A firm called Utah Cord Bank has been in the news related to stem cell clinics over the past year or two. Now they have received an FDA Warning Letter for a variety of manufacturing issues. Utah Cord Bank Background In terms of some brief backstory, Utah Cord Bank first popped up on my radar […]
FDA warning to stem cell clinic supplier Utah Cord Bank Read More »
Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics
What are the current FDA Approved Cell and Gene Therapies? In the past many of us have wished there was a list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me, but I couldn’t find a list. As a result, I made a comprehensive list of FDA Approved Cell and Gene Therapies,
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Those of you following the arena of unproven stem cells might recognize the name Dr. Joseph Mercola. He’s a promoter of alternative medicine. Over the years his name has also popped related to the marketing of unproven stem cell offerings in various ways. Now the FDA has warned Joseph Mercola on what it says are unapproved
FDA warns Joseph Mercola on COVID-19 claims Read More »
During the week as I’m doing other stuff I keep my eyes open for interesting things to read, including over the weekend about stem cell research, COVID, CRISPR, and more for The Niche weekly recommended reads. This week a lot was going as we updated The Niche site to our new theme and format. I
Recommended reads: jobs, FDA letter, & The Niche new look Read More »
In my view, it seems likely that the FDA has opened a big can of worms by starting to clear the COVID-19 trials and programs of for-profit stem cell clinics and other related firms. OK to Stemedica trial The FDA just approved another such effort, this one by the firm Stemedica. You can read more about
FDA OK’s more COVID-19 efforts of unproven stem cell clinics Read More »
When you sit down to read science on the weekends lately, assuming you are not primarily a COVID-19 researcher, how much COVID stuff seeps into your reading? As I was going over some of this year’s recommended weekly reads posts here on The Niche, I’ve realized that an increasing amount of COVID-19 research has joined
Recommended reads: PSC, COVID, FDA pledge, sci jobs Read More »
What’s been going on in the stem cell and regenerative medicine field over the past week and what are some worthwhile things to read? Today’s post has recommended recent reads from the scientific literature and the media. I’ve also got our weekly stem cell/regenerative medicine quiz question and the answer to last week’s. You can
Recommended reads: FDA warning, COVID updates, stem cell pubs Read More »
The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of
Politics & FDA OK of 2 stem cell clinic COVID-19 efforts Read More »
Graft-versus-host disease (GVHD) is counterintuitive In the weeks and months following a transplant, a major concern is the recipient’s immune system rejecting the “foreign” biological material. But in GVHD, the opposite happens: transplanted tissue unleashes a horde of T cells that spark a cascade of inflammation, within 100 days. Typically, GVHD follows a bone marrow
Mesoblast MSCs Quell Peds GvHD; On Road to FDA Approval? Read More »