Osiris, a cellular therapy biotech, recently received a so-called “untitled letter” from the FDA. The text of the letter seems on the whole negative in my opinion, while the company’s public reaction to the letter on the other hand could be seen paradoxically as rather cheery. What’s going on here? With Halloween coming, one has […]
Osiris FDA Letter: Trick or Treat? Read More »
The Australian stem cell biotech Mesoblast (MSB) has reportedly reached a deal with the American stem cell biotech Osiris (OSIR) to buy Osiris’ mesenchymal stem cell (MSC) unit. This is a big development in the MSC field. Osiris and Mesoblast are two major players in this particular subfield of the stem cell world so this deal,
Mesoblast (MSB) buys Osiris (OSIR) stem cell unit Read More »
This is the first in a series of guest posts on what folks believe are the best compliant stem cell companies out there. You can submit a potential guest post on this topic to me until August 30. Editor’s notes: Pete submitted this to me on Sunday, well before today’s big Osiris news. He must
Pete Shuster on His Choice of Best Stem Cell Company: Osiris Read More »
Stem cell & cellular medicine biotech, Osiris, reported a major success today with its cell-based treatment of Diabetic foot ulcers. The data are about as good as it gets. The company’s Grafix product for the ulcers was three times more effective than the control. A cross-over phase where those given the control were switched to
Osiris success with Diabetic foot ulcers is a giant step Read More »
Australian biotech Mesoblast has had a rollercoaster ride working toward FDA approval of its mesenchymal cell therapy product remestemcel-L. They are seeking approval for use in patients with graft-versus-host disease (GvHD). More specifically, it is intended for pediatric patients with steroid-refractory acute graft versus host disease, or SR-aGVHD. This is a serious condition and new treatment
Hoping for approval, Mesoblast says FDA wants new remestemcel-L trial Read More »
Stem cell stocks, meaning cellular therapy biotech companies, face many challenges, but their clinical research is crucial. Stem cell biotechs These biotechs have ups and downs, sometimes at the same time. This is kind of the standard of “life” as any biotech company. It is definitely the case in the volatile stem cell and cell
24 cell therapy & stem cell stocks I’m following Read More »
Graft-versus-host disease (GVHD) is counterintuitive In the weeks and months following a transplant, a major concern is the recipient’s immune system rejecting the “foreign” biological material. But in GVHD, the opposite happens: transplanted tissue unleashes a horde of T cells that spark a cascade of inflammation, within 100 days. Typically, GVHD follows a bone marrow
Mesoblast MSCs Quell Peds GvHD; On Road to FDA Approval? Read More »
Many are jumping on the bandwagon of trying stem cells for COVID-19 or testing other cellular therapies for the novel coronavirus disease, but there have been problems with either the rationales for the trials themselves or more often with how they portrayed. Sometimes there has even been outright hype. I’ve called this collective trend of
Overselling stem cells for COVID-19: WSJ article & UMN PR Read More »
Back in 2013, a half dozen years ago, I went out on a limb and made predictions for the stem cell field for 2020. These are different than my yearly predictions for the coming year (for instance, you can see my predictions made in 2018 for this year of 2019 here). As to my 2013
7-Year Glitch? Updates on my overly optimistic 2013 stem cell predictions for 2020 Read More »
Here are some stem cell reads for the weekend, ranging from media to research articles. TGIF! What are your stem cell or other science weekend reads? Let’s start with how difficult it is to make IPS cells from naked mole rats! Naked Mole Rat Cells Have a Stable Epigenome that Resists iPSC Reprogramming. It takes more than
Weekend Stem Cell Reads: Naked mole rats, geckos, brain gel, & more Read More »