July 13, 2020

The Niche

Knoepfler lab stem cell blog

exosomes

3 min read

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 to others including an untitled letter to Kimera Labs  and on the same date another to a physician who used Kimera products and was at one time amongst Kimera leadership, Doug …Read More

12 min read

One of the most common questions that patients have asked me over the last decade is, “how much do stem cells cost?” They actually ask seem to want to know more specifically how much the treatments should cost. To try to authoritatively answer this we need data from the present and past along with expert perspectives. Stem cells cost & questions These kinds of questions on what are common and reasonable prices have continued in 2020. However, the types of queries have also evolved …Read More

3 min read

The FDA needs to do more about clinics and suppliers of unproven “exosome therapies.” Dubious exosomes are sadly just the newest gimmick for some firms in the stem cell/regenerative medicine clinic arena right now. They are available at many stem cell and other clinics right now, but who knows what’s in the syringe? Also, people have been hurt in Nebraska by some product involving exosomes. There is legit, exciting exosome research ongoing all over now. I believe these little cellular bubbles full of different …Read More

3 min read

Remember our old friends Liveyon? Their leader John Kosolcharoen? Liveyon’s continuing metamorphosis This biologics supply firm has gone through several stages of corporate metamorphosis as a supplier of biologics including at first a purported living umbilical cord stem cell product. That stem cell thrust ultimately landed a dozen or more people in the hospital as some of the product was somehow contaminated with bacteria along the way before injection in patients. There was a recall, an FDA warning letter, lawsuits, and a voluntary suspension …Read More