A Justice Department press release details how a physician’s assistant (PA) in Texas was convinced of fraud related to amniotic fluid injections. This story tells us some important things about how Medicare handles things versus the FDA approach to such things. Amniotic fluid scam A jury found Ray Anthony Shoulders, a PA at a pain …
Man could get 240 yrs for amniotic fluid for knees Medicare scam Read More »
Today’s post takes a close look at the exosome manufacturer Kimera Labs in the context of the main exosome companies. What are exosomes? Exosomes are microscopic bubbles or vesicles produced by cells. Exosomes contain many cellular substances that are biologically active. Some of these materials may be helpful clinically, while others could pose risks. Clinical outcomes …
Where Kimera Labs fits into sphere of exosome companies Read More »
Does Medicare cover stem cell therapy? Readers of The Niche have regularly asked this question. They’re curious about insurance coverage too. The answer is “no” in almost every case, with some notable exceptions I’ll get to at the end of the post. Still, clinics appear to have already been charging Medicare for what collectively adds …
Those who follow the stem cell field might be familiar with stem cell clinic operator Neil Riordan. According to a recent press release and some news reports, Riordan just had some bad news in court related to a stem cell clinic in the U.S. Stem cell clinic lawsuit As background, why do those running stem …
$7.8 million verdict in stem cell clinics case against Neil Riordan Read More »
What a difference one day can make including in the types of questions I’m getting with this one rising to the top: should President Donald Trump get stem cells for his COVID-19? Whether he should or not, will he get them? This is more than a hypothetical as a surprising number of people in Trump’s …
A variety of states have stepped up to address unproven stem cell clinics within their borders and the latest is Vermont. According to the VTDigger and writer Anne Wallace Allen, the Vermont Medical Society is planning a number of steps to address this situation. For example, at their encouragement a Vermont lawmaker will introduce legislation …
Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by …
FDA needs to quickly act against IRBs enabling risky fat stem cell clinics Read More »
A new Florida bill (Bill 65 of 2019) could make the practices of stem cell clinics a felony. At the same time it would open the door to patients receiving still experimental stem cells that have at least started the clinical trial process. What’s going on? A number of states have been stepping up action …
New Florida bill mixes RTT spirit with turning unproven stem cell sales into a felony Read More »
Who is Michael Deem and what was his role in his former student He Jiankui’s purported production of twin CRISPR’d babies? Is Deem now trying to edit himself out of the project? He Jiankui relied on help from many people and Deem was reportedly a part of that team. Members of He’s own research team helped …
Is fat-free always a good thing…even for unproven stem cell clinics? It must be a challenge for a stem cell clinic firm like US Stem Cell, Inc. (USRM) to face an imminent possible future where it cannot sell injections of its main product, fat stem cells, in the US. After all, “US” and “Stem Cell” …
Is clinic firm US Stem Cell sued by FDA prepping for fat-free future? Read More »