Regulators in the United States and Australia are examining the burgeoning field of stem cell therapies.

Regulators in the United States and Australia are examining the burgeoning field of stem cell therapies. Using patients’ own stem cells extracted from fatty deposits in their bodies, doctors are treating dozens of conditions ranging from sports injuries to multiple sclerosis to dementia to hair loss.

However, the doctors don’t know how the stem cells work and there often is no evidence that they do work, other than optimistic anecdotes. According to a report by AP, more than 190 clinics in the United States are offering stem cell therapies. “It’s sort of this 21st century cutting-edge technology. But the way it’s being implemented at these clinics and how it’s regulated is more like the 19th century. It’s a Wild West,” says Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis.

Many of the clinics are franchises organized by large for-profit companies which provide equipment and some training seminars. The largest, says AP, is the Cell Surgical Network, co-founded in 2012 by, who a former Beverly Hills plastic surgeon, Dr Mark Berman. The company’s website lists at least 28 conditions which can be treated with injections of a “fat-based soup”. “I don’t even know what’s in the soup,” Berman told AP. “Most of the time, if stem cells are in the soup, then the patient’s got a good chance of getting better.”

The US Food and Drug Administration has been unable to regulate the stem cell market because the stem cells come from the patient and are not new drugs and only a minor surgical procedure is needed.

Stem cell scientists are highly critical of the industry. On his blog, Dr Knopfler interviewed Dr Berman and his partner and then drew his own conclusions: “

“One of the deepest differences that I have with Drs. Lander and Berman is related to my core belief in evidence-based medicine. I believe in having compelling pre-clinical evidence before you start to do a specific kind of new or experimental medicine on human patients. To my way of thinking, for example, prior to getting even one patient involved with an experimental medical approach you should do pre-clinical studies on animals for a given medical condition with the specific medical intervention in question. Then you collect data on safety and efficacy …

I do not personally believe in collecting millions of dollars from patients for interventions that are still arguably, in my opinion, experimental.”

In Australia, the Therapeutic Goods Administration, is studying whether autologous stem cell therapies ought to be regulated. Dr Martin Pera, of Stem Cells Australia, a consortium of stem cell researchers said in his submission to the TGA that “Immediate action is required to curb the growth of exploitative unproven and unfounded practices”.

“Under the current system there is no requirement for monitoring or reporting adverse events. We’re completely in the dark whether these treatments have the potential to do harm or any good,” he told the Sydney Morning Herald.

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Michael Cook

Michael Cook edits BioEdge, a bioethics newsletter, and MercatorNet, an on-line magazine whose focus is human dignity. He writes from Sydney, Australia.

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