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Advanced Medical Integration came on my radar about a year ago. I’ve written about many players in the chiropractic “stem cell” world and all are pretty much the same. However, AMI wants to be different which somehow involves best selling author Grant Cardone, so are they? Regrettably, in my opinion, they represent the same bait and switch scam being run by many chiropractic clinics and consultants. Let me explain.

Advanced Medical Integration

If you remember my blog on the new stem cell training being offered by Grant Cardone, you’ll remember a chiropractor and physical therapist were pitching Grant on how best to expand their business. After doing some more research, it turns out that the chiropractor was Mike Carberry. His company is Advanced Medical Integration or AMI.

Who is Grant Cardone? He’s a best selling business book author who is most famous for something called the “10X Rule”. That’s him sitting on one of the jet engines of his private jet. The pitch to Mr. Cardone was about how the pair were trying to scale their business of “integrating” chiropractic practices. So what’s that? Let’s dig in.

What is Medical Integration?

Medical integration is a controversial topic in the chiropractic world. The traditional chiropractors that I speak to hate the idea and think it’s laced with problems. However, some chiropractors believe it can enhance their practices. So what is this?

Medical integration is when a chiropractor adds medical services to a chiropractic office. Traditionally this has been things like medical weight loss or hormone replacement therapy. Given that these are pretty safe therapies, there have been few side effects or complications. However, now medical integration has taken on new wrinkle -“stem cell” treatments. Rather than better-tested bone marrow stem cell therapies, because of a lack of technical expertise, many chiropractic offices add umbilical cord “stem cells”. This has created a new world of issues as these are investigational therapies where not much is known about the application, outcomes, and complications.

AMI Wants to Be Different and Scale

In the Grant Cardone video, Dr. Craberry describes his model as “It’s basically supervised by the medical people who are recommending the chiropractic and physical therapy as needed and they’re doing things like regenerative medicine, injecting stem cells, and stem cell therapy…” The physical therapist with Dr. Carberry says that they do amniotic and umbilical cord IV drips. She also says, “All of our clients do the stem cell drips, they teach it right in Arizona…” They are coming to Grant to help their sales department and scale their business. The pair brings up that 90% of the population won’t go to a chiropractic office. The PT asks Grant, “Do you believe in chiropractic care?” Grant answers, “A little bit. I believe in stem cells more than chiropractic care.”

The AMI Website

At the Advanced Medical Integration website, we’re greeted by a welcome that asks if we want to add regenerative medicine to our practice. All of that looks pretty typical for chiropractic practice consultants selling regenerative medicine services. However, it’s very hard to see much else. I tried to get a copy of the materials, but never got a call or any materials. I was eventually able to get a hold of one of the books when a chiropractic colleague asked for information. Hence, to dive deeper, I took a look at the individual chiropractors who have left testimonials and then that book.

Dr. Libby Darnell

One of the testimonials on the website is from a chiropractor in Illinois, Dr. Libby Darnell. She is so happy with Dr. Carberry’s services that she wants to open multiple clinics, so let’s see what she claims. Dr. Darnell’s website states that they use “mesenchymal stem cells”.

“Where do the cells come from?-These human umbilical cord stem cells are collected from hospitals across the U.S. 

Are there any negative side effects? – In a very small percentage of patients, we occasionally see a minor reaction of flu-like symptoms. This does not last more than 24-48 hours maximum. This actually demonstrates the cells’ anti-inflammatory and immune-privilege potential.”

So let’s unpack that. Do the umbilical cord blood products that this clinic could buy have mesenchymal stem cells? Nope, when independent university labs test these products, there are no live and functional mesenchymal stem cells. See my video below:

The next issue is whether using IV infusions of potentially mismatched umbilical cord blood is a good idea and very safe. It’s not and is loaded with side effects. See my video below:

This is from the clinic sent by e-mail after I asked for more information:

“We use mesenchymal stem cells (they do come from the umbilical cord) that come from a publicly traded company called Predictive Biotech.

The procedure would be performed by our Nurse Practitioner.”

