One of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog. What does a warning […]
To stem cell clinics: do your homework & take FDA “current thinking” seriously Read More »
A team of researchers from Sun Yat-sen University in China and here in California at my graduate alma mater UCSD has published a remarkable, new report in Nature reporting human lens regeneration in cataracts. This is a truly amazing idea that endogenous stem cells can regrow new lenses. I wonder if we are on a path to someday
Eureka: Endogenous Stem Cells Regrow New Lens for Cataracts Read More »
A couple of months back, the FDA issued a warning letter to three co-owned stem cell clinics selling fat stem cell-based interventions to patients for a variety of ills. You can read all about the warning letter here. It went to lead clinic, Irvine Stem Cell Treatment Center as well as the two co-owned clinics, which
Content Wiped on Websites of Stem Cell Clinics Warned by FDA Read More »
There has been much attention to the link between Zika and microcephaly. How does Zika cause microcephaly or does it even directly cause microcephaly. Has the latter been concretely proven? There are even more questions. A cool new Cell Stem Cell paper gives us some key insights. The manuscript from a team led by Guo-Li
Zika infects and zaps human brain stem cells Read More »
Should we be injecting bone marrow cells into someone’s eyes? it seems like a terrible idea to me based on what we currently know. Whenever I see a stem cell headline like this one from a recent Baltimore Sun piece, it raises many questions: Stem cells apparently reverse woman’s blindness. First of all, is the reporter,
Study injects marrow cells into eye, charges $20K Read More »
Medical News Today (MNT) published an article yesterday on a stem cell clinic in Mexico that caused a lot of concern because to many of us it came off as unbalanced and even promotional of the clinic. You can read my post from yesterday on this situation. In response, MNT has now revised their piece and included this
Revised Medical News Today Stem Cell Article Improved But Still Unbalanced Read More »
A new article by Honor Whiteman in Medical News Today (MNT) on a Mexico stem cell clinic really takes the prize so far in 2016 amongst media pieces that engage in stem cell hype. Update; Many on Twitter are calling for retraction of this MNT article. The MNT article entitled “Stem cell therapy: is the US
Medical News Today article reads like an ad for Mexico stem cell clinic Read More »
Below is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments. This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to
New FDA Interview on April stem cell meeting & draft guidances Read More »
The FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs. That would be a good thing for patients who are often being put at risk by many of
FDA meeting on stem cell regs: mostly who’s who of anti-regulation forces Read More »
What is stem cell snake oil? Stem cells are exotic things ensconced away in biomedical research labs, right? Well, maybe not entirely so these days. It turns out that you can try to sell products for a lot of money by slapping “stem cells” on the label including cosmetics. Take Nordstrom’s. It has 80 stem
Stem cell snake oil for sale at Nordstrom, Amazon, & Ebay? Read More »