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Recommend reads: FDA SVF warning, big Aspen grant, CSI finale invokes stem cells

SVF

One of the most contentious areas in the regenerative medicine arena is whether a fat tissue product called stromal vascular fraction or SVF is a drug. The FDA says SVF, even in autologous form, is a drug. It is seeking an injunction against a California-based network of SVF clinics but lost the initial case. That […]

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Recommended reads: police act on phony autism cure, Aspen starts Parkinson’s trial, reprogramming to iBlastoids

stem cells for autism

People often ask me about stem cells for autism or even their hope of an autism cure. I’ve explained that there is no new treatment for autism based on stem cells. There aren’t even mildly encouraging data. Note that it can be hurtful to the community to talk about an autism cure and disregarding neurodiversity.

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Big spike in FDA warning letters to unproven biologics firms

Dr. Peter Marks, Director of CBER, FDA warning

This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve

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Recommended reads: Stem cells in Japan, iPS cells for COVID & hearts, He Jiankui

fruit fly intestine, stem cells in Japan

How are things going with regenerative medicine and stem cells in Japan? It’s still an exciting time there, but I’ve noted a sense that it is a time of transition too in some ways. For example, government funding is perhaps less certain than in the past. Let’s start with a few articles on how the

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Recent stem cell & regenerative medicine good news

stem cell good news, good news

Looking for some stem cell good news? You’ll like today’s post. One mission of this blog The Niche is to promote rigorous science-based regenerative medicine, which can lead to investigating and writing about not-so-upbeat stuff. Risky clinics. People getting hurt. Patient lawsuits. Serious FDA, FTC, or state AG regulatory developments. Such actions can be good

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Weekly reads: stem cells for MS, good news x2, extending dog years, Neuralink updates

stem cells for MS

For about as long as I’ve been writing The Niche, people have been asking about stem cells for MS. There’s a huge need for new therapies. While a chemo-based approach with autologous hematopoietic stem cell transplantation (HSCT) looks to work for certain cases of multiple sclerosis (although not yet approved in the US), other cell

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Weekly reads: big Retraction Watch news, stem cells & metastasis, an FDA approval, Iowa AG sues clinic

Retraction watch

Retraction Watch has been a great resource for those of us who have been following research misconduct. They widely cover and conduct research on retractions, corrections, and other developments in this space. Unfortunately, there’s been plenty to write about even just within the stem cell and cell therapy arena, which is my primary interest. Think

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Weekly reads: CRISPR sickle cell, Parkinson’s, pig-human chimera concerns

CRISPR gene editing

CRISPR gene editing has made rapid progress heading from bench to bedside. Perhaps the fastest has been its progress toward clinical use to combat sickle cell disease. We’ll start with a new paper on one major effort here. CRISPR gene editing. This process often involves cutting DNA, which then can be used as an opening to

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Weekly reads: embryonic stem cells, Parkinson’s, Alzheimer’s

Knoepfler lab stem cells

Early during my postdoc I was primarily interested in the role of Myc genes both in cancer and in stem cells, work that later included embryonic stem cells. These cells are often called ES cells. At first I first started studying N-Myc in neural stem cells using a conditional knockout approach. However, soon after I was

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