January 25, 2021

The Niche

Trusted stem cell blog & resources

FDA

4 min read

Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. While the FDA didn’t send R3 Stem Cell a formal warning letter, in my view the agency made it very clear in the “untitled” letter that this firm should make some changes. The letter went out both to R3 Stem Cell and its dozens of …Read More

3 min read

For me there was a sense of “finally” when just under 3 months ago the FDA filed suits via the DOJ against 2 stem cell clinic firms, U.S. Stem Cell (and its affiliate U.S. Stem Cell Clinic, collectively referred to here as USRM) and California Stem Cell Treatment Center/Cell Surgical Network (collectively referred to here as CSN) seeking permanent injunctions. However, since the filings in May not much of anything has changed on these fronts and it appears that the FDA has taken no action …Read More

6 min read

Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do about the hundreds of clinics currently marketing them without approval? If not, then how does the agency reconcile that with its past statements and even words this year under …Read More

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 The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation.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

It’s been somewhat of a helter-skelter time for the new technology often referred to as 3-person IVF or mitochondrial transfer as the UK considers whether to legalize this experimental technology for use in humans. I believe that this technology is not ready now for use in humans and for more background on why as well as other opinions you can see articles here. The admirable goal of this experimental 3-person IVF approach is to prevent transmission of mitochondrial diseases from mother to child, but …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

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

8 min read

This post is the first in a series about the Clinicaltrials.gov website. This piece is an interview the Director, Dr. Deborah Zarin. I want to thank her for taking the time to answer my questions. Later, I will post Part 2 in which I discuss my concerns about the trend of for-profit stem cell clinic trials being listed on Clinicaltrials.gov that in my view are not conventional trials. First a little background on Clinicaltrials.gov (see my various posts over the years on it here) before …Read More

2 min read

By Jeanne Loring Last week I visited NIST, the National Institute for Standards and Technologies in Gaithersburg, Maryland as a member of a review panel. NIST is the science branch of the US Department of Commerce, which is the business part of the government, and is not officially associated with other acronyms, the NIH, NSF, DOD, DOE, or the FDA. I discovered something exciting that is a secret to most biologists. It wasn’t the atomic clock, which is the official time standard, or the …Read More