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 »
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 »
The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways
One size doesn’t fit all? FDA may soften some cell therapy regs Read More »
Many of you readers know tech guru Peter Diamandis for his great X PRIZE, but he’s also involved in the regenerative medicine world including a new effort called Fountain Life. Teaming up with life coach Tony Robbins and others for Fountain Life raises some red flags for me. What’s in this article Peter Diamandis and
Review of Peter Diamandis Fountain Life clinics: more than stem cell hype? Read More »