January 16, 2021

The Niche

Trusted stem cell blog & resources

Month: August 2016

1 min read

The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which could be due to the FDA warning. An archive of the site (screenshot above) provides information on their products. Notably, CBER described the company’s products as unapproved biological drugs …Read More

1 min read

Journalist Melinda Beck has a new piece on fat stem cell clinics in the Wall Street Journal (WSJ) today that includes one very brief quote from me that I believe effectively ends up being an unintentional misquote because of a lack of context. Here in this blog piece I want to provide that important missing context. Melinda and I talked quite a lot about stem cells on the phone and I worked hard in that discussion to provide a great deal of depth as …Read More

4 min read

A stem cell/regenerative clinic firm called the Lung Institute is facing a filing of a proposed class action suit. Update: Note that this firm also goes by the name the Lung Health Institute and now as of 2019-2020 it does not appear to offer stem cells anymore, perhaps focusing on PRP. You might also find this WaPo article from 2019 useful:‘I’d need a drink’: WaPo deep dive on clinic firm Lung Health Institute. Is it possible that a growing number of lawsuits against stem …Read More

1 min read

The FDA continues to be very active with warning letters against makers of stem cell cosmetics even as it has been relatively dormant on stem cell clinics. You can read past posts on the long series of warning letters to manufacturers of stem cell cosmetic cream. Three new warning letters to stem cell cream makers popped up on the FDA site recently to makers Lavian Ltd, Sircuit Skin, and Annemarie Gianni Skin Care LLC. Lavian markets something called Resurgent Stem Cell Firming Activator, which the …Read More

2 min read

It’s been a big 2 weeks in terms of media interest in talking about the upcoming FDA meeting on stem cell oversight taking place in just a few weeks. There are many questions about this meeting and I’m planning to tackle some of the questions in upcoming posts including next week. These questions include, “who are the specific individuals attending and what are their perspectives?” What exactly are all the organizations that are on the agenda and what are they going to say? Another …Read More

3 min read

Last year I heard from several sources that there somewhere between 3-5 unpublished manuscripts reporting the use of CRISPR gene targeting in human embryos being shopped around at various journals in addition to the one that had been published. Since that time we’ve seen a grand total of one additional paper reporting on CRISPR of human embryos. So what gives? Were the sources wrong? I don’t think so and I believe there are additional labs pursuing research on the use of CRISPR in human embryos. …Read More

3 min read

A large and growing number of American clinics are selling stem cells to patients for a variety of ills and one in the San Diego area called StemGenex was the main focus of a recent LA Times piece by columnist Michael Hiltzik. In the piece called “These new stem cell treatments are expensive — and unproven” Hiltzik discussed the growing issues over stem cell clinics in the U.S. and he used StemGenex as a kind of test case or example. He started off with a …Read More

1 min read

One of the best things as a stem cell scientist is to see all the new stem cell papers that come out. Here are 5 thought provoking new ones. Dual targeting of p53 and c-MYC selectively eliminates leukaemic stem cells (Nature) Zika Virus Infects Neural Progenitors in the Adult Mouse Brain and Alters Proliferation (Cell Stem Cell; see image below) “If You See Something, Say Something” Editorial by Deborah Sweet on encouraging readers to take action on stem cell clinics. (Cell Stem Cell)

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After six and a half years blogging here, I’ve seen so much weird stuff. Not all of it was even “bloggable” due to its crazy, not-safe-for-work nature. For TGIF this week, here are 10 of the weirdest posts from this blog over the years. Where’s the Beef? Reality Check on Stem Cell Test Tube Burger Baloney You might also enjoy this 2017 post on lab-grown meat: Yum or yuck? Test tube bacon from stem cells. Stem cells in my Pepsi? A new weird stem …Read More

3 min read

I often am asked if there are ongoing or possible upcoming lawsuits against stem cell clinics. Doing periodic searches such as on Google is one way to learn more about whether there are stem cell legal cases out there. Recently I did such searches for a variety of terms including “stem cell lawsuit” and “stem cell fraud” and while no new actual Google results showed up that I hadn’t seen before, strikingly a new advertisement did show up for a law firm (see image …Read More