Monday, January 3, 2011
A new technology of creating stem cells from unfertilized eggs may remove one of the biggest ethical hurdles to the research. But controversial aspects to the research remain.
A new technology of creating stem cells from unfertilized eggs may remove one of the biggest ethical hurdles to the research. But controversial aspects to the research remain.
Michael Kalichman, co-director of the Center for Ethics in Science and Technology.
Jeffrey Janus, Senior Vice-President, Operations - International Stem Cell Corporation; President & CEO, Lifeline Cell Technology
Simon Craw, VP of the Parthonegenic Stem cell Bank
The next forum sponsored by the Center for Ethics in Science and Technology is this Wednesday at 5:30 in Balboa Park. This subject is: Do unfertilized human eggs offer another way?
MAUREEN CAVANAUGH: I'm Maureen Cavanaugh and you're listening to These Days on KPBS. Ever since research began into the use of stem cells, there's been great hope and great controversy. The hope is that the regenerative powers of stem cells might be the answer to a number of debilitate, even deadly, diseases, the. The controversial is about where the cells come from. Typically, researchers have preferred to use embryonic stem cells, which some people strongly object to on moral grounds of now, a new way to develop stem cells by a company here in San Diego, may take some of the controversy out of stem cell research. But may also open up different areas of ethical concerns of I'd like to welcome my guests, Jeffrey Janice is senior vice president of operations of the international stem cell corporation, and Jeffrey, welcome to These Days.
JANICE: Thank you Maureen.
MAUREEN CAVANAUGH: Michael Kalichman is codirector of the center for ethics in science and technology. Mike, good morning, welcome.
KALICHMAN: Good morning.
MAUREEN CAVANAUGH: Happy new year.
KALICHMAN: Happy new year to you too.
MAUREEN CAVANAUGH: Now, we invite our listeners to join the conversation. Are you surprised there's still controversial over stem cell research? Do you think there needs to be a legal answer to this question once and for all? Give us a call with your questions and your comments. Our number is 1-888-895-5727. That's 1-888-895-KPBS. Michael, let me start with you, because this has been a surprising year for stem cell research in the Court. Tell us about the injunction that happened earlier this year.
KALICHMAN: Yes, the injunction is actually part of a history that goes back to something called the Dickie-Wicker Amendment from 1995, and that amendment basically said that the Congress cannot appropriate funds that would result in the use or destruction of human embryos. We have had a really complex history since then of following the discovery of human embryonic stem cells. The question is, do those human embryonic stem cells, the use of those, does that constitute use or destruction of of a human embryo in and the decision, even in the bush administration was that it was possible to use human embryonic stem cells without being a problem. Not all of them, but some of them. Subsequently when Obama tried the same approach, we found that some people proposed that this is actually a violation of dickie wicker amendment. Which is what that injunction was about, it said that stem cell research needs to stop because even though you're just using the stem cells that come from human embryos, this constitutes a destruction of human embryos. And that remains in the Courts. There's a stay of the injunction, so researchers can still use federal funding for human embryonic stem cell research, not to actually work with human embryos, but with the stem cells.
MAUREEN CAVANAUGH: So, okay, so it stopped federal funding for a little while, then it was stayed, then that decision was stayed, and federal funding resumed but the legal battle continues.
KALICHMAN: The legal battle continues.
MAUREEN CAVANAUGH: What kind of effect does this legal battle have on embryonic stem cell research.
KALICHMAN: I think the biggest effect is the continuing confusion about what sources of funding you can use for your research. I want to be very year that this does not mean that human embryonic research has stopped, it's just a question of whether federal funding can be used for that research of we have a real bizarre situation in laboratories right now. Of there are some stem cell lines that are approved for federal funding but only approved for federal funding for certain finds of research. So this means that a stem cell line in your laboratory will be fine, for example, for diabetes or pancreatic research, but you can't use it for other things using federal money. Makes it very difficult for the researchers to know from one day to the next, is this stem cell line approved or not approved, and that determines which money they can use.
MAUREEN CAVANAUGH: I wanted toy are mind our listeners that we are taking your calls with your questions and your comments at 1-888-895-5727. And I'd also like to reintroduce Jeffrey Janice who is here, he is vice presidents of the -- and Simon Craw, he is vice precedent of the parthenogenic stem cell basic, and Simon, good morning.
CRAW: Good morning.
MAUREEN CAVANAUGH: Let me start with you, Jeffrey, because I know that your company specializes in developing stem cells in a different way, a different way than we've been talking about. Perhaps you can start by explaining how stem cells are typically developed from an embryo.
