From the beginning of the pandemic, I have been mostly skeptical about the idea of cell therapy for COVID including stem cell therapies. However, at the same time, I’ve closely followed the data, especially up until 2022. Now having just had a nasty bout with COVID myself for the first time this summer, I recently …
Update on stem cells & cell therapy for COVID trials 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 »
I usually associate NPR with solid journalism so I was scratching my head about a recent puff piece by WHYY on stem cell microneedling. Is this journalism or product promotion? The NPR piece by Maiken Scott doesn’t ask important questions. Scott received stem cell microneedling herself using a product from a company called AnteAGE. How …
WHYY oh WHYY: NPR puff piece on risky stem cell microneedling Read More »
It’s funny how sometimes there are many new articles about one general topic like this week with heritable (and somatic) human CRISPR gene editing and related tech. There are clear reasons for optimism in the somatic arena given advancing trials. Germline editing remains highly questionable in my view even just technically. Then there are loads …
Weekly reads: human CRISPR, MRT risks, private IRBs, skincare Read More »
Does Medicare cover stem cell therapy? Readers of The Niche have regularly asked this question. They’re curious about insurance coverage too. The answer is “no” in almost every case, with some notable exceptions I’ll get to at the end of the post. Still, clinics appear to have already been charging Medicare for what collectively adds …
The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past …
3rd Invitrx warning highlights FDA oversight weakness 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 »
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 »
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 »
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 »