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America’s growing Muse cell mess: Dezawa Muse cells, “counterfeits”, & FDA compliance questions

by rss feed | Oct 14, 2026 | Dezawa Muse cells, FDA, Muse Cell Innovations, News Feeds, stem cell clinics

Muse cells have jumped back onto my radar screen in the past year, including one specific type called Dezawa Muse cells. They are purported adult pluripotent stem cells. The combination of “adult” and “pluripotent” never made sense to me, but...

Quick perspectives on Karim Mikhail as new permanent CBER director

by rss feed | Sep 9, 2026 | CBER Director, FDA, News Feeds

Karim Mikhail, acting CBER director, has just been named the permanent branch leader. What might this mean for the cell and gene therapy field? Karim Mikhail is permanent CBER director, unusual background Most people in the field want more stability and logic-based...

FDA to end ‘grace period’ on stem cell clinics: agency should ‘go big’ on continued offenders

by rss feed | Apr 27, 2021 | FDA, News Feeds, stem cell clinics

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...

List of FDA Approved Stem Cell Therapies

by rss feed | Mar 12, 2021 | Blog, FDA, FDA approved stem cell therapies, News Feeds, stem cell therapy

Over the years many of us have wished that there was a list of FDA approved stem cell therapies. Patients and fellow scientists often asked me, but there was no list that I could find. Other researchers mentioned being asked too. As a result, the general answer was,...

Recommended reads: jobs, FDA letter, & The Niche new look

by rss feed | Jan 31, 2021 | Fact-check, FDA, FDA letter, FTC, Jobs, News Feeds, Organicell, stem cell meetings, the Niche, weekly reads

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...

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