JANICE: Well, in the case of embryonic stem cells, typically a fertilized embryo, which has been created in an IVF, or in vitro fertilization, situation is used to derive the embryonic stem cells better used under informed consent and all the other regulatory over sight. So that's in effect this is it a fertilized embryo which has the potential to become a human life. And that's what causes a controversy. Now, our company has developed awe method called parthenogenesis, which creates pluripotent stem cells that have similar characteristics to embryonic stem cells, but starts with an unfertilized human egg, and there is no viable human embryo used in this process. So from that point of view, the potential to destroy a human life is eliminated, and that's the ethical advantage of these cells.
MAUREEN CAVANAUGH: But Jeffrey doesn't an unfertilized egg only have one set of chromosomes? What happens to --
JANICE: Yeah, that's very true. And it is true. We can make these cells in two manners. And I don't want to get too technical here, but one manner uses the fact that an egg has 46 chromosomes up until a certain point in its development, and if parthenogenesis activation is used at that point, then you end up with parthenogenic stem cells that have 46 chromosomes. And another method that we use allows the 23 chromosomes to leave, leaving 23 chromosomes, and the parthenogenic process results in parthenogenic stem cells that still have 46 chromosomes. The 23 self duplicate at some time.
MAUREEN CAVANAUGH: Ah, ha.
JANICE: The advantage of these cells and they're called homozygous parthenogenic stem cells, is that they're simple from a genetic point of view. And they can be an immune match to millions of people. And that's the medical advantage of these cells.
MAUREEN CAVANAUGH: Right.
DEFENDANT: If they have a common immune type, they can be matched to millions of people.
MAUREEN CAVANAUGH: Simon, let me ask you, where does the name parthenogenic come from in these stem -- why are they termed that?
CRAW: Well, perhaps Jeffrey might be the best to answer that. Of but let me try and answer it first. Then maybe Jeffrey can step in. Parthenogenesis is a natural process in biology that a number of lower life forms, amphibians, and some plants and other types of animals use there to reproduce. There are no known mammalian examples of parthenogenesis, but it's a completely natural and biological process for reproduction.
JANICE: Now, parthenogenesis comes from a Greek, virgin birth.
JANICE: And that's the origin of the word.
MAUREEN CAVANAUGH: So that's where we get the reference to parthenogenesis, because there is no fertilization that takes place.
JANICE: No sperm involved, yes.
MAUREEN CAVANAUGH: We're taking your cells at 1-888-895-5727. Allen is on the line, good morning, Allen from mission beach. Welcome to These Days.
NEW SPEAKER: I'm sorry. Say again?
MAUREEN CAVANAUGH: Allen, good morning.
NEW SPEAKER: Good morning. Thank you for having me. Thank you for taking my call.
MAUREEN CAVANAUGH: You're welcome.
NEW SPEAKER: And I want also like to add into the conversation the fact that there are for many years, people have been getting stem cells from their -- from the patients' own fat. My wife for one is a veterinarian in San Diego, and she's doing stem -- removing the stem cells from the fat of the animal, injects it into the animal, and here you have a completely unbiassed patient, doesn't know he's supposed to be getting better, and yet within three months, he's jumping in and out of an automobile because of -- because of this degenerative joint disease or whatever.
MAUREEN CAVANAUGH: That's fascinating Allen, thank you, thank you for that. And you were shaking your head, Jeffrey. Does that kind of technology like what we hear referred to as adult stem cells?
JANICE: Exactly. Yeah, those mesenchymal stem cells from adipose tissue are very useful for diseases in of just exact he the sort that was just described of adult stem cells do have applications and are being used in research and medical regenerative medicine. And the there's two types of stem cells, basically, those that are called pluripotent, and those that are limited in their ability to divide and become every cell type in the human body. And adult stem cells have those limitations, where's whereas pluripotent stem cells, such as embryonic stem cells, parthenogenic stem cells, and a new type called induced pluripotent stem cells, or IPS cells, are pluripotent and from that point of view, they have some advantages over adult derived stem cells. Of.
MAUREEN CAVANAUGH: Because they can basically mimic any kind of cell in the body.
JANICE: Exactly. Yeah.
MAUREEN CAVANAUGH: Let me ask you something, Simon, about -- there was a reference made to the fact that the parthenogenic stem cells may actually be in a sense better in some ways than the embryonic stem cells in that they don't provoke an immune reaction the way embryonic stem cells may? ; is that right?
