CONGRESSIONAL TESTIMONY

Testimony Before House Government Reform Committee on Human Cloning
May 15, 2002

Statement by James Kelly
Activist for Spinal Cord Injury Treatment
Fort Worth, Texas
A wise man once said: "For those who perceive, one sign is enough. For those whose minds are closed, a thousand reasons are wasted."

The outcome of the present cloning debate will affect the lives of over a hundred million Americans. This is a cold, hard fact, not wild speculation. Every year twenty-six million Americans are diagnosed with diseases or conditions that stem cells are expected to someday play a major part in curing. Many more millions already suffer from these life-threatening or crippling conditions. Therefore it is not far-fetched to say that even a year’s delay in the availability of cures for these conditions will result in millions of Americans needlessly dying, suffering catastrophic impairment, or enduring needless misery. Their loved ones will know profound sadness and grief. Millions more will anxiously await the future with desperate hope. But what if their cures are delayed for three years, five, ten, twenty or more?

Americans are being told that cloning has the potential to play a large part in curing disease. Therefore, many who suffer these conditions (and many able-bodied Americans) support the cause of cloning regardless of the moral questions involved. They believe what they’re being told, and they’re speaking out in defense of their cures. But in my opinion the question we should be asking is not "Does cloning have therapeutic potential?" Rather, it is: "Will giving cloning research a green light speed the medical availability of cures, or slow or block their progress?"

Because of a 1997 spinal cord injury, I’m paralyzed below the chest. For the past five years I’ve closely followed medical research, learning the factors involved in curing my condition. Over the last several months I’ve compared the research progress and technical roadblocks of adult, embryonic, and cloned embryonic stem cells for all the conditions they’re expected to address. I focused on their therapeutic potential as well as safety, performance, and marketing potentials. In weighing these aspects I tried to determine objectively whether cloning research would speed or slow the availability of cures. My only priority is that millions don’t needlessly die, and that many others, including myself, regain lost mental or physical functions as quickly as possible.

I have arrived at a definite conclusion, and would like to present what I’ve learned. I hope each of you will draw your own conclusions, and speak up for your future while you still have a chance. But please do so while carefully considering the following points, for this issue’s outcome will all too soon be a matter of life or death for millions.

Embryonic stem cells taken from cloned embryos:

