There has been a steady stream of encouraging data on stem cells for MS. Particularly for certain kinds of MS. A new study adds to this upbeat direction. Good news on stem cells for MS Haematopoietic stem cell transplantation for treatment of relapsing-remitting multiple sclerosis in Sweden: an observational cohort study, Journal of Neurology, Neurosurgery, …
Weekly reads: stem cells for MS, Kimera Labs IND, FDA lawsuit 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 »
In the stem cell world some corporate names end up being very similar with the latest example being several companies with the name “BioLife.” Get a BioLife…name I guess BioLife is a catchy term. You’ve got life and biology in there in one name. Let’s deconstruct what’s going on out there with this corporate name. …
Perspectives on BioLife: one name, distinct companies 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 »
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 »
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 »
Was sind Stammzellen? Der menschliche Körper enthält Hunderte von verschiedenen Zellarten, die für unsere tägliche Gesundheit wichtig sind. Diese Zellen sind verantwortlich für das tägliche Funktionieren unseres Körpers, wie das Schlagen des Herzes, das Denken des Gehirns, das Säubern unseres Blut durch die Nieren, das Ersetzen unsere Hautzellen, und so weiter. Die wichtige und einzigartige …