CRAW: Yes. So if you remember what Jeffrey was telling you about there was -- approximate the two types of parthenogenic stem cells, we have what we call a heterozygous type and a homozygotes type where the -- half the chromosomes leave the egg and then the egg recreates the 46 chromosome genome. Well, are in the heme homozygous type, in that homozygous sample, it turns out that that replication confers some very interesting immunogenetic properties on the cells derived from those stem cells, and it provides a much simpler set of -- immune matching antigens for the cells. And the way it works is that the human body recognizes cells as self or foreign based on a certain set of antigens called the human leukocyte antigens, and with these special type of stem cells, they are much -- they provide a -- sorry, I'm struggling to explain this.
MAUREEN CAVANAUGH: Yeah, I can imagine.
CRAW: Jeffrey, perhaps you can explain it a little bit better.
MAUREEN CAVANAUGH: Try to put it into laymen's language.
JANICE: Yes, well, the characteristics of these homozygotes stem cells are such that their duplication of these HLA genes, if the genes are common in a population group, you have them duplicated, then the body will not recognize any foreign antigens if you have those particular duplicated antigens. The fact is some of these antigens are very common. So these stem cells do not present any foreign antigens to large segments of a population. It's sort of like in a building. If you have an office building and every office has an individual unique key, and the janitor has a key that opens all the doors because there are some basic qualities of that key that are recognized by every door in the building. And in some ways, this is similar to these simple, homozygotes parthenogenic stem cells. Another example or analogy would be blood type O, the universal donor blood type of so these cells are universal in nature as far as immune rejection and immune recognition goes. That's the very powerful medical advantage of these cells.
MAUREEN CAVANAUGH: Now, do you have any introduce something into these cells to make them reproduce their chromosomes? Reproduce in this manner that could potentially be harmful or -- in any way?
JANICE: No, the genetic -- there is no genetic manipulation of the DNA that's done in the process. We simply reproduce the activation that is normal in sperm and egg union. The calcium fluctuations and the calcium cycles that take place that drive the cells -- drive the original egg to divide and become a blastocyst. What international stem cell found is the effort to use this parthenote, we call a parthenote, which is an egg that has divided without fertilization, to derive stem cells. Before we did this, it was very difficult or impossible to pull stem cells out from a human parthenote. And that is exactly what we've done.
MAUREEN CAVANAUGH: Let's take another call before we go to the break. We're taking your calls at 1888-895-5727. Gale is calling from Tecate. Good morning, gale, welcome to These Days.
NEW SPEAKER: Good morning. Fascinating am program. Thank you. My question is, read this stem cell research with a lot of enter, and it seems to me that America has been kept way way behind other countries like countries in Europe and in Singapore, maybe Australia as well, simply because of the -- it's not simply, but because of the religious and political aspects. I'd like to know how far behind America actually is in this research.
THE COURT: Thank you very much, for the call, gale. And Michael, let me ask you. Do we know if the United States research into stem cells is lagging?
KALICHMAN: Well, I think one argument can be made that we might have been able to move more quickly did we did not have the federal restrictions of funding on human stem cell research of so that's the limitation we faced. I think internationally if you go to international stem cell meetings, it isn't as if the United States is not well represented. We've done very well. We are perceived as some of the international leaders. But much less has been, especially at the earlier stages in field because there was a restriction that kept people from working in this area, they're couldn't get federal funding for it, so they were less likely to work in that area. I'd be hesitant to say that we've stopped or that nothing's happened. Because you can use other sources of funding.
MAUREEN CAVANAUGH: Yes, Jeffrey?
JANICE: I'd like to comment, let's go back to the dickie wicker amendment, and it's very interesting to note that in 1995, 96, when this amendment was added, they included parthenogenesis as one of the methods that could not be used to create a human embryo for federal funding. And the interesting thing at that point was that stem cells had not been derived from parthennodes. Of so the dickie wicker amendment restrictions our ability to share our research with other federally funded researchers in the United States. So much of the work that we're doing is international, we're working with ourselves in Germany and Poland and India. Of but still can't give ourselves the federally funded labs in the you said.
MAUREEN CAVANAUGH: That's very interesting. I want to talk much more about your research and also about the fact that it is not entirely without its own controversial, and continue to take your calls at 1-888-895-5727. You're listening to These Days on KPBS.
