Therapeutic cloning The next big breakthrough for human healthcare Tay Yuan Quan (yqtay.2013@business.smu.edu.

.sg) 1st Year student, School of Business, Singapore Management University

Executive summary This paper hopes to explore the potential of Therapeutic cloning and how it could greatly extend the longevity of the human race. The paper will analyse the potential applications to healthcare and the implications of it. Ethical and social concerns as well as the setbacks pertaining to therapeutic cloning will also be discussed. Through the analysis of the benefits and detriments of therapeutic cloning, possible solutions will be suggested in this paper. An Introduction to Therapeutic cloning Firstly, there is a need to distinguish between therapeutic cloning and reproductive cloning. Reproductive cloning is basically what is shown in movies like The Island (2005) or the Resident Evil saga where an identical individual is cloned from the cells of another. Therapeutic cloning, on the other hand uses the same initial cloning procedures but the process is cut when the Egg cell becomes a blastocyst. The stem cells derived from the blastocyst is then induced into different forms to treat different disease. Biotechnology and stem cell advances offers huge potential in elongating our lifespans with its regenerative medicinal properties and its effective treatment of genetic defects. Therapeutic cloning basically derives pluripotent stem cells from a process known as SCNT(Somatic Nuclear Cell Transfer) and uses these stem cells to perform treatment for various disease. Pluripotent stem cells are cells that have the potential to turn into any specialized cells in our body; they are the building blocks of our body. These stem cells can then be induced to treat a variety of health issues, like the treatment of leukaemia or dividing into an organ for transplant. The diagram on the right is a simplified version of how SCNT works. Basically an egg cell is retrieved from a human female and its nucleus containing its original genetic material is removed. A normal body cell (e.g. skin cell) with the desired genetic material will then have its nucleus removed and inserted into the modified egg cell. The Zygote formed will then multiply into a Blastocyst which contains the pluripotent stem cells. At this point, the stem cells are removed from the blastocyst and specific growth hormones and markers are added to induce the cells to differentiate into the desired cell type.
Figure 1. SCNT Process
Reproduced from (stem cell battles)

This paper was reviewed by Siddarth Sethi and Zheng Tian Bai.

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Milestones of Therapeutic cloning

1938- The idea of cloning was conceptualized. The first SCNT experiment was proposed by Dr Hans Spemann from Germany. This was a very important moment as SCNT is currently one of the most effective methods of creating an embryo in the lab. 1953- Crick(Francis C. Crick) and Watson(James D. Watson) discovered the structure of DNA. 1995- Contrary to popular beliefs, the worlds first cloned sheep was not dolly the sheep. Megan and Morag were there first sheep to be cloned using differentiated cells by Dr. Ian Wilmut and Keith Campbell. 1997- The famous Dolly the sheep was cloned from an adult somatic cell through SCNT. The scientist involved were Dr. Ian Wilmut and Keith Campbell. 2002- Cow kidneys were successfully cloned through SCNT methods by researchers in the US. The kidneys that were implanted back in the cows were not rejected by the immune system of the cow. 2007- Monkey skin cells were converted into embryonic stem cells by scientist from the Oregon and Science University and Oregon National Primate Research Center. 2008- Researchers at the Memorial Sloan-Kettering Cancer Center have successfully used SCNT techniques to treat conditions similar to Parkinsons Disease in mice. 2013-Human skin cells successfully converted into embryonic stem cells by scientist at the Oregon and Science University and Oregon National Primate Research Center. This was followed by their success of converting monkey skin cells into embryonic stem cells in 2007.

Potential benefits of Therapeutic cloning

Cure for diseases previously thought incurable Therapeutic cloning has the potential to cure many diseases that health science have yet to find a solution to. Therapeutic cloning basically provides or replaces the cells or tissues that are missing, damaged or defective. Parkinsons disease, stroke patients and Duchenne muscular dystrophy disease are some examples of what therapeutic cloning could possibly cure. Parkinsons disease is the degeneration of the bodys central nervous system. It results from the death of cells that produce neurotransmitters and the cause of this is unknown. There is currently no cure for this disease. However, therapeutic cloning potentially offers a cure by providing customized dopamine neurons, which is missing in Parkinsons disease patients. (Tabar & Studer, 2008) This is done by using the skin cells of patients, create the neurons that are identical to the patient, and injecting them into the patients. Stroke and heart attack patients have damages in parts of their bodies that do not have regenerative properties. There are currently no effective drugs to eradicate the damages done by these diseases. Damages to the brain in stroke patients are replaced by scar tissues (Devolder & Savulescu) and that part of the brain loses its original function. Similarly, the area damaged by the heart attack is replaced
This paper was reviewed by Siddarth Sethi and Zheng Tian Bai.

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by scar tissues as well, and these scar tissues do not contract and the hearts ability to pump blood is usually reduced after an attack. ("Heart attacks and,") Therapeutic cloning offers the potential to replace those scar tissues with new cells so as to restore the organs to their original state.

