Beyond Stem Cells

Ethical Issues in Regenerative Medicine

by Christina M. H. Powell

In the days ahead, pastors will need to help parishioners with serious medical needs navigate the uncharted territory between future promise and current reality. 

Ask most pastors what ethical issues arise in regenerative medicine and you most likely will hear “stem cells.” Stem cell research commandeers the lion’s share of ethical attention because isolation of one type of stem cell involves the destruction of human embryos — the earliest stage of human life. These embryonic stem cells retain the flexibility to become any one of the more than 200 cell types in the human body. Thus, scientists prize embryonic stem cells as valuable research tools useful in finding treatments for diseases.

Isolation of two other types of stem cells, however, does not require destruction of human embryos: somatic stem cells (taken from adult tissues), and induced pluripotent stem cells (adult cells, such as skin cells, genetically reprogrammed to behave like embryonic stem cells). Some techniques in regenerative medicine, such as growing a new organ in the laboratory from a patient’s cells, do not involve stem cells at all. Thus, the field of regenerative medicine encompasses more than the embryonic stem cell controversy.

Without minimizing the importance of the embryonic stem cell controversy, I would like to highlight other ethical issues in regenerative medicine particularly relevant to pastoral ministry. In the days ahead, pastors will need to help parishioners with serious medical needs navigate the uncharted territory between future promise and current reality.

Regenerative medicine is medicine’s latest frontier. As with any frontier, risks and uncertainty coexist with the potential for great reward. Patients faced with difficult decisions will appreciate the support of knowledgeable pastors.

Understanding the Salamander

If regenerative medicine had a mascot, the animal of choice would be the salamander. No other animal with a backbone can regenerate a lost limb. Yet the salamander can regenerate a lost leg or tail in just weeks. Recently, researchers discovered that salamanders do not convert adult cells all the way back to stem cells as originally expected. Instead, the salamander only partially reprograms cells at the site of an injury. Such a finding makes sense. One of the major problems with stem cells is their tendency to form cancerous growths. Cells that turn back the developmental clock only partially, instead of fully resetting the clock to an embryonic state, are less likely to turn cancerous.

Even though a human being does not regenerate a lost limb, regrowth of tissue regularly happens within the human body. Every 2 weeks you change your skin. Every 10 years you replace your bones. The human liver can regenerate as long as one quarter of the organ remains.

Researchers in the field of regenerative medicine hope to expand the human body’s ability to repair itself. In some cases, doctors might be able to use biologically active molecules to stimulate tissue regeneration. In other cases, doctors might take a small amount of a patient’s own tissue and use it to grow a replacement organ in a laboratory. Researchers at Wake Forest University in North Carolina already have used this approach to grow new bladders for spina bifida patients.

The ability to grow organs in the laboratory from a patient’s cells solves two of the current problems with organ transplantation: the risk of rejecting tissues from another person, and the shortage of available organs. Any patient needing an organ transplant could benefit from regenerative medicine. Other potential patients include injured soldiers, accident victims, and those born with congenital defects.

Regenerative medicine represents the future of medicine. Consider the treatment of a patient with kidney failure. In 1943, a Dutch physician constructed the first working dialysis machine. The next major breakthrough in treating patients with kidney failure came in 1954, when Dr. Joseph E. Murray and Dr. J. Hartwell Harrison, two surgeons in Boston, performed the first successful kidney transplant between identical twin brothers. The next logical breakthrough is growing a new kidney in the laboratory from a patient’s own cells.

Regenerating Established Ethical Concerns

King Solomon wisely stated in Ecclesiastes 1:9, “What has been will be again, what has been done will be done again; there is nothing new under the sun.” In a new frontier, such as regenerative medicine, longstanding ethical issues resurface with fresh significance. The journey from exciting scientific breakthrough to routine medical procedure passes through the phases of clinical research trials. In the first stage of clinical research, Phase I trials, researchers test a new treatment on a small group of patients to evaluate if the treatment is safe and discover possible side effects.

Ethical issues arise any time patients become research subjects. Designing a clinical trial to yield the medical information needed while also protecting the rights of the patients in the trial requires careful thought. Avoiding both financial and nonfinancial conflicts of interest in human research studies is a perennial ethical challenge. New therapies arising from breakthroughs in regenerative medicine will face the same ethical concerns long established as significant for all medical research.

Certain aspects of regenerative medicine, however, make the established ethical concerns in clinical research particularly crucial in this new frontier. For example, the nature of regenerative research involves creating individualized therapies. In the typical development of a drug, researchers can apply knowledge gained from initial studies on a small group of people to the design of the next clinical study. Thus, the chances of harm to the participants in the next study decrease, while the chances of potential therapeutic benefit increase. The individualized nature of regenerative medicine makes the conclusions drawn from one study less transferrable to the next study.

Another distinctive feature of some regenerative research is the short time frame a patient may have to make a potentially irrevocable decision. For example, imagine a man in an emergency room deciding whether or not to choose an experimental protocol that may be able to fully restore the use of his injured hand. If he participates in the research study, he will forgo the standard treatment capable of partially restoring function to his hand. Should the experimental treatment fail, he could lose his hand completely. The stakes are high for the patient, who must try to think clearly in the midst of medical trauma.

Avoiding Patient Confusion

The ethical issue in regenerative research a pastor is most likely to encounter is therapeutic misconception. For a patient to provide informed consent, the patient must clearly understand the choice he is making. Therapeutic misconception is an ethical term for patient confusion about the nature of a clinical study.

Patients who participate in research studies often are encouraged to see themselves only as patients and not also as research subjects. Thus, patients focus on the possibilities for direct personal benefit when enrolling in a research study. The purpose of early clinical trials, however, is to determine safety and look for side effects, not to determine effectiveness. What the patient may consider therapy is truly only scientific research.

Consider all the excitement and media attention surrounding possible stem cell cures. Most uses of stem cells still qualify as research, not treatment. The hope surrounding stem cell research, which sometimes borders on hype, creates an atmosphere ripe for patient confusion. Participation in a Phase I clinical trial may be an appropriate choice for a patient willing to contribute to medical knowledge even if he himself receives little to no personal benefit. The danger to the patient, however, comes when the distinction between research and treatment is blurred, causing the patient to mistakenly choose a risky experimental protocol over an established clinical procedure.

What should a pastor standing by the bedside of a parishioner faced with such confusing medical choices do? In such a situation, the patient and his family need support in discerning a wise course of action. Ask them if they clearly heard the information provided by the doctor and read all consent forms completely. Make sure the patient has a realistic view of his condition and the likelihood of receiving medical benefit from his participation in a particular clinical trial. Is the patient at peace with the decision he is making or does he feel pressured to choose to participate in a study?

Of course, the importance of avoiding patient confusion about clinical trials applies to well-established medical fields such as cancer research as much as it does to the new frontier of regenerative medicine. After all, King Solomon was right in stating “there is nothing new under the sun.”