Search Results for: warning letter

Weekly reads: reprogramming hearing loss, heart disease, eye drops, sickle cell

Regener-Eyes, eye drops

It’s mostly been a week of good and encouraging news in the regenerative medicine space including with gene therapies maybe with the exception of some eye drops warnings (more below). There’s realistic hope for an approved sickle cell disease soon. I also see some long-term positive news on hearing loss research. Hematopoietic stem cell transplant […]

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Why did Duke autism team halt its troubling pay-for-play program?

Almost two years ago I publicly called on the FDA to freeze the unproven cord cell expanded access program (EAP) at the Duke Autism Center. Duke has been infusing kids with autism spectrum disorder (ASD) with unproven cord cells and requiring large payments for this. The cost was as much as $15,000. A halt and a

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Review of where Kimera Labs fits into sphere of exosome companies

Kimera labs exosome

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

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WHYY oh WHYY: NPR puff piece on risky stem cell microneedling

I usually associate NPR with solid journalism so I was scratching my head about a recent puff piece by WHYY on stem cell microneedling.  Is this journalism or product promotion? The NPR piece by Maiken Scott doesn’t ask important questions. Scott received stem cell microneedling herself using a product from a company called AnteAGE. How

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Why stem cell culture medium composition is such a big deal

Dr. Harry Eagle

Cells including stem cells are grown in liquid solutions called media and stem cell culture medium composition is crucial since the ingredients have a powerful impact on the cells. The media affects the cells’ identities and functions. It also impacts the risks of using specific regenerative products. My first job in science was isolating and

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Desperately seeking stem cells: celeb quests for elixirs often mislead

lady gaga, stem cells

What could go wrong with celebrities desperately hunting for stem cells as a fountain of youth? A flaskful of problems. Some famous folks can’t seem to get enough of stem cells, even if those supposed therapies are unproven and risky. In recent years, dozens of celebs have gotten stem cell procedures of various kinds. The

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Weekly reads: freeze-dried cloning, FDA signals, stem cell escapees

Human-cloning

Cloning is one of those topics that both fascinates and kind of scares people, especially the idea of duplicating people. I regularly cover the topic here on The Niche because stem cell technologies are involved. Also, one form of the process sometimes called “therapeutic cloning” involves embryonic stem cells. Duplicating mammals has now long been

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