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THERAPEUTIC CLONING,

TO CREATE HUMAN ORGANS

What is Cloning?

Cloning is the production of one or more individual plants or animals (whole or in part) that are genetically identical to an original plant or animal. 

Three very different procedures have been referred to as "cloning." Two are:

Adult DNA cloning (a.k.a. cell nuclear replacement): This involves removing the DNA from an embryo and replacing it with the DNA from a cell removed from an individual. Then, the embryo would be implanted in a woman's womb and be allowed to develop in to a new human whose DNA is identical to that of the original individual. This method has been used to clone a sheep. The initial steps of the procedure were tried using human DNA in 1998-DEC. Adult DNA cloning cannot ethically be used to produce a human clone, because experiments on animals have sometimes produced defective specimens. 

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Therapeutic cloning: This starts with the same procedure as is used in adult DNA cloning. The resultant embryo would be allowed to grow for perhaps 14 days. It's stem cells would then be extracted and encouraged to grow into a piece of human tissue or a complete human organ for transplant. The end result would not be a human being; it would be a replacement organ, or piece of nerve tissue, or quantity of skin. The first successful therapeutic cloning was accomplished in 2001-NOV by Advanced Cell Technology, a biotech company in Worcester, MA.

What is therapeutic cloning?

Therapeutic cloning would involve growing replacement organs (heart, liver, pancreas, skin, etc) from a sample of a person's DNA. The procedure would likely involve the use of a human embryo that has been modified by cell nuclear replacement, and the extraction of the embryo's stem cells. Therapeutic cloning has not yet been accomplished in the laboratory or clinic. However, a general approach by which it might be done in the future has been mapped out. It would probably involve a multi-step process:

A DNA sample would be taken from a sick patient.

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The sample would be inserted into an embryo in place of its original DNA.

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The embryo would be allowed to grow for perhaps two weeks.

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Stem cells would be removed from the embryo. This is a destructive step; the embryo would be killed in the process.

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The stem cells would be encouraged to grow into whatever tissue or organ is needed to treat the patient. Stem cells are a unique form of human cell that can theoretically develop into many organs or body parts the body. 

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The tissue or organ would be transplanted into the patient. 4

Future experiments may not succeed. There were four main hurdles to overcome:

Stem cells have to be "successfully isolated and grown in the laboratory." This has already been accomplished

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They have to be encouraged to "turn into specific cell types." This has been done for most of the 220 cell types in the human body.

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They have to be proven usable in treating patients with diseases, injuries, or disorders.

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The transplanted tissue must develop normally and must not represent significant "risks to the patient." 4

If scientists are successful, it would probably take many years of research before the first useful results will be obtained. 

What are its possible benefits?

If therapeutic cloning using embryos is successful, then perfectly matched, replacement organs could become freely available to sick and dying people. That would save countless numbers of lives, and increase the quality of life of countless others. Three possible examples of therapeutic cloning "might include the use of insulin-secreting cells for diabetes; nerve cells in stroke or Parkinson’s disease; or liver cells to repair a damaged organ." 4 There would probably also be side benefits resulting from the research. "Further advances in understanding of how organs regenerate would increase the range of possible treatments that could be considered." 4

In the United States during 1998, "More than 50 disease advocates and scientific societies, representing such concerns as diabetes, blindness, Parkinson's disease, glaucoma, AIDS, Down Syndrome, cystic fibrosis, stroke, lymphoma, infertility and cancer--as well as professional groups that focus on such issues as cell biology, aging, microbiology, ophthalmology, cardiology, pediatrics and reproductive medicine--recently sent a letter to members of Congress urging them to support federal funding for...[stem cell] research." 1

This procedure would have a number of advantages, when compared to regular organ transplant donated by a second person: 

There would be presumably be no danger of rejection of the transplant because the organ's DNA would match the patient's DNA exactly. 

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For transplants involving kidney (or theoretically any other organ that is duplicated in the body), another individual would not have to experience pain, inconvenience, and potentially shortened life span in order to donate the organ.

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The patient would not have to wait until an unrelated donor dies to obtain a transplant. A new organ could be grown for them as needed.

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The patient would not have to make-do with a replacement organ that is old and may have reduced functionality; a brand-new organ would be grown specifically for them.

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The procedure would save lives which would otherwise be lost waiting for a transplant that did not come in time.

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The potential exists to cure, or at least treat, certain diseases and disorders that cannot be effectively handled today.

Ethical considerations:

Ethics become a concern because of the source of the stem cells.

Stem cells could be obtained from other sources:

Embryos created during infertility treatment. These are sometimes called "spare embryos." They are usually frozen at a very low temperature in the event that they are needed in the future to attempt another a pregnancy.