MAUREEN CAVANAUGH: I'm Maureen Cavanaugh issue you're listening to These Days on KPBS. And we're talking about stem cell research, a new way to develop stem cells has been developed by a company here in San Diego. Of it takes some of the controversy out of stem cell research, but if also -- doesn't eliminate all of it. My guests are Jeffrey Janice, he's senior vice president of operations of the international stem cell corporation, Simon Craw is vice president of the parthenogenic stem cell bank, and Michael Kalichman is codirector of the Center for Ethics in Science and Technology. And we're taking your calls at 1-888-895-5727. Michael, as I said, this parthenogenic way of generating stem cells may remove the concerns of people who don't want fertilized eggs, embryonic stem cell research of but what other ethical concerns might it raise?
KALICHMAN: There are always many ethical concerns but the two major concerns have to do with how we get the eggs, in this case, how you get the material you're going to work with: And the second concern is really a question that we as a society need to think deeply about, and that is, what makes a human embryo special? What are we protecting, what are we worrying about? And why is this actually different? And there are ways in which it's clearly different. And there are ways in which it is very much the same. You can still get human embryonic Stem cells from it.
MAUREEN CAVANAUGH: How is it the same?
JANICE: Well, it's the same in the sense that you can -- something that looks like a human embryo, from which you can extract human embryo stem cells, but in this case, they're human parthenogenic cells. But we don't consider it a human embryo because there is at present no technology or means that suggests we can get that entity, that parthenote, to become a human child because it can't develop. And ironically, there is probably no way we could ever find out. Because nobody would presumably want to try this as an experiment to start implanting these parthenotes in humans in their uterus to find out if it would grow up. So we have to think more deeply about what is it, scientifically, biologically that we have sitting in tissue culture, and how does that differ from a human embryo, and for that matter, why are we protecting a human embryo? What is it that's character of this entity that's important?
MAUREEN CAVANAUGH: That's fascinating. And Jeffrey, I'd like you to respond to some of the ethical concerns this Michael brought up.
JANICE: Sure. From a scientific point of view, a parthenote has no male imprinting, and this is a scientific term meaning that the male, the sperm brings a specific message to the egg that allows placental development. So if you're looking at the science, if you implanted a parthenote into a woman, there would be no placenta, there would be limited development of those sorts of tissues. So you could not theoretically end up with a human being. Now, what Michael has said is ironic and is true. Those sort of experiments should never and will never be done. But we do have scientific evidence showing that, you know, certain components that would be necessary to develop to a human being aren't present.
MAUREEN CAVANAUGH: Right, but as he says, it opens up the whole question of what is it about taking stem cells from something that is not really a human being yet? In many people's idea, what kind of concerns we have about the entire idea of stem cells. I'm wondering issue Jeffrey, though, about the other concern that Michael talked about, and that is the way the eggs are collected. Are there ethical concerns that come about because of this.
KALICHMAN: I think Jeffrey's passing that one back to me. Of so there are. I will remind your listeners that in our society, when somebody wants to undergo reproduction and is having difficulty with that, and for whatever reason, the woman can't use her own eggs, they can advertise for women, particularly young women in college, and they'll pay them quite a bit of money for them to donate their eggs for the purpose of reproduction. So as a society, we're okay with that, because we just view this as a punish's right to sell and do what they want. But in the area of research, a question has been raised whether we should allow this same opportunity for women to be pay forward their eggs, so that the researchers can get the eggs for the purpose of studying them and perhaps developing therapies. And the answer so far from most bioethics communities around the world is that you should not pay women for their eggs in a research setting. So the question is, why is this different? And the answer is that without judging whether it's right or wrong in the first situation or reproduction, it's clear that in research, we are worried, if the public perceives science to be pushing too far and too fast, science has made mistakes in the past. And there is a worry that if somebody is paid, they may not think about all the implications of their decision to participate in the research.
MAUREEN CAVANAUGH: And so Jeffrey, if the women are not paid in this, well, then, where do you get the eggs?
JANICE: Ah, ha, well, yes, first of all, we do not pay women for their eggs, I'd like to make that clear. And I'd like to bring in Simon Craw because what he's doing is setting up a situation so that this can be done under the ethical and regulatory guidelines in the you said. So Simon?
MAUREEN CAVANAUGH: Simon are you with us? Ism I'm still with you. So from a regulatory perspective, the regulations are very clear, for federal regulations that look after the safety of donors that would donate eggs to our program. And then the state level, there is it another set of state regulations, again, that are very clear and layout what the process is and what the requirements are for donating egg or, indeed, embryos for research purposes. And we are in the process of setting up committees and an organization and a paper trail that meets all of those regulations. And basically like Jeffrey said, you cannot pay, and we do not pay our donors for their donated material. We have met a number of women that are willing to make a donation to our program purely for altruistic reasons, actually. And the reason usually is that they have had a family association with a disease, and so for altruistic reasons they've decided that they understand that they can't cure the disease with a particular donation. But they still would like to get involved and would like to help advance medical research by making a donation. And we've met several women that have expressed a desire to donate into our program for those reasons.
