Translating Aging cover image

Bone Marrow Banking for Cell Therapy Material at Scale (Kevin Caldwell, Ossium Health)

Translating Aging

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Do You Have to Do Clinical Trials for Cellular Products?

The FDA looks at the extent to which the product you're making has been manipulated. If it is less than minimally manipulated and it's used homologously, then the applicable regulatory framework can be different. For most of our programs, like the programs for treating GVHD, they're going through this pathway.

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