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 Grafix showed similarly dramatic results.
Wounds that won’t heal are a huge health problem in medicine so Osiris’ impressive results have huge implications. I see this also more broadly as a giant step forward for the cellular medicine field. The stock (OSIR) more than doubled so far today in PPS.
Note: I changed the title & some content from the original version of the post focused on the “stem cell” field to the “cellular medicine” field out of an abundance of caution.
Disclosure: I do not own any stock in Osiris.
Could someone let me know how to keep the MSC survival onto that sheet? (http://www.osiris.com/grafix), Thanks,
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Grafix is a 361 tissue and as such, it’s unlikely it contains all that many living MSCs by the time it’s delivered to the user. I’m sure it’s a great bio active scaffold, but calling it a stem cell product is a stretch, as if it were, it would be a 351 as this is a non-homologous use. I would expect it’s performance in wound healing would be similar to PRP or other bio active scaffolds like amniotic membrane. Having said that, sure looks like a compelling study, so congrats to Osiris!
Hi Paul,
Is it allowable to add a link so that us less knowledgable readers can see what “Grafix” is:
http://www.osiris.com/grafix
Is there a peer-reveiwed publication that describes the product? That would make for a better link.
I note that this is an allogenic “product”.
So are there questions regarding rejection in the longer term or transfer of genetic information to the patient.
Presumably, the donor MSC are culture expanded?
In your recent post you raise caveats for other cultured MSC therapies:
https://www.ipscell.com/2013/07/short-term-safety-of-lab-grown-stem-cells-for-arthritis-encouraging-but-key-caveats/
It seems to me that even more severe caveats would apply to “Grafix”.
Nevertheless, I think it’s a damn good thing if the FDA is letting “Grafix” go to market. Three cheers!
I can’t find anything via Pubmed regarding Grafix…maybe someone else will have better luck.
Here’s a CMS document that has one of the more helpful descriptions I’ve seen regarding what Grafix actually is:
http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/May-8-2012-Drug-Agenda.pdf.
Also, according to this page (http://solutions.academymedical.net/grafix.html) Grafix is covered by U.S. Patent 6,355,239 and U.S. Patents Pending 13/030,551, 13/030,562, 13/030,507 and 13/030,539 (none of which I’ve read particularly carefully yet)
I don’t mean to minimize the important achievement Grafix has notched, but I do wonder if we can really call it a “stem cell treatment.” I’ve been wrestling with this question myself for some time now. Grafix is processed, viable human chorionic placental tissue. As such it contains a collagen-rich stromal layer with endothelial cells, fibroblasts, some MSCs, growth factors and cytokines, and Lord knows what else. Although Osiris has always argued that the presence of MSCs in Grafix distinguishes it from all other skin substitutes, is that just marketing flurp or is that meaningful science? I ask because I’m not aware of any data demonstrating that the MSCs are important to Grafix’s performance (though I’ll admit I haven’t followed this closely, so maybe that data is indeed out there?). If the mere presence of some stem cells in a transplanted tissue qualifies it as a “stem cell treatment” then wouldn’t we need to call most or all organ transplants stem cell treatments?
You ask some great questions. Thanks, Bill.
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