Celling Blog

Autologous Stem Cell Medical Devices


July 12, 2016

Another One Bites the Dust III

StemCells, Inc. stated they would be closing their doors after disappointing results from a clinical trial they had been conducting on treating spinal cord injury patients with their in-house allogeneic neural stem cell preparation (see this for additional details). David Jensen (California Stem Cell Report) had an interesting post on the failure of StemCells, Inc. in which he shared comments from folks in the know, including the following: – Read More –

July 7, 2016

Another One Bites the Dust II

In the last post I touched on the less than stellar clinical performances of StemCells, Inc’s product, Osiris’ Prochymal product, and had just gotten to the Aussie-based Mesoblast’s product for treating low back pain with a single injection of one of their allogeneic mono-cellular, foreign DNA cells-in-a-bottle products. – Read More –

July 5, 2016

Another One Bites the Dust

As reported in the story found here, StemCells, Inc. (Newark, CA) will be closing its doors by the end of August. I suspect some of you might be shocked that another allogeneic stem cell company is going under, so I would like to offer up my take on this company’s demise in the broader context of translational cell-based regenerative medicine. – Read More –

March 8, 2016

Responding to a Reader II

In the previous post, I left off with a description of what I think the FDA followed that led to the publication of 21 CFR 1271, which is the 363 kg gorilla of cell-based regulation. In my opinion, a singular focus on structural tissues resulted in the FDA virtually ignoring cell-based therapies, which is why they are so feeble on the practical aspects of cell-based therapy, especially the autologous versions. On the other hand, I also want to call attention to what the FDA really loves: drugs. Since allogeneic, foreign DNA containing, cells-in-a-bottle products obviously are drugs, their emergence was music to the FDA’s ears. So it shouldn’t surprise anyone that the FDA is all in favor of making anything and everything a Section 351 category product (a drug), and what better candidate than the stem cell-containing preparation known as stromal vascular fraction (SVF)? – Read More –

March 3, 2016

Responding to a Reader

Dr. Richard Striano has provided his thoughts a couple of times to posts I have written, and I would like to respond to his concerns about the FDA’s approach to regulating cell-based therapies. It is especially timely given that the FDA is going to have a stakeholder meeting eventually (originally scheduled for mid-April, but just recently postponed) to discuss four critical draft guidances that affect the cell-based therapy community, which I just handicapped in the last couple of posts (here and here). – Read More –

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