WEBVTT Kind: captions Language: en 00:00:28.199 --> 00:00:33.280 Hello all, welcome back to the sessions in the 1st module. 00:00:33.280 --> 00:00:41.500 So, we in the earlier classes discussed regarding the clinical trial or ethics in the clinical 00:00:41.500 --> 00:00:44.329 trial of the biotechnological product. 00:00:44.329 --> 00:00:53.699 So, in today's lecture we are going to deal with one of the majorly growing areas of the 00:00:53.699 --> 00:00:55.940 biotechnology that is the Stem Cell Research.. 00:00:55.940 --> 00:01:02.240 So, in this lecture particularly we will be dealing with the aspects of the ethics and 00:01:02.240 --> 00:01:05.160 other issues with respect to stem cell research. 00:01:05.160 --> 00:01:10.790 And we will see how the research related to the human embryonic stem cells has become 00:01:10.790 --> 00:01:16.840 a concern in the area of the current bio technological research and what are the other ways it has 00:01:16.840 --> 00:01:23.380 been overcome and also the associated issues with that too. 00:01:23.380 --> 00:01:28.869 . So, the stem cells are the kind of the cells 00:01:28.869 --> 00:01:34.439 which has the ability into which has the ability to differentiate into different kinds of the 00:01:34.439 --> 00:01:35.439 cell. 00:01:35.439 --> 00:01:41.600 So, human body like we have different types of the stem cells depending on from which 00:01:41.600 --> 00:01:47.799 cell the stem cells has been derived which can regenerate into different tissues or different 00:01:47.799 --> 00:01:54.389 cells depending on its cyte or depending on the place where it is situated. 00:01:54.389 --> 00:02:02.049 So, this ability of the stem cells where it can regenerate into different tissues has 00:02:02.049 --> 00:02:09.280 been exploited in the biomedical sciences and that has given to the domain of the regenerative 00:02:09.280 --> 00:02:12.360 medicine or stem cell tissue therapy. 00:02:12.360 --> 00:02:19.170 So, this regenerative medicine is basically described as a set of innovative approaches 00:02:19.170 --> 00:02:26.010 which is used for the treatment of the illness or the injury and which basically focuses 00:02:26.010 --> 00:02:32.400 on the growth, replacement and the repair of the cells or the organs or specific tissues 00:02:32.400 --> 00:02:35.320 depending on the health need of the particular individuals. 00:02:35.320 --> 00:02:42.180 For example, it may be in the case of the diabetes where you need to replace the pancreatic 00:02:42.180 --> 00:02:47.900 tissue or it may be in the case of the brain disorder like Parkinson's disease where the 00:02:47.900 --> 00:02:49.730 nerve cells may need to be replaced. 00:02:49.730 --> 00:02:54.840 So, in these areas where we have we do not have specific treatment. 00:02:54.840 --> 00:03:04.739 The regenerative tissue approach or the stem cells can act as a miraculous thing. 00:03:04.739 --> 00:03:10.849 So, in the broad area of the regenerative medicine we have different area of research 00:03:10.849 --> 00:03:12.700 like the stem cell research. 00:03:12.700 --> 00:03:19.409 And the stem cell research not only includes the somatic stem cells it also include the 00:03:19.409 --> 00:03:23.730 embryonic stem cells like the cells which are derived from the embryo. 00:03:23.730 --> 00:03:31.069 And there they are also categorized into different types like depending on where they are used 00:03:31.069 --> 00:03:37.519 and how they are used, so, and the ability of the tissue to differentiate into what kind 00:03:37.519 --> 00:03:38.519 of the cells. 00:03:38.519 --> 00:03:42.450 So, it may be multipotent stem cells or it may be pluripotent stem cells. 00:03:42.450 --> 00:03:49.379 For example, so, depending on the place from where these cells has been developed like 00:03:49.379 --> 00:03:54.609 it may be a somatic cell stem cell or it may be embryonic stem cells when particularly 00:03:54.609 --> 00:04:00.450 it is derived from an human embryo or the fetus and again depending on the ability to 00:04:00.450 --> 00:04:01.450 regenerate. 00:04:01.450 --> 00:04:07.240 So, when a stem cells give rise to a particular type of tissue or the cell it is unipotent 00:04:07.240 --> 00:04:12.189 then there are multipotent stem cells, where it may differentiated into related categories 00:04:12.189 --> 00:04:13.660 of the cells. 00:04:13.660 --> 00:04:19.799 And there is another category is called induced pluripotent stem cells, where the somatic 00:04:19.799 --> 00:04:27.960 stem cells are induced to behave like a pluripotent stem cells which is the stem cell which can 00:04:27.960 --> 00:04:31.990 regenerate into different types of the tissue. 00:04:31.990 --> 00:04:35.370 It means all the tissue types which is available in the human body. 00:04:35.370 --> 00:04:41.280 So, basically I will just give you a brief introduction to this area. 00:04:41.280 --> 00:04:48.950 Now, coming to the issues with respect to the stem cells research, so, what kind of 00:04:48.950 --> 00:04:51.390 problem do we face? 00:04:51.390 --> 00:04:56.790 And as we have been discussing in case of the biotechnological research the ethical 00:04:56.790 --> 00:05:03.110 considerations becomes first and foremost major issue while we deal with the biomedical 00:05:03.110 --> 00:05:04.110 research. 00:05:04.110 --> 00:05:08.740 For example, here when we are talking about an embryonic stem cells. 00:05:08.740 --> 00:05:14.560 So, then arguments related to the status of the embryonic stem cells, is it really ethical 00:05:14.560 --> 00:05:18.110 to use an embryo for research purpose? 00:05:18.110 --> 00:05:19.890 That becomes a questions. 