Are “Stem Cells” Legal in the US?

Hi, this is Dr. Joy Kong again, and I want to talk about something that's been asked a lot. And this question pops up everywhere and seems a lot of people are confused. And the question is, are stem cell therapy legal in the United States? Because a lot of people still think it's not legal. So first of all, I want to explain that the stem cell research was started when it was really talking a lot more about embryonic stem cells. So embryonic stem cell research can be conducted, but when you want to use it on people, that's when it's not legal in the US Unless you're doing it under some kind of clinical study. So no one, no other, no doctor is going to say, oh, I'm giving you stem, you know, embryonic stem cells. So that, that is not legal. There are particular clinics overseas. They, they can do something like that. But the problem with embryonic stem cells is that it's so early in the developmental stage that these cells are so primitive that they have the potential to become anything. And it's almost like a wild, unharnessed potential. So sometimes these cells can go haywire. And that's what's happening at what we call as teratoma. So teratoma is an uncontrolled growth of different types of cells from different tissues. So in one ball of cells, you could have hair, teeth, you know, neurons. I mean, it can, can go really crazy. So people have experienced a growth of this uncontrolled tumor in a particular area where the stem cells, embryonic stem cells are injected. So, so that's embryonic stem cell, and that is not allowed in the US and what has been done in the US Are either using a person's own fat tissue to extract stem cells out of fat or bone marrow, or there are people who also get it from blood. That's much more rare. And then there's a newcomer in this whole field, which is the birth tissue derived stem cells. And you know, I have videos online if you want to look at our omic's core created equal. I talk about the differences between different tissue sources and why these cells are different and what might lead to one being superior to the others. So in my opinion, not really my opinion, opinions based on research that's been done throughout the world is that umbilical cord sores or birth tissue source are the superior source comparing to adult source. I also have videos on that particular subject. But when you look at umbilical cord sores, there's still people think, oh, I don't think it's legal. How can you be doing that? Okay, so the question of whether or not legal really depends on how the cells are made and how you're giving the cells. So, for example, the birth tissue, right? First of all, anything that I use in my clinic or, you know, know most other doctors I know, no one is using aborted fetuses. So nobody. There are other countries that have used fetal tissue, but not in this country. Not legal. Okay? So in this country, the umbilical cord or birth tissue are derived, are obtained from healthy births. So the mother has to carry the baby to full term. And when they are giving birth, before they give birth, they are asked if they want to keep the birth tissue or extract the cells from these umbilical cord, you know, tissue and blood to save for their babies. And 90% of the mothers will say no because it's kind of costly, costs a few thousand dollars. So when they say no, then they're asked if they would like to donate. So the donation is pure donation. There's going to be no incentives, no gifts to seduce them or entice them to donate because selling of human tissue is not legal in the US So you cannot sell it in any sense. So it's a pure donation. And before the tissue can be accepted, these mothers are asked whether or not basically they have to fill out a very long questionnaire regarding their own history, their own medical history, their family history, their work history, toxic exposure, travel history, their partner's history, and the prenatal history. So everything has to line up. And if they qualify, then at birth, you know, the baby is safe and sound delivered. And the birth tissue that usually will be tossed into biological waste are then collected by the procurement companies and put on ice and sent over to laboratories to process. So that's, you know, these are all healthy live birth, and the tissue comes from those births. And when you process cells out of those tissue, 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. So if these cells have never been exposed to chemicals or enzymes that kind of came out of the way, you know, you extract it to the product the way it kind of was in the tissue, and you never really expanded them, which means growing them into vast numbers, then it's considered minimally manipulated cells. So then you can give it to people without going through a clinical study. That's if you're using it for the same purpose. So that's, the FDA term is called homologous use. So FDA has basically categorized these stem cell product into two categories. One is section 361, which is the minimally manipulated product that's used for homologous purpose. I'll explain homologous purpose. And the Other one is 351 product, which means that if you don't fit those criteria, you manipulated the tissue and you're using it for purpose for these cells that's different from what these cells were in the body originally were for, then you need to, to conduct the treatment under clinical study. So there are these two categories. So if the cells are obtained with minimal manipulation, which means you're not using chemicals that could alter the cells or enzymes. So some people use enzymes either in processing umbilical cord or processing fat tissue. Because a lot of the cells, especially mesenchymal stem cells, are embedded in, in a lot of connective tissue. So the easiest way would just be to use collagenase to digest all the connective tissue. All of a sudden you got all these cells, they're freed up. But the problem is that these digestive enzymes can also digest certain receptors on the cells. So you could be altering the cells. So this is why I do agree