Controversial U.S. stem cell clinics have Canadian connections

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The U.S. Food and Drug Administration (FDA) moved this week to shut down several clinics in the U.S. offering unapproved stem cell therapies, including one network that hasaffiliated clinics in Canada.

The California-based Cell Surgical Network is facing a U.S. Department of Justice application for a permanent injunction to prevent the clinics "from experimenting on patients with adulterated and misbranded drugs," according to a legal document filed with a U.S. District Court in California.

Cell Surgical Network (CSN) confirmed to CBC News in an email that it has three affiliated clinics in Canada that also perform stem cell procedures one in Vancouver, one in Kamloops B.C., and one in Sudbury, Ont.

Dr. Martin Braun, a former emergency physician whospecializes in botox injections, runs the Vancouver clinic. He told CBC News his clinic has performed the stem cell procedures on 200 Canadian patients since 2015, treating multiple sclerosis, emphysema, asthma, and chronic back and joint pain.

There is no fee to be part of the Cell Surgical Network, he said,but affiliated clinics are required to buy CSN equipment and followCSN protocol to remove fat tissue and process it before re-injecting it either directly or intravenously into the same patient.

The procedures cost between $5,000 and $8,000 and Canadian patients are entered into the widerCNS database, Braun said. Patients are also required to sign the network's consent form, which tellsthem they are part of a research study.

"We tell people this is patient-funded medical research," Braun said. "We're not making any claims, warranties or assurances on anything."

He said he has not told Health Canada he is doing the procedures.

"I didn't alert them that I'm doing it," he said. "I get very upset when the governmentcertainlythe federal governmentinterferes with the patient-physician relationship."

Health Canada is reviewing Canadian affiliates

Health Canada told CBC News in an email that it is reviewing the situation.

"Health Canada is following up with regard to the Canadian clinics that you have identified," wrote spokesperson Anna Maddison. "Should the department identify any non-compliance with the Food and Drugs Act and associated regulations, it will take appropriate action."

Last November, Health Canada also said it was investigatingafter CBCNewsreported on aseries of private clinics that were performing unapproved stem cell procedures.

The Cell Surgical Network was established in 2012 by Elliot Lander, a urologist, and Mark Berman, a cosmetic surgeon. Ithas since expanded to include 100 clinics across the United States and international clinics in Europe, New Zealand, China andIran, as well as the three Canadian affiliates.

According to the court document, affiliates of the network are required to follow "instructions and treatment procedures," which involve extracting fat tissue from patients' buttocks and abdomen and processing it through a series of steps, before re-injecting it either directly or intravenously into specific parts of the body, including the brain and spinal cord.

Stem cells are 'drugs'

The FDA maintains that stem cells extracted from fat tissue are "drugs" and must be formally tested and approved. The agency had already warned the clinics last year that they were operating outsideFDA rules.

"There have been no adequate and well-controlled studies performed on the [company's]products demonstrating that they are safe or effective for any indication," the court documentstate.

"That's why these businesses are basically being taken to court by the FDA,"said Leigh Turner, a bioethicist at University of Minnesota who has been tracking the evolution of private stem cell clinics.

"They were flaunting federal law, they had multiple chances to stop, they refused to stop and so the FDA is now seeking a permanent injunction."

Braun, from the Vancouver clinic, arguesthe cells he is injecting into patients are not drugs,but simply the patient's own cells used in a new way.

He said he decided to start offering the stem cell procedures at his private Vancouver laser and skin care clinic because he'd tried it himself. In 2014, he travelled to California to have the stem cell treatment on his knees after a skiing accident. He's now had the procedure twice.

"The naysayers call it placebo effect," he said.

This is a regulatory space where they've been vague and very fuzzy. And businesses flock to gaps like that.- Leigh Turner, bioethicist

Health Canada hasn't approved any stem cell therapies for pain, chronic disease, or neurological or cardiac disorders. So far only one therapy has been approved to treat complications from a childhood cancer treatment.

"Health Canada authorization is required before any cell therapy can be legally used on human patients," Health Canada wrote in the email."Manufacturers and researchers are required to submit scientific evidence to support the use of these therapies."

FDA found records of patient harms: document

The court documentstateFDA inspectors found records that document adverse patient reactions, including infections, loss of consciousness and hospitalization.

Braun said he has not had any adverse reactions at his clinic.

The NardellaClinic in Calgary also has a relationship withCSN but it is not an official affiliate and says it doesn't conduct stem cell treatments. But practitionersat the naturopathic clinicsometimes refer patients to the California clinics run by Lander and Berman.

"A lot of patients come with stem cell questions because they know about themthey Google it," said Ed Trahan, Nardella's business manager. "If they were interested, [ournaturopaths]would put them in contact with a clinic."

When asked ifNardellawill still be referring patients to CNS after the FDA's move to shut down the clinics, Trahansaid he didn't know."We have to figure out what's going on."

CBC News reached out to the other two Canadian affiliates Welcome Back Regenerative Medicine Centre in Kamloopsand the Ontario Stem Cell Treatment Centre in Sudbury but did not receive a response.

Both are identified by CSN as being affiliated with the U.S. network.

In a statement to CBC News, CSN said it intended to "vigorously defend" itself against the FDA action.

"CSN strongly rejects the idea that a person's own cells should be regulated by the FDA as a drug," said the statement.

According to Turner, a lack of clear direction from regulatorslike Health Canadais creating avacuum for these treatments.

"This is a regulatory space where they've been vague and very fuzzy and businesses flock to gaps like that. They head straight for those regulatory gaps and they exploit them as long as they can."

• Unapproved stem cell therapies on the market in Canada
• SECOND OPINION | Stem cells for hair growth?
• SECOND OPINION | Health Canada investigates Canadian stem cell clinics

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