Joy Kong, MD explains what stem cell treatments are legal in the US. The FDA approves some for clinical trials and specific uses like blood transfusions, but many unproven treatments sold as cures operate in a legal gray area.
If you use any chemicals or enzymes, or if you start to take the cells out and start to grow them in big numbers, then if you want to give it to people, you can't just give it to people, because in some ways you could have altered the cells. In those circumstances, you have to give it to humans only under a clinical study. So then that makes it legal, right? If it's approved clinical study, then yes, you can give it to people. But you can also not be part of clinical study just by giving it to people. Just like blood transfusions, right? You don't need a clinical study to transfuse blood because it's considered tissue transplant.
