Search Results for: utah

‘Bottom of stem cell barrel’? Utah piece sparks legal threat

derek-lowe-e1564527793287

Up until now Utah hasn’t immediately come to mind as a hub for stem cell issues, but things are heating up there in 2019. Utah? I was going to do a blog post here on The Niche last month about perinatal (birth-related) biologics and stem cell-related supply companies in Utah. Some of their customers appear …

‘Bottom of stem cell barrel’? Utah piece sparks legal threat Read More »

What is an FDA warning letter & how should firms respond

FDA warning letter

Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come …

What is an FDA warning letter & how should firms respond Read More »

Fact-checking troubling R3 Stem Cell clinic chain

Map of R3 stem cell clinic locations

I’ve had concerns about an American unproven clinic firm called R3 Stem Cell for many years. They sell unproven stem cell-related “treatments” via dozens of affiliated locations. I put quotes around treatments because in my view there is no good evidence here for claims of treating numerous serious illnesses. The goal of today’s post is …

Fact-checking troubling R3 Stem Cell clinic chain Read More »

MO Rep Patricia Derges already indicted for alleged stem cell scheme, now sued by patient

patricia derges indictment for fake stem cells sm

The news just keeps getting worse for Missouri state lawmaker Patricia Derges, who was indicted last year by the feds for an alleged stem cell scheme. She is now also being sued by a former patient. Derges, who is not a physician but rather an assistant physician, was providing supposed stem cell or related biological …

MO Rep Patricia Derges already indicted for alleged stem cell scheme, now sued by patient Read More »

FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance

FDA-draft-guidance

The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …

FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »

Grading my 21 stem cell & regenerative medicine predictions for 2021

stem-cell-crystal-ball-300x3001

The world of stem cell research and regenerative medicine is unpredictable but it’s fun to be a part of it and try to do predictions. Each year in late December or early January I make prognostications for the coming year for stem cell research and regenerative medicine. I made 21 such predictions for the current …

Grading my 21 stem cell & regenerative medicine predictions for 2021 Read More »

Liveyon product hurt many more patients says new CDC study

Liveyon

Liveyon is a cord blood product marketer that distributed a batch of cells a couple of years back that led to many patients being hospitalized with infections. Some had sepsis and ended up in the ICU. It was thought at the time that about a dozen patients who had been injected with the Liveyon product …

Liveyon product hurt many more patients says new CDC study Read More »

Lawmaker indicted for selling fake stem cells for COVID & more

patricia derges indictment for fake stem cells sm

A grand jury indicted Missouri state representative and assistant physician Patricia Derges for allegedly selling and injecting patients with fake stem cells. The injection was reportedly just of amniotic fluid, but Derges allegedly claimed it was a stem cell treatment. NBC News was one of several media outlets that broke the story here after the …

Lawmaker indicted for selling fake stem cells for COVID & more Read More »