I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II […]
Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags Read More »
When I’m asked about the most promising areas of stem cell clinical research, cell therapy for type I diabetes is near the top including work by a biotech called ViaCyte. Other firms are in the mix too, boosting the overall odds of success in the coming decade. It’s really that promising even though there are
ViaCyte purchase puts Vertex in driver’s seat on stem cells for diabetes Read More »
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
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 »
As long as I’ve been writing The Niche as a professor here at UC Davis School of Medicine, people have been asking me about stem cell therapy for COPD. There is a lot of misinformation out there in this space. Let’s clear things up as to where the biomedical science stands today in late 2023
Stem cell therapy for COPD: challenges & hope Read More »
What if some legit place like The Mayo Clinic charged people just for the opportunity to talk to a doctor about possibly enrolling in a clinical trial? Imagine this kind of conversation. “Hey, Doc, I have this medical problem and heard you have a relevant clinical trial. Tell me about it.” Then the doctor fills
Mayo Clinic charges patients just to talk about clinical trials? Read More »
Stem cell clinic firms often come and go rather quickly, but a few like Regenexx have persisted. It’s even become a brand name. I’ve been writing here on The Niche for more than twelve years about stem cell clinics. Regenexx has been around that whole time. Along with its founder Dr. Chris Centeno. Patients have
Fact-checking Regenexx: reviews, data & cost Read More »
Professor Joanne Kurtzberg’s clinical work at the Duke Autism Center on umbilical cord blood for autism and cerebral palsy (CP) involves a partnership with a publicly-traded cord blood banking firm called Cryo-Cell. Kurtzberg is also the Medical Director at the firm. In addition they have intellectual property in this area. The Duke team’s efforts, including
Duke & Cryo-Cell plan big clinic for unproven infusions of kids Read More »
One of the most common questions I get from patients is about stem cell therapy for knees. Can it help knee arthritis and pain? Today’s post is a fact-check of where things stand today in 2024 on stem cells for knee issues. You can watch a video overview of this stem cell therapy for knees
Stem cell therapy for knees 2024: fact-check, costs, risks Read More »