I see all sorts of crazy stuff on stem cells all over the Internet. As the first physician on the planet to perform many of these injection-based, orthopedic stem cell procedures, what I see disturbs me greatly. However, I have to admit that I have become so used to seeing this stuff that I ignore most of it. Every once in a while I see something that’s so “out there”, I have to write about it or I’ll start pulling out hair. This brings me to the Southern Stem Cell Institute. Let me explain.
The Predictive Biotech Investor Report
Like all good stories, this one has a beginning. I was recently sent a report put together by an investment research firm on a company called Predictive Biotech. I got pulled into writing about Predictive years ago when I was sent a report authored by the University of Utah’s flow cytometry lab who tested Predictive’s Corecyte Wharton’s Jelly product. This stuff is taken from umbilical cords and processed and then frozen and sold to doctors in vials. Both the company and many doctors claim that it has millions of young stem cells.
At first, the report’s conclusion of high stem cell numbers in Corecyte made no scientific sense. Then I was later sent two copies of the report. One had the conclusions I had criticized, but another copy had no such conclusions about the stem cell content of the product. Eventually, I called the author of the report on the phone who confirmed that he had never concluded that the product had any stem cells and that the data he collected would never support that conclusion.
99% Success Rate?
In that long investment report was the slide below. This was so “out there” that I had to see who it belonged to, which is where our review of the Southern Stem Cell Institute begins.
This slide is from a webinar by Dr. Ambrozic who owns the Southern Stem Cell Institute. He is a family doctor in Atlanta who does mostly vein and cosmetic therapy. I actually spoke to this physician. This is him below:
This outcome slide above is so wrong on so many levels. First, hopefully, most clear to everyone is that there is no therapy for pain ever devised, including all orthobiologics like stem cells, PRP, exosomes, A2M, amniotic, or umbilical cord stem cells that has a 99% success rate. In fact, a patient class action was just certified against a clinic in California that made a similar claim. What is more surprising is that Dr. Ambrozic defended this claim on the phone, stating that he can make this claim because he offers other services like nutrition, vitamins, and functional medicine. However, as an actual board-certified expert in pain management, in my expert opinion, adding these adjudicative therapies doesn’t get you to these unrealistic numbers.
However, there’s also another HUGE red flag here. Note that the slide says that “97-99% of patients went from ten to zero on the pain scale”. So 97-99% of the patients had 10/10 pain? Think about that logically. 10/10 pain means the most severe pain that you can possibly have. I describe this to my patients as pain so severe that it would cause you to consider suicide. Assuming that most clinics treat predominantly knee arthritis, what is the real average beginning pain level for these patients? I just looked that up on our on-line knee outcome tool:
In 6,024 knee arthritis patients that were treated with our same-day stem cell procedure, the average pain score that we measured at the start of the treatment was 4.5/10. In fact, I can find no published research study for any clinical indication that has an average 10/10 pain.
It Gets Far Worse… The Magic Hip
Intrigued, I watched more of the webinar located at the Southern Stem Cell Institute’s website. I was not disappointed. How about this humdinger:
We have a severely arthritic hip on the left where there are bone cysts and a partially collapsed femur. It’s also dislocated toward the outside. On the right, we have a normal hip x-ray. Dr. Ambrozic tells us that the severe hip arthritis was completely cured by stem cell therapy. As the first physician to inject stem cells into a human hip joint using x-ray guidance way back in 2005, I have never seen a severely arthritic joint regrown into a new joint, no matter what technology or approach was used. How can this image comparison be real? It’s not. Note that in the film on the right there is a common congenital indent in the pelvis bone (yellow arrow). The patient on the left has no such indent. Why? These are not the same patient.
Hey, That’s My Picture!
Farther on in the presentation we see this slide:
This one looked familiar because it’s from one of my lectures! This was Dr. Schultz’s patient who was treated with a precise injection of his own hypoxic, culture-expanded, bone marrow stem cells into his disc bulge using ultra-precise fluoroscopic guidance.
Can Southern Stem Cell Institute Perform this Disc Procedure?
