Search Results for: Advanced Cell Technology

ISSCR KO’d in round one versus unproven clinics: where’s the FDA?

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What is ISSCR doing about unproven stem cell clinics? One of the greatest and most infuriating ironies of the stem cell-based regenerative medicine universe is that while the FDA strictly regulates the progress of therapy development by Advanced Cell Technology (ACT) and Geron and other legitimate companies, at the same time mysteriously the FDA essentially […]

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CIRM funds $25 million for Geron trial, $38 million for basic biology

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Geron-300x2212

CIRM announced two sets of awards today that both should make major impact including its first clinical trial via Geron and $38 million for 27 basic biology studies. First Clinical Trial. Today CIRM awarded $25 million to support Geron’s FDA-approved clinical trial for spinal cord injury. This is CIRM’s first award to a for-profit company

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Great news: FDA gives ACT the green light bringing hope to millions of people with blindness

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advanced-cell-technology

The FDA has given Advanced Cell Technology (ACT) the go ahead to begin their clinical trial using retinal progenitor cells derived from hESC by clearing the company’s IND application, bringing hope to those with vision loss and even blindness. The trial will be a combined Phase I/II to treat Stargardt’s Macular Dystrophy and has huge

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Big spike in FDA warning letters to unproven biologics firms

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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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Fountain Life update: lawsuit by doc, high performance aging, Celularity trial plan

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Fountain Life

A New Rochelle doctor has filed suit against the healthcare clinic firm Fountain Life alleging fraud. Now seems like a good time for an update on the firm. Peter Diamandis along with Bob Hariri, life coach Tony Robbins, and surgeon William Kapp founded Fountain Life, an early detection-focused healthcare company. Are they also a longevity firm? To

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Weekly reads: artificial wombs, mice with rat brains, Neuralink

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artificial wombs

It feels like we are marching towards a future in which key aspects of human reproduction, including the use of artificial wombs, could be substantially different than for most of history. The FDA is considering allowing a clinical trial for use of artificial wombs in people. Human trials of artificial wombs could start soon. Here’s

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Weekly reads: stembryos or human embryo models, new Macchiarini sentence

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stembryos, embryo models Monash

Researchers have been making stem cell-based embryo models for years now and a few folks have taken to calling these “stembryos.” Other names like gastruloids and blastoids are sometimes used too. “Embryo models” might be the simplest and best name. The embryo model research has advanced relatively quickly from very basic, not very organized structures

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If you lost a loved one, could you turn to human cloning?

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Human-cloning

One of the most interesting parts of running a website like The Niche is that reader’s questions can sometimes be so striking including recent ones on human cloning. They got me thinking about cloning again. Human cloning & loss of a loved one: things to consider Several readers have recently asked about whether human cloning

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Dissecting that Neanderthal brain organoids Science pub

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neanderthal human brain organoids

Organoids and especially brain organoids, which are made from pluripotent stem cells, are one of the most interesting developmental biology technologies of the last half a dozen or so years. Still some folks can’t help but get carried away when thinking about brain organoids it seems. A new Science paper from a team led by

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