Month: January 2017

Good stem cell news on trials, FDA, cool new papers & more

Pericyte-paper

In the whirlwind that is the stem cell and regenerative medicine world, there are many concerning things that need attention, but also good stuff happens too and this post focuses on the positive. The Asterias spinal cord injury clinical trial, a phase 1/2a trial called SCiStar, continues to make encouraging news with a clean safety profile …

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Scientists battle Trump agenda on multiple fronts

scientists-march

The first ten days of Donald Trump’s presidency have been just as extreme as many had feared including those of us in the scientific community, but the early reactions of scientists to fight Trump’s agenda have been encouraging. We’ve collectively been sparked to “get out of the lab” and do something about it. There are many …

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Perspectives on pig human chimera paper

human-pig-chimera

A new paper focused on human and other chimeras just came out today in Cell reporting a number of findings, but most strikingly successful generation of human-pig chimeras in utero. The paper, entitled, “Interspecies Chimerism with Mammalian Pluripotent Stem Cells” describes various chimeras including mouse-rat ones, although those have previously been reported. This work comes …

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FDA Regenerative Advanced Therapy Designation Rules Are Up in Response to Cures Act

The 21st Century Cures Act specifies some new FDA rules about investigational stem cell-based regenerative medicine therapies and perhaps most importantly defined a new class of product called a “Regenerative Advanced Therapy” or RAT, which is entitled to an expedited review. The FDA already has a new page up on RATs, which specifies the specifics of …

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Update on patients lawsuit against stem cell clinic, Stemgenex

Stemgenex

The website Law360 has an interesting update on the proposed class action lawsuit against the San Diego stem cell clinic Stemgenex.  Note that it seems you can read the full Law360 article without a subscription if you open the site in Chrome as your web browser. See more background on Stemgenex and on this case …

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Rick Perry resigns from stem cell clinic Celltex, where he earned $175K

Perry-Scripps

Former Texas governor Rick Perry, now the Trump Department of energy (DoE) nominee, has a long association with the Texas stem cell clinic, Celltex. He was a patient of Celltex, which some years back infused Perry with non-FDA approved stem cells. The company received a warning letter from the FDA and since that time has …

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What is your favorite stem cell/regen med biotech & why?

stem cell stocks

I’m putting together a list of stem cell and regenerative medicine biotech companies for a blog post, including both public and private. I’ve got a good list already, but want it to be fairly comprehensive. I’m also curious what readers think are the most promising ones and why. So weigh in with comments please or …

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Tom Price & MiMedx: a stem cell connection?

Tom-Price-HHS-Senate

What’s the deal with Trump’s HHS Secretary pick Rep. Tom Price (now testifying before the Senate) and the amniotic tissue/stem cell company MiMedx that’s caused some buzz in the last 48 hours? I’ve been following MiMedx for a few years since it received an untitled letter from the FDA and I noted its claim of one its …

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Fake stem cell news

One of my Top 20 Predictions for Stem Cells for 2017 was that we’d see more instances of fake stem cell news. One type of stem cell fake news consists of promotional press releases that seek to recruit paying customers for unproven stem cell “treatments” based on made up or exaggerated claims about safety and …

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