Research

Filling a Tissue Defect With Wharton’s Jelly Is Not Homologous Use: The Regenative Labs Warning Letter

I’ve blogged on Regenative Labs quite a bit. In part, that’s because this has been an interesting player in the regenerative medicine space. They first cooked up a plan to “fill tissue defects” and claimed that you could bill Medicare for their Wharton’s Jelly products when used to treat knee arthritis. When CMS pushed back,…read more

Can You Use ChatGPT to Do Medical Research?

If you read this blog regularly, you know that I’m a big fan of AI and predict that it will change science and medicine for the better. However, as ChatCPT came into focus this past few months, several colleagues have claimed that you can now use it to do online medical research and generate text…read more

Marrow Cellutions and the Regen Med IQ Test

Regenerative medicine and interventional orthobiologics are interesting because there is no standardized education for these topics in 99% of the residencies or fellowships. This creates an information vacuum that smart sales reps and device manufacturers can manipulate because they’re often where providers get their education. So today, I’ll challenge patients and providers with a Regen…read more

Playing “The Spread” with Birth Tissues: Organogenesis as a Cautionary Tale

Healthcare billing can be complex. IMHO, one of the dodgier things I have highlighted on this blog about the recent Medicare birth tissue billing scams was the concept of a reimbursement spread. Now we have more information on this potentially illegal practice in a class action lawsuit filed by the investors in a birth tissue…read more

Manipulating the Data to Get What You Want: The PRP Systematic Review by O’Dowd

In medicine, you can often break those that publish research into two categories. There are those who invest a huge amount of time and resources to study a clinical concept, whether in the lab or clinic, and then there are the “reviewers.” Today we’ll go over this duality by diving into how easy it is…read more

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

The Morality Test of Platelet-Rich Plasma vs Corticosteroids

IMHO corticosteroid use in knee arthritis has become a giant medical morality test. We know the stuff is toxic, but physicians can’t help themselves from injecting it because it’s covered by insurance companies. Now that PRP is here and known to be effective, this sets up an interesting duality as there is now a better…read more