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BioInvestor4

04/12/19 5:58 AM

#92539 RE: concordia #92537

Hello Concordia, I can appreciate what the slide show says, however the approved trial protocol clearly states the patients will be “hypo unaware” (small percentage of type 1 patients) and also states immunosuppression will be used. I’ve copied the wording from the protocol below.

I guess it’s possible they are doing this as just a first step in this trial for safety and in the final product Immuno won’t be necessary and it has the capability to help all type 1 patients. That would be awesome!

“The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. Participants are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch”