This week, prosecutors said they are investigating the Seoul-based RNL Bio, which has treated an estimated 8,000 patients, for selling unapproved stem-cell therapies, some of which are alleged to be prepackaged products patients had injected by other out-of-country doctors.
In a bid to protect patients and the legitimacy of their own work, scientists have taken the unusual step of trying to police suspect claims themselves. The ISSCR has launched a website where the public can glean facts about stem cells and report companies selling unproven treatments.
And this fall, the American Association for Aesthetic Plastic Surgery created a task force to investigate untested stem-cell therapies in the U.S.
Association president Felmont Eaves of North Carolina says stem-cell use in cosmetic procedures is an exciting, promising area of research, but to offer treatments now is “emotionally … [and]psychologically manipulative.”
Dr. Eaves says, “At this point, there is absolutely no clinical evidence that they're activating or even processing stem cells.” Some clinics claim to add them to transplanted fat tissue, he adds, “but fat grafts work pretty well on their own.”
To harvest stem cells and confirm their presence takes time, adds McMaster's Dr. Bhatia. Many clinics suggest that they can grow them in a few hours, yet he says it takes at least eight hours for any mammalian cell to grow.
If they really are using stem cells, it may be even worse: “Once you take a cell out of its normal environment and grow it in a dish, the ones that grow well do so because they have mutations that you call cancer – and then you are going to put these high growers back in another site of the body?”
He adds, “You hope the work is going to help someone legitimately, but I worry the claims compromise the whole legitimacy of the field. … And there is a frustration to all the testimonials these companies offer: If it is true, why isn't it published? Why isn't it out there?”
‘Turbo-charging the hair follicle'
John Satino says he has always intended to publish. He says he has long been involved in new technologies to treat hair loss, having run tests on Rogaine in 1985, on Propecia in 1989 and on the HairMax Laser Comb in 2003 – “every FDA-approved modality for hair loss.”
So in 2008, when a masseuse on his staff told him that Arabian racehorses in Sarasota, Fla., received stem-cell injections that healed their joints and regrew hair, he decided to give it a try.
Mr. Satino opted to do it with platelet rich plasma (PRP), essentially a substance that requires a patient's blood sample to be processed in a machine that separates and concentrates its platelets. The platelets, which hold a number of growth factors, are then injected back into the patient, often to heal sports injuries.
He says the U.S. Food and Drug Administration has approved PRP injections into soft tissue, but not specifically for hair loss nor as a source of stem cells.
He treated the first patients free, Mr. Satino says, thinking, “ ‘Let's just inject something and see what happens.’ … And it looked good,” he says. “And it wasn't going to hurt anyone.
He estimates that he has done 500 patients – men and women – and that 80 per cent of clients do respond. It works best for young men with thinning hair, he says: “I think stem cells are turbo-charging the hair follicle.”
Still, Mr. Satino admits that he does not know if he is actually injecting any stem cells into customers' heads. He does not extract, purify or count them, and does not track their presence after an implant. “We haven't really gone there,” he says. He would if they were conducting a formal study. “I cannot say for sure that it is stem cells.”
He agrees that it may be a placebo effect, the plasma or the injections themselves stimulating growth. Still, his clinic website features the procedure as a stem-cell treatment under the heading, “Breakthrough Technology.” Patients – charged $1,200 (U.S.) for one set of injections – have come from as far away as Scotland.
Mr. Satino says he thinks that it's a good idea to crack down on unproven stem-cell therapies in the cosmetics field, describing outlandish claims he has seen online. “If you're going to market a snake oil, call it a stem cell – that's the way to do it.
“Hopefully, we're not falling into that category,” he adds. “We're not promising anyone anything. … Really, we turn away as many people as we accept.”
He plans to publish his work next year in the Hair Transplant Forum. But it will not be peer-reviewed results of a rigorous clinical trial. For that, he says, you need funding – trials are expensive to run.