Why the Health Canada Cell Therapy Knee-Jerk Is a Big Deal…

by Chris Centeno, MD /

health canada stem cell therapy

As I have been warning for years, the out of control stem cell wild west would eventually cause regulators to kill even low-risk cell therapies. That’s exactly what happened in Canada this week, where Health Canada issued a position statement saying that even bedside therapies needed drug approval. This is a big deal that should have most US doctors using orthobiologics to help patients avoid invasive surgery very worried.

The Stem Cell Wild West

We have been in total out of control mode here in the US for these past few years, but this got much worse this past year. Why? Multiple vendors of dead birth tissues began convincing alternative health practitioners and uneducated physicians that these products contained million of live stem cells. The number of those practices were scaled through both unscrupulous orthopedic sales reps and third party marketing companies.

The Health Canada Reaction

While the ability of Canadian physicians to offer stem cell treatments has been in limbo for a few years, the new policy statement ends all Canadian autologous stem cell use. The policy basically makes any cell therapy derived from the patient, even those prepared at the bedside, into a prescription drug that requires a Health Canada approval. So your bone marrow, which is minimally processed in the doctor’s office, can’t be used to heal your injuries until someone pays many millions to run a drug trial for each clinical indication for which it’s used. Contrast that to the U.S., where the very same procedure is permitted as a medical procedure.

Will these now required Canadian clinical trials ever really happen? For a few indications, the research will get done by others. For example, we have already published a randomized controlled trial using bone marrow concentrate for knee arthritis. There are also a few more studies at universities coming down the pike. However, Health Canada could play fast and loose here for many years, keeping these simple and inexpensive therapies off the market while giving the expensive cell drug market time to catch up. Which brings us to what’s really going on.

Using Regulation to Stomp Out Competition

There is no doubt that part of this decision was sparked by the out of control stem cell treatment space. However, given that bone marrow concentrate has been used since the 90s to treat orthopedic conditions, the sensible thing to do would have been to carve out a niche for that treatment. You could argue that regulators are more comfortable with an all or none approach than they are with incrementalism, as the latter breeds pressure from advocates from other therapies to be let under the proverbial regulatory tent.

Having said all of this, after observing this field for a decade and a half, there’s likely another factor at play here. Getting drug approvals to use the patient’s own tissues is expensive. Even if you mass produce someone else’s cells and bottle it like a drug, it’s still expensive. Meaning that these therapies will never be able to compete on price with things like platelet-rich plasma or concentrating the patient’s own bone marrow. So to preserve markets for these more expensive therapies that will be approved through Health Canada, an easy step is to outlaw the less expensive therapies. Is this good for consumers or taxpayers? Nope. In fact, it’s antithetical to their interests.

Could this Happen in the US?

The stem cell wild west is far worse in the US than it ever was in Canada. Right now the FDA says that it’s going after bad actors that are putting patient health at risk. So far this has focused on adipose stem cell clinics and umbilical cord “stem cell” vendors. However, it’s just a short hop and skip from where they are to the move Health Canada just made. While the current administration is anti-big government, in 2020 that all could change with a new administration.

The Media vs. The FDA and the Baby’s Bathwater

The media aren’t making the distinction between responsible orthobiologics use and irresponsible use. They view this like Health Canada, that things like bone marrow concentrate should be drugs and that the FDA is allowing a regulatory loophole. I’ve blogged this past week as to why that position is based more on a lack of education of how physicians innovate than on anything scientific or real.

The agency pushed back this past weekend against a New York Times piece that all but accused it of sleeping at the wheel. So, for right now, the agency seems to be dedicated to its risk-based strategy for cell therapy regulation, allowing low-risk therapies like bone marrow concentrate to exist while going after clinics that use high-risk therapies like adipose stem cells or umbilical cord tissue to treat neurologic diseases. Will that position change?

What Do Doctors Think about the Risk of the Health Canada Decision Bleeding into the US?

I ran a poll on Linkedin this past 3-day weekend and the responses were interesting. As of this morning, I had 76 responses from physicians and others in the field. 79% of the respondents were very concerned about Health Canada’s policy eventually influencing US regulatory policy.

The upshot? As I’ve been saying for years, physicians coming together to clean up the stem cell wild west is critical. In addition, now we also need to educate regulators and the media about responsible orthobiologic care. In the meantime, this move by Health Canada is a big concern, as it shows what happens when physicians don’t act to regulate themselves.

Category: Uncategorized

Leave a Reply

Your email address will not be published. Required fields are marked *

6 thoughts on “Why the Health Canada Cell Therapy Knee-Jerk Is a Big Deal…

  1. Jay Wuchner

    That’s what cronie-ism and socialized medicine gets you. This is a prime example of government picking winners and losers. In this case the losers are the people that need stem cell and PTRP therapy.

    Very sad..

