October 24, 2020

The Niche

Knoepfler lab stem cell blog

Month: January 2017

1 min read

The 21st Century Cures Act specifies some new FDA rules about investigational stem cell-based regenerative medicine therapies and perhaps most importantly defined a new class of product called a “Regenerative Advanced Therapy” or RAT, which is entitled to an expedited review. The FDA already has a new page up on RATs, which specifies the specifics of RAT designation and how an entity may submit an application for RAT designation. This was remarkably fast of the FDA. Some things on the RATs page stand out including …Read More

2 min read

The website Law360 has an interesting update on the proposed class action lawsuit against the San Diego stem cell clinic Stemgenex.  Note that it seems you can read the full Law360 article without a subscription if you open the site in Chrome as your web browser. See more background on Stemgenex and on this case here. Not surprisingly, the plaintiffs and defense see this case in opposite ways as reflected in quotes in the Law360 article: “Plaintiffs make non-specific and conclusory allegations with respect …Read More

1 min read

Former Texas governor Rick Perry, now the Trump Department of energy (DoE) nominee, has a long association with the Texas stem cell clinic, Celltex. He was a patient of Celltex, which some years back infused Perry with non-FDA approved stem cells. The company received a warning letter from the FDA and since that time has sold its stem cells in Mexico away from FDA oversight. Perry has been a long-time supporter of Celltex.More recently he has served on the Celltex board and reportedly earned $175,000 …Read More

1 min read

I’m putting together a list of stem cell and regenerative medicine biotech companies for a blog post, including both public and private. I’ve got a good list already, but want it to be fairly comprehensive. I’m also curious what readers think are the most promising ones and why. So weigh in with comments please or email me. Ideally, you would indicate if you have an investment in these stocks for the publicly-traded ones. Don’t restrict yourself only to stocks traded on US markets necessarily …Read More