By Judy Foreman
The woman in L.A. simply wanted a facelift. That’s all. But what she got was a nightmare – and a lesson for any of us who might be lured into the under-studied territory of cosmetic stem cell procedures.
Several years ago, the woman went to a California clinic that offered her a cosmetic procedure in which her own adult stem cells were harvested from her abdominal fat. (Adult stem cells are undifferentiated cells found amidst differentiated cells in tissues throughout the body; these cells can not only make many endless copies of themselves, they can also differentiate to yield some or all of the major cell types of the tissue from which they came.
At the clinic, doctors extracted from the woman’s fat stem cells that could turn into bone, cartilage or fat, according to a recent Scientific American article. Apparently, these cells were either mixed with a facial “filler” called calcium hydroxylapatite or injected into the same area as the filler. The filler can nudge stem cells to turn into bone.
Three months later, the woman couldn’t open her right eye without significant discomfort, and she heard a strange, clicking sound every time she opened and closed her eye.
Worried, she sought help from a different clinic, The Morrow Institute in Rancho Mirage, and a different doctor, cosmetic surgeon Dr. Allan Wu, chief scientific officer of the institute’s stem cell research lab.
In a telephone interview this week, Wu told me that, during a multi-hour procedure, the Morrow team extracted bits of bone from her eyelid and the area around her eye. The clicking sound, he said, probably came from these bone fragments hitting each other. Though the woman, whose name has not been released publicly, appears to be fine now, he said, other facelifts using isolated and concentrated stem cells alone may carry a risk of unintended bone growth and other potential long-term consequences.
The operation “took all of us a lot of work, a lot of sweating,” Wu told me. “Why? Because when you see bone and fat, or if you happen to see hair [in parts of the body where they shouldn’t be] you worry about a teratoma [a kind of tumor] that stem cells can form. We were all very worried – the question was, was this cancer surgery or cosmetic reconstruction?”
Luckily, it was the latter, Wu said, adding that his group supports the need for controlled studies and oversight by the U.S. Food and Drug Administration.
The FDA is trying to protect consumers against some untested cosmetic stem cell practices. Currently, the only FDA-approved stem cell-based products are blood-forming stem cells used for certain indications, such as bone marrow transplants in people with leukemia.
In the summer of 2010, the FDA requested an injunction in the U.S. District Court of the District of Columbia to stop a stem cell clinic called Regenerative Sciences from preparing its treatments. The company told me it has never performed any cosmetic procedures and only treats orthopedic conditions. The company was not involved in the case of the woman from L.A., according to Wu.
In July 2012, according to a report in the journal Nature, that court affirmed the right of the FDA to regulate therapies made from a patient’s own processed stem cells. The company argued that the cells it injects back are not significantly modified and that because of this, the procedures should be considered normal medical practice. The FDA argued that the cells are more than minimally manipulated.
Put differently, the court basically agreed with the FDA that the stem cells were manipulated enough that they should be considered drugs, and thus subject to pre-marketing approval. A blog post on Cell Therapy Blog saw things differently, believing that the court ruling was “just the beginning of what will be a long and interesting battle.”
Meanwhile, Regenerative Sciences is still in business. In Broomfield, CO, lead physician Christopher Centeno does a simplified stem cell orthopedic procedure at the Centeno-Schultz Clinic in which stem cells are harvested from bone marrow and re-injected into patients the same day; the company is also doing the more involved procedure with stem cell manipulation at its clinic in Grand Cayman.
More recently, the FDA has also been concerned about another stem cell company, Celltex in Houston. In a “warning letter” to the company in September, 2012, the FDA said that, following an inspection of the company’s plant in Sugarland, Texas, the agency found that the company’s processing of harvested adipose tissue did not meet the definition of “minimal manipulation” required and that the company’s promotion of its CellTex product causes the product to be considered a drug.
Not surprisingly, some consumer advocates are concerned. “The anti-aging market is where we see some of the strangest technologies and ingredients. Consumers are often surprised to learn how little oversight there is over cosmetic ingredients,” a spokesman for Environmental Working Group, a non-profit consumer watchdog group, told me.
The cosmetic stem cell industry is “huge,” though mostly outside the U.S., Stanford University cell biologist Christopher Scott, who also teaches ethics and law at the university’s Center for Biomedical Ethics, told me by phone this week. “Japan is a big practitioner, as are other Asian countries – China, India, and yes, also Europe. It’s a huge market.”
Scott noted that there are numerous legitimate studies underway exploring the potential of stem cells, but warned consumers against clinics that “overpromise” on their results and ones that, in pull-down menus on websites, offer stem cells for disparate conditions. “Cells are very different and the procedures are different. If a clinic offers a one size fits all fountain of youth, that’s a red flag.”
And don’t be fooled, he added, by clinics that tout testimonials from happy customers. “Testimonials are worthless as scientific evidence.”
Judy Foreman, a health reporter in Boston, just completed a book about chronic pain: “A Nation in Pain: Healing Our Biggest Health Problem.”