What the Regenerative Medicine Industry Can Learn from the Failed Titanic Sub

As I begin this blog, I’m saddened by the news of the implosion of the Titanic Sub. Like many, I thought there could be some miraculous rescue of these poor souls. My heart goes out to the families of these five people.

In medicine, tragedies like this are always used as a learning experience to improve patient care in the future, so this morning, I’d like to dive into what the regenerative medicine industry can learn from this awful catastrophe.

The Tradition of M and M

Doctors have a long tradition of Morbidity and Mortality Conferences or M&M. These meetings allow physicians to openly discuss among colleagues when things don’t go as planned. They are a way of taking a bad outcome and using that data to help patients in the future. So I’d like to use what just happened as a way to conduct an M&M Conference for the “Stem Cell Wild West”.

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Ocean’s Gate vs. SCWW

The “Stem Cell Wild West” has many things in common with the company that built the Titanic sub called “Titan.” For example, as this disaster unfolded, I came across a video of the company founder giving a tour of the sub to a Spanish actor. If you watch for a few minutes below, you can see that the guy looks confident and talks a good game about all of the safety systems in the sub:

However, this guy was not an actual expert in deep-sea submersibles. For example, the submersible industry group had sent him a letter warning him that his experimental sub needed to be tested more rigorously and that they feared a catastrophic outcome due to its carbon fiber construction. It turns out that every other sub built for more than one use had utilized a more reliable and safer steel alloy sphere. That group was also concerned that an implosion outcome would tarnish the enviable safety record of all subs that adhered to these rigorous industry standards. Sound familiar? I and many others have been exposing the shoddy safety practices of “The Stem Cell Wild West” for years. I have also organized letters signed by experts stating that what these clinics claim or do is unsafe. There have already been Titan Sub like events that have happened, with shoddy clinics causing serious injury.

Let’s further explore more similarities.

Talking a Good Game and Gaining the Trust of the Rich

Really wealthy people are pretty smart; many have used those smarts to amass wealth. Despite this, the creator of the Titan sub managed to convince some of these smart people to take a ridiculous risk with their own lives. How? Each had a lack of subject matter expertise in what’s required to keep people safe at the depth of 3,800 meters. For example, a lawsuit by an ex-employee who was discharged because he wanted more rigorous safety testing, stated that the plexiglass viewport on the sub was only rated to a depth of 1,300 meters. However, that knowledge is expert level.

The “Stem Cell Wild West” is similar in that many smart people are swayed by slick sales pitches given by clinic owners and salespeople. The knowledge that would dissuade them from getting treated is also “expert” level. For example, an expert like myself can easily answer the question of what could go wrong.

In the case of umbilical cord “stem cells,” here’s a list:

  1. The “stem cells” you think you’re getting are dead.
  2. Because they’re dead, they’re not immunoprivleged like you were told.
  3. Because they are not invisible to your immune system, your body will attack these cells.
  4. Depending on the random markers on those cells, that attack may be a mild fever or swelling all the way up to and including a full graft versus host disease response that can cause serious injury or death.

However, otherwise, smart people will believe the sales pitch that they’re getting treated with young and healthy umbilical cord stem cells that will be invisible to their immune response and will make them younger and healthier.

Or, take the case of a family doctor directly injecting the carotid artery of a patient to try to get stem cells into the brain:

  1. The doctor performing the procedure has no advanced training in vascular injections
  2. A proper vascular injection takes a million-dollar catheterization suite and shouldn’t be done at the bedside
  3. The direct carotid injection route is high risk as it can cause plaque on the carotid walls to dislodge, causing a fatal stroke.

This expert-level knowledge will go over the head of even a smart patient.

Who Needs Safety Testing?

Before we deployed cells in patients commercially, we had gone through years of rigorous safety testing and published numerous peer-reviewed papers. In fact, I’ll often find those seminal papers on the websites of clinics that claim that our safety research in culture-expanded bone marrow mesenchymal stem cells or bone marrow concentrate has something to do with their crazy concoction of cells that they’ll be injecting into patients. Like Oceangate, the safety testing that should have been done is often never done in these clinics.

To get a sense of what I’m talking about, I watched this video recently of James Cameron’s deep dive:

I was struck by the intense safety testing that Cameron did on his sub. How the pressure chamber was a hardened steel sphere. How they tested that sphere in a potentially destructive test by exposing it to the exact pressures it would have to withstand. How they trained on emergency procedures if something went wrong. In other words, the Cameron dive was the opposite of the Titan.

So you need to ask yourself, where is the safety testing on the stem cell clinic website? Where is their published research? If you find it, was this testing done by the clinic with the same cell type? Have patients been followed for many years to ensure nothing went wrong? The stark reality is that almost everything you can find involving stem cells online is more Titan than James Cameron.

Yet another safety ticking time bomb is the lack of proper monitoring for in-house labs in physician offices. See my video below on that topic:

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Inexperienced Personnel

Stockton Rush, the owner of the Titan Sub and now deceased pilot, liked to claim that he didn’t hire 50-year-old white guys because they stifled innovation. Others have claimed that was because these more experienced engineers wouldn’t sign off on the design and safety shortcuts he wanted to take. The one 50-something engineer he fired sued the company for being let go because he wouldn’t sign off on the Titan.

The “Stem Cell Wild West” clinics do the same thing. For example, they often hire inexperienced and poorly trained physician assistants and nurse practitioners to perform procedures. Why? They cost a fraction of the physician specialists with the proper training. Again, many otherwise smart people never ask these critical questions.

The upshot? The “Stem Cell Wild West” is very similar to the attitude of Oceangate founder Stockton Rush. Clinics talk a good game but have skipped over the safety testing stage. They also commonly do things that an expert sees as dangerous but a non-expert sees differently. They also employ inexperienced and inept providers to cut costs. Before choosing to board a Sub to the Titanic or get stem cells injected at a clinic firmly in the same category, please do your homework!

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

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NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.

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