MAUREEN CAVANAUGH: Haven't there, in other nations though, haven't there been some stories about female lab assistants being kind of coerced, required to donate eggs for research? Is there any need to create an international ethical code on donation?
KALICHMAN: In fact, there are international stem cell groups that are looking at these questions, and I think most of the questions that we're talking about now are pretty well established, accepted internationally for those who look at them. That doesn't mean that everybody follows those refresh my memories. If you're giving is of a researcher in south Korea where he had his technicians asked to be donating eggs. He paid for those eggs, and most places would be worried that those two approaches would be coercive. That the women might not look at all of the risks, and there are some risks to go through the process of egg donation.
MAUREEN CAVANAUGH: Now, Jeffrey, an important point here for your kind of research is that you don't need an endless supply of freshly donated eggs, so to speak.
JANICE: That's exactly right. That's very important. Once we set up the bank of parthenogenic stem cells that have common immune types issue since they're pluripotent, we can make billions and billions of these cells, and not only the stem cells, but we can make the therapeutic versions of those cells, say liver cells or cells from the eye, that can be used to cure diseases that cannot be cured right now. And most personal this bank matches millions of people. So in some stem cell therapies now, it's individual medicine. Of an adult stem cell is matched to you and you alone. Maybe some of your members of your immediate family. But it is very limited. With our homozygotes parthenogenic stem cells, we could make a bank of, say, I think statistically and mathematically, it's kind of challenging. But I've read ten homozygous parthenogenetic stem cell lines request common immune types could match 37 purpose of the population in the UK. And you can imagine a basic of these cells with the associated therapeutic cells available right now for people who needed them. And that's what Simon is building.
MAUREEN CAVANAUGH: Right. Do you see the parthenogenetic stem cells eliminating the need for embryonic stem cells.
JANICE: No, I don't see that. I see all the stem cell types that we're working with today, adult, IPS, embryonic and parthenogenetic as being probably in the long run, they'll all have advantages and disadvantages for different disease types of even within embryonic stem cells, different lines are proving to be different from each other and more applicable for, say, nerve disease and one might be more applicable for liver disease. So there's going to be a lot of work. But our cells have different advantages in creation of banks, and that translates to economic advantages. Individual medicine is always expensive, if you can have a bank of stem cells that can be used for millions of people, then you don't need to go back for more eggs, you don't need to reintroduce that haplotype a hundred types over. You can reuse that line again and again. And it's been, if DA approved. It would be a high degree of utility.
MAUREEN CAVANAUGH: You know, Michael we hear so much -- when whey hear about the stem cells we hear about the controversial and federal funding and all of this legal and political kind of wrangling. But we don't here as much about what stem cells have actually been doing for medical research and helping people with disease. Can you give us a sort of a snapshot of where we are on how stem cells are being used to treat diseases.
KALICHMAN: Well, sure, so first we need to remember that there are two broad categories of stem cells. Those that are more restricted in what they can be used for, and here I'm thinking of adult or tissue specific stem cells. In that area, we have tremendous success, especially for blood born diseases. And those are the successes people point to that have happened or many, many years, and there's no doubt that that's been important of the second area where you talk about pluripotent stem cell it is, cells that can become any cell in the body. This is a new area of research, and like any new research, it take a while to get up and running. There are two clinical trials that have just started in that area. So this is just at its very earliest stage. One has started and one is projected to start. One is gonna be looking at spinal cord paralysis, and another is gonna be looking at macular dystrophy, which is a particular kind, It's a rare childhood disorder. In both cases, this is, as I said, at the very earliest stages, a clinical trial in these cases constant mean a trial to demonstrate that it really does work. These are attempts to find out if it's safe. We have a long way to go.
MAUREEN CAVANAUGH: Well, we are out of time, gentlemen, I want to thank you all so much for speaking with me. Jeffrey Janice, Simon Craw, and Michael Kalichman. Thank you very much. I want to let everyone know that the next ethics forum will discuss human embryonic stem cells. Do unfertilized human eggs offer another way? That discussion takes place this Wednesday at the Ruben H. Fleet science center in Balboa park. It's open to the public, it start it is at 5:30. And thank you once again. Thanks for listening to These Days. Stay with us for hour two, right here on KPBS.