00:05:19.890 --> 00:05:25.390 Then also there are certain safety concerns raised by the induced pluripotent stem cells, 00:05:25.390 --> 00:05:32.010 where with the various genetic interventions the somatic stem cells are converted into 00:05:32.010 --> 00:05:34.930 induced stem cells with multi pluripotent activity . 00:05:34.930 --> 00:05:44.260 So, again it is easier to say, but in practical when it is done there are a number of issues 00:05:44.260 --> 00:05:47.230 or health concerns or safety concerns which has been observed. 00:05:47.230 --> 00:05:51.310 So, that is one of the major considerations also. 00:05:51.310 --> 00:05:58.090 And how the research is designed particularly in the case of this biomedical thing, I mean 00:05:58.090 --> 00:05:59.750 the stem cell is another important area. 00:05:59.750 --> 00:06:09.840 The number of embryos used or the how the other specimens have been used in this whole 00:06:09.840 --> 00:06:12.800 process that becomes issue here. 00:06:12.800 --> 00:06:18.750 Then, the issues to consider the first time and intervention when it is tested in the 00:06:18.750 --> 00:06:25.930 human subjects and also the problems related to the informed consent and therapeutic misconception. 00:06:25.930 --> 00:06:31.490 So, these are the major issues which generally which are generally faced during the stem 00:06:31.490 --> 00:06:32.490 cell research. 00:06:32.490 --> 00:06:41.580 So, in the next few slides, I would be dealing one by one with these areas. 00:06:41.580 --> 00:06:48.400 So, before coming into adult or the embryonic stem cells let us first discuss about the 00:06:48.400 --> 00:06:51.050 multipotent stem cells. 00:06:51.050 --> 00:06:57.350 So, the multipotent stem cells are basically derived from the adult stem cells which are 00:06:57.350 --> 00:07:04.610 present in various tissues and they have a kind of ability to differentiate into specialized 00:07:04.610 --> 00:07:12.870 cells and basically they gradually trance differentiate into various specialized cells 00:07:12.870 --> 00:07:15.980 which have particular characteristics and other tissues. 00:07:15.980 --> 00:07:21.570 For examples, these hematopoietic stem cells, the blood stem cells if you can if generally 00:07:21.570 --> 00:07:22.570 said. 00:07:22.570 --> 00:07:29.720 So, they have the ability to differentiate into the three blood cells type like the RBC, 00:07:29.720 --> 00:07:38.050 WBC or platelets and also they may differentiate into the neural stem cells or the cardiomyocytes 00:07:38.050 --> 00:07:42.280 means, the cells present in our heart which develops into the heart or the liver cells. 00:07:42.280 --> 00:07:47.710 So, these are the specialized cells have an limited ability to differentiate related group 00:07:47.710 --> 00:07:50.900 of the tissues. 00:07:50.900 --> 00:07:57.710 And these stem cells are separated from the adult stem cells through a process known as 00:07:57.710 --> 00:07:59.770 the plasmapheresis. 00:07:59.770 --> 00:08:07.770 And these are already been clinically well proven and has been in use and basically these 00:08:07.770 --> 00:08:12.730 multipotent stem cells has been have been used in the treatment of the hematological 00:08:12.730 --> 00:08:14.610 malignancies. 00:08:14.610 --> 00:08:20.820 And it also is majorly used for the treatments of the side effects arising out of the cancer 00:08:20.820 --> 00:08:21.820 chemotherapy. 00:08:21.820 --> 00:08:27.980 So, this is one of the areas where already much research has been done and it has been 00:08:27.980 --> 00:08:33.600 proved quite a safe procedure to carry out these things. 00:08:33.600 --> 00:08:38.550 And because these are derived from the somatic cells or other stem cells. 00:08:38.550 --> 00:08:46.750 And generally used in the specific or homologous individual this adult stem cells are the cord 00:08:46.750 --> 00:08:50.940 blood stem cells do not raise special ethical issues. 00:08:50.940 --> 00:08:56.520 And it is been widely used in research and clinical trials across the countries including 00:08:56.520 --> 00:08:58.000 India. 00:08:58.000 --> 00:09:03.330 And basically as I mentioned it has been widely used for the allogeneic as well as the autologous 00:09:03.330 --> 00:09:04.610 stem stem cell transplant. 00:09:04.610 --> 00:09:08.380 So, means, related individual or in the same individual. 00:09:08.380 --> 00:09:17.360 However, when the research comes when the question comes to the area of embryonic stem 00:09:17.360 --> 00:09:23.450 cell research then the problem with related to ethics or ethical dilemma it comes into 00:09:23.450 --> 00:09:24.450 picture. 00:09:24.450 --> 00:09:32.320 Now, this pluripotent stem cells, means the cells which has the ability to differentiate 00:09:32.320 --> 00:09:34.170 into various types of the tissue. 00:09:34.170 --> 00:09:39.690 So, that it can replace the damaged organs or it can replace the damaged tissues and 00:09:39.690 --> 00:09:44.760 can be an effective treatment method of very various diseases for which we do not have 00:09:44.760 --> 00:09:48.030 any effective treatment so far. 00:09:48.030 --> 00:09:56.400 So, the problem is that these kind of pluripotent stem cells are generally derived from the 00:09:56.400 --> 00:10:04.440 human embryo when the human embryo is around 5 to 7 days old, it divides into a mass of 00:10:04.440 --> 00:10:07.860 cells which are known as the blastocysts. 00:10:07.860 --> 00:10:14.300 And these human embryonic stem cells are derived from these 5 to 7 days old blastocysts in 00:10:14.300 --> 00:10:16.490 their mass of the cells. 