#CBC: “Controversial U.S. stem cell clinics have Canadian connections ” #Toronto #Montreal #Calgary #Ottawa #Canada
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The U.S. Food and Drug Administration (FDA) moved this week to close down a number of clinics within the U.S. providing unapproved stem cell therapies, together with one community that has affiliated clinics in Canada.
The California-based Cell Surgical Network is dealing with a U.S. Department of Justice utility for a everlasting injunction to forestall the clinics “from experimenting on patients with adulterated and misbranded drugs,” in line with a authorized doc filed with a U.S. District Court in California.
Cell Surgical Network (CSN) confirmed to CBC News in an electronic mail that it has three affiliated clinics in Canada that additionally carry out stem cell procedures — one in Vancouver, one in Kamloops B.C., and one in Sudbury, Ont.
Dr. Martin Braun, a former emergency doctor who focuses on botox injections, runs the Vancouver clinic. He informed CBC News his clinic has carried out the stem cell procedures on 200 Canadian sufferers since 2015, treating a number of sclerosis, emphysema, bronchial asthma, and continual again and joint ache.
There is not any payment to be a part of the Cell Surgical Network, he mentioned, however affiliated clinics are required to purchase CSN gear and observe CSN protocol to take away fats tissue and course of it earlier than re-injecting it both immediately or intravenously into the identical affected person.
The procedures value between $5,000 and $8,000 and Canadian sufferers are entered into the broader CNS database, Braun mentioned. Patients are additionally required to signal the community’s consent type, which tells them they’re a part of a analysis examine.
“We tell people this is patient-funded medical research,” Braun mentioned. “We’re not making any claims, warranties or assurances on anything.”
He mentioned he has not informed Health Canada he’s doing the procedures.
“I didn’t alert them that I’m doing it,” he mentioned. “I get very upset when the government — certainly the federal government — interferes with the patient-physician relationship.”
Health Canada is reviewing Canadian associates
Health Canada informed CBC News in an electronic mail that it’s reviewing the scenario.
“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 additionally mentioned it was investigating after CBC News reported on a sequence of personal clinics that have been performing unapproved stem cell procedures.
The Cell Surgical Network was established in 2012 by Elliot Lander, a urologist, and Mark Berman, a beauty surgeon. It has since expanded to incorporate 100 clinics throughout the United States and worldwide clinics in Europe, New Zealand, China and Iran, in addition to the three Canadian associates.
According to the court docket doc, associates of the community are required to observe “instructions and treatment procedures,” which contain extracting fats tissue from sufferers’ buttocks and stomach and processing it by way of a sequence of steps, earlier than re-injecting it both immediately or intravenously into particular components of the physique, together with the mind and spinal twine.
Stem cells are ‘medication’
The FDA maintains that stem cells extracted from fats tissue are “drugs” and should be formally examined and authorised. The company had already warned the clinics final 12 months that they have been working exterior FDA guidelines.
“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 docket doc state.
“That’s why these businesses are basically being taken to court by the FDA,” mentioned Leigh Turner, a bioethicist at University of Minnesota who has been monitoring the evolution of personal 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, argues the cells he’s injecting into sufferers usually are not medication, however merely the affected person’s personal cells utilized in a brand new means.
He mentioned he determined to start out providing the stem cell procedures at his non-public Vancouver laser and skincare clinic as a result of he’d tried it himself. In 2014, he travelled to California to have the stem cell remedy on his knees after a snowboarding accident. He’s now had the process twice.
“The naysayers call it placebo effect,” he mentioned.
This is a regulatory area the place they have been imprecise and really fuzzy. And companies flock to gaps like that.– Leigh Turner, bioethicist
Health Canada hasn’t authorised any stem cell therapies for ache, continual illness, or neurological or cardiac issues. So far just one remedy has been authorised to deal with problems from a childhood most cancers remedy.
“Health Canada authorization is required before any cell therapy can be legally used on human patients,” Health Canada wrote within the electronic mail. “Manufacturers and researchers are required to submit scientific evidence to support the use of these therapies.”
FDA discovered information of affected person harms: doc
The court docket doc state FDA inspectors discovered information that doc adversarial affected person reactions, together with infections, lack of consciousness and hospitalization.
Braun mentioned he has not had any adversarial reactions at his clinic.
The Nardella Clinic in Calgary additionally has a relationship with CSN however it isn’t an official affiliate and says it would not conduct stem cell remedies. But practitioners on the naturopathic clinic generally refer sufferers to the California clinics run by Lander and Berman.
“A lot of patients come with stem cell questions because they know about them — they Google it,” mentioned Ed Trahan, Nardella’s enterprise supervisor. “If they were interested, [our naturopaths] would put them in contact with a clinic.”
When requested if Nardella will nonetheless be referring sufferers to CNS after the FDA’s transfer to close down the clinics, Trahan mentioned he did not know. “We have to figure out what’s going on.”
CBC News reached out to the opposite two Canadian associates — Welcome Back Regenerative Medicine Centre in Kamloops and the Ontario Stem Cell Treatment Centre in Sudbury — however didn’t obtain a response.
Both are recognized by CSN as being affiliated with the U.S. community.
In a press release to CBC News, CSN mentioned it supposed to “vigorously defend” itself in opposition to the FDA motion.
“CSN strongly rejects the idea that a person’s own cells should be regulated by the FDA as a drug,” mentioned the assertion.
According to Turner, a scarcity of clear course from regulators like Health Canada is making a vacuum for these remedies.
“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.”
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Note: “Previously Published on: 2018-05-12 09:00:00, as ‘Controversial U.S. stem cell clinics have Canadian connections