Embryonic stem cells

Is the FDA Umbilical Cord Game Plan Clear? An Invitrx Update

Many watchers of the illegal selling of fake umbilical cord “MSC” products have been asking what’s up? We’re long past the FDA discretionary period and not much seems to have happened except for a bunch of letters that were sent in 2020 and 2021. However, if you look at the FDA correspondence on these issues,…read more

Can You Use the FDA Expanded Access Program to Treat Orthopedic Patients with Culture Expanded Umbilical Cord MSCs?

Over the past almost two decades, I have seen more creative attempts to get around the FDA’s biologic drug approval process than I can count. However, I had thought that with the FDA officially ending its regulatory discretion phase we had heard the last of umbilical cord companies trying to avoid a BLA. I was…read more

Perinatal Gaslighting

This is my first blog back from my 6-week sailing journey. I have to confess that while out there on the water and in and out of Marinas, I didn’t feel much like writing, but now that I’m back in the states, it’s time to dive back in. In fact, I feel my “Piss and…read more

Magic Tricks, Electron Microscopy, and Umbilical Cord Tissue

Sleight of hand is a staple in magic tricks. Basically, you get the audience to look over here at an illusion, while the reality behind that illusion happens over there. While this works well on stage, it can also work in research and publications. After all, who really reads and dissects what research papers conclude…read more

Has Medicare Reversed Course on It’s Injectable Birth Tissues Clawback?

As you may recall, Medicare recently announced a major clawback of payments made for injectable birth-tissue products. However, in a surprise move, a recent letter from CMS seems to rescind the prior clawback. What in the world is going on? Let’s dig in. The Recent Medicare Clawback Several years ago, multiple birth tissue vendors selling…read more

Our Latest Paper on Umbilical Cord “Stem Cell” Products Gets Published!

One of the staples of the “Stem Cell Wild West” has been tissue manufacturers claiming that they’re selling Umbilical Cord stem cell products. Based on our lab testing of many products we knew this was fiction, but that also needed to be peer-reviewed and published. That just happened. Let’s dig in. Umbilical Cord “Stem Cells”…read more

What if the Sopranos Created an Umbilical Cord Product?

This has been an interesting month or so since the beginning of the FDA enforcement period. We’ve seen countless birth tissue companies take their amniotic and umbilical cord products off the market for fear of FDA enforcement. You would think that this would mean that all of these companies would be running for the hills.…read more

VSELs – State of the Art Regen Med or Fairy Dust?

There has been a two-decade-long debate in Regenerative Medicine concerning tiny stem cells. I had largely forgotten about these Very Small Embryonic Like (VSEL) stem cells until a patient came into the clinic claiming that he had been treated with them. So what is this and why should we care? Let’s dig in. What Are…read more