Legal Issue

Should a Scientific or Medical Standard Be Used for SVF Regulation: A Review of the Bernal Decision

The recent Bernal decision on the use of Stromal Vascular Fraction (SVF) by California doctors has thrown the whole cell therapy industry into disarray. In particular, there have been many scientists commenting online or in press releases that the judge got it wrong. So this morning let’s delve into the science behind the decision and…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

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

US Stemology and Dr. Tami to Pay Consumers 500K

I’ve blogged many times about US Stemology and Dr. Tami in Seattle. This clinic was recently sued by the State of Washington and they just announced a $500,000 settlement. What can we learn from this? Let’s dig in. The Stem Cell Wild West The evolving world of regenerative medicine has always existed in two defined…read more

What Is Procenta? What Is Human Tissue Therapy (HTT)? Why Is a Former Employee Mixed Up in This?

This week, I had a colleague send me information about yet another birth tissue company selling a product for use in treating orthopedic injuries. The sales rep claimed to my colleague that this product, called Procenta, was “FDA Approved” for that purpose. Let’s dig in. What Is Procenta? Procenta is a placental tissue sold by…read more

Why Did a Major University Sell Amniotic Fluid to a Fraudster?

This week’s blog on the Missouri woman who is being charged for fraud by selling Amniotic fluid brought up an interesting question. She bought this fluid from the University of Utah. Huh? Let’s dig in. The Missouri Case The feds this week brought criminal charges through a grand jury against a Missouri woman who was…read more

He Blinded Me with Science! David Singer Strikes Again

I wrote about David Singer a while back. He’s a chiropractic practice consultant who has now reinvented himself as a stem cell expert. IMHO, he and others like him are helping to perpetuate stem cell fraud in hundreds of chiropractic clinics all over the country. Today we’ll dig into the fraudulent use of research to…read more