  2. Sylvain Simard

    The message is for dr Centeno. I requested last year a agreement with Regenexx but because of the Health Canada régulation the project was stop. I have been the first medical doctor to used BMC to treat osteoarthritis mainly knees in 2016. I will send you my websites and my resume. I will get my license to work in Vermont soon and will like to treat Canadian patients with your group. I cancelled last week 20 patients scheduled for BMC because of Health Canada. Also I will challenge health Canada in court because their decision is medically and legally wrong. Could you help me 🙏

  3. Joe

    Thank you for this article. I’m involved in provincial and federal regulatory discussions around the use of orthobiologics to treat pain in Canada. I couldn’t agree more that we all need to come together to clean things up. I’d love to chat with you to provide you some context to how these regulations came about and some of the influencers that are shaping them. There is a network of responsible physicians up here that would gladly “join the fight”.

  4. Lynn Magee

    I am a Canadian Regenex patient. Since 2017, l’ve had multiple injections of stem cells and plasma rich palettes. I am totally satisfied with Regenex. I found Regenex all by myself because I was desperate. The Canadian doctors l saw only knew how to hand out prescriptions. They can diagnose but they don’t know how to treat joint injuries nor joint disease. They are arrogant, unscientific and narrow minded. They are in the pockets of Big Parma. Health Canada leaves a lot to be desired. I am pain free and fit thanks to my own stem cells, blood palettes and Regenex interventional orthopedics. No drugs needed. Health Canada drug regulatory requirements will never address the need for self regulations of what doctors do behind closed doors.

  5. Patricia. E. Rockwell

    Do you treat chronic migraines?

    1. Regenexx Team

      Hi Patricia,
      Please see: https://regenexx.com/blog/7-headache-causes-and-cures-your-doctor-never-told-you-about/ We treat these issues, which are among the most common causes of headaches. Has a Doctor ever looked into any of these areas?

Chris Centeno, MD

Regenexx Founder

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications.
View Profile

Get Blog Updates by Email

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Regenerative procedures are commonly used to treat musculoskelatal trauma, overuse injuries, and degenerative issues, including failed surgeries.
Select Your Problem Area
Shoulder

Shoulder

Many Shoulder and Rotator Cuff injuries are good candidates for regenerative treatments. Before considering shoulder arthroscopy or shoulder replacement, consider an evaluation of your condition with a regenerative treatment specialist.

  • Rotator Cuff Tears and Tendinitis
  • Shoulder Instability
  • SLAP Tear / Labral Tears
  • Shoulder Arthritis
  • Other Degenerative Conditions & Overuse Injuries
Learn More
Cervical Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Knee

Knees

Knees are the target of many common sports injuries. Sadly, they are also the target of a number of surgeries that research has frequently shown to be ineffective or minimally effective. Knee arthritis can also be a common cause for aging athletes to abandon the sports and activities they love. Regenerative procedures can be used to treat a wide range of knee injuries and conditions. They can even be used to reduce pain and delay knee replacement for more severe arthritis.

  • Knee Meniscus Tears
  • Knee ACL Tears
  • Knee Instability
  • Knee Osteoarthritis
  • Other Knee Ligaments / Tendons & Overuse Injuries
  • And more
Learn More
Lower Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Hand & Wrist

Hand & Wrist

Hand and wrist injuries and arthritis, carpal tunnel syndrome, and conditions relating to overuse of the thumb, are good candidates for regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Hand and Wrist Arthritis
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Thumb Arthritis (Basal Joint, CMC, Gamer’s Thumb, Texting Thumb)
  • Other conditions that cause pain
Learn More
Elbow

Elbow

Most injuries of the elbow’s tendons and ligaments, as well as arthritis, can be treated non-surgically with regenerative procedures.

  • Golfer’s elbow & Tennis elbow
  • Arthritis
  • Ulnar collateral ligament wear (common in baseball pitchers)
  • And more
Learn More
Hip

Hip

Hip injuries and degenerative conditions become more common with age. Do to the nature of the joint, it’s not quite as easy to injure as a knee, but it can take a beating and pain often develops over time. Whether a hip condition is acute or degenerative, regenerative procedures can help reduce pain and may help heal injured tissue, without the complications of invasive surgical hip procedures.

  • Labral Tear
  • Hip Arthritis
  • Hip Bursitis
  • Hip Sprain, Tendonitis or Inflammation
  • Hip Instability
Learn More
Foot & Ankle

Foot & Ankle

Foot and ankle injuries are common in athletes. These injuries can often benefit from non-surgical regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Ankle Arthritis
  • Plantar fasciitis
  • Ligament sprains or tears
  • Other conditions that cause pain
Learn More

Is Regenexx Right For You?

Request a free Regenexx Info Packet

REGENEXX WEBINARS

Learn about the #1 Stem Cell & Platelet Procedures for treating arthritis, common joint injuries & spine pain.

Join a Webinar

RECEIVE BLOG ARTICLES BY EMAIL

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Subscribe to the Blog

FOLLOW US

Copyright © Regenexx 2019. All rights reserved. | Privacy Policy

*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.