September 28, 2020

The Niche

Knoepfler lab stem cell blog

FDA draft guidance

3 min read

One of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog. What does a warning letter really mean? What triggers it? Why do some businesses selling stem cells get inspected and others don’t? What do some entities get warning letters over the years, while …Read More

1 min read

In the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies. These steps come in the form of several draft guidances  (see here, here, and here) . The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has requested that the FDA clarify the term “main function” for human cell and tissue products (HCT/Ps). ARM rightly points out that HCT/Ps can have more than one function. For example, adipose …Read More

4 min read

With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem cell “treatments” to patients and almost all of them use non-FDA approved stem cell products isolated from fat tissue. The clinics have argued that they do not need FDA …Read More