Mesenchymal Stem Cells

Mesenchymal stem cells (or “MSCs”) are multipotent stem cells found in bone marrow that are important for making and repairing skeletal tissues, such as cartilage and bone. Mesenchymal stem cells can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells), and adipocytes (fat cells which give rise to marrow adipose tissue).

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Is a Rocky Mountain High a Problem for Your Regen Procedure?

I live in the highest state in the Union, both in reality and figuratively. Given that Colorado has had legal recreational marijuana sales for more than a decade, I’ve noticed a few trends with cannabis use and patients undergoing regenerative medicine procedures. Now new national guidelines have concluded that cannabis use is very important for…read more

The New SIS Fact Finder Paper on Intradiscal Biologics

Is it safe to inject the intervertebral disc with orthobiologics? That’s the topic taken up by the Spinal Intervention Society (SIS) in a recent paper published by their Patient Safety Committee. After reading this paper, I have to say that I agree with some of the caution, but I also recognize that there is a…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

California Clinic Chain Wins It’s Case with the FDA: What Implications Will this Have?

A big event happened this week that may shake up what we all thought we knew about the FDA regulation of autologous orthobiologics. Let’s review what happened and how the ruling may change things. Let’s also review the fascinating and long history of the FDA’s regulation over your own tissues. What Just Happened? The court…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

The Alien Abduction Model of DDD: Why Cellular Drug Trial Results Have Been Underwhelming

Let’s say that you’re sleeping one night and get awoken by an alien in your bedroom who takes you back to the mothership for experiments on your low back. That’s pretty much what we’ve been doing with animal degenerative disc disease research for decades. It’s this artificial DDD model that has caused many cell therapy…read more

Rebutting Misinformation in Orthopedic Journals: Ittleman and Shapiro

Orthobiologic treatments represent a disruptive technology that I have blogged on dozens of times. Given that many patients who used to get invasive orthopedic surgery are now skipping those procedures and instead using interventional orthobiologics, orthopedic surgeons have varied reactions to this new playing field. We’ll explore those issues today in the context of an…read more

VittiLabs, the Sopranos, and an FDA Warning Letter

I’ve blogged quite a bit on the crumbling amniotic and umbilical cord fake stem cell market. Despite peer-reviewed research demonstrating that these products clearly have no stem cells, throughout social media, we still see patients who are getting bombarded by influencers who claim they are loaded with young and vital stem cells. One of the…read more
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