Solution for shortage of organs/tissues/cells There are many people out there that are awaiting an organ, tissue or cell transplant. Diseases like Leukaemia, Kidney failure or liver failure requires the patient to find a suitable organ or stem cells from a donor to treat the disease. The waiting time for such donations are usually long and the patients suffer considerable discomfort and pain during the wait. In Singapore, it takes about 8 years for a kidney failure patient to get a kidney donation from a deceased person. ("Kidney transplant," ) During this long wait, patients have to go through, in serious cases, at least 3 times a week of Hemodialysis to filter off the toxins in their blood. The process is both time consuming and painful, and the fees are expensive as well. Therapeutic cloning has the potential to produce organs, tissues or specialized stem cells inside the lab that are genetically identical to the patient. If such a feat was completed, donor shortage would be solved as the required parts of the body could be cloned and implanted into the patient at a significantly short period of time. ("Cloned fetal cow," 2002)

Low risk of immune rejection from a transplant Body parts that are cloned using therapeutic cloning methods would be of identical genetic makeup as the patient that requires the organ, tissue or cells. Hence, it heavily reduces the possibility of a transplant rejection. Current methods of transplanting an organ from another person runs the risk of the host body rejecting the organ by producing antibodies to destroy the foreign organ. ("Organ transplant: After," 2010) Patients will have to take antirejection medicine for the rest of their lives in order to suppress their immune system. Such medicines have heavy side effects and often weakens the patients immune system, making them more susceptible to diseases. The organs, tissue or cells produced by therapeutic cloning are almost genetically identical to the host patient and the bodys immune system will not recognize it as a foreign body, hence immune rejection is often not present. Such will reduce the need for antirejection medicine for patients and the possible consequences of immune rejection is eradicated.

Current situation of therapeutic cloning

Currently, therapeutic cloning has not been completed. There are still many areas that need to be further researched and fine-tuned. Furthermore, there has been many issues surrounding the research and development of therapeutic cloning. The greatest roadblock in therapeutic cloning today is the lack of human egg cells for experimentation. Human egg cells, better known as ovum, are the reproductive cell belonging to the female Homo sapiens. They are the basis of therapeutic cloning, and the shortage of it means that they are unable to properly research and experiment with this science. Approval for research of therapeutic cloning was given to a group of researchers at Harvard university, yet a year and a half after this approval this group of researchers have made no progress due to the lack of unfertilized human eggs. (Singer, 2007) Unfertilized human eggs can only be derived from human females. However, a combination of social and ethical issues have gave rise to a number of factors that inhibits the supply of human eggs. Such

This paper was reviewed by Siddarth Sethi and Zheng Tian Bai.

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factors include policies to restrict research and the mind set of people. The ethical and social concerns will first be discussed followed by the restricting factors.

Ethical concerns The main concern regarding this issue is that in order to retrieve the stem cells during SCNT, the Blastocyst is destroyed. Prolife partisans regard the destruction of the blastocyst as murder (Kfoury, 2007) since it is one of the stages of the human reproduction process as it possibly have the potential to develop into a human being. This argument of potential has sparked many debates, and the structure of the argument is as below. premiss 1: It is morally wrong to kill a potential person premiss 2: Human embryos are potential persons conclusion: It is morally wrong to kill human embryos (Staudacher & Vossenkuhl, 2009, p.91) The argument is based on the premise that human embryos are considered potential human beings and that they can grow to become beings with personal qualities. There have been many successful instances of animals being cloned, for example dolly the sheep. Such experiments proved that embryos grown inside a lab can grow and develop if given the right conditions. Protestants of cloning hence, brought forth that these embryos used for therapeutic cloning do have the potential to develop personal qualities and that they are indeed potential people. (Staudacher & Vossenkuhl, 2009)

Social Concerns The social concerns surrounding this science is that since reproductive cloning and therapeutic cloning stem from the same process, there is a concern that by allowing the development of therapeutic cloning, reproductive cloning development could be completed in the process. (Kfoury, 2007) Both therapeutic cloning and reproductive cloning uses SCNT to create the blastocyst containing the pluripotent stem cells. The key difference here is that in therapeutic cloning, the stem cells are harvested from the blastocyst and the growth of the blastocyst stops there. In reproductive cloning, the blastocyst is implanted into the mother and is allowed to grow into a human being. As such, there is much fear that if therapeutic cloning research was unrestricted, reproductive cloning will be completed in the process.
F i g ure 2. Differences between therapeutic and reproductive cloning. Reproduced from (Cloning 101, 2005)

Reproductive cloning is the creation of a new organism with identical DNA as an existing organism. There are fears that there may be a misuse of such a technology, for example there may be a loss of
This paper was reviewed by Siddarth Sethi and Zheng Tian Bai.

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identity since the clone is genetically identical to the person who provided the genetic material. In other words, they will have very facial features and identical finger prints. There are also people who regard reproductive cloning as an act of Playing God. (Bainbridge, 2003) Religious people that believe in a higher being feels that the act of giving life should be solely done by god himself. Due to the above concerns, many are afraid of giving therapeutic cloning research the green light due to the similarities between the two in their initial process.