00:10:16.490 --> 00:10:25.520 But, this procedure makes it ethically as well as the politically controversial thing 00:10:25.520 --> 00:10:29.780 because it needs the destruction of the human embryo. 00:10:29.780 --> 00:10:35.140 So, once you take out the or if you want to take out the human embryonic stem cells from 00:10:35.140 --> 00:10:39.180 the blastocysts we need to destroy that embryo. 00:10:39.180 --> 00:10:48.310 So, there are different proponents or there are different arguments in or against the 00:10:48.310 --> 00:10:54.279 use of the human embryonic stem cells for in the biomedical research. 00:10:54.279 --> 00:11:00.380 One of the proponent like the main questions which is generally posed is that what is the 00:11:00.380 --> 00:11:02.480 moral status of the embryo? 00:11:02.480 --> 00:11:08.460 So, when you are going to destroy the embryo, so, are you really going to kill a living 00:11:08.460 --> 00:11:10.960 organism or it is just a mass of cells? 00:11:10.960 --> 00:11:17.170 So, can the embryo be equated with all full fledged living organisms? 00:11:17.170 --> 00:11:23.020 If yes, let us begin the direct answer, but if no then when can we say that it is the 00:11:23.020 --> 00:11:30.380 perfect time that the human life has begun in that embryo and can we provide the same 00:11:30.380 --> 00:11:37.580 moral status as a live born child or as an adult to an embryo at that stage? 00:11:37.580 --> 00:11:43.470 So, these are the few important questions which are generally raised and to be frank 00:11:43.470 --> 00:11:45.360 there is no settled principle. 00:11:45.360 --> 00:11:52.220 So, far it is a ongoing continuing argument among the proponent as well as the among the 00:11:52.220 --> 00:11:58.140 groups which oppose the research in the area of the embryonic stem cell. 00:11:58.140 --> 00:12:04.340 So, if you see majorly there are three views in the area of human embryonic stem cell research. 00:12:04.340 --> 00:12:11.300 As per the first group of people who believe or the pro life category which of which we 00:12:11.300 --> 00:12:16.390 may say they believe that the human life begins at the conceptions. 00:12:16.390 --> 00:12:24.460 Means, when a sperms meet an oocyte or develops into a fertilizers and develops into a zygote 00:12:24.460 --> 00:12:28.620 from that stage itself the human life has started beginning. 00:12:28.620 --> 00:12:37.020 So, if you are taking a blastocyst and removing the inner cell mass to get an human embryonic 00:12:37.020 --> 00:12:44.529 stem cells then it is equivalent to murder of an full fledged life live adult. 00:12:44.529 --> 00:12:46.990 So, they are very clear cut that. 00:12:46.990 --> 00:12:52.630 You know were in inside the body of a human or a woman when the embryo or the blastocyst 00:12:52.630 --> 00:13:00.070 whether it is like 4 days or 7 days old from the very first day it attains the status of 00:13:00.070 --> 00:13:05.460 a full fledged human being. 00:13:05.460 --> 00:13:11.600 And there are again 2nd view which is little bit contrary to the first one. 00:13:11.600 --> 00:13:18.530 So, these belief that the embryo becomes a person in a moral sense at the later stage 00:13:18.530 --> 00:13:20.210 of the development than fertilization. 00:13:20.210 --> 00:13:28.150 So, we cannot really say or equate the embryo with a full fledged individual. 00:13:28.150 --> 00:13:31.620 So, it is they believe that it is like a clump of cells. 00:13:31.620 --> 00:13:35.570 So, that needs to be further developed. 00:13:35.570 --> 00:13:39.150 So, that that expresses the human characters. 00:13:39.150 --> 00:13:44.260 Means, again there are few criteria means, some believe that till the time the primitive 00:13:44.260 --> 00:13:51.480 streak develops in the human that zygote or embryo then only we can consider them as an 00:13:51.480 --> 00:13:53.450 individual or at a live individual. 00:13:53.450 --> 00:13:57.810 Before that it is just a mass of cells and if you are deriving something some embryonic 00:13:57.810 --> 00:14:05.200 stem cells for the from them to carry out certain research then it should not be a problem. 00:14:05.200 --> 00:14:13.630 Again there is a 3rd view which lies in between the first two views. 00:14:13.630 --> 00:14:22.230 They believe that the early embryo deserves special respect, but as a potential deserves 00:14:22.230 --> 00:14:28.920 the early embryo should deserve respect as a potential human being, but again when needed 00:14:28.920 --> 00:14:32.930 those can be used for particular type of the research. 00:14:32.930 --> 00:14:40.080 Provided there should be a good scientific justification and it should be carefully evaluated 00:14:40.080 --> 00:14:46.310 again the pros and cons of social how much you what you are gaining out of the experiment 00:14:46.310 --> 00:14:51.830 and how much suffering you are giving by extracting those kind of the cells that has to be properly 00:14:51.830 --> 00:14:52.930 weighted. 00:14:52.930 --> 00:14:59.051 And proper informed consent from the woman or the couple who are donating the embryo 00:14:59.051 --> 00:15:04.899 for the research has to be taken, so that they should get that thing and then this kind 00:15:04.899 --> 00:15:06.510 of research should begin. 00:15:06.510 --> 00:15:09.130 So, as I mentioned, so, this is an ongoing debate. 00:15:09.130 --> 00:15:17.160 So, whether or not to consider these 3 to 4 to 7 days old embryo as a full human being, 00:15:17.160 --> 00:15:23.170 so, that is continuous debate. 00:15:23.170 --> 00:15:29.240 Because again as I mentioned, so, the from the conception itself; so, they believe that 00:15:29.240 --> 00:15:33.780 the human life starts because there are certain emotional attachment or certain religious 00:15:33.780 --> 00:15:34.780 belief. 