorities: help patients who are in chronic pain, and comply with all applicable federal and state guidelines.

Our Regenerative Medicine program uses minimally manipulated cell-based products to help initiate the body’s healing response to ultimately help restore structure and function to the affected joint/tissue.

This elective treatment is offered primarily to patients who are looking for an alternative solution to surgery, have no other available treatment options, and/or are too young for an arthroplasty (joint replacement). This is not a first line treatment for a new onset of joint issues, and by no means is a panacea for treating joint issues.

You can read his full statement here.

Experts weigh in

Chiropractors also alleged their therapies are highly efficacious and have no side effects or incidents of adverse events.

“Our results are 90 percent effective,” Bupp said. “Effective enough, meaning that the patient is satisfied with the results as far as their function and their pain, their activity level.”

“What is the downside?” Ungar told the crowd. “What are the side effects? There’s really not any.”

“I can tell you I hope these are not my patients,” Imitola said when we showed him footage from Ungar’s seminar.

“What we have found, by our own investigation, it’s not [safe] because many patients that have used stem cells, especially abroad, they have ended up with some sort, a lot of, different complications,” said Imitola, who has written about the dangers of stem cell tourism.

He referred to a case involving a California man who went overseas for stem cell treatments after a stroke damaged his spinal cord. 

The treatments were supposed to help restore his mobility. Instead, they mutated into a large mass, forming a tumor that filled the lower portion of his spine.

“Depending on what are you getting in these preparations, you're at risk of having big complications,” Imitola said.

Bill’s battle

Janet Boyuk and her husband, Bill, did not know about the risks when they decided to take out a loan to cover the costs of stem cell treatments.

“We were desperate,” she said. “He thought, ‘Well, maybe this is our answer.’”

Bill was battling chronic obstructive pulmonary disease (COPD) a chronic lung disease, that made it hard for him to breathe.

“He just wanted to get better so bad,” Janet said.

She said her husband received treatments at the Lung Institute in Pittsburgh, a stem cell franchise, with offices in Tampa, Nashville and Scottsdale, Ariz.

Soon, he lost hope and grew depressed.

“We saw no results whatsoever,” Janet said.

 Bill continued to struggle to breathe. He passed away in January of 2017.

“He was a great, great husband,” she said. “I miss him every second of every day. Every day.”

After his death, Janet joined an ongoing class-action lawsuit alleging the Lung Institute used deceptive advertising.

‘Snake oil’

We also showed portions of the footage we captured to Hyun, including Bupp’s answer to a question about the duration of the injection’s effects.

“How long does it last?” Bupp said. “We don’t know.”

“He couldn’t answer a basic question,” Hyun said. "If you can't answer the basics, then I suspect you don't really know what it is you're doing."

Hyun helped create guidelines for the International Society for Stem Cell Research (ISSCR), a global organization of scientists studying stem cells.

The group has condemned the sale of unproven stem cell therapies.

"They use the word condemn,” Hyun said. “It is unethical. It's a violation of professional ethics.

I would classify this…and many other bioethicists who’ve thought about this problem do classify it as a type of snake oil.”

Failure to regulate

So how are Ohio chiropractors able to sell stem cell treatments?

We found the Ohio State Chiropractic Board has conducted little oversight of the burgeoning sales of stem cell treatments.

The board’s website includes a warning issued by the U.S. Food and Drug Administration about stem cell procedures. 

The board also banned chiropractors from personally administering stem cell injections earlier this year.

However, the five-member board has failed to further regulate the sale, use and practice of stem cell treatments.

After he ignored our phone calls and emails, 5 On Your Side investigators met up with the board’s president, Dr. Greg Palkowski, moments before a recent meeting in Columbus.

Palkowski is also the clinical director of First Team Medical Clinics. According to its website, the Dayton-based business offers regenerative cell medicine to patients with pain in the shoulder, back, neck, knee, or other locations.”

The website features scientific studies touting the success and benefits of stem cells.

Medical experts who reviewed the website said the studies involved rats, not clinical trials involving humans.

We asked Palkowski if the board’s lack of action is related to his chiropractic practice. We wanted to know how he could effectively regulate stem cells when he is also profiting from them.

“Why haven’t you done more to regulate stem cells? Is it because you’re selling them?” Our producer asked him, adding that our team wanted to give him an opportunity to respond as part of our report.

“The director of the board is spokesman for the board, and I am not able to comment,” Palkowski said.

“But you run the board,” our producer replied. “Don’t you help with regulations? Is there a reason why you don’t regulate stem cells more?”

Palkowski again declined to answer our questions and repeatedly referred our team to the board’s spokesperson.

 “The board is not acting, as far as the International Society for Stem Cell Research is concerned, in the most fully appropriate manner,” Hyun said. “I think where the chiropractors have to claim responsibility is to do their due diligence. If they want to present themselves as healthcare professionals, [they have] to act like real healthcare professionals.”

Hyun said the board should heed the ISSCR’s advice to be skeptical about stem cell treatments.

As for patients, he advised against spending money on stem cells. 

“Frankly, in my opinion, [it] would amount to have cells injected into your joints, having them migrate haphazardly throughout your body and be flushed out of your system along with your money,” he said.

From the experts: What you need to know about stem cell treatments

Experts encourage people considering stem cell therapies to be cautious, ask questions and arm themselves with as much information as possible about the treatments.

According to the FDA and Consumer Reports, here are some actions to take and key questions to ask the doctor, chiropractor or clinic:

• Ask if the treatment has been reviewed and approved by the FDA. You can view the list of approved products for limited use here.

• Ask the clinical investigator to give you the FDA-issued New Drug Application number.

• Ask to review the FDA communication acknowledging the Investigational New Drug Application (IND). This means there has been a clinical investigation plan submitted and allowed to proceed by the FDA.

• If you are interested in participating in a clinic trial, understand the process and known risks before signing the consent form. Ask the study sponsor for the clinical investigator’s brochure, which includes product description, and information about safety and effectiveness.

• Be cautious of hefty fees and flashy promotions associated with stem cell treatments. Carefully controlled clinical trials “usually don’t promote their offerings” with ads that “promise dramatic improvements or total cures,” according to Consumer Reports.

• Ask the doctor offering the therapy where the cells come from and what will be done to the cells before they are injected in your body.

• Ask how many people the therapy has been tested on and whether the tests were done in individual case studies or clinical trials. You can also ask what the outcomes were of these tests.

• If you are considering stem cell treatment outside of the U.S., know the FDA does not have oversight of treatments done in the U.S. Because of this, it may be difficult to know if the experimental treatment is safe with a stem cell-based product, especially if that country does not require regulatory review of clinical studies.