Where is the stem cell field now and where the heck is it heading? There are hundreds of questions. Readers often email me questions or leave them as comments. It’s not unusual to get questions about CRISPR as well. As time permits, I’m hoping once or twice a month on Sundays to post a video answering …
Q&A video with Paul Episode 1: your stem cell questions answered Read More »
In the comments section of a recent post on adult stem cell treatment safety on this blog, the CEO of RNL Europe, Glenn McGee made the philosophical statement that “silence kills science”. It’s an interesting thought and I think to some extent there is truth in it. Openness, data-sharing, dialogue…these are all good things. In …
I’m enjoying Celltex’s new website and I’m appreciative of their great responsiveness to my questions. Transparency is a beautiful thing! My latest question to them was whether they, given that the FDA called them a “drug manufacturer”, are now planning to or have already filed an IND. An IND is an application for an investigational …
More Celltex Q&A: we are not a drug manufacturer Read More »
How does Texas stem cell clinic Celltex make their stem cell drug? This is a very key question as the answers will help the stem cell field evaluate this drug’s potential safety and efficacy. I’m calling it a “drug” because the FDA called Celltex a “drug manufacturer” and by all past FDA precedent as well …
My ongoing Q&A with Celltex on their stem cell drug production methods Read More »
The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges, …
Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics Read More »
Most of us have heard of organoids but what about the related model called an “assembloid”, which is a term growing in use including from organoid researcher Sergiu Pasca of Stanford? Before we jump into that, be sure to enter The Niche stem cell image contest for your chance to win $100 or some swag. …
The recent news of Vertex Pharma buying small stem cell biotech ViaCyte and Doug Melton moving to Vertex brought to mind an old stem cell biotech called Advanced Cell Technology (ACT) and its leader, stem cell biologist Dr. Robert Lanza. Years ago, big pharma firm Astellas bought ACT and Lanza moved to be a leader of regenerative …
I’ve been busy recently focusing more on grant and paper writing than reading papers on stem cells, but my piece on trying to de-extinct mammoths via cloning-like methods drew strong opinions on both sides. Recent news and resources on stem cells We’re still awaiting a verdict in the big California federal court case where the FDA is …
Weekly reads: news, legos for stem cells, FDA, cancer, more Read More »
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 »
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’ (ATMP)? Whoever decided that cell and gene therapy products should be described …
Cell and gene therapy products: what is an ATMP? Read More »