Huh? So where are the “medical people” described by Dr. Carberry above? Instead of seeing a specialist trained physician, it looks like the AMI model is for patients to get an IV infusion or simple injection from a nurse. Who is Predictive Biotech?

Predictive Biotech

I’ve covered Predictive Biotech a couple of times on this blog (Predictive Biotech 1, Predictive Biotech 2, and Predictive Biotech 3). Suffice it to say that I don’t believe that based on the published data and now data from the CSU lab, that Predictive’s umbilical cord products have any viable and functional MSCs. In addition, there’s a really interesting blog post by Hindenburg Research on the company that’s a must-read.

Do We Have Any Evidence that Umbilical Cord Tissue IV Infusions Work?

No, we have no clinical trials or even large case series showing that the type of intravenous Umbilical Cord products being used by the AMI clinics are effective. We also have no studies published with any Predictive Biotech product that shows that this product works for the things described on Dr. Libby’s website, like knee arthritis.

Is AMI Upholding Its Core Values?

The book that you get when you request information from AMI on regenerative medicine (see above) concludes with this:

“At AMI we have three rules:
1. At all times, do what’s best for the patient
2. Always assure compliance with the law
3. Make it profitable for the owner”

If we focus on the first two, then, near as I can tell, AMI is not living up to its own principles. As far as doing what’s best for the patient, delivering IV infusion of non-matched umbilical cord tissue may come with serious side effects. In addition, AMI has not produced nor published any outcome data, so how would it know that what it’s doing is best for the patient? Finally, given that the research shows that these products contain no live and viable MSCs, in my opinion, AMI is involved in a bait and switch fraud.

As far as compliance with the law is concerned, by claiming that it’s using umbilical cord stem cell products (which is discussed in this book), AMI is not in compliance with FDA guidelines. While the book goes into the difference between a 361 registered tissue and a 351 drug, AMI’s classification of the Predictive Umbilical Cord Product as containing mesenchymal stem cells makes it an unapproved 351 drug product.

How Can Merely Claiming Something Change the FDA Classification of  Product?

The FDA website gives a great example of how claims determine the regulatory status by using Charcoal as an example. If you sell charcoal to use on a grill, that’s not an FDA regulated product. However, the moment you take Charcoal and claim that it can be used to treat poisoning, it becomes a product that needs FDA approval. The same is happening here with the umbilical tissue sold by Predictive Biotech and used by Dr. Libby. Once she (and AMI for that matter) claims it has living and functional mesenchymal stem cells that can cure or mitigate disease, it becomes a 351 cell drug without FDA approval.

Why Is Best Selling Author Grant Cardone Involved?

As I blogged last week, best-selling author Grant Cardone is now pitching stem cell sales training:

Given that the above video of Dr. Carberry is a studio production, in my opinion, Mr. Cardone is involved in helping sell fake stem cell products to the public. I have no idea if he knows that what AMI teaches chiro clinics to sell is misrepresented. In addition, on the Grant Cardone Sales University page we see:

“Learn how to tackle sales and closing deals on new stem cell therapy research, exosomes, cellular therapy, cord blood banking, and general medical research.”

Here we see that Mr. Cardone is also selling a program on how to sell illegal exosome drugs. One only need to look at this recent FDA Warning:

The warning above very clearly shows that the exosomes that Mr. Cardone is pitching are an illegal drug product. Regrettably, for Mr. Cardone, it’s my understanding that there is an entire portion of the US Code that deals with the promotion of illegal drug products.

The upshot? Advanced Medical Integration is the same old song and dance. Meaning, it’s no different from Dr. Singer or others who are working with chiro clinics to misrepresent what they’re selling to the public and using in my opinion, medical providers who were never meant to deliver investigational care. Why is Grant Cardone involved? Great question.  For now, I’ll assume that Mr. Cardone believes that he is helping these clinics sell a legitimate stem cell or exosome therapy. Hopefully, he will quickly right that ship, as right now, in my opinion, he’s in the middle of a massive consumer fraud operation.

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