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JBizzle703

07/04/18 7:45 PM

#40438 RE: uvaphd #40435

UVAPHD, that is my understanding as well. The AmnioStem cells are going to be different, and I believe that is why they are submitting an investigational new drug application for using to treat radiation toxicity.

https://www.medicaldevice-network.com/news/creative-medical-technology-holdings-reveals-stem-cell-product-success/

I don't know if they will have to follow a similar process for all treatments derived from AmnioStem. Seem's like having the patents for the various treatments with AmnioStem, is the first step, which they have accomplished.

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NSX

07/04/18 7:48 PM

#40439 RE: uvaphd #40435

NO!

CELZ adheres to a strict model of using only the highest potency Stem Cells which are Adult Derived Bone Marrow Mesenchymal Stem Cells and taking absolute measures to NOT adulterate any of it so as to adhere to "not a drug" definition set by FDA.

Then, the administer this Adult Derived Bone Marrow Mesenchymal Stem Cells to the same patient During the same procedure so that they are protected by CFR 721 which I posted earlier:

Part 1271--Human cells, Tissues, and Cellular and tissue-based products
Sec. 1271015 are there any exceptions from the requirements of this part?

(b) "you are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure."