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 »
A firm called Kimera labs just received an untitled letter from the FDA. The firm has been supplying non-FDA-approved exosomes to various customers including at least one stem cell clinic without sparking any obvious action from the agency, but on April 10th that changed with the letter, which in my view is quite serious. What …
Kimera Labs FDA letter cites exosomes for COVID-19, more issues 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 »
What science and stem cell pubs are you reading right now and what do you hope to get too soon? Sometimes science means getting out in the field. Now there are no wild stem cells out there roaming the fields to catch and analyze, but there are other ways. A couple of my kids and …
Weekly reads: Hox, exosome IND app, stem cell quiz, more Read More »
The FDA dropped a lengthy, extremely critical warning letter on a supplier of unproven exosome product called EUCYT Laboratories. For broader context, exosome therapy has somehow burst onto the scene when there’s no good data yet in my view to back up its use in the clinic. The FDA is taking notice with letters already sent …
Getting 30 F grades? FDA Strongly Warns Exosome Firm EUCYT Read More »
The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift. Background on …
Historic spring storm of FDA letters to stem cell clinic industry Read More »
It’s been a busy week for the cellular and regenerative medicine space for COVID-19 news with some possible ups including for Mesoblast and some definite downs. Starting with the more positive media buzz with have Mesoblast. Mesoblast made COVID19 news “Thinly traded Mesoblast Limited (NASDAQ:MESO) rockets 51% premarket on average volume in reaction to its announcement of an …
COVID-19 cellular medicine buzz: Mesoblast, FTC hammer, more Read More »
When the number of stem cell clinical studies and trials listed for COVID-19 first started spiraling upward it seemed likely that stem cell clinics and other firms in that arena would get interested. I thought that we’d see the unproven regenerative medicine coronavirus bandwagon quickly grow. Unfortunately, there are reasons to be increasingly concerned here. For instance, …
As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes? Read More »
Time to sell exosome therapies to patients? No. Some stem cell clinics and related firms are looking for new ways to make profits and toward that goal a few have latched onto the legitimate buzz around exosome research. What are exosomes? Imagine if you could bubble up a pea-sized sphere off your skin full of …
As exosome work advances, clinics pitch unproven therapies to patients 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 »