Human Fertilisation and Embryology Bill [HL]

I apologise for taking more of your Lordships’ time. The noble Lord is quite right: I said at Second Reading that Yamanaka had used in his work in Japan vectors which subsequently produced tumours in mice. He is right also that only last week—in fact, just a few days ago—there was an article in Nature Biotechnology headed: "““Generation of induced pluripotent stem cells without Myc from mouse and human fibroblasts””." That meant that there will not be tumorogenicity of the same degree, but I shall come back to that in a minute, because the story is not quite as glorious as the noble Lord just made out. He was quite right, though, that science is moving fast in this area and may be promising. There is no doubt that this recent publication, related to induced pluripotency in adult cells, is a scientific advance that most scientists working in stem cell science would not have expected to come with the speed with which it has. It heralds tremendous promise for achieving every stem cell scientist’s holy grail—the noble Lord, Lord Alton, will remember that I mentioned it—of being able to reprogramme an adult cell to a pluripotent cell and differentiate it in the cell types that they need to treat the diseases. That is what every scientist is chasing. It is not that they wish to do embryonic stem cell research for amusement or any other purpose; it is solely for the purpose of looking for treatments. I return to the main point of the amendment, which relates to two issues: interspecies embryos, and embryos created for cell nuclear-transfer technology. Perhaps I may read a document that I received from Sir Martin Evans, this year’s winner of the Nobel Prize in Physiology or Medicine. He is the man who identified embryonic stem cells decades ago and showed that it was possible to obtain cells with normal chromosomes from early blastocysts. In a recent publication, Jamie Thomson, in Wisconsin, first identified chromosomally normal stem cells from human embryos and early blastocysts. Sir Martin states: "““At the moment, and for the foreseeable immediate future, neither induced pluripotent stem cells nor adult stem cells will suffice for either research or development of stem cell-based therapeutic approaches. It should be pointed out that, presently, the induced pluripotent cells all have integrated within them factors””." Those factors are viral factors. In the original article by Yamanaka, there were four factors. One of them was an oncogene called Myc, which subsequently induced tumours in the mice. Their oncogene is now removed. What if scientists removed that and used other vectors to induce pluripotency? Yamanaka said that he had induced in his experiments 20 factors in every cell. That means that the chance of a cell subsequently derived not having any of these factors in it would be one in 10 million. We do not know at this stage what results that may produce. The Bill defines four types of interspecies embryo and prohibits creation and use of these except under licence. At present, the main research focus for the use of those entities would be the use of cytoplasmic hybrids, as the noble Lord said—and I agree with him. Scientists currently wish to use only cytoplasmic hybrids to do the experiments, and not others. The Bill also allows for further regulations to be made by the Secretary of State to include other as yet unforeseen and therefore indefinable entities in the remit of the legislation. Stem cell research is one of the most exciting areas of 21st century science, as has been said many times. I have said before that if last century was the century of the physical sciences, it looks as if this century may be the century of the biological sciences. If it produces the same degree of advances as the physical sciences produced last century, our lives will be changed—and certainly, the lives of those with debilitating diseases will be changed. As we all know, the UK has an international reputation as a leader in stem cell science. Somatic cell nuclear replacement technique may prove a reliable method of generating human embryonic stem cells, with particular properties that are not readily available using donated supernumerary embryos. SCNT, as somatic cell nuclear transfer is often referred to, has three specific aims: to create disease-specific stem cell lines that can be used to model disease processes and open up new opportunities for developing therapies; to generate stem cell lines with particular genetic backgrounds to be used in drug development assays; and to create patient-specific stem lines for therapeutic use, which would avoid rejection by the recipient immune system, either because they are created using a patient’s donor cell nucleus or selected to be immunocompatible. SCNT techniques have proved effective in numerous animal species. Just two weeks ago there was success in achieving SCNT in monkeys, which suggests that current technical barriers might be surmountable. Nevertheless, many eggs will be required to develop SCNT techniques to derive human stem cells, and the problem with SCNT is the low availability of human oocytes, which is limited by the prior needs of patients undergoing infertility treatment and the invasiveness of the donor procedure. It may therefore be more acceptable to use animal rather than human eggs, since they could be used to generate cytoplasmic hybrid embryos for the derivation of embryonic stem cell lines of essentially human nature. At the time when these cells