Regenera Activa Procedures in Canada 2022: Still Not Allowed
Regenera Activa Treatments in Canada: Still Not Permitted to be Performed
I have received alot of questions lately as to whether I offer a procedure known as Regenera Activa in my hair loss practice.
The answer is no. The short answer is that it’s not allowed in Canada. Let’s take a look at the longer answer.
I have mentioned to several patients this past year that Regenera Activa is a treatment I’m interested in exploring to see if it helps a lot or a little …. or not at all. I’ve seen some of the data in various studies but numbers of patients studied are small and so I’m interested in exploring the efficacy myself. I’d like to know whether this is a good treatment or not here in our clinic with our patient population. If I feel anything is a good treatment for patients, we’ll add it to the treatment toolbox. If not helpful, it won’t go on the list as a first, second or third line treatment. I’d like to study this treatment more.
What is Regenera Activa?
Regenera Activa is a procedure which involves taking little cores of skin from the back of a patient’s scalp and crushing up the skin to release cells - including “stem cells” that live in the area. The suspension is then injected into the area of hair loss from that same patient. An important “technical” difference between Regenera and a hair transplant is that cells are no longer in their natural arrangement with Regenera and one is moving “cells” rather than “clumps of hair and skin” into the areas of hair loss with Regenera vs a hair transplant. This difference is subtle but important to how regulatory bodies view the treatment. We’ll get into that in a bit. (Regulatory bodies are happier with minimal amounts of tissue manipulation than greater degrees of tissue manipulation).
Regenra Activa Still Not Allowed to Be Done in Canada.
As I report to my patients, Regenera is still not allowed in Canada and it’s considered malpractice for a Canadian physician (or practitioner of any kind in Canada) to offer it. A Canadian physician or naturopath or any practitioner could in fact, lose his or her medical license, and face stiff penalties for performing this treatment within Canada. Simply put … the treatment is not allowed.
Regenera cannot be imported for use on patients without proper medical device licenses in place. Those licenses don’t exist in Canada.
Will Regenera treatments ever be allowed in Canada? Well, that’s up to the company to seek out licenses and up to Health Canada to approve the device and approve the treatment. You can use the following link to determine when Regenera becomes permitted in Canada:
https://health-products.canada.ca/mdall-limh/prepareSearch-preparerRecherche.do?type=active
If Regenera ultimalely gets the “green light” to sell to the Canadian market, we’ll need to make sure Health Canada okays the procedure. That’s the really, really important second step. Just because a device is given a license for import doesn’t necessarily mean it’s okay for Canadian physicians to offer this procedure!
The country of Canada has some of the strictest rules about stem cell treatments anywhere in the world to protect the public. Health Canada no longer allows stem cell treatments to be performed without really good evidence to back up the procedure. It’s not that this data should be published in medical journals. This data needs to be submitted to Health Canada for review. Gone are the days when any clinic could do anything they wanted just because it’s new and exciting.
Stem cell procedures of this kind may or may not be permitted depending on the views of Health Canada and whether they view the Regenera technique as a simple or complex autologous procedure. Many autologous stem cell procedures are banned in Canada and so a formal ruling will be needed on these types of techniques.
In 2019, Health Canada issued a public policy position on that point stating that
"All cell therapies are considered drugs under the Food and Drugs Act. This means that they must be authorized by Health Canada to ensure that they are safe and effective before they can be offered to Canadians," Health Canada said in their news release.
Regenera Activa is likely to be viewed as a type of stem cell procedure by Health Canada. Taking stem cells from the scalp is likely going to be seen by Health Canada regulators as safer than taking the cells from fat (ie liposuction or adipose related stem cell procedures). But the procedure will still likely be considered a ‘drug’ and need to be approved under the Food and Drug Act. It will probably be easier to get approval for Regenera in Canada than some kind of autologous fat stem cell procedure given that Regenera does not require enzyme treatments only crushing. (Fat procedures require lots of digestion of the fat by enzymes).
Both Regenera and fat stem cell procedures are banned in Canada.
For now, these procedures are under complete control and direction of Health Canada and clinics can be closed, fined and doctors penalized for operating outside of these strict Health Canada rules.
Reference
This article was written by Dr. Jeff Donovan, a Canadian and US board certified dermatologist specializing exclusively in hair loss.