Yes it's onerous and painstaking.
Unfortunately if you want the correct answer, if you really want to know if the cells work with a certain degree of confidence then you have to follow meticulous, logical scientific methodology.
And for the USA, the body empowered to ensure that scientific method is properly followed is the FDA. If you want to get rich selling your treatments in the USA, you have to follow the rules and convince them it works. You can rail against it all you want, but the gate will stay closed until you calm down and follow the rules.
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