Regulatory Issues

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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

Why Language from a New FDA Amniotic and Umbilical Cord Warning Letter Is a Big Deal

I’ve covered the stem cell wild west for years. One of the crazier things out was amniotic and umbilical cord tissue vendors claiming to sell “stem cell” products that don’t actually contain any live and functional stem cells. In addition, despite an FDA crackdown on these companies, there are still vendors selling this stuff with…read more

The Bench Scientist False Dilemma

Credit: Shutterstock I’ve blogged a few times about the widening rift between a handful of media-savvy bench scientists and physicians who use regenerative medicine techniques to help patients avoid invasive orthopedic surgery. This past few weeks we’ve seen several unscientific things in the news and in bench science blogs about PRP and Bone Marrow Concentrate.…read more

TMB Cracks Down on Faux Chiro “Stem Cell” Clinic Medical Director

One of the crazier and frankly more insulting components of the Stem Cell Wild West are “faux medical directors”. As you’ll see this scam is often run by chiropractic clinics offering fake birth tissue “stem cell” treatments. Let’s dig into what the Texas Medical Board just did to one of these medical directors and why…read more

Why the Health Canada Cell Therapy Knee-Jerk Is a Big Deal…

As I have been warning for years, the out of control stem cell wild west would eventually cause regulators to kill even low-risk cell therapies. That’s exactly what happened in Canada this week, where Health Canada issued a position statement saying that even bedside therapies needed drug approval. This is a big deal that should…read more
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