00:15:34.780 --> 00:15:35.780 So, we cannot really. 00:15:35.780 --> 00:15:41.860 So, this pro pro-life movement or the other person who believes in those thing they believe 00:15:41.860 --> 00:15:48.380 that destruction of those kind of the embryo is not ethically justified. 00:15:48.380 --> 00:15:55.550 And also it is related to the other issues of the abortion where deliberate abortion 00:15:55.550 --> 00:16:01.270 or abrtions through which they are getting the embryos and doing the other scientific 00:16:01.270 --> 00:16:02.270 research. 00:16:02.270 --> 00:16:08.270 So, that may expedite those process and it has been also a debate in the many western 00:16:08.270 --> 00:16:09.500 countries. 00:16:09.500 --> 00:16:17.300 And the number of pro-life supporters of this support this number of pro life leaders support 00:16:17.300 --> 00:16:19.920 the stem cell research using the frozen embryo. 00:16:19.920 --> 00:16:26.149 So, one of the way through which this issues of destroying the human embryo directly may 00:16:26.149 --> 00:16:29.880 be circumvented by the use of the frozen embryos. 00:16:29.880 --> 00:16:36.120 So, like in case of this IVF or alternative reproduction therapies, so, where the there 00:16:36.120 --> 00:16:43.029 are in vitro fertilizations or there are clinic reproductive clinics where these sperms or 00:16:43.029 --> 00:16:48.670 the eggs are fertilized outside the human body and majority of them are not used. 00:16:48.670 --> 00:16:54.242 So, in those those kind of the zygotes if they are available or embryos which if they 00:16:54.242 --> 00:16:59.150 are available those can be used for this kind of research purpose. 00:16:59.150 --> 00:17:05.530 So, in that case it may not be a issue, but again the question lies whether such couples 00:17:05.530 --> 00:17:12.040 or such women are informed about the use of such embryo in this kind of the research or 00:17:12.040 --> 00:17:13.040 not. 00:17:13.040 --> 00:17:21.209 So, but still it would not directly harm the embryo as the earlier cases and this kind 00:17:21.209 --> 00:17:28.039 of view was also endorsed by the former first lady Nancy Reagan and the US Senator Orrin 00:17:28.039 --> 00:17:30.470 Hatch in the United States. 00:17:30.470 --> 00:17:36.390 So, if you see the political or the debate surrounding these kind of human embryonic 00:17:36.390 --> 00:17:38.159 stem cells, it is worldwide. 00:17:38.159 --> 00:17:44.279 Now, irrespective of the country whether you say it US where these research in that area 00:17:44.279 --> 00:17:50.950 has begun quite early in during the 1970s itself, but still then if the debate is still 00:17:50.950 --> 00:17:56.309 going and now we have lot of regulations or lot of streamlined process. 00:17:56.309 --> 00:18:02.590 So, these kind of questions can be answered in a proper scientific manner. 00:18:02.590 --> 00:18:12.929 So, instead of directly harming a embryo inside inside the womb of an women, so, there is 00:18:12.929 --> 00:18:19.159 the alternate way is to use the new embryonic stem cells lines from the frozen embryos. 00:18:19.159 --> 00:18:26.470 So, the frozen embryos are generally preserved in biobanks or in as I was mentioning in the 00:18:26.470 --> 00:18:27.470 in vitro fertilization clinics. 00:18:27.470 --> 00:18:35.239 So, after the treatment or procedure of the infertility treatment these frozen embryos 00:18:35.239 --> 00:18:37.759 are kept in those kind of clinics. 00:18:37.759 --> 00:18:44.139 And generally they are donated for the research instead of using that for another couple. 00:18:44.139 --> 00:18:50.080 However, again the use of such donated frozen embryo may raise certain ethical issues. 00:18:50.080 --> 00:18:56.769 First like, whether or not the informed consent from the woman or the couple donating the 00:18:56.769 --> 00:19:03.700 embryo has been taken or not, they are the couple couples informed about the possible 00:19:03.700 --> 00:19:11.640 usage or the the way the embryos are going to be used whether proper informed consent 00:19:11.640 --> 00:19:16.659 has been taken out or not, whether they realize that what kind of research is that? 00:19:16.659 --> 00:19:19.499 So,that is a big question. 00:19:19.499 --> 00:19:23.690 And then consent of the gamete donors involved in the creation of the embryo. 00:19:23.690 --> 00:19:29.450 So, if we have the gametes like the sperms or the eggs then individual consent has been 00:19:29.450 --> 00:19:30.780 taken or not. 00:19:30.780 --> 00:19:37.200 In there has been studies or the surveys where in many cases the woman did not like that 00:19:37.200 --> 00:19:44.210 their eggs should be used for any kind of the research whereas, in some cases the embryos 00:19:44.210 --> 00:19:50.119 donating the embryos for biological science research has been favored in some countries. 00:19:50.119 --> 00:19:54.740 So, there are different views depending on their religious belief or depending on their 00:19:54.740 --> 00:19:55.799 personal choices. 00:19:55.799 --> 00:20:01.330 And further the issue of the confidentiality is also a major concern here. 00:20:01.330 --> 00:20:06.909 Because if the identity of the donor is revealed, so that may lead to a problem for the donor 00:20:06.909 --> 00:20:12.450 or may be a threat from the groups, who believe that destroying an embryo for this kind of 00:20:12.450 --> 00:20:14.669 research purpose is not good. 00:20:14.669 --> 00:20:22.909 So, the ethical concern with related to the frozen embryos is also prevalent. 00:20:22.909 --> 00:20:28.880 And sometimes there are further ethical concerns related to the donated oocytes. 