January 19, 2021

The Niche

Trusted stem cell blog & resources

Month: November 2019

2 min read

Here in the U.S. we just had our big Thanksgiving holiday, but science goes, stem cells keep growing and needing attention, and it’s another weekend chance to catch up on our paper reading. Here’s this weekend edition of recommended reads including news items and pubs. From Cell Stem Cell: Single-Cell Transcriptome Analysis of Uniparental Embryos Reveals Parent-of-Origin Effects on Human Preimplantation Development. and another there on stem cell machinery in cancer: Humanized Stem Cell Models of Pediatric Medulloblastoma Reveal an Oct4/mTOR Axis that Promotes Malignancy. …Read More

4 min read

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 untitled letter went to RichSource Stem Cells, Inc. and its CEO Sara Oracle, a firm which markets an unusual “combo” product described this way by the FDA, “a combination …Read More

3 min read

I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A. I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have been hurt. It’s important to know that reality and to hear directly from the real people who’ve been hurt. The podcast focuses in large part on a supplier called …Read More

3 min read

Once upon a time this blog and major outlets around the world were regularly writing about a Japanese stem cell researcher named Haruko Obokata (小保方 晴子). Whatever happened to Obokata and the other folks directly involved in STAP cell research? First, a bit of background because maybe still a few people never heard of STAP cells and Obokata or forgot the key points behind the controversy. Haruko Obokata became well known because of her research claiming to make pluripotent stem cells like IPS cells without …Read More

6 min read

By Guillaume Levrier Human germline editing has been done before. It will be done again in the future, as it is relatively easy to perform. No mechanism with the de facto ability to prevent it from being organized has yet been designed, let alone implemented. But the fact that germline editing has, can, and will happen again does not deprive anyone of their right to have an opinion on this capacity. The CRISPR Consensus symposium (see video below) set up at the Innovative Genomics Institutes …Read More

2 min read

Once or twice a month I do a post on notable stem cell publications and news, which often but not always include research on iPS cells. It’s sort of a recommended reads kind of post, but I often include one or two things that aren’t necessarily recommended exactly yet seem kind of surprising or novel in some ways. Here’s today’s list. One bit of news first On the RMAT front: “FDA Grants RMAT Designation for CAR T-Cell Therapy for Multiple Myeloma.”  You can see …Read More

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

5 min read

I’ve been concerned about a stem cell group called MD Stem Cells for many years. Now it comes under more scrutiny from a new must-read piece by Donna Young over at S&P Global. Young’s article reports a puzzling, purported right-to-try (RTT) program that MD Stem Cells appears to working on with Richard Garr. Note that Garr is the former CEO of Neuralstem (for reference, that company just renamed itself Seneca Biopharma) who now runs a CRO focused on RTT. My SCOTS concerns Two physicians …Read More