  • are projected as a source of embryonic stem cells with the patient’s DNA, so that these cells will not be rejected by the body’s immune response.
  • are expected to replace damaged or diseased adult tissues in humans, such as heart cells, nerve cells, insulin-producing islet cells, and others.
  • have safety and performance obstacles that need to be overcome before they can be medically tested in humans. These include short- and long-term genetic mutations and unreliability (1), a tendency to form tumors when injected into animals (2), and, unexpectedly, foreign tissue rejection. Say the authors of a recent study: "Our results raise the provocative possibility that even genetically matched cells derived by therapeutic cloning may still face barriers to effective transplantation for some disorders" (3).
  • may be of questionable benefit in terms of treating medical conditions with a genetic basis. In his March 5 testimony before the Senate Judiciary Committee, Dr. Stuart Newman of New York Medical College noted: "Genetically matched cells from cloning may well be useless in treating conditions with a genetic basis such as juvenile diabetes – for these cells will have the same genetic defect that caused the problem in the first place."
  • have yet to play a necessary part in any treatment that improves a lab animal’s or a human’s medical condition.
  • would require fifteen million women’s eggs to cure all diabetic Americans, if every cloning attempt produces a viable embryo and ultimately a cell line. However, most sources claim a hundred attempts or more may be needed to create a single usable stem cell line, with each attempt needing another egg. If that is true, one and a half billion eggs would be required to use cloning for diabetic uses alone. Heart disease would require at least five to seven times more (with twenty-one million new cases of heart disease a year).
  • Thomas Okarma, chief executive of Geron Corporation, a cell therapy company, has said that he has no interest in using cloned embryos to produce customized treatments for disease, because the odds favoring success "are vanishingly small" and the costs are daunting. Okarma says it would take "thousands of [human] eggs on an assembly line" to produce a custom therapy for a single person. "The process is a nonstarter, commercially," he says. He points out that it would take "100 eggs if you're lucky" to produce an embryo whose stem cells will be usable. His view is shared by Alan Robins, chief scientific officer of BresaGen Ltd., a cell therapy company in Australia and Athens, Georgia. "Where do you source that many eggs?," Robins asks. "Sourcing human eggs is a contentious issue in itself… It is not something we want to get involved in." (4)
  • are expected by leading scientific supporters to be too expensive to use on an individual patient basis. The April 5, 2001 issue of Nature reports that the idea of human "therapeutic cloning" is "falling from favour" and that "many experts do not now expect therapeutic cloning to have a large clinical impact." James Thomson of the University of Wisconsin, a leading embryonic stem cell researcher, says this approach would be "astronomically expensive." In light of the wastefulness of the cloning process and the damage it does to gene expression, this article notes that "many researchers have come to doubt whether therapeutic cloning will ever be efficient enough to be commercially viable." (5)
  • In the previously cited L.A. Times article, Lutz Giebel, CEO of CyThera, a cell therapy company in San Diego, points out: "Quality control presents another hurdle. The Food and Drug Administration is set up to sample drugs produced in large commercial lots, not individual cell therapies. It is not commercially viable. Quality control is difficult; the FDA can't regulate it, [and] no one can afford the treatment." Giebel calls therapeutic cloning a "research tool only."
  • are not expected by scientific supporters to lead to medically available cures for "a very long time." Scientist Janet Rowley is a member of the President’s Council on Bioethics who supports cloning for research. In speaking of the therapeutic potential of cloned embryonic stem cells she recently cautioned: "I think it's not fair to say that the promise will not be realized, but I think that it is fair to say that the promise may take a very long time. And I just want to point out that we began the war on cancer in 1970 with the notion that it was all going to be over in 10 or 20 years and we're far from it." (6)
    •

    Adult stem cells:

  • can have the patient’s DNA when needed.
  • have been proven capable of maturing into tissues needed to cure the same conditions that cloned embryonic stem cells are expected to address (7, 8, 9, 10, 11, 12).
  • are readily available. Recent advances have taught researchers how to harvest multipotent stem cells from the skin, blood, bone marrow, and intestines (13, 14, 15).
  • are affordable (they’ve been used for years in humans for certain types of cancers and other illnesses with the backing of health care providers).
  • are much further advanced towards clinical use. Experimental use of adult stem cells has already led to functional improvements in both animals and humans for the following conditions: Heart Disease (16), Stroke (17), Traumatic Brain Damage (18), Diabetes (19), Spinal Cord Injury (20), Immune Deficiency Syndrome (21), Multiple Sclerosis (22, 23), certain forms of Cancer (24), Parkinson’s Disease (25), and others.
  • require further research to simplify, perfect, and expand their uses.

    • The FDA approves clinical testing of new treatments based on their merits as a whole, including each of their component steps in context with the rest. Therefore, cloning’s potential for causing short- and long-term genetic mutations, tumor formation, and tissue rejection will need to be ironed out separately for each of its purported uses. Due to the complexity and magnitude of these obstacles and the number of applications that cloning is projected to address, while its clinical potential in the foreseeable future is completely nil, its potential to divert crucial resources for "a very long time" from other avenues, such as adult stem cells, is enormous.

    Adult stem cell usage is not the only therapeutic avenue closer to providing beneficial treatments than cloning. In fact, for my condition, spinal cord injury, three primary approaches have been identified with the potential to restore lost neural functions (26, 27, 28). These are: bridging the injury site with a growth-permissive scaffolding or neutralizing inhibitory molecules within the site’s "glial scar"; inducing robust sprouting of existing axons to cross the injury site; and specialized neural cell replacement. Of the three, stem cells from whatever source (specialized cell replacement) have very little potential to lead to even minimal functional gains in the chronic condition if used alone (29). Overcoming the inhibitory injury site and inducing existing axons to sprout, cross the injury site, and remake broken neural connections offers far greater functional benefits (30, 31, 32, 33).

