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 »
Happy New Year and get ready for another 364 more days of stem cell excitement and craziness in 2022. In the next day or two I’ll post my predictions for this new year. Recommended reads EO Wilson obit by Carl Zimmer in NYT. Who’s the next EO Wilson or someone like him with such big impact these …
Weekly stem cell reads: COVID kidney, FDA letter, H3.3, EO Wilson Read More »
The world of stem cell research and regenerative medicine is unpredictable but it’s fun to be a part of it and try to do predictions. Each year in late December or early January I make prognostications for the coming year for stem cell research and regenerative medicine. I made 21 such predictions for the current …
Grading my 21 stem cell & regenerative medicine predictions for 2021 Read More »