June 1, 2020

The Niche

Knoepfler lab stem cell blog

stem cell law

4 min read

The four words “California stem cell research” go nicely together and I hope they will continue to resonate in a special way to people around the world in the coming decade. We are at a crossroads for stem cell research in California as the original form of the California Stem Cell Agency (CIRM) winds down. Will CIRM get a new infusion of billions in state funding via a ballot initiative a la Proposition 71 from more than a decade ago? Will CIRM instead find …Read More

4 min read

A new Florida bill (Bill 65 of 2019) could make the practices of stem cell clinics a felony. At the same time it would open the door to patients receiving still experimental stem cells that have at least started the clinical trial process. What’s going on? A number of states have been stepping up action related to stem cells and specifically stem cell clinics. The steps on unproven clinics range from bills, some of which have become law such as here in California and …Read More

2 min read

California broke new ground with our stem cell law that went into effect on January 1. It requires stem cell clinic firms to post notices informing patients of important information such as the fact that their offerings are non-FDA approved. At this point, 4+ months into the enforcement period, I’m not sure if anyone has looked into compliance. Anyone know? If you run a stem cell clinic, have you posted notices? Is you are a patient in California who has been to such a …Read More

3 min read

Did you hear the one about the deep state FDA, big pharma stem cell conspiracy theory? This is the phony idea that the FDA, big pharma, and, heck, sometimes even certain academics (who could that be?) are plotting together as some kind of biomedical secret society or “deep state” to block promising stem cell therapies from reaching patients. It is one of the more persistent stem cell myths out there. Unfortunately, the stem cell arena is more prone these days to this kind of fake news. …Read More

4 min read

The ability of for-profit stem cell clinics to pitch unproven, risky stem cell offerings to patients may soon get much tougher in Australia. The country’s Therapeutic Goods Administration (TGA), which has some similar responsibilities there as the FDA does here in the U.S., announced planned new reforms that’ll put stem cell clinics under more scrutiny and more thorough oversight. Hopefully it’ll in many ways provide patients with more protections. While details remain to be determined, there are four major components to the TGA policy change, which …Read More

4 min read

For-profit stem cell clinic secrets are bad news for patients. Stem cell clinics are in the business of making profits above all else and to make steady money they need a strong flow of patients as their paying customers for their non-FDA approved offerings. In order to keep the money pouring in, some of the clinics may not be completely truthful with patients. These clinic secrets can be directly told to prospective customers or implicit in the operation of the business. Below are the top …Read More