The novel coronavirus and the disease it causes, COVID-19, have swept the world with few proven treatment options. Vaccines are only recently being rolled out the last 2 or so months, which gives some real hope. While the novel coronavirus-caused illness is generally a mild disease in kids (many of whom don’t even show symptoms), …
Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in …
Why did clinic supplier Liveyon halt sales but others kept going despite FDA? Read More »
Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day …
FDA spike: clinic supplier Liveyon warning letter & 483s; notice on exosome harms Read More »
Magenta Therapeutics is a biotech company with a portfolio including stem cell products. Their most well known investigational drug product is an expanded umbilical cord stem cell product called MGTA-456, an “ex-Novartis” product. Magenta just released new trial data on MGTA-456, which I see as a case of good news-bad news, and investors seem to …
Magenta Therapeutics Good News-Bad News Trial Data Read More »
My first job in science was as a lab technician at UCSD School of Medicine and a big part of that job was growing cells called HUVECs or human umbilical vein endothelial cells. We isolated and grew the HUVECs from umbilical cords that we retrieved from the maternity ward of the UCSD hospital, which first …
Why we shouldn’t view the human embryo as a gizmo even in the CRISPR era Read More »
Advanced Cell Technology (ACT; $ACTC) has a new paper out on using human embryonic stem cells (hESC) to make MSCs with potentially powerful therapeutic potential. The paper, entitled Mesenchymal stem cell population derived from human pluripotent stem cells displays potent immunomodulatory and therapeutic properties, was published in the journal Stem Cells and Development. What’s the scoop on this …
By Dr. Susan Lim A record 4100 delegates attended the 11th Annual Meeting of the International Society for Stem Cell Research (ISSCR), held at the Convention and Exhibition Center in Boston from 12-15 June 2013. Co-sponsored by the Harvard Stem Cell Institute, the Meeting featured 7 Plenary sessions including a Presidential Symposium, 20 concurrent scientific …
Delightful overview of ISSCR 2013 by guest blogger Dr. Susan Lim Read More »
What does the FDA define as “minimally manipulated” when it comes to biologics such as stem cells? You will be shocked to find out, but they include irradiation and treatment with the super toxin/carcinogen, ethylene oxide. In a recent post I discussed the issue of an apparent “minimal manipulation” exception (some might even call it a …