In mid-November the Catholic Church, in fact the Vatican itself, will do something it has never done before in its very long existence. It will hold a conference on stem cells. Perhaps equally unusual and of interest is the fact that the basis for this conference is a $1 million (USD) gamble by the Vatican […]
More on the Vatican $1 million gamble on NeoStem and their upcoming conference in Rome Read More »
What’s up with Advanced Cell Technology (ACT) and Geron? ACT announced today that it has treated two patients in its clinical trials: one for Stargardt’s Macular Dystrophy (see official trial page for a lot more info) and one for Dry Age-Related Macular Degeneration (see official trial page here for a lot more info). The patients underwent
The latest scoop on ACT and Geron Read More »
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
ISSCR KO’d in round one versus unproven clinics: where’s the FDA? Read More »
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
CIRM funds $25 million for Geron trial, $38 million for basic biology Read More »
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
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
Big spike in FDA warning letters to unproven biologics firms Read More »
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
Fountain Life update: lawsuit by doc, high performance aging, Celularity trial plan Read More »
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
Weekly reads: artificial wombs, mice with rat brains, Neuralink Read More »
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
Weekly reads: stembryos or human embryo models, new Macchiarini sentence Read More »
It’s that time of year again when I grade my previous year’s predictions for the stem cell & regenerative medicine space. Overall, I did better than a typical year. I give the 2022 predictions an A- overall. This exercise can be kind of fun but also humbling. For example, I tend to be too optimistic
Grading my 2022 regenerative medicine predictions Read More »