A short YouTube transcript by Joy Kong, MD describing that in the U.S. stem cells should be obtained by mechanical methods (no enzymes/chemicals) and not expanded in incubators; such native, non-expanded cells are presented as tissue transplants rather than drugs, analogous to blood transfusion or organ transplantation.
In the U.S. you do not use enzymes or chemicals when you obtain the cells, which means everything is obtained through mechanical methods. And once you obtain cells that way, and you do not put them in incubator, let them expand to huge numbers, then you are creating a native stem cell product and that can be given to doctors to be used for patients as a tissue transplant. So that's not a drug, it's a transplantation, just like a, a blood transfusion or organ transplantation.
