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Re: None

Friday, 03/23/2018 9:20:33 AM

Friday, March 23, 2018 9:20:33 AM

Post# of 106837
I've been trying to wrap my head around the FDA stem cell / USRM disagreement. Does IVF seem like a good example to give friends and family?

A fertilized egg from IVF would literally be a primary stem cell, manufactured by culling eggs, isolating them, genetically modifying the egg (fertilization), growing it in a lab for 2-6 days, then returning it to the woman's body. This does not represent "minimal manipulation" and involves extracting and returning undifferentiated cells from the woman... Does that mean the FDA regulates IVF like it is the manufacture of a drug? Does FDA consider the fertilized embryo; a collection of stem cells, to be a manufactured pharmaceutical drug?

When I hear the FDA responding to USRM and USRM insisting that Adipose stem cells are a patients own cells and CAN'T possibly be a "drug", the adipose cells get returned within a 2 hour procedure window, this is the example that comes to my mind...

IMO, USRM is in a very strong position here and going to go the distance pioneering this new field, GLTA!