A short YouTube talk explaining legal/regulatory distinctions in the U.S. for stem cell/tissue products: using enzymes or chemicals or expanding (growing) cells can classify a product as a manipulated, drug-like product requiring IND approval. The speaker states their clinic avoids enzymes, chemicals, and cell growth so their products are treated as tissue transplants rather than drugs.
So in the United States, if you're using enzymes or chemicals, that's considered potentially altering the cells. And that will make these products basically a drug manipulated product. So that's what's considered manipulation. So our product, what I use, definitely do not use any chemicals or enzymes. So there's no manipulation. And we don't grow the cells. There are certain laboratories that grow the cells and then sell product without an IND approval, which is not legal in the U.S. we are able to provide tissue transplantation provided to physicians or to give it to patients because they're not drugs.