When I spoke to Dr. Ambrozic, he admitted that he had no training that would have allowed him to perform this disc procedure. When I asked where he got our patient’s images, he claimed that he got them from a distributor called “Vitality Medical”. He seemed to believe that he had no liability for false statements because they were not his slides. However, this is what he said on the webinar, describing this slide:
“This MRI shows an MRI of the back, but instead of having surgery, this person was given an injection of stem cells. Within a few weeks, their pain was gone and you can see on the other side of the picture where the MRI is totally normal.”
First, it sounds an awfully lot like this is Dr. Ambrozic’s patient. Second, this patient was part of an actual research study we published and generally within a few weeks, not much happened in these patients other than INCREASED PAIN. Their positive results generally took 2-3 months to be recognized, so that part seems to be totally made up by Dr. Amborzic.
Hey, More of My Data!
Next, I found this slide:
This also looked familiar. Dr.Ambrozic claimed this was a prospective study where this Iowa congressman took about two hundred patients and had them undergo knee replacement and about the same number got stem cell therapy instead. What is an elderly, former congressman doing involved in a stem cell study and directing patient care like a medical doctor?
In fact, this was NOT a study conducted by a former Iowa congressman as discussed by Dr. Ambrozic in his webinar. Here’s the link to where this information was poached. In that document, congressman Bedell references a retrospective study that we at Regenexx published on culture-expanded, bone marrow stem cell use in knee and hip arthritis and lumbar degenerative disc disease. He also references our 2011 complications study that included some outcome data. However, this data is grossly exaggerated in the Bedell report and copy/pasted as still inaccurate here in the Southern presentation. What actual outcomes were reported by our study? “75% improvement was reported in 41.4% while decreasing the improvement threshold to > 50% improvement, 63.2% reported an improvement. ” In addition, all comparisons to the knee replacement group were based on historical data in Medicare databases. Meaning this was NOT a prospective study.
Why wouldn’t Dr. Ambozic do this minimal amount of homework before agreeing to use someone else’s slides and pretend that these represent the work he does? Your guess is as good as mine, as all it took was a simple Google search and looking up two references. In my opinion, once Dr. Ambrozic agreed to go on camera, the responsibility lies with him to ensure that what he is telling patients is accurate.
Not to mention that our treatments for the disc and the knee are NOT in any way similar to the treatment offered by Southern. Dr. Ambrozic seems to have erroneously conflated the fact that our therapies that involved culture-expanded mesenchymal stem cells derived from the patient’s bone marrow are the same as or similar to commercially available, umbilical cord products derived from another human which have no living and functional mesenchymal stem cells. In fact, there are no existing publications listed in the US National Library of Medicine on the efficacy of The Southern Institute’s “Stem Cell” injections used to treat the low back, knee arthritis, or any other clinical condition.
Comments from Southern Stem Cell Institute
I spoke to Dr. Ambrozic and I was hopping mad. He claimed that these slides weren’t his, but had been provided by the company that was selling him vials of “stem cells” (meaning dead tissue that he calls stem cells). However, there he was on the webinar, using these slides to represent the “stem cell” work that he performs at his vein clinic. He also stated that these slides were taken down from his website, which turned out to be true, but this only happened after we spoke on the phone. However, the full video is still up on YouTube at the time of this writing.
Why Take the Time?
This all takes an immense amount of time. I’ve been working on this blog for three days. Why do this? Because Southern is just the tip of a very big iceberg. Meaning there are countless stem cell clinics out there using data that has nothing to do with what they offer. There are also clinics that exaggerate outcomes that can’t be verified and that make no common sense. That’s bad for all patients because it’s a massive bait and switch. Hence, calling out Southern is a public service to all patients, as it’s not just Southern that does this, but many, many clinics. Hopefully a patient reads this and learns enough to ask hard questions of any “stem cell” clinic offering therapies that seem too good to be true.
The upshot? This is an interesting one. As you can see, the outcome data makes no sense and is so unrealistic that it’s very problematic. Next up is a result for a disc injection that the Southern Stem Cell Institute could never pull off that used a completely different treatment than they offer. Finally, Dr. Ambrozic presents my complications papers from 2010 and 2011 with grossly exaggerated clinical data. You can’t make this stuff up!