The number of stem-cell clinics across the United States has surged from a handful in 2010 to more than 170 today, according to figures compiled by The Associated Press. Many of the clinics are linked in large, for-profit chains. New businesses continue to open; doctors looking to get into the field need only take a weekend seminar offered by a training company.
Berman, a Beverly Hills plastic surgeon, is co-founder of the largest chain, the Cell Surgical Network. Like most doctors in the field, he has no formal background in stem cell research. His company offers stem cell procedures for more than 30 diseases and conditions, including Lou Gehrig’s disease, multiple sclerosis, lupus and erectile dysfunction.
There are clinics that market “anti-aging” treatments; others specialize in “stem-cell facelifts” and other cosmetic procedures. The cost is high, ranging from $5,000 to $20,000.
Berman and others point to anecdotal accounts of seemingly miraculous recoveries. But while stem cells from bone marrow have become an established therapy for a handful of blood cancers — and while there are high hopes that the cells will someday lead to other major medical advances — critics say entrepreneurs are treating patients with little or no evidence that what they do is effective.
Or even safe. They point to one stem-cell doctor who has had two patients die under his care.
“It’s sort of this 21st century cutting-edge technology,” says Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis. “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.”
Stem cells have long been recognized for their ability to reproduce and transform into other cell types. Because of their ability to repair and replace tissue, they are thought to hold potential for treating many diseases and injuries.
Embryonic stem cells are the most versatile because they have the ability to form all the various cell types in the body, but their use in medicine is considered controversial by some because it involves the destruction of human embryos.
Adult stem cells are less versatile, but can be easily harvested from various tissues in the body, including bone marrow and fat. For decades, they have been routinely transplanted, first in bone marrow transplants and then in procedures that transfer the cells alone. They have been useful in combatting leukemia, lymphoma and other blood diseases, saving the lives of tens of thousands of people each year.
The stem cell clinics, though, promise results far beyond those currently considered prudent by mainstream medicine.
“I think responsible professionals have a broad consensus that marketing of these unproven interventions is premature and unprofessional, if not unethical,” says Dr. George Daley, a founding executive of the Harvard Stem Cell Institute and professor at Harvard Medical School. “This field, sadly, is contaminated by lots of poor-quality data that people are using to move forward and actually treat patients.”
Murky regulation
The regulators tasked with weeding out dangerous medical practices are the 50 state medical boards responsible for licensing and disciplining health professionals.
State sanctions against stem cell doctors are rare because medical boards generally begin investigating practitioners only after patients have been harmed. That’s led many industry critics to conclude that regulation must come from the FDA, which regulates experimental drugs and medical products on a national level.
But the FDA’s authority to regulate stem cell procedures is not clearly defined and has been debated by legal experts for years.
The key issue in FDA’s oversight of cell-based medicines turns on how much processing the stem cells undergo. According to FDA regulations, human cells that are more than “minimally manipulated” are subject to the same regulations as prescription drugs. But “minimal manipulation” is not clearly defined in FDA guidelines.
When the FDA has shut down stem cell clinics, it has usually been for growing stem cells in the laboratory for weeks at a time. In at least two cases, the FDA said that that approach exceeds the “minimal manipulation” threshold and could endanger patients due to potential contamination and infection.
But the FDA appeared less interested in policing the far more common practice of same-day stem cell procedures, in which cells are extracted and returned to patients in a few hours.
Many stem cell doctors continue to argue that they don’t need FDA permission because they are not creating drugs, but performing in-office surgical procedures, which are not regulated by the agency.
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