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Embryos created for the purpose in the laboratory by manually fertilizing an ovum with donated sperm.

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From the germ cells or organs of an aborted fetus. These "appear to be limited in the type of tissue they can be developed into."

Unfortunately, organs grown from stem cells from one of these sources would have foreign DNA that did not match the DNA of the organ recipient. The recipient would have to take anti-rejection drugs for the rest of their life and could suffer organ rejection at any time.

There are four other sources that would produce organs that are perfectly matched to the recipient's DNA. They would presumably prevent organ rejection:

Via cell nuclear replacement, as described above. The nucleus in an ovum is removed and replaced by the nucleus from an adult cell from the patient.

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From bone marrow and some other adult tissues. These are expected to have limited usefulness.

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From "mature adult tissue cells reprogrammed to behave like stem cells." This mechanism is purely speculative at this time.

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From umbilical cord blood collected at the person's birth. This would require cord blood to be collected when a person is born and stored for possible future use. These stem cells also appear to have limited flexibility and usefulness.

Embryos appear to be the only source of stem cells that would have wide potential in therapeutic cloning. No societal consensus exists about the ethics of destroying a human embryo in order to collect stem cells.

Many conservative Christians and others believe that human personhood starts at conception. Therapeutic cloning would require that the embryo first be created by cell nuclear replacement, then killed.

Scientists would start with an living embryo. They would replace its DNA, producing a still-living embryo with a different DNA. This might be likened by some pro-lifers to replacing a person's arm. At this point, the embryo could be implanted in a woman's uterus. It would then have about one chance in four of developing into a fetus. Conservative Christians generally believe that a human person is present at this time. After growing for about 14 days, the embryo's stem cells would be removed, killing the embryo.  Most pro-lifers would consider this to be the killing of a human person -- simply one form of murder. The would find a therapeutic cloning laboratory to be the ethical equivalent to the Nazi death camps at Belsen or Auschwitz. They believe that it is immoral to kill one person in order to save or extend the life of another.

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"...some argue that the embryo requires and deserves no particular moral attention whatsoever." 4 They believe that an embryo is simply a collection of cells containing DNA, not much different from skin cells that each person sheds by the millions daily. It is not a human being, not a person. It is composed of a few cells with no internal organs, arms, legs, sensory organs, brain, or self-awareness. It may eventually become a person, but only if allowed to mature in a woman's uterus. They believe that human personhood comes later in gestation, perhaps when the fetus "looks like" a human, or when its brain develops to the point where it becomes conscious of itself, or at birth. 

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"Others accept the special status of an embryo as a potential human being, yet argue that the respect due to the embryo increases as it develops and that this respect, in the early stages in particular, may properly be weighed against the potential benefits arising from the proposed research." 4

There appears to be no hope of reaching a consensus on the ethics of harvesting stem cells from young embryos. Even within Christianity, Judaism, and other religions, a range of beliefs exists about when a fertilized ovum becomes a human person.

Legal developments:

1997 - USA: Commission recommends limitations on creating embryos: The U.S. National Bioethics Advisory Commission recommended in 1997 that:

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No federal funds be used for creating embryos as a source for stem cells.

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Stem cell research use only material harvested from aborted fetuses or from embryos left over after infertility treatments.

The U.S. National Institutes of Health drafted a set of guidelines in 1999 that:

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Would allow federal funding of stem cell research only using cells derived from aborted fetuses or from embryos left over after infertility treatments.

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Would not allow federal funding for research in methods of extracting stem cells from embryos.

No limitations exist for private research, not funded by the government.

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1998 - Korea: Researchers at a private company claimed that they had produced the first cloned human embryo. However, they offered no proof. According to the National Post: "Most researchers doubted the experiment ever took place." 7

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2000 - England: Recommendation to lift ban: On 2000-AUG-17, a chief medical officer's expert group recommended that the government ban be lifted on human "therapeutic cloning." In England, limited experimentation using young human embryos is permitted. Therapeutic cloning were seen to not raise "fundamentally new ethical issues." 2  "Government ministers have already indicated that they support...[the proposals]. Members of Parliament will vote on the issue later this year." 2

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2001-JUL-30:  USA: House subcommittee approves bill to ban therapeutic cloning: A sub-panel of the House Judiciary Committee approved a bill sponsored by Representative Dave Weldon (R-FL). It would ban all human therapeutic cloning for both reproduction and therapeutic research. It would provide for up to ten years in prison and up to $1 million in fines for persons who attempt to clone a human being. The Import of cloned embryos would also be banned. The Biotechnology Industry Group, which includes almost 1,000 member companies opposes human reproductive cloning, However. they wrote that therapeutic "cloning techniques in research are integral to the production of breakthrough medicines, diagnostics and vaccines." 5 T Their bioethics counsel, Michael Werner, said "Cloning for research purposes [could] open the door to the development of cures ... for unmet medical needs like diabetes, stroke and diseases of aging. Cloning is the way we can figure out how to turn valuable insights from stem-cell research into products that are transplantable into patients." The bill is expected to be debated by the Senate in early 2002.

