The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a […]
New data on stem cell clinics, INDs, & more including from FDA itself Read More »
Something called the 14-day rule on growing human embryos in the lab helped keep a tough question in check for a long time: when is it ethically wrong or just practically unwise to continue growing a human embryo for research? There is no good answer based on science or anything else. ISSCR moves beyond strict
Risks rise as ISSCR drops strict 14-day rule on human embryo growth in the lab Read More »
Sometimes things in the stem cell world get complicated and this week is no exception with news of Orchard Therapeutics dropping a seemingly life-saving clinical trial. There are hundreds of kids who could possibly benefit. Rotten apple decision from Orchard Therapeutics From David Jensen at California Stem Cell Report we have something of a scoop:
Weekly reads: Orchard punts on life-saving SCID trial, cardioids with cavities, more Read More »
The journal Stem Cells Translational Medicine has a long track record of publishing great work. I also have a lot of respect for the editors there and I’ve published there myself. But a few recent events have sparked concerns including over possible undisclosed conflicts of interest in some papers there about cord blood for autism.
Cord conflicts at the journal Stem Cells Translational Medicine Read More »
A human embryo model is a laboratory-produced collection of living cells that has some key things in common with real human embryos. They are made from pluripotent stem cells, which include embryonic stem cells and induced pluripotent stem cells or iPS cells. This research is both exciting and ethically complicated, raising some difficult questions. Embryo
One of my main research interests is in oncodevelopmental factors. These include factors that are important both for normal stem cell biology and development as well as driving cancer when misregulated. One example includes the MYC family of proto-oncogenes. When I was a postdoc I got especially interested in trying to understand the normal role
Weekly reads: oncodevelopmental factors, iPSC cancer vaccine, more Read More »
Stem cell clinic firm US Stem Cell has just had a major paper retracted. Two of the notable authors on that paper are US Stem Cell leader Kristin Comella and stem cell researcher Thomas Ichim, who was senior author. It’s not clear to me if Comella currently has a role in the firm or not.
Stem cell clinic US Stem Cell has key paper retracted Read More »
I wrote earlier this week about Medeus clinic in Ukraine seemingly trying to recruit genetics researchers to CRISPR people for trait enhancement. Aiming for CRISPR people with trait enhancement? In the recruitment emails they sent out it seemed fairly clear that they were planning to do CRISPR on people somehow via stem cells. They mentioned
Ukraine clinic seems to backpedal from CRISPR people idea Read More »
It was a couple of years back that researcher He Jiankui claimed he made three “CRISPR babies.” No one would think about doing any kind of rogue gene-editing again, right? Not even somatic gene edits. After all, as far as we know he’s in jail. We still don’t know the health risks that these three
Ukraine clinic plans to sell CRISPR enhancements: hair color, skin, & breast size Read More »
If you were to see the phrase ‘Advanced Therapy Medicinal Product’ (ATMP) you might guess, ‘an advanced treatment that is a medicine?’ but you will not get much more from this without doing a lot more homework. What is an ‘Advanced Therapy Medicinal Product’ or ATMP? Whoever decided that cell and gene therapy products should
Cell and gene therapy products: what is an ATMP? Read More »