Fetal Stem Cell Treatment: More Amniotic Scams…
A patient from Utah sent me an e-mail advertisement yesterday that continued the current trend of amniotic stem cell scams sweeping the nation. These seem to be aggressively being driven by orthopedic sales reps trying to cash in for a quick buck and most of the poor physicians caught up in the sales pitches don’t know that they’re committing consumer fraud by advertising that they’re injecting amniotic stem cells. Why? These tissues being hawked as a miracle cure contain no living cells, let alone stem cells. Patients sometimes call these a “fetal stem cell treatment”.
Here’s what the ad says:
“The stem cells we use at xxx Centers to treat patients are called “Amniotic Stem Cells.” (This type of stem cell comes from the amniotic sac – not an embryo.) While ethical debates have arisen about embryonic stem cell therapy, most everyone agrees that the use of Amniotic Stem Cell Therapy raises no ethical or moral questions. They are harvested from a donating mother during a scheduled C-section and processed at an FDA approved lab. The cells go through rigorous testing like any other biologic before they are sent to our clinics. Amniotic stem cells are “neutral cells” that do not contain any DNA. Because they are neutral, a patient cannot have a rejection or reaction to them. These cells are completely safe to use. As a matter of fact, there has not been one adverse side effect ever documented since 2007.
Amniotic Stem Cells are very unique and we feel are really the best choice to use for Stem Cell Therapy for a few reasons: They are brand new cells which are extremely potent because of how new they are which means they may be able to heal tissue very quickly. They can turn into almost any type of tissue (They just grew a baby!) which means if they are injected into the knee, for instance, any parts of the knee which are damaged can potentially be healed.”
The problem? The Interventional Orthopedics Foundation did an independent assessment of these amniotic products that was presented at the IOF 2015 conference. The research found that these tissues didn’t contain any living tissue, let alone stem cells! So this physician is likely injecting dead tissue and hawking it as a stem cell therapy. So is this deliberate fraud, or just a physician who doesn’t know what he doesn’t know? Most of the doctors who I’ve met and educated about this scam had no idea that what an orthopedic sales rep was selling them was dead tissue. Hence it’s likely a doc who bought what he thinks are living stem cells and who doesn’t know enough basic cell biology to understand the likelihood that the sales pitch he heard was fiction. In addition, the doctor has no way to independently test for himself whether these tissues contain lives cells, so he’s wholly dependent on the sales pitch. Finally, these tissues aren’t regulated by FDA to contain live cells, in fact if they did contain lives cells they would switch from a simple 361 registration of a transplant tissue to a full 351 drug approval costing hundreds of millions of dollars and requiring 5-7 years worth of clinical trials per indication.
The upshot? I get asked by patients all the time about “Amniotic Stem Cells” or “Fetal Stem Cells”. I dutifully explain that there is no such thing, but this is a powerful meme, one that plays off the “forbidden fruit” of embryonic stem cells. Personally, it’s awful that unscrupulous companies are out there convincing unsuspecting doctors that vials of dead “baby juice” contain live stem cells!