Human trials of ES cell research could begin soon
23 November 2009
By Alison Cranage
Appeared in BioNews 535
Stem cell therapy came one step closer to being tested for the first time in people this week, as a US company applied to the Food and Drug Administration (FDA) for a licence to start a clinical trial. The embryonic stem (ES) cell therapy is being developed to treat Stargardt, a currently incurable disease that causes blindness in young people.
Advanced Cell Technology, a Massachusetts-based firm, has tested the treatment on rats and mice which model the human Stargardt disease, and found it prevented further vision loss without adverse side effects.
Stargardt's macular degeneration destroys a part of the retina, leading to loss of vision. The treatment involves a single injection of a type of retinal cell that supports the photoreceptors needed for vision. The researchers have generated the retinal cells from ES cells derived from day-old human embryos left over from IVF (in vitro fertilisation) treatment and donated for research purposes. ES cells have the potential to develop into any type of cell in the body and, as such, scientists envisage they could be used to mend any broken part of the body, from kidney and liver to brain. They hold promise as a treatment for a range of diseases from Parkinson's to heart disease. However, using ES cells in medical research is controversial as many view the embryo as sacrosanct and inviolable, and oppose the use of human embryos in research.
'After years of research and political debate, we're finally on the verge of showing the potential clinical value of embryonic stem cells,' said Dr Robert Lanza, the chief scientific officer at Advanced Cell Technology. He added: 'We've seen absolutely no adverse effects whatsoever in any of the preclinical experiments and our cells are more than 99.9 per cent pure.'
'Our research clearly shows that stem cell-derived retinal cells can rescue visual function in animals that otherwise would have gone blind. We are hopeful that the cells will be similarly efficacious in patients,' Dr Lanza continued.
The trials would involve 12 Stargardt patients, and could begin early next year if the FDA grants approval. The clinical trial could be the first in the world as US company Geron, the only company so far to have received a licence from the FDA, has delayed the start of its clinical trial until the end of next year due to safety problems.
A similar proposal to treat age-related macular degeneration with ES cells is being developed by scientists in the UK led by Professor Pete Coffey of University College London, but this clinical trial is unlikely to start until early 2011.
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SOURCES & REFERENCES
Company seeks FDA permission to conduct clinical trial using human embryonic stem cells
LA Times | 19 November 2009
Embryonic stem cells to cure eye disease
Nature blogs | 19 November 2009
First human trials for stem cell blindness therapy
The Daily Telegraph | 20 November 2009
Huge potential balanced against ethical fears
The Independent | 20 November 2009
People facing blindness may pioneer stem-cell therapy
The Times | 20 November 2009
Stem cells: the first human trial
The Independent | 20 November 2009
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I believe that the use of ES in the treatment of various diseases of the brain, eyes, or other important tissues is a great leap forward in the prospects of science; however, it cannot come without ethical dilemmas and issues about whether it is right for us individuals "to play god."
ReplyDeleteAs demonstrated in the article, Embryonic Stem cells have the potential to treat many ailments such as Stargarght's and Leukemia [in bone marrow transplants]; however, there are many ethical issues with using stem cells - many of them being deontological. One of the important concepts of deontology is that the lives of individuals are ends within themselves. As such, the bodies of individuals are important in a similar fashion and should not be altered to an absurd degree that would not be done so normally. With regards to this particular case, the problem is that stem cells themselves are very unnatural as they are not normally harvested and used as therapy tools in nature. As opposed to conventional medicines, stem cells are living, and it might seem odd from a deontological view to use living treatments on individuals.
However, I believe that the prospects and good that comes out of these procedures outweigh these issues. From a utilitarian view, these procedures are incredibly ethical in the sense that more people would be saved and many diseases could be cured. Applying these methods of reasoning, the prospects of completing the procedures and these advances in ES research will only benefit people in the long run. As such, I believe that what is happening with regards to ES research is extremely ethical despite the implications provided by the other side of the story.
~Tully Cheng
On a personal level, I consider the issue more from a utilitarian perspective, and therefore believe that the use of embryonic stem (ES) cells to treat a disease like Stargardt’s is definitely ethical. To me, preventing blindness in young people will open up countless opportunities for the individuals, and would certainly serve for the good of society in the long run. The benefits described far outweigh the costs to society (the destruction of blastocysts with the purpose of acquiring the ES cells). Then again, to me the cost of destroying blastocysts isn’t very significant in the first place, as I don’t believe them to yet be a person. I find that it’s also important to note that the blastocysts being used for this specific trial are only discarded ones from in vitro fertilization (IVF). That is to say, they serve no other purpose and have therefore been discarded anyways.
