Weekly reads: BioCardia, HeLa suit, illegal bio lab in CA

A days ago the news came about Mesoblast not getting FDA approval for its MSC product for GvHD. The MSC area has had a rough few years with various clinical trials including for COVID. The “stem cells for heart disease” arena has also had a tough time. Here’s more news along these lines: BioCardia pauses enrollment in PhIII trial of heart failure stem cell therapy, EndPoints. 

A review board said the trial of the product CardiAMP was unlikely to succeed. (You might find this broader look to be useful: Stem cell therapy for heart disease: what you need to know.) Here’s the trial listing on Clinicaltrials.gov. BioCardia also has an MSC product called CardiAllo, which is a lab-expanded investigational allogeneic cell therapy.

mesenchymal cells, MSCs, mesenchymal stem cells, multipotent stem cells, MSC
Human MSC or mesenchymal cell cultures grown in the Knoepfler lab are good examples of multipotent stem cells. So far clinical trials on MSCs have not yielded an approved product in the US, but many trials continue.

More recommended reads

Illegal medical lab containing bioengineered mice and infectious agents including HIV and herpes discovered in California, Insider. What in the world were these folks thinking? Apparently the Feds are investigating this crazy situation. From coverage:

“The lab was run under a company called Prestige Biotech unlicensed for business in California, whose president Xiuquin Yao said was a successor to the now-defunct company Universal Meditech Inc.”

In vivo Delivery of Therapeutic Molecules by Transplantation of Genome-Edited Induced Pluripotent Stem Cells, Cell Transplantation. Notably, all the transplanted mice got teratoma. Could pre-differentiation address this issue for more translational potential? It’s still intriguing to think about cellular delivery of drugs in vivo.

Stem Cell Therapy May Restore Fertility After Ovarian Failure, Technology Networks.

Science Corrects Itself, Right? A Scandal at Stanford Says It Doesn’t, Sci Am. This piece centers on the resignation of Marc Tessier-Lavigne, Stanford’s president over serious publication issues.

Brian Culley, Lineage Cell Therapeutics
Brian Culley, CEO of Lineage Cell Therapeutics.

Lineage Cell CEO says that cell therapy isn’t about the ‘magic’ of stem cells – it’s about how you control them, Longevity.Technology. This is an interesting interview with Brian Culley. I agree there’s too much hype out there.

In my view, one of the traps is some cell therapy biotechs taking a spaghetti-against-the-wall approach of throwing their investigational cell therapy against too many health conditions in trials, some of which don’t have as solid rationales.

Leave a Reply