Hundreds of U.S. Clinics See Unapproved Stem Cell ‘Therapies’

In an online search, researchers found at least 570 clinics offering unapproved stem cell “therapies.” Most often, the clinics market stem cell procedures for orthopedic conditions, such as arthritis and injured ligaments and tendons. This does have science behind it, but is still experimental, medical experts said.

In other cases, with little or no supporting evidence, clinics hawked stem cell “facelifts” and therapies for serious conditions such as chronic lung disease, Parkinson’s disease and multiple sclerosis.

If these pricey stem cell treatments are unproven and unapproved by federal regulators, how can these clinics exist?

“I ask myself that question all the time,” said Leigh Turner, a bioethicist who worked on the study.

Turner, an associate professor at the University of Minnesota’s Center for Bioethics, said attention used to focus on “stem cell tourism” – where people travel to countries such as China, India and Mexico to get unproven treatments.

“I think there’s a misperception that everything here [in the U.S.] is regulated,” Turner said. “But these clinics are operating here, and on a relatively large scale.”

Stem cells are primitive cells with the potential to mature into various types of body tissue. Medical researchers have been studying the possibility of using stem cells to repair damaged tissue in a range of chronic ills – with limited success so far.

But the general public has heard about the “promise” of stem cells for years, and it can be easy to be taken in by clinics’ marketing tactics, Turner said.

The businesses are usually not engaging in interstate commerce, which helps them “fly under the radar,” said Arthur Caplan, a bioethicist who was not involved in the study. Plus, there’s a regulatory gray area when it comes to so-called “autologous” stem cell therapy – which refers to treatments that use a person’s own stem cells.



Of the businesses Turner’s team found, most marketed autologous therapies, usually using stem cells from people’s body fat or bone marrow. But about one-fifth of the businesses claimed to use stem cells from umbilical cord blood or amniotic or placental tissue.

The U.S. Food and Drug Administration has taken steps against specific businesses. Last year, it sent a warning letter to a network of clinics that operate in California, Florida and New York. According to the FDA, the clinics illegally use stem cells from people’s fat tissue to treat conditions such as Parkinson’s MS, amyotrophic lateral sclerosis (ALS) and autism.

The new study findings appear in the June 30 issue of Cell Stem Cell.

My Take:
Yes, the public is desperate for more effective treatment of chronic disease. However, the research on stem cell therapy lagged for many years under political pressure from the health care industry. The potential for stem cells is so great, many fear that current forms of treatment will become obsolete.

Their fear is well founded. Imagine an injection of stem cells in the knee that eliminates the need for total knee replacement at less than 1% of the cost. The loss of income by physicians and hospitals would be astronomical.

Today, a teenager with a torn ACL (anterior cruciate ligament) can have an injection of his or her own stem cells for about $500 and have complete recovery of the knee in ten days.

The major remaining hurdle for the treatment of chronic disease is that the number of stem cells we produce declines with age. Current research is looking at ways to harvest a small number of cells, reproduce them, then inject them back into the body. This will create a viable treatment option for older patients.

The Bottom Line:
Sure we want stem cell therapy. It’s long overdue and it’s horrific to think that the people we elect have stifled this promising health treatment for personal and financial gain at the expense of all of humanity. The FDA should be supporting legitimate stem cell clinics rather than continuing to slow the progress of this revolutionary from of health care.

Source: June 30, 2016 National Institutes of Health