Why clinics offering stem cell therapies need a caution sign

A staggering 54 million Americans suffer from some form of arthritis. Millions more have muscle, tendon or ligament injuries. Short of surgery, physicians usually focus on controlling pain and inflammation, which doesn’t always resolve these problems. Often patients simply stop doing activities they previously enjoyed.

Wouldn’t it be great if doctors could treat problems’ root causes without major surgery? Like replacing worn-out or missing cartilage with an infusion of cells?

Someday, perhaps within a decade, this will be reality. In fact, we believe so fervently in regenerative medicine that we’ve staked our careers on it. Scientists like us are accumulating evidence every month. When the day comes that a clinical trial proves that an injection of cells into a patient’s body creates the exact tissue needed, we will be dancing in the streets.

We can say emphatically (and with some frustration) that we’re not quite there.

That reality, though, has not stopped private, for-profit clinics from stepping into the void.

Across the country, fueled by a multimedia advertising blitz, these businesses pledge relief from arthritis and other conditions through the use of stem cells that help the body regenerate naturally. Their websites claim benefits well beyond the musculoskeletal, improving conditions such as erectile dysfunction and autism. These are brow-furrowing statements.

Here’s what happens during an office visit at these clinics: Typically, practitioners inject cells into joints and other painful locations. The cells can be from the patients themselves – harvested from fat, blood or bone marrow – or from someone else, for example, recovered from fetal amniotic membranes.

If you can imagine “state of the art” medicine, this is pretty much the polar opposite. The knowledge necessary to perform these “treatments” was available a century ago.

Here is the critical part: These therapies have not been shown safe or effective in a clinical trial and they are not approved by the Food and Drug Administration (FDA). Without this approval, private insurers and Medicare/Medicaid will not provide reimbursement.

Still, patients desperate for relief pay out of pocket, sometimes upward of $10,000. Some who have trusted their bodies to these clinics have sustained great injury – left blind and paralyzed, for instance – from injections into an eye or spine.

UW Medicine’s research pursuits at the Institute for Stem Cell and Regenerative Medicine target heart failure, arthritis, diabetes, blindness, kidney failure and other afflictions. These conditions result from a deficiency of a critical cell population, all of which now can be made in the laboratory. Animal testing shows promise in each condition, and in some areas early-stage patient tests have begun.

This is painstaking, expensive work, but there is no substitute for getting it right at each step. Currently, only one medically approved stem cell therapy exists: transplantation of blood-forming stem cells for diseases of the blood. Recent approvals of the first T-cell therapies and gene therapies herald the dramatic advances to come, but stem-cell therapies beyond the blood system are experimental and unapproved.

The FDA recently announced a three-year plan to crack down on stem-cell clinics. But as one clinic is shuttered, another springs up. The FDA has called on states to help protect their citizens.

Washington’s Legislature is responding. House Bill 2356 involves a small, common-sense requirement: that stem-cell clinics post a visible notice that their injection procedures are not FDA-approved and that patients should consult with primary-care providers before undergoing one. This step would not preclude patients from access to these clinics, but it would ensure that their decisions are better-informed.

HB 2356, sponsored by Rep. Eileen Cody, would make Washington the second state, after California, to protect its citizens from these unproven, possibly dangerous treatments.

Regenerative medicine’s potential value to improve human health might rival that of antibiotics and vaccines. But a Wild West approach that skirts the science will waste patients’ money, put them at risk, and undercut legitimate therapies as they emerge. Let’s limit would-be predators and focus our energies on legitimate science and medicine.

Dr. Charles Murry is a professor of pathology, bioengineering and medicine/cardiology at the University of Washington School of Medicine. Dr. C. Anthony Blau is a UW professor of medicine/hematology. They co-direct the UW Medicine Institute for Stem Cell and Regenerative Medicine.