The meeting room in the Carlsbad Holiday Inn was filling quickly with men and women, mostly in their 50’s, 60’s, and 70’s, in search of relief from their bad knees and chronic back pain.
They were there to attend a free seminar, enticed by TV and newspaper ads promising “the most significant breakthrough in natural medicine” for improving mobility and reducing pain in muscles and joints.
But what the ads never mention, and the seminar’s speaker neglected to inform the audience, is the $6,500 procedure is not FDA-approved. The seminar speaker also does not mention that the “cutting edge treatment” may require additional stem cell shots costing thousands of dollars more.
While the printed advertisements and TV commercials state “Stem Cell Health Centers of San Diego”, the group behind the seminars and clinics is West2North Medical Solutions.
NBC 7 Investigates attended the Carlsbad seminar, using a hidden camera to film the start of the presentation. Six minutes in, cameras and recording devices were asked to be turned off.
At the seminar, attendees heard and saw a series of videos, presented by Chiropractor Michael Van Derschelden, the West2North Medical Solutions Clinic Director for the center’s San Marcos location.
The Carlsbad presentation was interspersed with videotaped testimonials from clinic clients who said “it worked” for them. Van Derschelden told the crowd he specializes in regenerative medicine and uses “unadulterated” stem cells taken from placentas from consenting donors. The injections come from “shipments from the same placenta,” improving the quality of the injected materials, Van Derschelden explained.
A Carlsbad scientist in the audience who had seen the ads said his curiosity had drawn him to the seminar.
Edward Fox, a retired microbiologist-immunologist noted that the attendees at the seminar never heard "how many people were actually helped by this” or “how many people were actually treated." The one reference to a specific piece of data was when the chiropractor told the audience, “10,000 injections have been performed without a single report of adverse side effects.”
"These people were selling a methodology, an unproven methodology,” Fox said.
For most of the seminar, Van Derschelden had the audience nodding in agreement with his complaints about how lobbyists and “big pharma” were trying to keep these types of procedures from the public.
It’s a claim rejected by Jeanne Loring, a stem cell researcher from Scripps Research Institute. Loring believes the FDA is doing a good job engaging researchers like herself, echoing a recent New England Journal of Medicine article describing the FDA process for developing “highly innovative product.” She says claims of a conspiracy to stymie new breakthroughs is not credible.
“I don't work for a pharma company and I don't work for the FDA,” said Loring, who has worked in stem cell research since 1999 and is considered by many an expert in the field.
While Loring did not attend the seminar, she’s familiar with the claims made about “regenerative cures” from stem cell injections.
“I wouldn't walk into one of those sales pitches,” Loring said, referring to the seminars. “But if you find yourself there you should be asking them what efforts they're making to get this approved by the FDA.”
Kevin McCormack with the California Institute of Regenerative Medicine tells NBC 7 Investigates clinics offering regenerative therapy with little scientific support are gaining in popularity, with hundreds opening up across the state.
“We're very concerned about these kinds of clinics and the therapies they are offering because they haven't gone through rigorous scientific testing,” he said. “When you have someone who stands up there and says you're a doctor, whether it's chiropractor or medicine or orthopedic surgery, you'll listen to them.”
After the Carlsbad seminar, NBC 7 Investigates attempted to speak with Van Derschelden, however, he declined our request and said he would call us back later. Van Derschelden has not called us back.
Dr. Sarah Apollo, the Medical Director and CEO of the San Marcos West2North Medical Solutions clinic told NBC 7 Investigates over the phone that she was “surprised” that Van Derschelden had not told the seminar audience the procedure was not FDA-approved. Apollo was also surprised when we told her the clinic’s advertisements never mention the procedure is not FDA-approved.
In an email to NBC7 Investigates, Apollo thanked NBC 7 Investigates for “bringing these potential issues to us.” She says the clinic is “dedicated to meeting our duties and responsibilities with respect to compliance.” She added that she believes the clinic is in compliance with state and federal laws.
“Moving forward, we will mention that this procedure is not FDA-approved,” she said. Apollo added that there is a posting in the clinic stating the procedure is not FDA-approved, something that is required by state law, as of January 1, 2018.
To read West2North Medical Solution's full statement, click here.
The email from Apollo was signed by Dr. Dean Jones, a chiropractor and CEO of West2North Medical Solutions.
Jones runs another West2North Medical Solutions clinic out of Bismarck, North Dakota, one that can no longer administer stem cell injections to patients without FDA approval.
The North Dakota Attorney General’s Consumer Protection unit filed a lawsuit against Jones and his clinic, alleging the clinic’s sales claims and solicitations are “untrue, misleading or unsubstantiated” for making claims its stem cell injections would: “End your pain now, get your life back, regenerate any cell in the body, regenerate cartilage”.
To read the North Dakota Attorney General's lawsuit, click here.
Without admitting any guilt, Jones agreed to not sell stem cell therapy without FDA approval. He also agreed to pay back thousands of dollars to patients for deposits and services, along with a state fine.
Parrell Grossman, the North Dakota Assistant Attorney General who handled the case against Jones and West2North Medical Solutions told NBC 7 Investigates, “Many of these clinics tie into the Stem Cell Institute of America out of Georgia. It has a ‘package’ that it promotes to chiropractors for marketing, forms, etc. They typically set up all the consumer seminars that bring the patients into their clinics.”
In an email, Grossman told NBC 7 Investigates, “The North Dakota Attorney General, however, has not yet made any formal decision on whether it will pursue [any] formal investigation or legal action against the Stem Cell Institute of America for its role and participation in the alleged misrepresentations in the clinic in North Dakota, but is considering that matter further as a result of that entity’s critical role in promoting and facilitating these stem cell injections.”
Grossman also added his office has been in contact with the California Attorney General regarding West 2 North Medical Solutions.
After sharing what we had observed at the Carlsbad seminar with the Stem Cell Institute of America, the group told us they were severing their ties with Jones as well as 29 other customers in the stem cell business. The Stem Cell Institute denied having anything to do with promoting or setting up seminars as the Attorney General’s Office in North Dakota contends.