September 26, 2020

The Niche

Knoepfler lab stem cell blog

FDA Expanded Access

13 min read

A new right-to-try company called Beacon of Hope is stirring some intense discussion. State and federal right-to-try laws could potentially change the fabric of how many investigational studies are conducted. That may happen through firms like Beacon of Hope. However, we don’t know much about the firm. I’m hoping to help change that. Today’s post includes a detailed interview with the leader of Beacon of Hope, Richard Garr. For background, Garr was formerly CEO at Neuralstem. During his tenure at Neuralstem it became well-known …Read More

4 min read

What happens if we mix stem cells with populism? From a populist view of stem cells, everyday patients should be able to do nearly anything they want with stem cells without any governmental interference or excessive expense. Even stem cells not proven to be safe or effective. This can sound like an appealing idea to patients looking for hope and also to some companies looking for profits. Stem cell populism poses serious questions and risks too. What exactly is “populism”? The Internet defines it …Read More

3 min read

On one level a reasonable argument can be made for letting terminally ill patients have a right to try experimental as yet unproven therapies, but in the real world Right-To-Try laws have many downsides. On the whole, they are likely to be negative for patients as a group.  Raising the stakes is a push for a federal Right-To-Try law in the U.S. A bill passed the U.S. Senate so a law is a real possibility in coming months. What are the problems and risks? …Read More

7 min read

It’s been a seemingly rather quiet year on the regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank the FDA for taking the time to do this interview. Below are their answers covering regulation of SVF, homologous use, FDA action/inaction on dubious stem cell clinics, Right To Try …Read More