Factors inhibiting research of therapeutic cloning Due to the social and ethical issues present, laws and policies have been put in place to restrict the research of therapeutic cloning. The policies and laws that govern the research of therapeutic cloning is one of the biggest reason why there is a shortage of human eggs for research purposes. In the US, Massachusetts regulations does not allow scientist to provide monetary benefits in exchange for womens eggs. (Singer, 2007) Such regulations have being put in place in order to prevent poorer women from selling off their finite number of eggs just for the money. However, it has resulted in a huge disincentive for women to donate their eggs. There is a certain amount of discomfort and risk involved in the extraction of egg cells from women. Women will not only have to go through hormone treatment and counselling, there are health risks involved and the process can be painful and uncomfortable. Without any sort of incentives, women are very unlikely to want to donate their eggs. Due to this fact, researchers are having great difficulties obtaining egg cells to further their research. The lack of funding has also greatly slowed the progress of therapeutic cloning. In the United States, federal funding is not available for research in therapeutic cloning for most of the states. (Kfoury, 2007) Hence, researchers have to rely on the limited funding from private sources. The lack of funds would mean that researchers have less efficient technology to work with and less man power to facilitate experiments. Furthermore, the absence of state funding would mean that companies are less willing to take up research and development projects in the field of therapeutic cloning due to the high cost it might incur. Such as led therapeutic cloning coming to a standstill, with only a minimal number of companies doing research on the subject with limited funds.

Technical issues There are still many technical that remain unresolved in therapeutic cloning. The presence of genetic material in the Mitochondria of the human egg cell causes complication in the therapeutic cloning process. There is a mismatch between the genetic material of the mitochondria between the stem cells recovered and the patient requiring the implants. This genetic mismatch could result in immune rejection within the cells, resulting in the need for immunosuppression drugs. (Kfoury, 2007)

There is also a lot of research that needs to be done on what kind of conditions would coax the pluripotent stem cells into the type of specialized cells needed. There are currently very little
This paper was reviewed by Siddarth Sethi and Zheng Tian Bai.

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development in this area as most of the resources are still used up on trying to complete the process of SCNT.

Future considerations

There are many hurdles to clear before therapeutic clonings full benefits could be reaped. Therapeutic cloning will be the next breakthrough for humankinds healthcare, providing more effective and faster solutions to diseases we are currently facing. There is a need for people to better understand and realize the potential of this technology. The first imminent issue at hand is for people to differentiate reproductive cloning and therapeutic cloning. There is a general misunderstanding that therapeutic cloning equates to reproductive cloning, and people fear the possible consequences of reproductive cloning materializing. Governments around the world are currently very reluctant to pass any laws that allow therapeutic cloning due to fears of angering the people and losing votes in their elections. In democratic countries, the citizens cast votes to affect the election of governmental positions. Political leaders are thus, reluctant to try to pass laws that angers their citizens. Therapeutic cloning is a very controversial subject in many countries, especially in countries like the United States. Attempts to legalize cloning research could lead to these political leaders losing votes and support in the next election. Hence, actions need to be taken to ensure that this negative perception of therapeutic cloning is reduced. Governments can increase awareness of the vast potentials of therapeutic cloning in their citizens and come out with strict and effective policies that forbid any sort of research into reproductive cloning. Such could possibly make the general public more accepting to this technology and reduce the pressure on the government to hinder the progress of therapeutic cloning. There is a need for new methods of therapeutic cloning that reduces the ethical and social issues faced currently. For example, the ethical issue of killing off an embryo could be reduced through the egg sharing program. (Singer, 2007) Women who are going to go through in vitro fertilization, which is fertilizing an egg first before inserting it into the ovum of the women to stimulate pregnancy, could agree to donate the excess eggs for research purposes in exchange for a subsidized fee. (Singer, 2007) The excess eggs, which would otherwise be wasted, could be used for research purposes. Furthermore, it will lower the cost of in vitro fertilization for women who are less well-off and in need of in vitro fertilization. Using such excess eggs is also more ethical as they are excess and would be wasted otherwise.

Conclusion In conclusion, therapeutic cloning has great potential for humans health. Diseases that are previously thought untreatable could be cured by this science. Health care cost for governments will decreases significantly with the improved and more efficient methods to tackle diseases. There is too much to gain from completing therapeutic cloning for us to stop because of social and ethical issues that can be resolved. With a good combination of effort from the government and the public, it is definitely possible to come out with a solution that allows therapeutic cloning to progress without fully compromising the social and ethical issues. It is imperative that clear borders are set so that the development does not stray into the reproductive cloning areas. This is the next breakthrough for

This paper was reviewed by Siddarth Sethi and Zheng Tian Bai.

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human healthcare and efforts should be placed into clearing the road blocks that are stopping therapeutic cloning from happening.

This paper was reviewed by Siddarth Sethi and Zheng Tian Bai.

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This paper was reviewed by Siddarth Sethi and Zheng Tian Bai.

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