    In his online spinal cord injury forum, neuroscientist Wise Young of Rutgers recently noted "a growing consensus in the field that the most desirable cells for transplantation are cells that are far enough along the way to differentiating into desirable cells, such as neurons, insulin-secreting cells, radial glial or olfactory ensheathing glial cells, that they have a high likelihood of producing such cells." He was commenting on a recent study using fetal "progenitor" cells -- stem cells that are committed to becoming a specific adult cell type but still retain stem cell characteristics. (34) Embryonic stem cells taken from cloned embryos are the very earliest and least developed of all stem cell types. Without implanting cloned embryos in a woman’s womb and then later removing the fetus, medical science has no reliable way to bring stem cells from cloned embryos to this "most desirable" stage. This study also points out that many scientists believe adult progenitor stem cells are equally desirable and are already being clinically tested in humans.

    I began my inquiries with a chip on my shoulder. It appeared to me (from media reports of comments made by pro-cloning scientists) that religious groups and moralists might keep me from being cured. Also, I didn’t want to consider these moral aspects, in case my inquiries led me to conclude that my best chance of being cured lay in being cloned. Only a daily barrage of facts that conflicted with my preconceptions allowed me to see past my resentment and fear. That I uncovered these facts myself, rather than being told them by others, probably contributed to my gradual acceptance of what I learned.

    After uncovering the information presented in this testimony I was able to objectively consider the moral aspects of cloning. Until then, I refused to consider these aspects in case my investigations led me to conclude I needed cloning to regain the use of my body. Once I made my conclusions based on what I’d learned, I still didn’t give any thought to the moral aspects of cloning, since my conclusions made its morality a moot point (regarding my own priorities). But as an ex-train dispatcher and ex-locomotive electrician, I tend to see things in black and white. So while attending the President’s April 10th speech in support of Senator Brownback’s proposed ban on human embryo cloning for any purpose (human somatic cell nuclear transfer), for the first time I looked squarely at the morality of cloning. This is what I saw.

    No matter what it’s called, an embryo, a blastocyst, or whatever, if implanted into a woman’s womb, the living entity made through cloning would someday be an infant. Regardless of whether its eyes are blue or its hair is brown, the infant would have to be human, not a bird, or a dog, or a pig, or a zebra. Simply put, a cloned embryo is certainly a very small and very early stage of human life, but nonetheless it is a valid stage of human existence. So how could I continue to ignore the fact that cloning involves intentionally creating human life with the prior intention of killing it? Or how could I reason that any end justifies such a means…even if the end is supposedly to save my life?

    The scientific and practical facts presented in this testimony led me to conclude that it’s highly unlikely that human cloning will ever be medically useful. Without a doubt it is a highly problematic avenue, requiring the diversion of substantial funds and resources from research avenues that offer more than futile hope. Therefore human cloning research is far more likely to slow the availability of cures than to hasten their development. Because of this and the moral perspective I’ve just presented, I totally support the Brownback-Landrieu Human Cloning Prohibition Act (S. 1899).

    Most of us are instinctively horrified in a deep inner way by fatal sickness, lingering disease, and crippling conditions. Speaking for myself, I know I’m terrified of never regaining my body, or the life I loved. Therefore I can easily understand why we have a strong need to believe the primary goal of researchers is to make us well, or to protect our health, rather than to safeguard their careers, advance their special field, or protect the continued growth of science for the sake of science. But this life and death matter is much too important to allow us to choose our course through fear, resentment, trust, ambition, or hope. We need to get it right!