00:20:28.880 --> 00:20:37.880 So, maybe for some woman participants agreed to donate the oocytes for further research, 00:20:37.880 --> 00:20:45.690 but again the the process of taking out the oocytes from the body is a very risky process. 00:20:45.690 --> 00:20:51.450 And it may have many side effects as well as effects like this ovarian hyper stimulation 00:20:51.450 --> 00:20:56.659 syndrome, it may lead to bleeding or other infection or complications of anesthesia. 00:20:56.659 --> 00:21:02.460 So, if something like this is has been carried out it has to be done properly and it should 00:21:02.460 --> 00:21:05.759 be carefully evaluated. 00:21:05.759 --> 00:21:11.350 And then because sometimes we have come across the unethical practices in the scientific 00:21:11.350 --> 00:21:19.269 world, so, care must be taken to protect the reproductive interest of such donors or the 00:21:19.269 --> 00:21:21.360 woman in the infertility treatment. 00:21:21.360 --> 00:21:27.989 So, the first reproductive needs must be prior prioritized rather than prioritizing the extraction 00:21:27.989 --> 00:21:31.570 of the oocyte for the scientific or research purpose. 00:21:31.570 --> 00:21:36.919 Then the proper informed consent for the oocyte donation. 00:21:36.919 --> 00:21:42.190 In many cases the woman does not understand what is this informed consent or why this 00:21:42.190 --> 00:21:49.450 thing has been taken out or what is the purpose of this kind of the research and so, it they 00:21:49.450 --> 00:21:56.119 has to be properly understood regarding the usage of the oocyte and how it is going to 00:21:56.119 --> 00:22:01.619 be used in the research and what are the future consequences or in what way those are going 00:22:01.619 --> 00:22:02.700 to be used. 00:22:02.700 --> 00:22:08.389 So, with related to the embryonic stem cells these are the the whatever we have discussed 00:22:08.389 --> 00:22:14.030 so far were the major issues like weather from the frozen embryos or for the donated 00:22:14.030 --> 00:22:20.519 oocytes or directly from the human embryonic 4 day old or 6, 7 days old embryos. 00:22:20.519 --> 00:22:24.559 So, when it is coming to the embryo or the fetus? 00:22:24.559 --> 00:22:29.929 So, that is directly raising an ethical question. 00:22:29.929 --> 00:22:36.059 So, scientists have been working in developing the stem cells like these embryonic stem cells 00:22:36.059 --> 00:22:41.580 or the pluripotent stem cells which has the ability to develop into many different kinds 00:22:41.580 --> 00:22:46.779 of the tissues from the somatic stem cells itself. 00:22:46.779 --> 00:22:53.950 So, there was a popular example of the sheep which is known as the named as Dolly. 00:22:53.950 --> 00:23:03.309 So, the Dolly sheep was a clone of their mother sheep and if you know though that kind of 00:23:03.309 --> 00:23:10.580 technique where the somatic cells where the nucleus of the somatic cell has been inserted 00:23:10.580 --> 00:23:16.820 into a fertilized egg is known as the somatic cell nuclear transfer. 00:23:16.820 --> 00:23:23.409 So, it is basically the reprogramming of the somatic cells to produce the induced pluripotent 00:23:23.409 --> 00:23:24.679 stem cells. 00:23:24.679 --> 00:23:31.960 Means, the it is the pluripotency has been induced by some kind of genetic interventions. 00:23:31.960 --> 00:23:38.289 And this is one of the way the ethical consideration to the related to the embryonic stem cells 00:23:38.289 --> 00:23:40.850 is trying to be or has been avoided. 00:23:40.850 --> 00:23:47.320 So, this process of the somatic cell nuclear transfer transfer is quite prevalent in many 00:23:47.320 --> 00:23:53.840 of the animal breeds like sheep is another example Dolly was a popular example. 00:23:53.840 --> 00:24:00.980 But, the nuclear DNA was transferred into oocyte from which the nucleus was removed, 00:24:00.980 --> 00:24:07.200 but when it comes to the human again it raise a several questions. 00:24:07.200 --> 00:24:12.640 Like, there are again different kinds of arguments. 00:24:12.640 --> 00:24:19.820 Again creating the embryos with the intentions of using them for the research and destroying 00:24:19.820 --> 00:24:26.619 them in the process is it really required and does it taught violates the respect for 00:24:26.619 --> 00:24:27.999 the nascent human life? 00:24:27.999 --> 00:24:34.019 So, you are deliberately creating a human embryo and destroying it for your scientific 00:24:34.019 --> 00:24:35.019 endeavours. 00:24:35.019 --> 00:24:41.169 So, it is a kind of violation to the human value. 00:24:41.169 --> 00:24:48.919 Then the another issues is that another issue is that the pluripotent entities which are 00:24:48.919 --> 00:24:54.169 created through the somatic cell nuclear transfer process are biologically and ethically distinct 00:24:54.169 --> 00:24:55.269 from the embryo. 00:24:55.269 --> 00:25:01.889 So, here what happened is that the nucleus of a somatic cell has been incorporated into 00:25:01.889 --> 00:25:02.889 the oocyte. 00:25:02.889 --> 00:25:08.249 So, it is not equivalent to the embryo which is generally developed to the normal process. 00:25:08.249 --> 00:25:10.750 So, they say, these are two different kinds of the cells. 00:25:10.750 --> 00:25:12.890 So, that should not be a problem. 00:25:12.890 --> 00:25:19.480 It is about solving certain science scientific or certain issues in the biomedical research. 00:25:19.480 --> 00:25:25.720 So, it should not be taken as same or at par with the embryonic stem cell research. 00:25:25.720 --> 00:25:35.940 And when it comes to use of this process in the human reproduction again there are many 00:25:35.940 --> 00:25:36.940 objections. 