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 »
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 »
Should we call it stem cell synchronicity for stem cell supplier firm Invitrx? What was it about March 16? Sometimes strange things happen in the stem cell world such as last week on March 16 I wrote that the FDA needs to do more about unproven exosomes, and then on the same day a new FDA warning …
‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter Read More »
People ask me questions about stem cells all the time so I decide to do a new blog series answering your questions. Today’s post is the first in this new stem cell Q&A series. Past series have included my Elephant in the Lab series that provides some insights into the craziness that sometimes goes on …
Patients stem cell Q&A#1: can clinic injections cause GVHD? Read More »
We’re seeing more muddy waters in the stem cell universe. A chiropractic stem cell and alternative medicine clinic has popped up calling itself, of all things, CIRM. On another front, an already controversial docuseries set to air tomorrow combines interviews with prominent academic stem cell scientists and unproven stem cell clinic folks, muddying the waters. …
Muddy waters: stem cell clinic calls itself CIRM & docuseries sparks controversy Read More »
The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry. E. coli and other pathogens ended up in some of the Liveyon product somehow …
Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry Read More »
Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the …
Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters Read More »
The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.” An emerging big player in the birth-related stem cell clinic area? I’ve been hearing the name Liveyon pop up …
FDA recalls Liveyon stem cell product: blow to big clinic supplier? Read More »
What does homologous use mean? Navigating the arena of clinical use of a biologic such as stem cells or differentiated cells made from stem cells can be challenging. There are many important issues including what defines “minimal manipulation” of biologics such as cells. One particular issue that is critically important and has drawn less attention …
Time to bone up on homologous use in the stem cell field Read More »
What should patients think about and ask about when they are considering a stem cell treatment, particularly from a for-profit, unproven stem cell clinic? Patient guide to stem cell therapies For better or worse, I am in the unique position in 2021 of being a stem cell scientist and also a former cancer patient. Looking …