Vermont lawmakers will be asked in the coming year to consider regulating stem cell clinics like Vitality Healthcare in Williston and Regenexx in Winooski, which promote using stem cells to heal tissue.
Sen. Ginny Lyons said she plans to introduce legislation that addresses how clinics inform patients of the risks and benefits of unproven treatments.
“The use of untested or unapproved clinical interventions is something I think we should all be concerned about,” said Lyons, D-Chittenden.
The Food and Drug Administration has issued warnings as recently as September about unapproved stem cell treatments, in which a patient’s own cells are extracted and then injected back into their body.
Regenexx, a Colorado-based company that lists several physicians in clinics around the country, including Dr. Jonathan Fenton of Winooski, says that it uses “your body’s natural healing ability to repair damage to bones, muscles, cartilage, tendons, and ligaments non-surgically.”
“Our proprietary, research-driven techniques allow us to concentrate your cells and to place them in the precise area of your injury to promote healing and to achieve optimal outcomes,” the company says on its website.
The FDA said that while some stem cell therapies might offer the potential to treat diseases or conditions for which few treatments exist, more research is needed. It said some patients have been injured – and in some cases blinded – by unauthorized use of stem cell therapy.
The Vermont Medical Society asked Lyons to take action. In a resolution adopted at the society’s annual meeting Nov. 2, the society said the clinics “engage in aggressive and false marketing to the public, with promises that stem cell treatments can improve cosmetic appearance as well as help a variety of conditions ranging from arthritis to autism, COPD, neuropathy and chronic pain.”
Dr. Daniel Weiss, a pulmonologist and professor of medicine at the University of Vermont, said the number of stem cell clinics offering unproven therapies is escalating quickly. He said they are using untested therapies and could harm patients.
“This is a huge global problem,” said Weiss. “There is so much hype behind stem cell therapies.”
Weiss said the fact that a clinic can legally take tissue from a person and inject it back to the same person is the result of a loophole in FDA regulations. The clinics craft their message of potential healing to appeal to desperate patients and their families, he added.
“They are taking advantage of this population,” he said. “Yes, there are some really exciting legitimate research potential clinical use but it’s not there yet; it may never be there. Hopefully it will be there. But the clinics offer things that are simply just not proven, and some of these approaches are potentially dangerous.”
Fenton, who owns the Regenexx clinic in Winooski, said the technology used at Regenexx is safe and that his work has been wrongly grouped with the work of places like Vitality Healthcare, which are carrying out unapproved therapy. Vitality Healthcare did not take phone calls Dec. 12 at the phone number listed on its website, and did not return an email.
“He’s lumping us in with the Williston clinic or the four New Hampshire clinics where it’s a nurse practitioner injecting embryonic membrane or umbilical cord products claiming to be stem cells,” he said of Weiss. “In New Hampshire, they claim to treat COPD and autism and have no safety studies, no studies at all saying it works.”
Regenexx says on its website that it was founded by physician Chris Centeno of Colorado, in 2005. Fenton spoke to VTDigger Wednesday from the Cayman Islands, where he said he was able to carry out stem cell work that is not authorized in the U.S. He is listed as treasurer on the website of the American Academy/Association of Orthopedic Medicine, a group that is dedicated to regenerative orthopedic care.
The Vermont Medical Society plans to disseminate evidence-based information to its members regarding stem cell clinics and therapies and encourage those members to talk to patients about the services.
The resolution also calls for the medical society to coordinate with professional licensing boards, the Attorney General’s Office and other regulatory bodies to make sure that the clinics provide evidence-based information and services.
The FDA is also increasing its oversight and enforcement. It recommended to potential patients that they make sure all therapies are FDA-approved, or are being studied under an Investigational New Drug Application, or IND – a clinical investigation plan that has been allowed to proceed by the FDA.
Weiss, who is a professor of medicine at UVM Medical Center, is chief scientific officer at one of the leading scientific stem cell organizations, the International Society for Cell and Gene Therapies. He has also been carrying out research in the cell therapy field for several years. He said the society and the other leading stem cell scientific organization, the International Society for Stem Cell Research, have been active in working against companies that offer unproven cell therapies.
“There are organizations with various titles that are in fact promoting this type of approach, and it is confusing; it is confusing to us as well sometimes,” he said. “It is a complex field. But the FDA over the past few years has taken much more action to try to regulate these clinics.” The Federal Trade Commission has also stepped in to enforce truth in advertising laws.
Weiss said several states have developed legislation to stop clinics from making untrue claims.
Lyons said her legislation doesn’t call for lawmakers to assess the veracity of the Vermont company’s claims.
“We certainly don’t want to have a mini-FDA in the state of Vermont,” Lyons said. “On the other hand, I think it’s critically important that we look at the effect of any stem cell intervention on patients.”
