Stem Cell Institute of America Review: Chiropractic Amniotic Bait and Switch

I recently got an e-mail from a colleague that explained that he had seen an explosion in local chiropractic clinics offering amniotic “stem cells.” I’ve blogged on this phenomenon in the past. While there’s nothing wrong with a chiropractor learning the ropes of stem cell use and hiring competent physicians to do good work, that’s not what we’re seeing here. What we’re seeing instead is a moneymaking venture from start to finish being hawked by chiropractic management groups that promise to boost the revenues of struggling clinics. This sales pitch starts with a faulty premise—that the amniotic fluid they’re injecting has stem cells—and is exploitative in every way. One such outfit is Stem Cell Institute of America (formerly known as Stem Cell Clinics of America, or SCCA). So this will be a Stem Cell Institute of America review as told firsthand by a knowledgeable physician who attended one of their seminars and then my expert commentary on what was relayed.

What Are Amniotic Stem Cells?

When a baby is born, there’s fluid in the birth sac. When this liquid is fresh from a delivery, there is a low concentration of stem cells present. However, once it’s left to sit in a hospital, processed in a tissue bank, irradiated to kill pathogens, frozen for storage, and shock-thawed in a doctor’s office, not much living remains. In fact, our research and that of a third-party nonprofit shows that there are no living cells, let alone stem cells.

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The E-mail from My Colleague

This arrived in my e-mail inbox this week unsolicited: “Chris, I had one of those…Chiropractors put on a marketing show for the public in a hotel down the street from my office…My PA and I attended the meeting of 10 unsuspecting older citizens from my town and he introduced himself as doctor ” so and so” from the “Stem Cell Centers of America”. They are injecting a Cryopreserved Amniotic Fluid injection for joints and soft tissues and IV. In his snake oil presentation he describes how BMC and adipose stem cells are multipotent but the “live stem cells” in ?XXXX? are pluripotent, don’t ever die, keep growing once injected in, require no targeting because these cells are much smarter than MSCs from fat and bone marrow and will regrow whatever your joint needs. This will regrow you a new joint. You will be pain free to have a normal active life style once again. Because in the end who has time to be in pain and go from doctor to doctor or risk serious side effects and death from risky medications and surgery?” Oh yea, and they are charging 5K a shot for a non-guided injection of this 2cc vial of fluid! I spoke to him afterwards and he admitted he’s a chiro and part owner of the company SCCA. I explained to him that his statements are not grounded in any science and he said all their clinics are operating as data centers with patient registries and they have over a hundred studies in progress!”

My Stem Cell Institute of America Review: Let’s Dissect the Science of the Seminar Presentation

