June 2, 2020

The Niche

Knoepfler lab stem cell blog

patients for stem cells

2 min read

For the first time I have ever seen in at least half a dozen years, a major newspaper in the form of The Boston Globe has published an editorial on FDA regulation of stem cells. The editorial, entitled “It should be safety-first on stem cell therapies”, argues that while we should take patient concerns into consideration, it must be safety first on experimental stem cell therapies.  I commend them for this editorial and their common sense approach to this hot topic. It’s great that the …Read More

5 min read

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 the clinics. This is the reality no matter what some of the patient advocates who promote the clinics might say. Such finalized FDA regs that unambiguously state that, for …Read More

3 min read

Remember the Texas stem cell clinic Celltex, most famous for treating Texas Governor Rick Perry? Celltex had a busy few years, but has been relatively under the radar for most of 2013. Does that mean it’s gone? Hardly. Their saga became more serious when the FDA sent it a warning letter that was predicted by this blog. The firm was, according to the FDA, manufacturing an unapproved stem cell drug. The FDA apparently told the business to stop treating patients in the US unless a …Read More