June 5, 2020

The Niche

Knoepfler lab stem cell blog

stem cells

1 min read

Now that in the past few months the FDA has issued stern statements (one this summer and more recently), both final and draft guidances, and at least one warning letter, what comes next?  What will the clinics do if anything moving forward? What if anything will the FDA do in terms of actual concrete actions? Please take our polls below. Regarding potential FDA actions, I’ve just used the word “letters” in the poll since the FDA can issue impactful letters that are either untitled …Read More

2 min read

One of the special projects on this blog is something called the Stem Cell Outreach Program for Education (SCOPE). My goal with SCOPE has been to provide a basic page of facts about stem cells in as many languages as possible with the motto of “Stem cells not lost in translation!” It has been a big hit and as the number of languages has grown, the number of page views of my white paper “What are stem cells?” in languages besides English has skyrocketed. For example, as of July 2017 here …Read More

3 min read

Right-To-Try laws have been passed in many states across America, paving the way in theory for gravely ill patients to have the right to try unproven treatments of various kinds, and now there is a serious push underway for a national Right-To-Try law. What is a Right-To-Try law? Typically, these Right-To-Try laws allow for a patient facing serious illness, with consent of their physician and the business that makes the still investigational therapy, to not have to wait for full vetting of the new treatment. They …Read More

3 min read

New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in store. How might that unfold? In one of his first statements that includes stem cells and regenerative medicine as Commissioner, Gottlieb perhaps gave us some hints within a new …Read More