ReplyDeleteThose considering the issue from a deontological perspective though, and also considering blastocysts as persons, will find the whole process as unethical. Since these blastocysts clearly do not have the ability to exercise any of their rights, one might suggest that the choice be left up to the parents (the subjects of the IVF, the source of the blastocysts) as to whether or not they want their discarded blastocysts to be used for ES cell trials.
I think that the main hurdle here is the disagreement in defining personhood. Some people argue that since an embryo is a potential human being, that it is a person. The idea of beneficence dictates that it would be immoral to cause harm to the embryo, and furthermore, as articulated by Tully above, deontology would advise that human life is not a means to and end.
ReplyDeleteHowever if one considers that an embryo is merely a collection of cells that although are classified as living are not yet human beings, then at the instant that these cells are harvested, they have no more personhood than a colony of fungi. From this point of view, it can easily be argued that since we have no qualms killing a colony of fungi (as one might by chlorinating a pool) we should hardly have a problem harvesting ES cells to restore sight to the blind.
The harvesting of ES cells to restore sight to the blind, I beleive, is an ethical action. These cells, whether classified as living or not, provide the medical world with a utilitarian job to provide the greatest good for the greatest number of people. If not taken for testing, the "owners" of these cells did not have a motive for using them to procreate. They had a motive for research. Medical professionals have a deontological duty to do as much as they possibly can to care for people and correct negative aspects of a person. The ethical dilemma does not lie in the hands of the researchers, using what they were given to do the best with it, but in the people willing to donate these cells. The people willing to donate are acting autonomously in giving away their cells - there is nothing forcing them to do so. Therefore the issue of this stem cell research, I do not beleive, is more of an issue than abortion. It is a personal decision and the doctors and researchers have a duty to use what the can to better the world.
ReplyDeleteI believe that the use of these Embryonic Stem cells to cure young children of Stargarght's disease is a large step in medicine. The ethical issue does still exist in that some may argue that we do not have the power to "play God" as Tully mentioned earlier. The use of the stem cells would be a great advance in trying to cure many diseases that are still plague many people, causing lifetime disabilities or even causing death. The deontological issue rests in medical professionals' duty to care for as many people as they can. However, many believe that the use of stem cells from embryos is unethical. Many argue that the use of these cells is equivalent to the destruction of human life. However, I still rest with my belief that by using the stem cells, the greater good is done for a greater number by giving many the chance at a longer, healthier life free from any lifelong disabilities or life threatening illnesses.
ReplyDeleteFewer than two months after taking office in January, President Obama lifted the restrictions on federal funding for stem cell research, reversing a policy that “had put surplus embryos at the crossroads of science, ethics, and religion for eight years.” More recently stem cell therapy came one step closer to being tested for the first time in people as a Massachusetts based company has applied to the Food and Drug Administration for a license to start a clinical trial. The embryonic stem cell therapy is being developed to treat Stargardt, a currently incurable disease that causes blindness in young people.
ReplyDeleteThis is potentially the first step in demonstrating the capabilities of the usage and potential research of embryonic stem cells. Researchers are interested in embryonic stem cells because they have the unique potential to become any type of cell in the body and may hold promise for treating conditions such as Alzheimer's disease, Parkinson's, spinal-cord injuries, and others that involve the death of brain cells and other nerve tissue, in addition to, Stargardt explained in this report.
Unfortunately, the new law won't necessarily end the patchwork nature of stem cell research funding. Almost immediately following the March announcement from the Obama administration, some state governments moved to restrict such research. So the laws and simplicity of donation still vary from state to state and drastically in most cases. Expect in the next few weeks to hear a great amount of debate regarding the usage and research of stem cells to arise and be prepared for governing bodies to further restrict the usage of stem cells.
In addition to legal issues, there are many ethical issues with using stem cells, many of them being deontological. One of the important concepts of deontology is that the lives of individuals are ends within themselves. As opposed to conventional medicines, stem cells are living, and it might seem odd from a deontological view to use living treatments on individuals. Deontologists believe that an individual gains their rights at the point of conception, regardless if it occurs naturally in the womb or in a petri dish. Therefore, they would oppose killing the embryonic stem cells regardless of the outcome and no outcome could justify killing the cells based on their position. However, I believe that the potential good and the vast possibilities that can come out of these procedures outweigh the issues opposing them. From a utilitarian view, these procedures are incredibly ethical in the sense that more people would be saved and many diseases could be cured.