are harvested from the blastocysts, most of the genetic material is human to the extent of 99.9 per cent or more. Some say that if you harvest it early enough it would be virtually 100 per cent, because more of the animal material from the mitochondria is transmitted later in the blastocysts. Animal eggs are readily available from abattoirs. Proposed research on interspecies embryos in the United Kingdom would involve taking the somatic cell from an adult with a degenerative condition and placing the nucleus in a nucleated animal egg to create stem cell lines to use as diseased models to study pathogenesis and test therapies. Currently, SCNT-derived cells could not be used therapeutically, and no one has the intention to do so, given the exposure to material of animal origin. I say ““currently”” because we do not know whether it will be possible in science in due course to remove all the animal material. In the United States it is likely that within two years the original embryonic stem cell lines created by James Thomson will be used, with FDA approval which has already been given. Those stem cell lines had rabbit feeder cells; by using a scientific technique, those feeder cells have been removed. The FDA has accepted that technique and allowed permission for those cells to be used for therapy for the first stage of the trial. Generation of cytoplasmic hybrid embryos using readily available animal eggs would also provide invaluable experience in SCNT technology, thereby increasing technical efficiency and expertise so that a much smaller number of human eggs would subsequently be needed to generate ““patient-specific”” stem cells that could be used for clinical treatment. The information and technique would also be relevant in research looking at deriving stem cells by programming adult somatic stem cells. In that respect, I also have to say to my noble friend Lord Alton that a technique of reprogramming adult cells to become pluripotent cells used the technique developed by using embryonic stem cells. Without learning from embryonic stem cells, that particular technique would not have been possible as we had to know which vectors were needed to induce pluripotency. My noble friend may challenge that and we will have an interesting discussion if he does. Recent advances in the methods of direct reprogramming of human somatic cells without the use of oocytes or early embryos, from the Thompson and the Yamanaka groups in the US and Japan, are exciting and welcome. However, that work is at a very preliminary stage and the current technology involves engineering the cells in a way that raises a number of safety issues that will need further refinement before the use of iPS cells in the clinic can be contemplated. To give one example: adult cells have a problem with what we call telomere, or the ageing process. If these cells are used for therapy there will always be a problem because of the loss of telomeres when inserted for treatment. They may produce cancers in the patients treated because of the limited senescence of these cells. Not enough is known about any particular route to generating stem cells to be sure of predicting which approach will bear fruit, and all avenues of research should be left open. Discoveries in all types of stem cell research inform the field and have the potential to accelerate the delivery of safe and effective stem cell therapies. Indeed, the leading stem cell centres in the UK and overseas contain groups that are working with both embryonic and adult stem cells, and no doubt iPS cell technology will be incorporated in the very near future. In fact, scientists in the UK have already started using the iPS technology following the two reports. Regulating the creation of interspecies embryos for research under the strict regulatory regime of the Human Fertilisation and Embryology Act will ensure that it is undertaken in a responsible and appropriate manner, subject to rigorous transparent review. Such work will undoubtedly progress in other countries and it would be preferable for the UK to conduct research in its tightly regulated environment rather than rely on results from countries where the same standards may not apply. The Bill clearly prohibits placing an interspecies embryo in a woman. Furthermore, interspecies embryos cannot be kept after the earliest of the following: the appearance of the primitive streak, or the end of a period of 14 days beginning with the day on which the process of creating the interspecies embryo began. The regulation is firm enough to stop that happening. There are other issues related to induced pluripotent cells derived from adult cells because of the state of senescence that I have already mentioned. iPS cells, even if they are made safe for transplantation cell therapy, may be useful in patients of a certain age only before their inherited state of senescence turns the cells cancerous. What do we do for the teenager who suffers spinal cord injury in a motorcycle accident? The answer still has to be that ES cells retain real potential in that situation. One can assess whether induced pluripotent cells have the same behavioural potential as embryonic pluripotent stem cells by comparing them with the gold standard of embryonic pluripotent stem cells. My plea is that at this stage we should allow research on all types of stem cells: adult stem cells, cord blood stem cells, cord stem cells, bone marrow stem cells, embryonic stem cells, induced pluripotent cells and even menstrual blood stem cells.