There isn’t a week that goes by these days that I don’t see some sort of umbilical cord product company violating FDA guidelines and claiming to have live stem cells. This week’s addition to that long list is CharaCore, an umbilical cord nucleated cell product from Chara Biologics. This one is unique as the company seems to be owned by a practicing medical doctor rather than the usual random business guy. Let’s review.
The Birth Tissues Industry
The birth tissues industry splits into two parts. Most companies try hard to do the right thing and don’t advertise that their dead cellular products contain live stem cells. However, the dark underbelly of the industry actively makes these claims because it pushes product sales. The problem? This isn’t actually true.
This statement surprises doctors who don’t know what they don’t know about stem cells. They point to “viability” tests produced by the company that seems to show live cells. To provide an explanation as to why those tests don’t, in fact, tell you much about live and functional stem cells, see my video below:
Don’t take my word for this, listen to Lisa Fortier from Cornell, who has also studied these products:
Chara Biologics Products
Chara Biologics has two products. The first is CharaCore, and the second is CharaFlex. About the former, the website says the following:
CharaCore—“High cell count, with valuable components from umbilical, cord tissue and amniotic membrane. Delicately processed, thus maximally preserving therapeutic elements. Contains a high amount of MSC’s and various growth factors.”
Note that I have bolded a claim that the product “contains a high amount of MSCs.” Why? The product is not allowed to contain any living cells. How do we know that? Through multiple FDA Warning Letters sent to other companies, the Tissue Reference Group Documents on birth tissues, and the actual FDA regulations on FDA-registered tissues. To learn more, see my video below:
Since a 361-registered tissue is a free online registration where the FDA doesn’t review any part of the product application, the FDA allows these companies to say very little about what they’re selling and even less about what the company believes it can be used to treat. Meaning, any claim that a product can be used to treat any disease is way over that FDA line. So I was blown away to see this graphic pop up on the Chara Biologics website when I mouse over “Conditions”:
You almost can’t make this stuff up. Here we have 35 different medical conditions listed as being able to be treated with Chara’s products. My personal favorite? Alcoholism. How does that work? I have no idea. In addition, these products can be used to treat aging? Autism? Erectile dysfunction? Hearing loss?
Who Is Behind Chara?
Chara is a Greek word that means “joy,” and the founder is a psychiatrist by the name of Joy Kong, MD. Dr. Kong on the Chara website says this about herself: “Dr. Kong is an anti-aging and regenerative medicine specialist, and the president of Thea Center for Regenerative Medicine in Los Angeles, California.” For the purposes of this blog, we’ll focus on the “regenerative medicine specialist” part. Her bio continues, “Dr. Kong has lectured internationally on stem cells.” Given that in medicine, to be a specialist or expert lecturing on a topic, you need the street cred provided by peer-reviewed scientific publication, what has Dr. Kong published on stem cells? A search of the US National Library of Medicine for “Kong, J” and various stem cell search terms turned up nothing that leads back to Dr. Kong the psychiatrist in Los Angeles.
Why do I care if Dr. Kong can demonstrate that she knows the science in this area through publications? Because she’s out there advertising herself as an expert and trying to educate doctors via YouTube presentations. Regrettably, she makes many common rookie mistakes in that effort. For example, on Youtube, in a lecture entitled “Pick the Most Effective MSCs for Clinical Use,” she asserts a slew of information about umbilical cord stem cells, but all of the data she presents is actually from studies that used fresh tissue from which stem cells were then isolated and culture expanded so that the research used only “pure” mesenchymal stem cells. Which is something completely different from the frozen umbilical cord, nucleated cell product that Chara offers for sale.
Let’s look at some of the studies Dr. Kong covers. Take, for example, this study by Fong et al. First, the study uses a proprietary and nonstandard culture substrate and process. Second, the study uses stem cells that have been isolated and culture expanded, which is nothing like Chara’s frozen and centrifuged umbilical cord product. Meaning, this study USED LIVE STEM CELLS IN A VERY DIFFERENT NUMBER, CONCENTRATION, AND MIX! Or how about this one? This study by Hsieh is the same thing: it uses stem cells from an umbilical cord that have been isolated and culture expanded. The other studies reviewed either make this same mistake or they are on adult stem cells having nothing to do with those derived from umbilical cords.
I call this practice the research bait and switch. Meaning, since Chara has done no actual clinical or lab-based research that would equate with how it compares to bone marrow concentrate, it substitutes research that has nothing or little to do with its product. This is common in this field, and it works because physicians are not yet sophisticated enough to know the difference.
To learn more about these research comparison problems, see my video below:
Any More Info on This Product?
The Chara CEO and lead salesperson claimed on LinkedIn that they had lab data on the product that I should review. However, they refused to send it when I asked to see the documentation. I also asked the company to comment on these questions:
1. Can you provide the legal justification using 21 CFR 1271, pertinent TRG entries, or FDA communications as to why your product is correctly registered under the 361 pathway?
2. Can you provide data per the ISCT guidelines discussed above that supports the presence of MSCs?
3. Can you provide an IND/BLA?
4. How can you justify quoting papers that use a different cell source (i.e., isolated and culture-expanded MSCs from Wharton’s jelly) with a frozen and centrifuged Wharton’s jelly product?
5. What clinical studies have been published with CharaCore?
I received no answers to these questions.
The upshot? So far, Chara is just another company claiming live stem cells in a likely dead product. Interestingly, it’s run by a physician who should know better. More disturbing is Dr. Kong’s use of bait-and-switch research that has nothing to do with the product she’s pushing.