Search Results for: R3 Stem Cell

R3 Stem Cell still raises red flags for me after FDA letter including do one-get one meeting

R3-Stem-Cell-Course

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 …

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FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates

R3-Stem-Cell-testimonials

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a …

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Duke & Cryo-Cell plan big stem cell clinic for kids for unproven infusions

cryo cell duke stem cells autism cp

Duke Professor Joanne Kurtzberg’s clinical work on umbilical cord blood for autism and cerebral palsy (CP) involves a partnership with a publicly-traded cord blood banking firm called Cryo-Cell. Kurtzberg is also the Medical Director at the firm. In addition they have intellectual property in this area. The Duke team’s efforts, including those done outside of …

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Weekly reads: cancer stem cells & other pubs plus a puzzler

kyu yum nature cancer stem cells niche

Cancer stem cells are one of the most interesting areas of research, intersecting the stem cell and cancer fields. Today’s weekly reads post highlights some new cancer stem cell articles along with some other interesting papers. I also note a recent weak stem cell clinical trial paper that is not a recommended read but is …

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Spicy stem cell pathways & other recommended reads

Nociceptor-mediated HSC mobilization. "Schematic representation showing that nociceptive-nerve-derived CGRP, but not substance P, acts via CGRP receptors on HSCs to enhance their mobilization via a cAMP-mediated signalling pathway. "Gao et al Nature, Capsaicin acts via nociceptor signaling to mobilize blood stem cells.

The stem cell paper of the week is a fun one about how capsaicin and nociceptors reportedly mobilize blood stem cells.  However, since the authors only show this in mice, could it also happen in humans? They argue it’s likely happening in people too. Note that nociceptors are special structures in our bodies that sense …

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CAR-T cells review: cancer & a critical look at possible uses in aging & COVID-19

CAR-T-cell-infographic

Introduction to CAR-T cells CAR-T cells are an exciting cutting-edge technology that has been garnering great interest including in the stem cell field. Potential therapeutic uses of CAR-T, which stands for Chimeric Antigen Receptor T-Cells (CAR-T), are being studied in clinical trials as immunotherapies to potentially fight cancer as well as many other diseases by …

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Recommended reads: COVID-19 updates, FDA stem cell nod, PRC2, more

Fig.-3d-Rai-et-al-Nature-Communications-2020

Today’s post is the latest edition of my weekly recommended reads, which this week include Fate Therapeutics, COVID-19 updates, AAMC, and more including some great pubs such as one on 2 modes of PRC2 function. Also check out this handy resource: Helpful 2020 List of Stem Cell Journals and this blast from the past post of 10 …

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Stem cell reads: IPS cells, p53, mini-livers, baldness

stem-cell-grown-mini-liver-small

We’ve had another week of interesting stem cell news and papers. Here is an aggregate of the stem cell and regenerative medicine week that was. Stem cell therapy for baldness I’ve covered stem cells for hair loss for about a decade here on The Niche. While it seems like it’s taken a long time for …

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Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game?

FDA-untitled-letter

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest …

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FDA warns another perinatal stem cell supplier Stemell

Stemell-logo

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain …

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