1. Injecting amniotic fluid IV—Yikes! This seems to have been borrowed from the magic-fat-stem-cell clinics I’ve blogged about. Given that the dead cells in these shock-thawed amniotic-fluid vials have large amounts of exposed collagen, which activates the fibrinogen in blood to produce a fibrin clot, injecting this stuff IV is ill-advised. All it will take is one clot to form and make its way into the lungs and everyone will have a bad day…In addition, in regard to the amniotic-fluid product being used, it says this on their website: “XXXX^® should not be injected into the spinal canal, in vital organs (including the heart and other areas of the central nervous system), nor the circulatory system.” Didn’t someone read the product labeling on this stuff?
2. The stem cells in amniotic fluid are somehow different from the cells in your body’s bone marrow or fat and grow forever in your body once injected. The stem cells that are likely active for orthopedic purposes in fresh amniotic fluid are mesenchymal stem cells (MSCs). They’re slightly different from those in your bone marrow or fat and obviously younger. There is a second type as well, which the chiropractor seems to be trying to discuss, called amniotic-fluid stem cells (AFSCs), which are a different animal. They can grow longer than adult MSCs and do form more different tissue types, but there are practical issues. First, unlike MSCs from bone marrow, there is no clinical research showing that these fresh cells help real-world orthopedic problems. Second, as I’ve blogged before, there are no living cells in these vials of “amniotic stem cells” being used by these clinics, so a dead AFSC is a dead cell capable to doing nothing. Finally, even if through some miracle some AFSCs survive in some of these vials, you don’t want someone else’s cells growing forever in your body. One of the nice things about MSCs is that they will only grow enough to cover an area and then stop, providing a very nice safety feature. Note that while Regenexx has published the world’s largest safety paper in orthopedic bone marrow MSC use, not a single paper exists on the safety of AFSCs when injected to treat arthritis in real treated humans.
3. Amniotic tissues have issues between what’s claimed and reality. I’ve blogged on these amniotic “stem cell” product before. In summary, many physicians claim amniotic fluid and membrane have live cells. The problem is twofold. First, none of these products that we’ve tested have any live, functioning cells. The research scientist at the Interventional Orthopedics Foundation noted that amniotic tissue has a bizarre property of looking alive on the most simple live-dead stain test. Once you look with more sophisticated tools, everything is really dead.
4. Stem cells will grow you a new knee! This is a novice mistake we see many medical providers just entering this space make. If you have severe arthritis, no matter what type of stem cells are used, you will not be grown a new knee—that’s simply not how stem cells work in severe-arthritis patients. Given that there are no stem cells in the stuff this chiro group is hawking, you’re definitely not getting a new knee out of this procedure.
5. This is a blind injection. You’re going to pay $5,000 for someone to inject dead amniotic tissue into your knee, which a chiropractor with no cell-biology background or research experience erroneously tells you will grow you a new knee, but the doctor or nurse practitioner they’ve hired to inject it uses a blind technique? This means that since no guidance is used, he or she has no idea whether this stuff is really in your knee joint!
6. This company has over a hundred studies in progress! I’ve researched the group running these seminars, calling themselves Stem Cell Institute of America. They’re headquartered in Canton, Georgia. On Google they list themselves as a “Research Institute” and here’s the street view. Note that their “Research Institute” is sited right next to the gift shop on main street (they’re to the right, in suite #204). What other businesses are listed at this same address? “Physicians Business Solutions” (PBS). What is PBS? Is it a research institute? No. PBS is a company that helps chiropractors add a physician or nurse practitioner to their practice to add “more freedom and greater profitability.” It also helps to “Add exciting and in demand services to your practice” (like stem cells). They will also help you sell braces out of the office and help you learn how to bill insurance companies for medical services. The group is listed on this “Chiropractic Products” page, along with supplies for the office. Does this group have any research studies listed on ClinicalTrials.gov? Nope. Have they published any in-vitro or clinical research to back up their claims? Nope.

Performing Minimally-Invasive Procedures in a Chiro Office?

First, there are a few chiropractors out there who I know are trying to do a good job with orthopedic stem cells. Second, Stem Cell Institute of America doesn’t appear to be in that category. Their business plan includes running many national seminars aimed at the elderly. Once they have a patient who’s interested, a physician or nurse practitioner comes to a chiro office to perform an injection. However, to get a sense of why that’s an issue, compare and contrast that to one of our procedure rooms:

None of the things you see here is common in a chiropractic office, nor is such an office a sterile environment. So what risks are generated by performing a stem-cell-injection procedure in an environment where if something goes wrong, the nearest stocked crash cart is across town at the local hospital?

No Lab Means No Ability to Check the Claims of Sales Reps

As I’ve blogged in the past, medical sales reps and used-car salesmen have much in common. In my career, I have been told countless things by reps just to make the sale, things that weren’t remotely true. In this case, PBS doesn’t have its own research facilities to check the claims that amniotic stem cell companies make. They don’t know enough about basic cell biology to know that that the chart above includes bogus data. They have no ability to perform independent live-dead stain tests, flow cytometry, or tissue culture to check the manufacturer’s claims. So they’re literally at the mercy of the guys selling the product. As a result, by telling elderly patients that this stuff has loads of stem cells that will grow them a new knee, they’re misleading patients in the worst possible way.

The upshot? There isn’t really any scientific or face validity to what Stem Cell Institute of America is selling. The amniotic fluid they’re selling as a miracle stem cell cure for arthritis that can regrow a new knee joint has no credible data showing it contains viable cells or that it can regrow a new knee. They are also injecting it IV, against the labeling of the product, which is a serious safety concern! Finally, based on our research to date, this $5,000 shot of dead amniotic-fluid cells is likely to be about as or less effective than a $1,000 PRP shot that any of these elderly people could get down the street through their local sports-med clinic. Buyer beware!

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