What is Chara Biologics? Why did the FDA just warn them and another firm? FDA’s CBER keeps up fast pace of warnings Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13 months. I wrote late last year how 2024 […]
Platelet-rich plasma or PRP has become one of the most commonly used regenerative products at unproven clinics. The orthopedics departments at many universities are now offering PRP as well. What is behind this trend? How much data are there to back up all this enthusiasm for platelet-rich plasma? The goal of this post is to
2025 PRP fact-check and review: cost and possible benefits Read More »
QC Kinetix is a relatively new regenerative clinic brand in the U.S. selling unproven cell therapies. I see several specific red flags including a proposed class action lawsuit. The company reports having 150+ locations, making it potentially the largest chain of unproven clinics in the U.S. Collectively, these clinics could be seeing tens of thousands
QC Kinetix review: concerns on huge regenerative clinic chain Read More »
The FDA just warned a Florida stem cell clinic firm called Mother Stem Institute run by Dr. Alvaro Skupin. Background: Mother Stem Institute past issues I’ve written about this clinic and Dr. Skupin in the last few years. Just about a year ago I blogged the news that a patient suit against the clinic was
FDA warns Mother Stem Institute & Alvaro Skupin Read More »
Even for a stem cell research wonk like me the broader regenerative arena never ceases to surprise me with the latest thing being stem cell shampoo. Stem cell shampoo A news item that seems promotional discussed the stem cell shampoo as yielding positive results. So after you are done with your vampire facelift, stem cell
Weekly reads: stem cell shampoo, Neobiosis FDA warning, trogocytosis Read More »
So many things go wrong during the lead up to clinically-evident Alzheimer’s disease. This complex disease pathway has, in turn, led to a vast array of approaches to try to treat or prevent Alzheimer’s. Most of these efforts one way or another have something to do with the amyloid plaques and tangles that accumulate in the
In today’s post, I reviewed a stem cell clinic firm called Docere Clinics. In my opinion, there are some concerning issues here and reasons for caution. One type of procedure at Docere is particularly surprising and raises risks in my view. What is Docere Clinics? | What kind of stem cells does Docere use? | What they
Review of Docere Clinics run by Harry Adelson including total-body injections 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 »
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 »