00:25:36.940 --> 00:25:42.619 So, one of the objections is because of the possible safety concerns. 00:25:42.619 --> 00:25:49.039 So, when someone is trying to reprogram this genetic material from a somatic cell to those 00:25:49.039 --> 00:25:57.039 kind of cell, so, that may lead to the fault expression of different kinds of the gene. 00:25:57.039 --> 00:26:01.059 So, there may be hundreds of the genes which are misexpressed. 00:26:01.059 --> 00:26:06.309 So, it may lead to the development of certain undesirable proteins or certain undesirable 00:26:06.309 --> 00:26:14.080 functions which is very harmful to the human beings and it may generate lot of errors in 00:26:14.080 --> 00:26:15.100 the humans. 00:26:15.100 --> 00:26:20.909 And the chances of this kind of errors like this misexpression of the genes are very high 00:26:20.909 --> 00:26:25.989 in case of the in humans rather than in animals. 00:26:25.989 --> 00:26:32.649 And somewhere it also violates the human dignity or it undermines the traditional or fundamental 00:26:32.649 --> 00:26:37.200 morals or religious or cultural values of the human being when someone is approaching 00:26:37.200 --> 00:26:40.259 or using this kind of process. 00:26:40.259 --> 00:26:46.520 And the other issue is that in many case the cloned child like this Dolly sheep. 00:26:46.520 --> 00:26:52.450 So, if it is in case of the human, so, it would be considered as a twin of that parent 00:26:52.450 --> 00:26:56.499 because the genetic material becomes the same because it has been taken from the body of 00:26:56.499 --> 00:26:58.230 that mother or that cell. 00:26:58.230 --> 00:27:03.809 So, when you are again incorporating that into the oocyte and it is developing into 00:27:03.809 --> 00:27:07.019 the full fledged human being, so, it is basically a genetic twin. 00:27:07.019 --> 00:27:13.269 So, that emotional attachment or that value or the the feeling that a couple gets while 00:27:13.269 --> 00:27:18.860 considering their child or when the child is born is not equivalent to the clone child. 00:27:18.860 --> 00:27:25.309 So, these are the few objections which are also being taken to the use of this somatic 00:27:25.309 --> 00:27:31.600 cell nuclear transfers process in for developing the cloned individual. 00:27:31.600 --> 00:27:37.429 However, if you see there are examples in the animal. 00:27:37.429 --> 00:27:42.590 So, cattle industry or sheep industry that has been tried, but there there the ethical 00:27:42.590 --> 00:27:50.809 issues are not that, what you called not raised in that way how it has been raised in the 00:27:50.809 --> 00:27:52.900 case of the humans. 00:27:52.900 --> 00:28:01.250 So, also there are 3rd kind of issue where the animal oocytes are used using the human 00:28:01.250 --> 00:28:02.250 DNA. 00:28:02.250 --> 00:28:08.179 Means, instead of the like the earlier example here the human DNA is injected into the animal 00:28:08.179 --> 00:28:09.179 cell. 00:28:09.179 --> 00:28:14.919 So, it may lead to the development what we call as the cytoplasmic hybrid embryos and 00:28:14.919 --> 00:28:19.509 which is called the hybrid chimeras what you called mythological characters of the beast 00:28:19.509 --> 00:28:25.200 or other character were nonhumans like as mixture of the human with the animal. 00:28:25.200 --> 00:28:30.720 So, those kind of things generally becomes a concern when we come to this kind of research. 00:28:30.720 --> 00:28:36.419 But anyway, but in case of the animal like we have known the example of the mule or other 00:28:36.419 --> 00:28:45.330 animals where it is a kind of a hybrid chimera, but when it comes to human DNA into the animals 00:28:45.330 --> 00:28:48.870 then it is not ethically acceptable by many part of the society. 00:28:48.870 --> 00:28:54.720 So, this is also a kind of issue which comes to forefront when we deal about the stem cell 00:28:54.720 --> 00:28:57.710 research. 00:28:57.710 --> 00:29:10.529 So, one of the simplest way to derive this fetal stem cell is like it; so, if a natural 00:29:10.529 --> 00:29:15.019 abortion occurs then the pluripotent stem cells can be derived from the fetal tissues 00:29:15.019 --> 00:29:18.269 after that abortion process. 00:29:18.269 --> 00:29:23.970 Again since it is associated with the abortion process again it is an objectionable to many 00:29:23.970 --> 00:29:31.450 groups and so, it because it may lead to deliberate abortion or a money making process. 00:29:31.450 --> 00:29:35.909 You never know how much incentive is been given or other things. 00:29:35.909 --> 00:29:39.919 So, that is again a controversy here. 00:29:39.919 --> 00:29:44.340 So, whether abortion should be allowed or not allowed and the fetal tissue can be used 00:29:44.340 --> 00:29:47.669 in the stem cell research or not. 00:29:47.669 --> 00:29:56.599 So, not only the use of the embryos or the stem cells or the pluripotent for the derivation 00:29:56.599 --> 00:30:01.559 of the stem cells is an issue now we have discussed the multiple ways through which 00:30:01.559 --> 00:30:07.599 the stem cells can be recovered from direct from the embryo or fetal tissue. 00:30:07.599 --> 00:30:12.399 After the abortion or induced pluripotent stem cells where a different genetic manipulation 00:30:12.399 --> 00:30:18.980 or interventions has been done to make a some adult stem cells or the normal stem cells 00:30:18.980 --> 00:30:21.100 into a pluripotent stem cell. 00:30:21.100 --> 00:30:26.399 So, again those are the issues at the stage where the stem cells is being developed and 00:30:26.399 --> 00:30:33.649 used for the biological research or means the first stage of isolation of the stem cells. 