    REFERENCES

    1. Tsunoda Y; Kato Y, Recent progress and problems in animal cloning, Differentiation 2002 Jan; 69 (4-5):158-61.
    2. Nozaki T; Masutani M; Watanabe M; Ochiya T; Hasegawa F; Nakagama H; Suzuki H; Sugimura T, Syncytiotrophoblastic giant cells in teratocarcinoma-like tumors derived from Parp-disrupted mouse embryonic stem cells. Proc Natl Acad Sci U S A 1999 Nov 9;96 (23): 13345-50.  
    3. Rideout W; Hochedlinger K; Kyba M; Daley G; Jaenisch R, Correction of a Genetic Defect by Nuclear Transplantation and Combined Cell and Gene Therapy. Cell 2002 Apr 5; 109 (1): 17-27.
    4. Quoted in Gellene D, Clone Profit? Unlikely, Los Angeles Times, May 10th, 2002, Business Section.
    5. Aldhous P, Can they rebuild us?, Nature 2001 Apr 5; 410: 622-5 at 622.
    6. Transcript, Meeting of the President’s Council on Bioethics, April 25, 2002 (www.bioethics.gov/meetings/200204/0425.html).
    7. Villa A; Snyder EY; Vescovi A; Martinez-Serrano A, Establishment and properties of a growth factor-dependent, perpetual neural stem cell line from the human CNS. Exp Neurol 2000 Jan.; 161 (1): 67-84.
    8. Uher F, A stem cell ... is a stem cell?, Orv Hetil 2000 Sep 17; 141 (38): 2085-6.
    9. Cornelius JG; Tchernev V; Kao KJ; et al., In vitro-generation of islets in long-term cultures of pluripotent stem cells from adult mouse pancreas, Horm Metab Res (Germany) 1997 Jun; 29 (6): 271-7.
    10. Zulewski H; Abraham EJ; Gerlach MJ; et al., Multipotential nestin-positive stem cells isolated from adult pancreatic islets differentiate ex vivo into pancreatic endocrine, exocrine, and hepatic phenotypes, Diabetes (United States), 2001 Mar; 50 (3): 521-33.
    11. Billinghurst LL; Taylor RM; Snyder EY, Remyelination: cellular and gene therapy. Semin Pediatr Neurol 1998 Sep; 5 (3): 211-28.
    12. Kocher AA; Schuster MD; Szabolcs MJ; Takuma S; Burkhoff D; Wang J; Homma S; Edwards NM; Itescu S, Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function. Nat Med 2001 Apr; 7(4): 430-6.
    13. Toma JG; Akhavan M; Fernandes KJ; Barnabe-Heider F; Sadikot A; Kaplan DR; Miller FD, Isolation of multipotent adult stem cells from the dermis of mammalian skin, Nat Cell Biol 2001 Sep; 3 (9): 778-84.
    14. Zhao LR; Duan WM; Reyes M; Keene CD; Verfaillie CM; Low WC, Human bone marrow stem cells exhibit neural phenotypes and ameliorate neurological deficits after grafting into the ischemic brain of rats, Exp Neurol 2002 Mar;174 (1):11-20.
    15. Verfaillie CM, Hematopoietic stem cells for transplantation, Nat Immunol (United States), 2002 Apr; 3 (4): 314-7.
    16. Vasa M; Fichtlscherer S; Adler K; Aicher A; Martin H; Zeiher AM; Dimmeler S, Increase in circulating endothelial progenitor cells by statin therapy in patients with stable coronary artery disease, Circulation 2001 Jun 19; 103 (24): 2885-90.  
    17. Kondziolka D; Wechsler L; Goldstein S; Meltzer C; Thulborn KR; Gebel J; Jannetta P; De Cesare S; Elder EM; McGrogan M; Reitman MA; Bynum L, Transplantation of cultured human neuronal cells for patients with stroke, Neurology 2000 Aug 22; 55 (4): 565-9.
    18. Mahmood A; Lu D; Yi L; Chen JL; Chopp M, Intracranial bone marrow transplantation after traumatic brain injury improving functional outcome in adult rats, J Neurosurg 2001 Apr; 94 (4): 589-95.
    19. Ramiya VK; Maraist M; Arfors KE; Schatz DA; Peck AB; Cornelius JG, Reversal of insulin-dependent diabetes using islets generated in vitro from pancreatic stem cells, Nat Med. 2000 Mar; 6 (3): 278-82.