A second bill, sponsored by Representative James Greenwood (R-PA) would ban the implantation of a therapeutically cloned embryo in a woman's womb to produce a baby, but would allow the creation of cloned embryos for medical research and the development of single organs.

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2001-JUL-30: Europe: Status of therapeutic cloning in the UK and the rest of Europe: Currently, therapeutic cloning of humans is banned in 29 European countries, but is permitted in the UK for research purposes. In 1991, the UK Parliament established the Human Fertilization and Embryology Authority, which licenses both fertility clinics and research institutions that study embryos. To date, the agency has allowed 118 embryos to be created for research purposes -- none yet for therapeutic cloning. However it has the authority to approve that form of cloning. "In the past decade, 925,747 [embryos] have been created and more than 50,000 babies have been born; 294,584 embryos have been destroyed and 53,497 have been used for research." 6 If therapeutic cloning is banned in the U.S., there would probably be an immediate "brain drain" of American medical researchers to the UK.

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2001-NOV-25: USA: Company successfully produced human clone: Advanced Cell Technology, a biotech company in Worcester, MA, announced that they had produced an embryo with human DNA which had grown to the six-cell level. The company's chief executive officer, Michael West, told NBC's Meet The Press that if the embryo had been implanted in a woman's womb, it might have developed into a newborn. However, the technology will be used only to generate stem cells for research. Mary Ann Liebert, publisher of the online journal e-biomed, said: "New technologies are frequently controversial and I think people right away think 'Oh my God, we're going to clone a human being,' but that is not what this is about. It will be sad and tragic if this does not go ahead." 7

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2001-JAN-29: USA: Company creates kidney-like organ via therapeutic cloning: Scientists at Advanced Cell Technology in Worcester, MA have proven the principle of therapeutic cloning. They took a cell from a cow's ear, inserted its DNA into a cow ovum which had its DNA removed, grew stem cells, extracted the cells, and produced a number of kidney-like cow organs. When implanted into the original cow, they were not rejected. They started to function like ordinary kidneys and produced urine. The impact of this development on humans suffering from kidney disease is immense. If the technology will work on humans, it would dramatically reduce the need for donor kidneys and transplants; fewer people would die; persons suffering from kidney disease would lead much improved lives. This development comes at a critical time, politically. The House has passed a bill that would criminalize both reproductive cloning (the production of cloned babies) and therapeutic cloning (the production of cloned organs). The Senate is debating a bill that would ban reproductive cloning but permit therapeutic cloning. 8

Related essay on this website:

Menu: Cloning - all aspects 

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Stem cell research

References:

1.      "Comment: Stem Cell Research," Mary Woodard Lasker Charitable Trust, at: http://www.fundingfirst.org/comment/16/comm2.html

2.      "British experts back cloning," 2000-AUG-16, at: http://www.7am.com/cgi-bin/twires.cgi?

3.      "Stem cell research: Medical progress with responsibility," Chief medical officer's expert advisory group on Therapeutic Cloning," at: http://www.doh.gov.uk/cegc/ 

4.      "A report from the chief medical officer's expert group reviewing the potential of developments in stem cell research and cell nuclear replacement to benefit human health," Department of Health (UK), at: http://www.doh.gov.uk/cegc/stemcellreport.htm The report is available as an executive summary or as full report in PDF format. You can obtain a free software to read PDF files from Adobe.

5.      Todd Zwillich, "House subcommittee approves ban on human cloning,"  at: http://www.reutershealth.com/ 

6.      "Embryo, stem cell research moving full bore in Britain," New York Times, at: http://new.omaha.com/index.php?

7.      Tom Arnold, "Embryo research raises issues of morals, ethics: Laws on human replication lagging behind science," National Post (Canada), 2001-NOV-26. See: http://www.nationalpost.com/artslife/life/health/

8.      Rick Weiss, "Scientists Claim an Advance in Therapeutic Cloning: Mass. Firm Uses Embryonic Cow Cells to Create Kidney-Like Organs; Transplant Success Reported," Washington Post at:  http://www.washingtonpost.com/wp-dyn/

Copyright © 2000 to 2002 incl., by Ontario Consultants on Religious Tolerance
Originally published: 2000-AUG-17

Last updated 2002-JAN-31
Author: B. A. Robinson

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