Based on the remaining ethical and legal issues and the actions of many state governments tightening the restrictions on stem cell research, the new position of the federal government clearly does not solve all of the legal and ethical issues brought about by stem cell research. In addition, I unfortunately believe that the FDA will take its time and will probably decline the application for a license just to avoid the potential repercussions imposed by the ethical issues regarding the usage of embryonic stem cells. The continued research using embryonic stem cells will only increase the number of ethical and legal considerations.
-KEENAN
After reading this article regarding the use of ES cells for treatment of Stargardt, I believe that this could be the key to unlocking endless opportunities in the medical field as a few students have already mentioned. Whenever research involving the use of ES cells is discussed, there is always the ethical issue of whether cells that could potentially develop into a human being should be manipulated to the desires of researchers. At least one of the goals of the proposed clinical trials is to find ways to improve quality of life which some would say goes along the lines of doing good for the greatest number of people. That is, from the utilitarian standpoint, one would argue that this type of research and use of ES cells will result in providing the greatest number of people with the greatest good available. At this point in time, technological advances have come so far that I do not believe it is even justifiable to say that using ES cells is going against the acts of God. I agree with the fact that the ES cells would otherwise be discarded (as mentioned in a previous post) and believe that the proposal to test (and use if human test results are significant) in humans is ethical. What I think distinguishes this particular action from an unethical one is the fact that the ES cells are not being recklessly used by the researchers (assuming this is true).
ReplyDeleteI believe that the use of ES cells to help patients with stargadt's is extremely important and not very controversial. If they are planning on doing a trial, that clearly indicates that the individual who chooses to be part of the experiment is fully aware of all benefits as well as consequences. As long as the patients are signing off on the experiment there is nothing really that controversial about it.
ReplyDeleteStargadt's is a horrible disease and knowing that their is maybe a way of helping it and curing is incredible. Seeing it in a utilitarian way leads to the understanding that it would benefit more people than not. The ES cells although they are alive are not being destroyed, they are left over. Personally, I do not see many harms in this treatment other than to the potential harms of the individual being treated.
One of the more interesting parts of this article is learning where the stem cells that were used in this study actually came from. The article says that the ES cells were donated to the study and were leftover day-old embryos from an in vitro fertilization. I think it is important to make the distinction between these two procedures (in vitro and the research) that essentially use the same material and why it is considered ethical or unethical to use these materials for these two different reasons especially since IVF is a relatively common and accepted procedure in the medical field while stem cell research is still hotly debated.
ReplyDeleteWhen someone has in vitro fertilization extra embryos are created because it is unlikely that a single one will implant the first time. This means that the unused embryos have the potential for life but are ultimately discarded. Embryos whose ES cells are used in research also have the potential for life, but are used for research purposes instead. Both of these procedures make the choice to cut off the potential for life in the embryos. The reason that stem cell research may be considered immoral while in vitro fertilization is not might be the nature of each of their outcomes. The goal of in vitro fertilization is to create a new life, while in stem cell research the goal is to a save an existing life. This is an interesting observation because it shows that society believes that creating a new life may be more morally worthy of using an embryo than saving an existing life. One could argue that stem cell research is using the life of another person (the embryo) as a means of saving someone else and this is why it is more acceptable to show this. But, alternatively, it could also be argued that in vitro fertilization uses these embryos as a means to an end as well. I just think it is interesting how people think it is ok to discard embryos from IVFs but that it is no ok to use them for stem cell research purposes.
Isabel Shanahan
As stated above by others, an extremely important part of this case is to determine the definition of a person. In my view, taking the utilitarian perspective is an ethical route to take when looking at this situation. The ES cells outlined in the article have the potential to do an extreme amount of good for uncountable people. Because of this, it is ethical to continue research using these cells. Finding cures or better treatments for diseases like Stargardt would advance the quality of life for many.
ReplyDeleteThe other side of this would be the issue of considering the ES cells life in themselves. If this were the case, it could be argued that we have an obligation to do no harm. By using the ES cells, we would be causing harm to the life. In addition, they would also argue the amount of life the ES cell would have to live as a human and the potential that person could have. Although these are both important considerations, I believer that the more important consideration would be the above one, regarding how many people would benefit from the research. Finally, some of the people that would potentially benefit from this would have the sam amount of life and potential to live as the ES cells, we cannot say that for sure.