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Stem Cell Manufacturing - Contradiction in Terms?


A headline in the San Diego Union-Tribune trumpets: “Stem cell manufacturing now ready.” The article is about a process developed by the Lonza company to manufacture stem cells in a way that is compliant with the FDA’s “Good Manufacturing Process” certification. The idea is that these stem cells will be available to patients off the shelf – they will be HLA-matched, so that incompatibility between stem cell and recipient should be minimized (not eliminated, just minimized). Their peer-reviewed paper[1] was published on Sept 23, 2015 in Stem Cell Reports, and reviewed by Alexey Bersenev, director of the Advanced Cell Therapy Lab at Yale University, here.

The whole process is based on the premise that induced pluripotent stem cells are a good thing to (a) manufacture and (b) use in the treatment of disease.

One of the issues with iPSC is that these cell lines have been shown to have difficulty turning off some of the growth genes. They sometimes produce germ cell line tumors – teratomas – even when transplanted back into a normal mouse. And when transplanted into an immunodeficient mouse, over half of them developed tumors.[2]

My biggest question lies with the whole concept of artificially inducing umbilical cord stem cells to become pluripotent again. The process of harvesting one’s own stem cells for administration into one’s own body is, in concept, so simple, that it boggles my mind why we would want to go to such lengths to induce someone else’s stem cells for “off the shelf” administration. Unless, perhaps, once they become a drug, there is more money to be made…

If you have questions about whether stem cell therapy, using your own stem cells, might be right for you, give us a call at 480-240-2600. You can schedule a free 15-minute consultation with one of our practitioners to discuss the question.

[1] Baghbaderani BA, Tian X, et al. cGMP-Manufactured Human Induced Pluripotent Stem Cells Are Available for Pre-clinical and Clinical Applications. Stem Cell reports (Sept 25, 2015). Open access. DOI:[2] Kamada M, Mitsui Y et al. Tumorigenic risk of human induced pluripotent stem cell explants cultured on mouse SNL76/7 feeder cells. Biochem Biophys Res Commun. 2014 Oct 24;453(3):668-73. doi: 10.1016/j.bbrc.2014.10.009.