The Trouble With Stem Cell Therapy – Consumer Reports

There's no shortage of opportunity for consumers like John Rodolf to encounter the promise and peril of experimental stem cell treatments. They are being studied by blue-chip medical centers like the Mayo Clinic, offered in the exam rooms of dermatologists and orthopedists, and advertised in newspapers and online by more than 500 stem cell specialty clinics.

The level of scientific vetting these treatments have been subjected to runs the gamut. Some have been carefully developed and sanctioned by the FDA; others haven't been formally studied but have some evidence to support their use. Others still are untested and dangerously unscientific.

It can be difficult to tell which of those categories any given stem cell therapy falls into, in part because websites and advertisements that promote bogus treatments can look just as professional and trustworthy as the ones that discuss legitimate clinical trials. "I found out about the Lung Institute in a magazine advertisement in my doctor's office," says Maureen Rosen, a 75-year-old resident of Ocala, Fla., who, like John Rodolf, paid the Lung Institute thousands of dollars for COPD treatments she says didn't work at all. "And it looked impressive to me. And when I went online, the website looked like any other website that you'd see for a hospital."

Another problem is that questionable treatments are sometimes advertised alongside promising ones. For example, according to court documents and a case study published in the New England Journal of Medicine, three women suffered serious vision impairment (one went completely blind) after participating in a study they found listed at clinicaltrials.gov, a website maintained by the National Institutes of Health (NIH).

The site lists more than 1,000 stem cell-related clinical trials. Some of them have secured investigative new drug (IND) approval from the FDA, a process that can take years of research and involves careful vetting of protocols for safety and close monitoring of patients, as a rule. But other trials listed on the site haven't completed those steps, and there's no easy way to tell the two groups apart.

The clinical trial that allegedly cost the three women their vision was administered at U.S. Stem Cell Clinic (USSCC) in Sunrise, Fla. It involved extracting stem cells from the women's belly fat and injecting them into their eyes to treat their macular degeneration. Researchers say the protocol violated basic safety principlessuch as treating only one eye so that the other would be spared in the event of complicationsand that it used a type of stem cell that hasn't demonstrated any potential for treating macular degeneration. "Fat stem cells can only turn into fat," says Temple of the Neural Stem Cell Institute. "There's no reason to think they would do anything for diseases of the eye." U.S. Stem Cell Clinic declined to be interviewed for this article.

The NIH recently added a disclaimer to its clinical trials home page, warning that not all of the listed studies have been vetted by a federal agency. But critics say that notice isn't enough to protect consumers, many of whom are desperate for miracle cures. "Some clinics effectively use this site as a marketing tool," says Leigh Turner, Ph.D., a bioethicist at the University of Minnesota who has studied the stem cell industry. "They post studies there because it gives them an air of legitimacy, which in turn helps them attract patients."

An NIH spokeswoman told Consumer Reports that the government agency is considering additional measures to help consumers navigate the site better, but she didn't mention specifics.

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The Trouble With Stem Cell Therapy - Consumer Reports