An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from …
FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics Read More »
Viacord is one of the most well known firms in the for-profit cord blood banking industry. Today’s post is a review of the firm. I see concrete reasons for concern. What is Viacord? | Dubious autism claims | Viacord cost | Overall Review | References What is Viacord? As a cord blood banking firm, Viacord freezes …
Review of cord banker Viacord: dubious autism claims & other concerns Read More »
Exosome therapy is a still-experimental cell therapy approach aimed at treating specific diseases using secretions from cells. It’s novel since most attention on cell therapies has been given to using the actual cells themselves. In addition, this approach is a newer idea than using cells as the drug to treat diseases. Interestingly, the term “cell …
Fact-checking exosome therapy: costs, risks, & lack of data Read More »
In today’s post I review the cord blood firm Cryo Cell International and discuss specific concerns I have about it. A major issue is their plan to open a clinic selling unproven cord cell infusions to kids. I believe this is risky both for the firm and more importantly for the children. What is Cryo …
Cryo Cell reviews: dubious cord cell clinic plans, risks, other issues Read More »
The FDA stem cell clinic problem just continues to grow, while the agency has been oddly quiet in this space for more than a year. It’s been a major disappointment, particularly as in recent years FDA leadership had implied that bold action was coming. Their own words spiked expectations that the agency would tackle unproven …
Stem cell reviews of clinics and unproven therapies are an important relatively new part of The Niche. Data point to thousands of stem cell clinics in the U.S. selling a wide variety of supposed cell therapies. How does one evaluate such clinics? This question is on my mind regularly as so many patients ask me …
Stem cell reviews: clinics, therapies, & dubious ideas Read More »
Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come …
What is an FDA warning letter & how should firms respond Read More »
I grew up in the Seattle area so it wasn’t great to see stem cell clinics operating there recently, but better news was the WA State AG filing suit against a clinic there. The action included the clinic parent firm US Stemology along with its leader Dr. Tami Meraglia. The suit was filed only months ago …
WA AG wins half million from Seattle stem cell clinic US Stemology Read More »
I’ve had concerns about an American unproven clinic firm called R3 Stem Cell for many years. They sell unproven stem cell-related “treatments” via dozens of affiliated locations. I put quotes around treatments because in my view there is no good evidence here for claims of treating numerous serious illnesses. The goal of today’s post is …
Fact-checking troubling R3 Stem Cell clinic chain Read More »
A few people in the stem cell field keep arguing that adult pluripotent stem cells exist, including so-called “very small embryonic-like stem cells” or VSEL stem cells. These days the supposed cells are called VSELs or V-cells too. Only a handful of researchers have ever been able to report finding and studying these cells. Others …