    20. Hofstetter CP; Schwarz EJ; Hess D; Widenfalk J; El Manira A; Prockop DJ; Olson L, Marrow stromal cells form guiding strands in the injured spinal cord and promote recovery, Proc Natl Acad Sci U S A 2002 Feb 19; 99 (4): 2199-2204.
    21. Uher F; Puskas E; Torbagyi E; et al., Regeneration of the immune system after bone marrow transplantation. Orv Hetil (Hungary) 2001 Jan 14; 142 (2): 59-65.
    22. Sasaki M; Honmou O; Akiyama Y; Uede T; Hashi K; Kocsis JD, Transplantation of an acutely isolated bone marrow fraction repairs demyelinated adult rat spinal cord axons, Glia 2001 Jul; 35 (1): 26-34.
    23. Kraft G; et al., Clinical Application of Autologous Stem Cell Transplantation in Severe Multiple Sclerosis Treated with High-Dose Immunosuppressive Therapy, Presentation at the 54th Annual Meeting of the American Academy of Neurology (Denver, Colorado), April 16, 2002.
    24. Voog E; Le QH; Philip I; Benetaib B; Michallet M; Fiere D; Thomas X., Autologous transplantation in acute myeloid leukemia: peripheral blood stem cell harvest after mobilization in steady state by granulocyte colony-stimulating factor alone, Ann Hematol 2001 Oct; 80 (10): 584-91.
    25. Barclay L, Autologous Neural Stem Cells Improve PD Symptoms, MedscapeWire, April 10th 2002
    26. Geller HM; Fawcett JW, Building a bridge: engineering spinal cord repair. Exp Neurol (United States) 2002 Apr; 174 (2): 125-36.
    27. Lehmann M; Fournier A; Selles-Navarro I; Dergham P; Sebok A; Leclerc N; Tigyi G; McKerracher L; Inactivation of Rho signaling pathway promotes CNS axon regeneration, J Neurosci 1999 Sep 1; 19 (17): 7537-47.
    28. Zhang SC; Ge B; Duncan ID, Adult brain retains the potential to generate oligodendroglial progenitors with extensive myelination capacity, Proc Natl Acad Sci U S A 1999 Mar 30; 96 (7): 4089-94.
    29. Davies SJ; Goucher DR; Doller C; Silver J, Robust regeneration of adult sensory axons in degenerating white matter of the adult rat spinal cord, J Neurosci, 1999 Jul 15; 19 (14) : 5810-22.
    30. Teng YD; Lavik EB; Qu X; Park KI; Ourednik J; Zurakowski D; Langer R; Snyder EY, Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells, Proc Natl Acad Sci U S A 2002 Mar 5; 99 (5): 3024-9.
      31.
    31. Bradbury EJ; Moon LD; Popat RJ; et al., Chondroitinase ABC promotes functional recovery after spinal cord injury, Nature (England) 2002 Apr 11: 416 (6881): 636-40.
    32. Woerly S; Doan VD; Evans-Martin F; Paramore CG; Peduzzi JD, Spinal cord reconstruction using NeuroGel implants and functional recovery after chronic injury, J Neurosci Res, 2001 Dec 15; 66 (6): 1187-97.
    33. Lu J; Feron F; Mackay-Sim A; Waite PM, Olfactory ensheathing cells promote locomotor recovery after delayed transplantation into transected spinal cord, Brain 2002 Jan; 125 (Pt 1): 14-21.
    34. EurekAlert, First report of stem cell signal of intention to become specific neuron, May 9th, 2002, Rush-Presbyterian-St. Luke's Medical Center.
    Audio/Video          Cloning Information          Commentaries          Congressional Testimony
    Fact of the Day          Founding Statement          Latest News          Press Releases/Public Statements
    Contact Your Senators              Email Signup          HOME

    Copyright 2002 by Americans to Ban Cloning; www.cloninginformation.org
    Permission to reprint granted as long as this web site is referenced.