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Madison-area stem cell clinics part of “gray market” under increased scrutiny

May 22, 2019

At least three Madison-area clinics are offering stem cell injections for joint pain, joining hundreds of clinics around the country promoting stem cell therapies for a variety of disorders — some of which federal regulators have tried to shut down, saying the treatments are unapproved and can be harmful.

Joint injections like those available in Madison, where the field of embryonic stem cell research began two decades ago, are thought to be less risky than other treatments, such as shots into eyes that blinded three patients in Florida, according to the U.S. Food and Drug Administration.

But the FDA said at least 12 people were hospitalized last year with infections from E.coli and other bacteria after receiving contaminated joint injections involving stem cells. The agency has told some manufacturers of such products that they’re violating federal law.

Operators of the Madison-area clinics — which charge $4,000 to $5,000 for the shots, which are not covered by insurance — and the businesses that supply them say they are abiding by federal rules.

In 2017, the FDA notified stem cell clinics that the therapies would come under the agency’s full authority by November 2020. In the meantime, regulators say they are trying to police a “gray market” by focusing on the most egregious offenders — such as clinics that mix stem cells with smallpox vaccine or that claim stem cell shots can treat autism, Alzheimer’s disease or ALS — while letting others continue, including those targeting joint pain.

However, “we’re not OK with it,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said this month at an Association of Health Care Journalists conference in Baltimore. He was referring to stem cell joint injections.

“What we’re playing now is a game of whack-a-mole,” Marks said. “We continue to try to take action.”

Chiropractors, surgeon offer shots

Two chiropractic practices in Madison — Springtime Health and Wellness, and Dow Chiropractic — offer injections that the clinics say include stem cells from donor umbilical cord tissue to treat injuries, arthritis or other conditions in knees, hips or shoulders and other joints. The tissue includes cord blood and/or Wharton’s jelly, a gel in the umbilical cord, the clinics said.

A physician assistant or nurse practitioner administers the shots, and an off-site doctor oversees the procedures, the chiropractors said. Springtime’s injection products come from Utah-based Predictive Biotech and Dow’s come from Florida-based New Life Regenerative Medicine.

Jamie Lenz, the chiropractor at Springtime, said she started offering stem cell joint injections in March. “If it can help people, that’s great. If people want to take part in it, that’s an option for them,” Lenz said.

Stem cell shots can help some patients avoid surgery, said David Dow, the chiropractor at Dow Chiropractic, which started making the shots available in October. Dow said patients with some amount of joint damage, but not too much, might benefit the most. “The amount of improvement they get is going to vary,” he said.

Until this week, Dow’s website said stem cell therapy could treat neurological and autoimmune diseases such as ALS, multiple sclerosis, Parkinson’s disease and lupus. When a Wisconsin State Journal reporter asked Dow about that Monday, he said he hasn’t offered the shots for those conditions and removed the information from the website.

Dr. Matt Niesen, an orthopedic surgeon at Columbus Community Hospital, offers a different kind of joint injection at Badger Stem Cell in Middleton. He uses bone marrow aspirate concentrate, or BMAC, taking stem cells and other cells from a patient’s own bone marrow and injecting them into painful joints.

Niesen, who opened Badger Stem Cell in September, said he tells patients to try ice, braces, anti-inflammatory drugs and other measures before considering BMAC injections. He said he manages expectations, telling patients the shots could be an alternative to surgery but won’t regenerate tissue.

“I make it clear to them that this is not the magic injection,” he said. “It does now regrow anything. It doesn’t turn back the clock.”

Buyer beware

Dr. Tim Kamp, director of UW-Madison’s Stem Cell and Regenerative Medicine Center, said patients should be aware that the injections carry risks with no proven benefit, as the treatments haven’t been subject to rigorous clinical trials required before federal approval. James Thomson, who is also at UW-Madison, was the first scientist in the world to isolate and grow embryonic stem cells in a lab, in 1998.

“People are taking the hope and excitement that’s related to stem cells and using it for short-term profit to sell products that are unproven, with the motivation not necessarily completely in patient care but more in revenue generation,” Kamp said. “It’s inherently bothersome to those of us who are trying to push for evidence-based therapies.”

Alta Charo, a UW-Madison law and bioethics professor, said patients might not realize that stem cell injections from umbilical cord tissue are different from bone marrow transplants — which are approved and have been performed for decades — and experimental therapies using embryonic or induced pluripotent stem cells, for which clinical trials are in early stages or have not begun.

“It can be hard for a patient to distinguish,” said Charo, who advises people to use only products that have been FDA approved for the indication involved. “It’s the only way to be sure that an independent eye has been cast upon this and confirmed that it’s safe and effective.”

‘Ginormous gray zone’

James Elliott, of Middleton, said he could barely get through the day at his construction job last year because of pain in his left knee.

The 50-year-old had surgery on the knee 20 years ago and in 2017. Last year, he received two gel injections. Those shots helped, but he was considering a partial knee replacement until he tried a stem cell shot at Dow Chiropractic this January.

Elliott said his pain nearly went away, allowing him to stop taking pain medication. “I can actually walk and work all day now,” he said. “I don’t feel like I’m bone on bone in there anymore.”

Elliott paid $3,500 — a discount, Dow said, because Elliott was one of his first patients for the shots — for an injection of stem cells from donor umbilical cord tissue and for platelet-rich plasma, or PRP.

PRP uses platelets extracted from a patient’s own blood. Springtime, Dow Chiropractic and Badger Stem Cell each offer PRP, which is widely available around the country and has been available at UW Health for 10 years.

PRP, like stem cell injections, is typically not covered by insurance. But PRP doesn’t fall under FDA authority for cell therapy because platelets, which don’t have a nucleus, technically are not cells, said Dr. Jacques Galipeau, director of UW Hospital’s Program for Advanced Cell Therapy and leader of a committee of the International Society for Cell and Gene Therapy.

With cell therapy, including stem cell injections, FDA authority applies if cells are more than “minimally manipulated” or used in a “non-homologous” manner, Galipeau said. That means the cells are cultured or manipulated in a lab or given for purposes other than their original function.

“What constitutes non-homologous use is a ginormous gray zone,” Galipeau said. “This is where a lot of outfits deploy unproven therapies. It doesn’t necessarily mean they’re bad. They’re unproven.”

FDA to ramp up action

Eric Olson, CEO of Predictive Biotech, said in a statement that the company expects its products to “remain in compliance” with the FDA’s definitions of “minimal manipulation and homologous use.” Earlier this month the company said it would conduct a clinical trial and seek approval of one of its products for osteoarthritis of the knee.

New Life describes itself as “FDA registered.” CEO Vicki Mansavage said the company’s products contain a “minute amount of stem cells.” New Life’s website describes the product used by Dow Chiropractic as containing stem cells that “can readily change into the cell type that is needed to repair.”

Niesen said he believes he can provide BMAC shots because many clinics are offering them around the country. “There needs to be clarification,” he said. “I don’t want to be doing anything that’s not approved.”

Marks, of the FDA, told the State Journal the joint injections offered by the Madison-area clinics, including those involving donor umbilical cord tissue and BMAC, require FDA approval because they are non-homologous use.

“Last I looked, there aren’t too many placentas growing in joints,” and BMAC usually isn’t present in joints, Marks said.

Clinics offering such injections are “not at the top of our list to get to,” he said, describing a “gray market.” But, he added, “we’re really going to get serious 18 months from now.”

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