We’ve all seen promising claims like “Miraculous Stem Cell Treatments, proven to get you your life back!” A recent study revealed that only 2% of patients research a procedure recommended by their Healthcare provider before actually undergoing the treatment. Another aspect of this procedure that patients need to be aware of is Stem Cell Fraud , which is far more common than most of us would like to think.
The purpose of this blog is to discuss the differences between Amniotic or Placental Tissue and Bone Marrow Stem Cell. There are important things you need to consider before having a “stem cell” procedure. Bodyworks Medicine wants you to be informed before making a decision on a life-changing procedure such as this.
What is Amniotic Tissue, anyway?
When a mother’s water breaks, Amniotic fluid is what surrounds the baby while in the amniotic sack. While amniotic fluid does contain helpful growth factors and cytokines, basically similar to a much cheaper PRP (platelet rich plasma) injection, it is NOT considered a viable stem cell product by specialists in the field. In addition to growth factors, it also contains collagen and other extracellular matrix proteins that may be useful as a scaffold for regenerative medicine. However, as far as viable stem cells that survive processing and the freeze-thaw cycle that make up an amniotic fluid product, no independent researchers have been able to find any trace of viable cells that are claimed by those marketing the product.
“When orthopedic sales reps tried to sell this stuff as what it is, it didn’t sell well. So the reps, based largely on the fact that the amniotic fluid and membrane have a low content of stem cells when fresh out of the obstetrics ward, began to tell physicians that the stuff was loaded with stem cells. Never mind that freeze drying or processing the living membrane made sure it had no remaining living cells of any type, let alone stem cells. Most doctors, who were new to the concept of stem cells anyway, bought this marketing ploy.” says Dr. Chris Centeno, founder of Regenexx.
What is Bone Marrow Stem Cell?
The bone marrow is the store house of stem cells in the body. These stem cells are the very same cells that the patient normally uses to heal injury and rebuild bone, cartilage, muscle, tendons, and ligaments. Bone marrow stem cells are harvested from the patient’s own body and are typically drawn from the iliac crest region. After the bone marrow has been aspirated, most physicians use a bedside machine to separate the stem cells. More specialized physicians, like those in the Regenexx network, process the marrow by hand in a lab on site to derive 5-20 times more stem cells per unit volume.
These stem cells are then injected by a trained physician using image guidance into the precise area of your injury to rebuild, repair, or mitigate the effects of damaged tissue. Regenexx has done extensive research using MSC (Mesenchymal Stem Cells) derived from bone marrow which has shown excellent outcomes in treating all but the most severe orthopedic injuries.
So, what do I need to know about stem cell fraud?
There is an epidemic of fraudulent activity being conducted in this country by the manufacturers of Amniotic products. While the manufacturer themselves make no outright claims of stem cells in their product, they often employ salesmen who make “off-the-record” claims of stem cell viability as well as FDA approval despite being fully aware that both statements are false. Though their product may be “registered” as a tissue by the FDA, none of these products have taken the steps of being “FDA approved”. Further, a “registered” tissue cannot, by definition, contain any live cells (section 361). Any product with viable cells would have to be “approved” as a drug (section 351). None of the amniotic, cord blood, or wharton’s jelly products have done this.
Without overtly claiming “stem cells” publicly, the manufacturer cannot be held responsible for this fraud. The sales representatives of the company know this and commonly targets chiropractors and other non-specialized practitioners as a means of “medically integrating.” In response, earlier this year, true experts in the field consisting of specialized clinicians and academic researchers released a position paper condemning the practice and multiple media outlets have picked it up.
Providers around the country involved with amniotic “stem cell” treatments often claim that amniotic fluid products have millions of live stem cells when really, they are injecting dead tissue without any living stem cells. In most cases they are charging outrageous prices like $3,000-15,000 for joint injections and are making promising claims like:
- “State of the Art Healing Procedure: Regenerative Stem Cell Therapy”
- “There are 30x more stem cells in Amnio than in Adult tissues”
- “These remarkable treatments can repair tissue”
- “Regenerating new cells and tissues”
- “Safe, Ethical and Effective”
- “Stem Cell Therapy is now offering painless, Amniotic injections for advanced arthritis.”
The question we prompt you to ask yourself is, “How do I know if I’m receiving live stem cells from a trusted physician?”
Read these Top 10 Questions to Ask a Stem Cell Clinic to answer all of your inquiries before making a decision.
If you are interested in regenerative medicine, seek a musculoskeletal specialist with one of the following levels of specialty medical training (A chiropractor is not a medical doctor):
- Physical Medicine and Rehab (PMR) or Neuromusculoskeletal Medicine
- Orthopedic surgery
- Interventional Pain Management (PMR or Anesthesia)
- Interventional Radiology
- Family Practice with a Sports Medicine Fellowship
You can also download Dr. Conliffes The Truth About Stem Cell Therapy book here.