I have been secretly hoping that one of the many sales reps that have been hitting our and other practices isn’t an idiot peddling magic reindeer pixie dust. You see, for the last 24 months, we and others have been bombarded by sales pitch after sales pitch concerning vials of stem cells that come from some part of a live birth. First, it was amniotic stem cells and then chorionic stem cells, and, now, the most recent sales pitch is for cord-blood stem cells. I have always wanted to believe, like an older kid believing in Santa after he’s been told by his friends that Santa isn’t real. Why? I want to have another source of stem cells that come from otherwise discarded fetal tissue very badly. The more stem cell tools I have, the better. However, our recent scientific tests on a cord-blood product have me wanting, like Virginia, to write the newspaper, to be reassured that the stem cell Santa exists. Let me explain.
When a baby is delivered, there are many things discarded: the amniotic fluid; placental tissues, like the amniotic sac; and the umbilical cord. I’ve blogged before about my initial excitement that these tissues might have live stem cells that could help patients. However, after testing numerous amniotic products and then watching the Interventional Orthopedics Foundation test them, I was disappointed. It turns out that despite what the sales reps selling these vials of tissue claim, they are dead tissue products. The sophisticated lab tests showed that these products contain no significant numbers of live stem cells. This little inconvenient fact hasn’t prevented numerous clinics from committing rampant consumer fraud by claiming that they are injecting live stem cells when they use these products.
The cord-blood banking industry is fascinating. So far, it’s stayed out of the stem cell clinic fray. Why? I always thought that the industry was smarter than the silly tissue vendors claiming that there were live stem cells in their amniotic and placental products. However, these last six months have proven me wrong.
Cord blood is what it sounds like, the blood from the umbilical cord. The umbilical cord is what connects the growing fetus to the womb. The blood inside does have some stem cells that should be very active because of their very young age.
About a year ago, I got a call from a cord-blood bank that wanted us to use their product to inject orthopedic patients. They claimed it had copious stem cells. I knew enough about how cord blood was regulated to know that used this way, this was a new drug that would require a full FDA approval, costing at least tens of millions of dollars and taking a decade or more to complete. When I confronted the medical director of the cord-blood bank about these issues, he begrudgingly admitted that this use would require a new FDA approval, which they didn’t have. Hence, I forgot about the issue until about six months ago when I began getting e-mails from colleagues that they, too, were getting hit up with cord-blood products.
While many sales reps claim that cord blood is a rich source of mesenchymal stem cells (the kind that might help orthopedic conditions), it doesn’t contain this stem cell type in abundance. Those cells live in another part of the cord called the Wharton’s jelly. So, right off the bat, the sales reps hawking this stuff are misrepresenting their products.
The IOF received several calls from southern California physicians over this past few months, relaying that a local clinic and cord-blood company were sponsoring full-page ads in the local newspapers telling consumers that they were performing stem cell injections. When one physician did some investigating, he found out that what was being injected was a cord-blood product produced by a company called Invitra. After another physician had been hit up by sales reps for Invitra, who claimed that this cord-blood product had live and useful stem cells, he arranged for a sample of the Invitra product to be sent to the Interventional Orthopedics Foundation (IOF) lab for testing .
The IOF extensively tested the product in the lab many different ways, all designed to determine if this product had live stem cells or any live cells for that matter. I really wanted to believe, like Virginia, that this product or others like it have live stem cells. Why? Because having more tools helps patients. However, was I willing to trust a medical sales rep who said that the product had live cells? No. That’s like trusting a used-car salesman who says that the sedan you want has only had one elderly owner from Pasadena and had never been in a fender bender. No thanks, I’ll get the Carfax report.
What did the IOF testing show? There is no stem cell Santa Claus in his cord-blood product. In other words, there are no viable stem cells in the Invitra ECM Suspension product. In fact there are very few viable cells at all. How was this determined?
The video below goes through the tests one by one:
The upshot? Like Virginia, I really want to believe in the stem cell Santa Claus present in fetal-tissue products. While I desperately want to believe, the scientific data continues to prove the opposite—that these are dead cell products. Hence, the data continues to show that representing these products as containing live stem cells is consumer fraud. Thanks to the IOF for agreeing to test this product at the request of interested providers!
About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…