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Cell therapy weekly: Scott Gottlieb resigns from FDA and Japan to commence iPSC trial for corneal disease

This week: Cell and Gene Therapy Catapult manufacturing center gains first manufacturing license variation and BioLife Solutions plans release of 2018 financial results.

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Go to the profile of James L. Sherley, M.D., Ph.D.

If the Japanese iPSC-derived corneal cell preparation does not include asymmetrically self-renewing  limbal stem cells, if any beneficial effects are obtained initially, they will fade with time.   All adult stem cell tissue replacement trials must start including thinking about how the natural tissue is maintained by the asymmetric self-renewal of the tissue stem cells.  Gene therapy trials are not missing this crucial point.  Instead, worse, they are just ignoring it for the fast news...which will leave their patients still needing  a durable therapy in a few years or less.  Come on, people, stop ignoring adult tissue stem cells' essential asymmetric self-renewal kinetics!

James L. Sherley, M.D., Ph.D.


Asymmetrex (