The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges, […]
Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics 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 »
Retraction Watch has been a great resource for those of us who have been following research misconduct. They widely cover and conduct research on retractions, corrections, and other developments in this space. Unfortunately, there’s been plenty to write about even just within the stem cell and cell therapy arena, which is my primary interest. Think
A patient who got scientifically unproven and non-FDA-approved stem cells from Dr. Alvaro Skupin, filed suited against him, his wife who is often known as Doctora Nancy or Dra Nancy Alvarez, and associated businesses. These firms include the stem cell clinic known as Mother Stem Cell Institute in Florida, where the injections apparently took place.
Suit against Dr. Alvaro Skupin & Dra Nancy Alvarez over blinding at clinic is settled Read More »
Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this
FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity 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 »
A days ago the news came about Mesoblast not getting FDA approval for its MSC product for GvHD. The MSC area has had a rough few years with various clinical trials including for COVID. The “stem cells for heart disease” arena has also had a tough time. Here’s more news along these lines: BioCardia pauses enrollment in PhIII trial
Weekly reads: BioCardia, HeLa suit, illegal bio lab in CA 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
Where Kimera Labs fits into sphere of exosome companies Read More »
State regulators are starting to catch up with stem cell clinics and Georgia is a hot spot at the moment with a firm formerly known as Superior Healthcare now getting a large monetary hit. It was just a couple of weeks ago that we heard that a Georgia court in a different case sentenced a
Superior Healthcare stem cell clinic to pay $250K+ in AG settlement Read More »