00:30:33.649 --> 00:30:41.029 But again, the problem is not only that first stage of the process, the in the next downstream 00:30:41.029 --> 00:30:44.960 research process it is also a major problem. 00:30:44.960 --> 00:30:51.320 So, we have to now see what kind of usage this stem cells might have or the induced 00:30:51.320 --> 00:30:57.059 pluripotent stem cells might have and what kind of sensitive questions can be associated 00:30:57.059 --> 00:30:58.750 with those usage. 00:30:58.750 --> 00:31:08.529 So, when the pluripotent stem cells are derived from some donors or from any other process, 00:31:08.529 --> 00:31:13.720 so, generally they would be used in the future genetic modification of the cells or they 00:31:13.720 --> 00:31:21.599 would be used in deriving like using that cells which would be injected to certain non 00:31:21.599 --> 00:31:27.450 human animals to demonstrate the various functions or it may be injected into the brains of the 00:31:27.450 --> 00:31:34.229 non human animals to see how it is affecting the development of the neural cells or other 00:31:34.229 --> 00:31:35.229 things. 00:31:35.229 --> 00:31:39.269 Then it might be used in the large scale genome sequencing to understand the development of 00:31:39.269 --> 00:31:41.110 the cell line and how where the fault. 00:31:41.110 --> 00:31:46.009 So, that the whole cell biology or the cell differentiation process can be understood 00:31:46.009 --> 00:31:50.581 at the fundamental level to diagnose proper diagnosis of the disease or the treatment 00:31:50.581 --> 00:31:52.580 of the disease. 00:31:52.580 --> 00:31:59.019 And further the patenting issue or intellectual property issues develop related to the discoveries 00:31:59.019 --> 00:32:04.590 or the inventions related to the commercial test or the therapies which are now produced 00:32:04.590 --> 00:32:09.349 through the embryonic stem cells and the future income and the royalty sharing. 00:32:09.349 --> 00:32:14.030 So, these are the future or the downstream research process which may arise with the 00:32:14.030 --> 00:32:16.440 help of the stem cells. 00:32:16.440 --> 00:32:22.850 But, again the donor when the donors or the persons from from whom the stem cells are 00:32:22.850 --> 00:32:31.639 being received they might not agree to use their cells or the body body parts to for 00:32:31.639 --> 00:32:32.979 use in those direction. 00:32:32.979 --> 00:32:39.270 For example, when there is large scale genome sequencing, so, one may able to understand 00:32:39.270 --> 00:32:45.460 what kind of genetic threat or probable disease he might be getting in future or when the 00:32:45.460 --> 00:32:53.909 cell lines are injected into certain non human animals then they might have certain religious 00:32:53.909 --> 00:32:56.779 reservation or they should they may not like it. 00:32:56.779 --> 00:33:03.259 Or when it is genetically modified or further manipulated that may be may not be acceptable 00:33:03.259 --> 00:33:08.639 to certain individual who have agreed to give the embryonic stem cells or the stem cell. 00:33:08.639 --> 00:33:19.690 So, even at the later stage also the informed consent process or the normal ethical considerations 00:33:19.690 --> 00:33:21.200 has been majorly seen. 00:33:21.200 --> 00:33:28.210 So, these are the few issues in general I wanted to discuss regarding the ethical issues 00:33:28.210 --> 00:33:34.440 with respect to the embryonic stem cells are if we go the earlier one of the developed 00:33:34.440 --> 00:33:39.450 nations like United States, where the embryonic stem cells has started early in the 1970s 00:33:39.450 --> 00:33:40.639 itself in. 00:33:40.639 --> 00:33:45.619 So, if you see the evolution or the time line how the things has been perceived there. 00:33:45.619 --> 00:33:53.269 We will find that in as early as 1974, initially the till then it was federally funded at the 00:33:53.269 --> 00:34:00.020 all these embryonic stem cell research, but the Congress banned nearly all federally funded 00:34:00.020 --> 00:34:01.479 fetal tissue research in 1974. 00:34:01.479 --> 00:34:09.760 And until the National Commission for the Protection of the Human Subjects of Biomedical 00:34:09.760 --> 00:34:14.790 and Behavioural Research was established by the National Research Act and they devise 00:34:14.790 --> 00:34:19.070 guideline for how to go about this embryonic stem cell research. 00:34:19.070 --> 00:34:26.270 Then in 1975, Ethics Advisory Board was established which basically a body which allowed the functioning 00:34:26.270 --> 00:34:33.770 or allowed permitted gave permission for this kind of the research. 00:34:33.770 --> 00:34:39.859 Again in 1980, President Reagan Killed this Ethics Advisory Board which laid to the 00:34:39.859 --> 00:34:44.849 de facto moratorium halting the federal funding for the human embryo research. 00:34:44.849 --> 00:34:51.659 And again in 1988 there was lot of debates regarding the merits and demerits of the human 00:34:51.659 --> 00:34:59.650 embryonic research and finally, in 1990 by President Bush the all the federal funding 00:34:59.650 --> 00:35:03.770 to the stem cell research was denied. 00:35:03.770 --> 00:35:10.849 And there are further major few changes has been also done after that, but the major change 00:35:10.849 --> 00:35:17.210 came in 1995 which is known as the Dickey-Wicker Amendment which is named after the sponsors 00:35:17.210 --> 00:35:19.690 Jay Dickey and Roger Wicker. 00:35:19.690 --> 00:35:26.980 So, basically with this amendment they prohibited the federal funding towards the embryonic 00:35:26.980 --> 00:35:33.690 research for all the purposes where the use of the human embryos was seen as a violation 00:35:33.690 --> 00:35:35.160 of the human rights. 