with the FDA that if you're going to do that, then you, you probably want to have an extra layer of protection for safety. So you wanna do it under a clinical study. Um, and you do. When you grow cells into vast amount of, you know, number of cells, which is what they do overseas a lot, that also changes cells. The cells surface receptors start to express and they also, depending on the medium the condition the cells are in, they could, you know, that is much more unpredictable. They can develop into different directions. And you know, as I explained before, that when you expand the cells so grow the cells to a vast number, the cells often do not divide symmetrically into two identical stem cells. So one stem cell would divide often into one stem cell and one daughter cell. That one daughter cell has already further differentiated. So there's more surface receptors, receptors marking it as something Different, Right. It's expressing the donor's genetic characteristics. So those markers could potentially cause genetic reaction or immune reaction. So one stem cell dividing into one stem cell and one daughter cell. And that one stem cell could then divide again into one stem cell, one daughter cell, and the daughter cells could also divide. So then you can imagine when we have a pool of cells and we have originally this much stem cell, and when you keep dividing it, you could have a lot more daughter cells than the stem cells themselves. This is why I, you know, unless you can control the environment precisely, and you really characterize that these are still the original stem cell. I am not a big fan of growing the cells to big numbers because I believe that the human body is the ideal incubator. We don't need to sit, put it outside in some kind of artificial incubator and put certain nutrients in it that's completely different, very different from our own body, and grow them to big numbers and then give it to people. When you have all these cells that are already differentiated, this is why there's larger percentage or much higher likelihood of rejections or of adverse reactions. Because you, on one hand you're reducing the potency of the product, on the other hand, you're expressing more surface markers from these daughter cells, then you can cause more immune rejection. And I've seen that happen to people when they were receiving stem cell treatments, some such as in Panama when they do three treatments in a row, that by the second and third people are having more and more reactions. So that's kind of the legal or not. It depends on whether or not the product has been manipulated and whether or not you're using it for this homologous purpose. And if you are, then you can give it to people. So under the FDA guideline is a 361 product, then you can give it to people legally. And if you have manipulated cells and you're using it for purpose, that's very different from what the cells were in the body, what the function was originally, then you need to do it under clinical study, and then it's legal. So either way, there are two pathways. So then I want to answer, what is homologous use? Homologous use is what it's a particular idea that the fda, I think, has come up with that what the cells were for in the body, let's say certain cells in the fat, they were in the fat tissue. So the FDA believes that these cells, when it's put back in the body, if it's put back into fat tissue, that makes it homologous because what it was doing before is what it's doing after. So that's kind of give you, you know, sort of a glimpse of what homologous use is. So, you know, there's, you know, there's still tremendous amount of learning we need to do about how the cells work, what they were doing in the tissue in the first place, right. So if you don't know what it was doing in the tissue before, how do you know it's fulfilling the same function as what it's doing after? So that is the big question. So mesenchymal stem cells, if you look at what it was doing in the body before, right? So mesenchymal stem cells are the cells that huddles around blood vessel. So they are the master of regeneration. They have this overall modulating, you know, you know, capability. And they're monitoring the body's internal environment through the blood and they're monitoring the local environment about what's going on in the local, you know, population of cells. So they are, you know, have their pulse of the whole body and of the local tissue. So that, that's what, what they do in the body, right? And then they send signals. They send signals everywhere to help the body to heal. And if they need to, they can go into the blood vessels and swim upstream, upstream to the areas of the signal which signals are generated by inflammation and injury. So, so that's what they were doing before. So if you use mesenchymal stem cells and you use that for the same purpose, that would make it homologous. So that's kind of the overall idea. And I hope that has given people a better understanding of the legality. For example, in California, doctors can give stem cell treatments as long as they post a note. So I'm in California, I'm in Los Angeles. They need to put this placard on their, you know, somewhere in their clinic that says. So this is from the Senate bill, the California Senate Bill 512 basically says that this physician is conducting stem cell therapy. And this is not an FDA approved therapy that you understand this is experimental and you have cleared with your primary care physician about this treatment. So if you post that, then that's fine. You're informing the public openly that this is what, what is you're informing them. So some other states may have something similar. But, and I know in, in Texas it's definitely legal. They have made stem cell therapy legal. So every state is a little different. But in general, there's nowhere that in the law that says it's illegal in the US but there's a lot of nuances. So I hope this has been helpful and you can write in a comment if you have other questions, and I look forward to talking to you next time. Thank you for watching.