Sharks are experts at growing new teeth from stem cells. What if we humans could grow new teeth from stem cells too? It seems like a stretch. Compared to sharks, on tooth regrowth we are biological amateurs. While humans and some other animals like dogs have only two sets of teeth in our whole lives, […]
Reasons to smile at sharks? Growing new teeth from stem cells Read More »
What are possible side effects of stem cell therapy ? Patients often reach out to ask about such risks They usually refer to unproven stem cell clinics. Today’s post addresses the scope of stem cell therapy side effects and risks based on available hard data. It’s also important to discuss possible unknown risks. Stem cell
Stem cell therapy side effects & risks at clinics Read More »
The U.S. Supreme Court could soon have a historic opportunity to limit the scope of FDA stem cell oversight. A large stem cell clinic firm now says it plans to ask SCOTUS to review a case it recently lost on appeal to the FDA. If SCOTUS takes the case, the FDA could find its powers
FDA stem cell oversight at risk as clinics to ask SCOTUS to weigh in Read More »
In a landmark decision, today the FDA approved Ryoncil from Mesoblast for GvHD. This is the first time the FDA has approved a mescenchymal stromal/stem cell or MSC therapy of any kind. There have been many ups and downs for Mesoblast toward this approval of Ryoncil or remestemcel-L, an allogeneic marrow MSC product. See my
In landmark, FDA approves first MSC therapy, Mesoblast’s Ryoncil for GvHD Read More »
Toward the end of each year I make predictions for the stem cell and regenerative medicine field for the coming year. I’ve been doing this for more than a dozen years in various forms. In this post I’m looking at the (gene-edited, stemness enriched) tea leaves for 2025 for the regenerative arena. These predictions include
25 stem cell & regenerative medicine predictions for 2025 Read More »
Remember former Trump’s FDA Commissioner Scott Gottlieb? Gottlieb’s back in the news in an interesting way related to the upcoming second Trump administration. I just wrote about what to expect from new FDA Commissioner nominee Marty Makary. In that piece, I noted that Scott Gottlieb first came to lead the FDA after a record of
Weekly reads: Scott Gottlieb v. RFK Jr., DNA typewriters, Arnold Caplan Read More »
What happens if unproven stem cell clinic firms like GIOSTAR start getting okays from the FDA to do clinical trials? On the one hand, it could reflect a positive trend of stem cell clinic firms working with the FDA and toward compliance. Having more robust data. However, I worry about some of these types of
The cell therapy biotech Capricor recently released new data from their Duchenne Muscular Dystrophy (DMD) trial work. The data have generated excitement in the patient advocacy community. The stock has skyrocketed. How exciting are these new data? CEO Linda Marbán is quite upbeat and I think it’s justified. The firm is now seeking FDA approval
Capricor seeks FDA approval of deramiocel for Duchenne based on encouraging data Read More »
I’ve met people who are excited about using stem cells for Parkinson’s Disease. Some of these folks have Parkinson’s or are loved ones. Talking to them makes things real. It feel personal and not just scientific. The current treatment options are far away from what is needed for many people. I am optimistic that a
Weekly reads: Parkinson’s & the gut, sports, cat stem cells Read More »
How are things going with regenerative medicine and stem cells in Japan? It’s still an exciting time there, but I’ve noted a sense that it is a time of transition too in some ways. For example, government funding is perhaps less certain than in the past. Let’s start with a few articles on how the
Recommended reads: Stem cells in Japan, iPS cells for COVID & hearts, He Jiankui Read More »