00:35:35.160 --> 00:35:41.810 So, after this Dickey-Wicker Amendment if any of the embryonic research where the embryo 00:35:41.810 --> 00:35:48.780 has been destroyed or there is a use of the human embryo then it it did not allow the 00:35:48.780 --> 00:35:49.940 funding of such kind of the research. 00:35:49.940 --> 00:35:57.579 So, till the time the embryonic stem cell research was basically based on the extraction 00:35:57.579 --> 00:36:02.059 on the embryo extraction of the cell lines from the human embryo itself. 00:36:02.059 --> 00:36:11.089 But, in 1998 James Thomson isolated the first human embryonic stem cells and this discovery 00:36:11.089 --> 00:36:16.619 again initiated the ethical debates and how the human embryonic stem cells research is 00:36:16.619 --> 00:36:24.529 required or is really as needed or not because again it was derived through a process where 00:36:24.529 --> 00:36:29.619 it has destroyed the human embryo. 00:36:29.619 --> 00:36:35.710 In 2001, President Bush prohibited the federally funding schemes for the human embryo embryonic 00:36:35.710 --> 00:36:41.700 stem cell research, but again it did not affect the research in the private sector. 00:36:41.700 --> 00:36:46.319 And the research was conducted with the state funding. 00:36:46.319 --> 00:36:53.000 In 2005, the National Academies Releases; release the guidelines on the human embryonic 00:36:53.000 --> 00:36:58.270 stem cell research and it basically said the guidelines and requirements for the stem cell 00:36:58.270 --> 00:37:00.040 research. 00:37:00.040 --> 00:37:07.150 And the major breakthrough came in 2017 2007 where two independent scientist Professor 00:37:07.150 --> 00:37:09.400 Yamanaka and Professor Thomson. 00:37:09.400 --> 00:37:16.099 So, they independently derived this induced pluripotent stem cells and they separately 00:37:16.099 --> 00:37:17.160 discovered it. 00:37:17.160 --> 00:37:24.190 So, after this induced pluripotent stem cells like outside the human body when these with 00:37:24.190 --> 00:37:30.710 the help of certain genetic interventions the stem cells are converted into the pluripotent 00:37:30.710 --> 00:37:31.710 stem cell. 00:37:31.710 --> 00:37:37.770 So, that gave a big breakthrough where the use of the human embryonic stem cells can 00:37:37.770 --> 00:37:39.010 be reduced. 00:37:39.010 --> 00:37:47.410 So, again 2009 President Obama reverse the Bush's order George Bush order for stopping 00:37:47.410 --> 00:37:52.859 the federally fund and they tried to remove the barriers for the responsible scientific 00:37:52.859 --> 00:37:54.869 research involving the human stem cell. 00:37:54.869 --> 00:38:02.000 So, there are many changes because all these are politically is debatable issues, so, linked 00:38:02.000 --> 00:38:06.200 with many other religious and as I said political debates. 00:38:06.200 --> 00:38:12.920 So, there has been changes according to the situations. 00:38:12.920 --> 00:38:17.700 One of the important decisions which like this Sherley versus Sebelius. 00:38:17.700 --> 00:38:26.099 So, here this was again a case related to the issue of federal funding towards the embryonic 00:38:26.099 --> 00:38:29.130 stem cell embryonic stem cell research. 00:38:29.130 --> 00:38:35.130 So, in this case if court of appeal upheld this federal funding of the embryonic stem 00:38:35.130 --> 00:38:36.130 cell research. 00:38:36.130 --> 00:38:43.020 So, basically in this case the decision was made by a three judge panel. 00:38:43.020 --> 00:38:51.240 So, there they found that this NIH funding towards the research inspite of this other 00:38:51.240 --> 00:38:56.799 amendment which is the Dickey-Wicker Amendment, where it said that the research where there 00:38:56.799 --> 00:39:01.660 is a destruction of the human embryo or use of the human embryo directly should not be 00:39:01.660 --> 00:39:03.349 funded. 00:39:03.349 --> 00:39:11.930 But, here in this case the research was not directly using the human embryo and so, it 00:39:11.930 --> 00:39:16.460 is not coming under the purview of that and it should be federally funded. 00:39:16.460 --> 00:39:22.549 So, that is why, there has been number of issues moral ethical consideration related 00:39:22.549 --> 00:39:28.960 to these embryonic stem cells though it has a bigger potential in treating various diseases, 00:39:28.960 --> 00:39:33.980 but because of this ethical issues so far we have not been so successful in this arena. 00:39:33.980 --> 00:39:39.869 In US there has been some clinical trials with the stem cells therapy. 00:39:39.869 --> 00:39:43.180 Already one or two product has been approved by the US FDA. 00:39:43.180 --> 00:39:48.950 But, in other countries because of these ethical issues only it has not been successful and 00:39:48.950 --> 00:39:51.220 also there are safety concerns definitely. 00:39:51.220 --> 00:39:57.900 But, overall in stem cell research and particularly human embryonic stem cell research the ethical 00:39:57.900 --> 00:40:07.160 issues are a major setback or major controversial point which is stopping from going easy towards 00:40:07.160 --> 00:40:11.779 in compared to the other biomedical field of research. 00:40:11.779 --> 00:40:16.460 So, these are the few reference, you may go through it. 00:40:16.460 --> 00:40:23.020 So, with this I am just concluding the portion on these stem cell ethical issues in general. 00:40:23.020 --> 00:40:27.950 In the next class we will discuss about the Indian perspective towards the stem cell research. 00:40:27.950 --> 00:40:28.580 Thank you.