Joy Kong, MDRegenerative Medicine Physician, Educator, and Entrepreneur

Are stem cell treatments ILLEGAL in the U.S? #stemcells #stemcelltreatment

25 Jul 2026 · 1 min

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1:24

In this video, Dr. Joy Kong clarifies which stem cell therapies are prohibited in the United States and why. She explains that treatments using embryonic stem cells, cells derived from aborted fetuses, or any cells that have been chemically, enzymatically, or culture‑expanded (i.e., manipulated) are illegal because the FDA classifies such manipulated cells as drugs, which must undergo clinical trials before being administered to patients. Dr. Kong then describes the clinic’s approach, which uses umbilical‑cord‑derived cells that are harvested solely by mechanical forces, frozen without enzymes, chemicals, or culture expansion, and therefore are treated as tissue transplants rather than drugs, provided they perform the same function as in the donor. She emphasizes that as long as these specific parameters are met, the therapy is legal, and she notes that she has taught hundreds of physicians how to comply with these regulations.

Chapters

Someone made a comment that some stem cell treatments in the US are not allowed. Correct. So these are treatments that are not allowed in the United States: embryonic stem cell treatment, treatments from aborted fetuses, or treatments using cells that have been manipulated in some way, such as using chemicals or enzymes to change the cells, and also growing them in a tissue culture. That's also considered manipulation. So when you manipulate The FDA says that now you have created drugs, and now you have to conduct drug studies. So if you just give it to patients without a clinical study, then that is not allowed. However, what we do in the clinic are actually cells that have not been manipulated. These are cells from the umbilical cord. They were carefully extracted using mechanical forces, and then they are carefully frozen without enzymes, chemicals, and we don't grow them in cultures. So how they came is how we're going to give to patients. And that's considered tissue transplant, not drugs, as long as these cells are performing the same functions as they were in the donor's body. So I hope this answers the question of whether some stem cell therapy are not allowed in the U.S. So as long as you follow certain parameters, yes, it's very much legal. And I've taught hundreds of doctors, so it is very much legal if you follow certain parameters.