I've blogged quite a bit about the birth-tissue products claiming to be "stem cell" rich cocktails ready for injection. While there are many companies pushing the envelope of reality in this space, one of the splashiest is Liveyon. However, recently the group went through a product recall for bacterial contamination, and I thought they might come clean when they introduced their new "PURE" line of products. I was sadly disappointed. Let me explain.
The Birth-Tissues Industry
When a live birth happens, there's tissue waste. This includes the "water" (amniotic fluid inside the birth sac), the birth sac (amniotic membrane), umbilical cord (Wharton's jelly and umbilical cord blood), and placenta. For many years, some of these tissues were sometimes used in surgery.
This occasional surgical use was a niche industry selling mostly amniotic membrane, but about five to six years ago, some sales reps got the idea that they could sell the snot out of these products if they claimed that they had live stem cells. This spiked sales and the rest is history. The problem? Our tests in the lab showed no living cells at all. See my video for details:
Then came umbilical cord blood. The claims also were made that these were stem cell products and, again, we tested this and found this to be false. In fact, it would be rare that umbilical cords would be expected to have many mesenchymal stem cells. See my video below for more info on that topic:
Liveyon Enters the Picture
A few years back, Liveyon entered the picture selling umbilical cord blood and claiming that it had many live stem cells. What was interesting was that unlike some of the other companies making similar claims, Liveyon's ads had a serious artistic flair, a bit like a cross between a cosmetics line and a lifestyle brand. More importantly, I blogged on the white papers the company produced. I clearly demonstrated that while to the uneducated eye they seemed to show that there were live stem cells in the Liveyon product, the science supporting that conclusion wasn't there. My video below has more details:
Liveyon's Contamination Problems
A few months ago, I reported that Liveyon had issued a voluntary recall of its products after several reports of patient bacterial contamination and sepsis. At this point, I learned that Liveyon was merely a marketing company, meaning that its manufacturing was done by a company in California called Genetech. Others also reported on this contamination and the lawsuits that followed.
Would Liveyon Change Its Tune?
Liveyon's founder and CEO has had legal troubles in the past, and with the FDA recall, their website went dark. I believed that when they re-entered the market, they would come clean and become one of the regulatory-compliant companies that talk about the growth factor content of these tissues and that don't violate the FDA regulations by claiming that these products have live stem cells. Why does this claim violate the law? Please watch my video below to learn more:
The New Liveyon "PURE" Series
Recently, I saw that Liveyon's website was back up. I have to say that I was flabbergasted. I had expected Liveyon to stop making claims about stem cells. Did that happen? Let's review what's on the site.
Well, the splashy is still there. I do have to hand it to their ad agency, this is really cool stock imagery.
One of the things that's emphasized on the Liveyon site is that the cellular solution is clear yet contains 30 million nucleated cells. In fact, the pictures show a product that appears to be as clear as water. We also read, "If the glowing clear color of the vial and perfectly transparent cellular solution inside isn’t enough to help us solidify the point, allow us to elaborate on a more scientific level, as to what went into the bio-engineering of the Pure® product." This is puzzling to me as I recently demonstrated what 20 million mesenchymal stem cells looked like in 1 cc of platelet lysate (an otherwise clear amber solution). Check that out below for comparison:
Meaning, as my science team agrees, you can't pack 20 or 30 million stem or nucleated cells in a 1–2 cc vial of solution and have it be clear. First, the cells will always want to settle out, which would make the bottom of any vial full of whitish gunk. If you try to suspend the cells by shaking, they will cause the liquid to be cloudy. This is the simple physics of tens of millions of cells in the 6–30 micron range. So I have no idea how Liveyon could claim that their product both has 30 million cells and is clear as water.
Next up are the continued stem cell claims. First, we read, "Scientifically validated to be the most 'Pure' stem cell offering on the market to date." If you download the PDF, which is the Liveyon product catalog, you are greeted by the "Liveyon LUMA LIFT, Stem Cell Enhanced Skin Treatment." So they're sticking to the idea that Liveyon has stem cells.
Even the Employees Advertise Liveyon as a Stem Cell Product
I went on LinkedIn and tried to find out who was working for Liveyon. I was surprised that even the employees and contractors for this company are also boldly advertising or suggesting that Liveyon is a stem cell product. For example, Dean Brior states that he is "Regional Director for Liveyon Stem Cell Therapy" Steve Mangar states that his job title is "Stem Cell Therapy Sales" and that he is currently in sales at Liveyon. Mike Tillman states that he is with "Rejuva Stem Cell Clinics LLC" and also vice president of Liveyon LLC. The list goes on…
What Is Clinical Trials Grade?
Scattered throughout the website is a notion that Liveyon is a "clinical trials grade" product. In addition, the video claims that Liveyon has aspirations to get its product FDA approved. Why are those aspirations? Because it's not FDA approved right now, but merely registered with a 45-minute free online 361 form. Meaning, there is no FDA review of the product once that form is submitted, merely the right for the FDA to show up and expect the manufacturing lab to ensure that it's following tissue-processing standards.
This is the conundrum of Liveyon and every other birth-tissues vendor that claims live stem cells. if you claim that what you're selling is a live stem cell product, even if that claim isn't true, you must go through full FDA drug trials to prove safety and efficacy BEFORE the product can be sold. Meaning your 361 tissue registration isn't the correct regulatory category for your product. The video above explains this more thoroughly. If you don't claim that you have live stem cells, sales lag.
So what is "clinical trials grade"? This seems to be a reference to Liveyon's FDA approval aspirations. However, I can't find much information on this phrase as it doesn't bring back anything on a simple Google search. Hence, the term seems to be made up by the company.
The upshot? Liveyon hasn't come clean with the idea that it's NOT selling stem cells. In fact, it seems to have doubled down on the concept. I'm not sure that's wise from a regulatory standpoint, and I have no idea how you suspend 30 million cells in a clear liquid, so I can't wait to test a vial of the new PURE series in our advanced research lab.