Remember the Lung Institute? Many patients raised red flags about their experiences there. It was also once known as the Lung Health Institute. More generally, patients who have been harmed by stem cell clinics have had to rely on other ways beyond the FDA to try to do something about it. The FDA has been […]
Lung Institute stem cell clinic loses class action suit, patients awarded $9M Read More »
Looking for some stem cell good news? You’ll like today’s post. One mission of this blog The Niche is to promote rigorous science-based regenerative medicine, which can lead to investigating and writing about not-so-upbeat stuff. Risky clinics. People getting hurt. Patient lawsuits. Serious FDA, FTC, or state AG regulatory developments. Such actions can be good
Recent stem cell & regenerative medicine good news Read More »
The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The
Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up? Read More »
It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several
Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions Read More »
Unproven stem cell clinic firm US Stem Cell and many others are apparently facing potential malpractice lawsuits. How it came to light via US Stem itself is somewhat surprising. US Stem Cell and malpractice notice The news popped up in an SEC filing by US Stem Cell, which I wasn’t even sure was still active
US Stem Cell says it & 10 others face malpractice suits 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
Review of where Kimera Labs fits into sphere of exosome companies Read More »
Toward the end of each year, I make stem cell & regenerative medicine predictions for the coming year. It’s a fun tradition here on The Niche that goes way back. The stem cell field has changed dramatically as reflected in each year’s predictions. Here’s a list of past predictions with my grades of how they
2023 stem cell & regenerative medicine predictions Read More »
In a ruling that could turn FDA stem cell clinic oversight on its head, Federal District Court Judge Jesus Bernal last night ruled in favor of the stem cell clinic chain Cell Surgical Network and other defendants. The FDA had been seeking permanent injunction against them. Here’s the court ruling. Drs. Mark Berman and Elliot
Judge drops a bomb on FDA in Cell Surgical Network stem cell clinic case Read More »
The site Top Class Actions reports that StemGenex, a former stem cell clinic in LaJolla, CA will have to pay out big in a settlement for a class-action lawsuit alleging fraud. Who gets what in StemGenex lawsuit settlement? In the piece, StemGenex, Lead Doctor to Pay $3.65M for Fraudulent Stem Cell Therapy Scheme, we learn that
Clinic StemGenex & doc face $3.6 million class action settlement Read More »
Before starting the umbilical cord cell supplier and marketing firm Liveyon, John Kosolcharoen was involved in some alleged health care fraud. The feds brought a case against him related to prescription drugs. Older case coming to a head As Liveyon was having its misadventures in the stem cell clinic sphere, the status of that past
Feds want $3M, prison for Liveyon founder in old fraud case Read More »