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08/17/2015

A Matter of Ethics and Policy in the Era of Regenerative Transplantation in the United States

by Macey L. Henderson and Brianna L Doby

Why do we need to care about the ethical development of health policies that impact research, donation, and transplantation in the United States? The story of Zion Harvey is a good place to start.

Zion lost all of his limbs to amputation from sepsis at the age of two. The infection that ravished his body and took his limbs also caused renal failure, resulting in a successful kidney transplant when he was 4 years old. Like all transplant recipients, Zion must take anti-rejection medications for life, making him a good candidate for hand transplantation. Previously, the ethics of transplanting a child with donor hands instead of fitting them with prosthetics was centered around post-transplant medication harms. In July of 2015, Zion became the first pediatric double hand transplant recipient in a landmark 11 hour operation which took place at the esteemed Children’s Hospital of Philadelphia.

Trauma, birth defects, bone or soft tissue malignancies, and other systemic diseases like diabetes can cause disability and sadly, loss of limbs. Amputations create both physical and psychosocial impacts that can be difficult for an individual in regards to day to day functioning, not to mention the aesthetic challenges posed by living in the world without limbs. Prosthetics are a phenomenal advance in biotechnology allowing for both occupational and psychological improvements for patients, but they don’t mimic the sensations or intricate actions that a human hand does.

Until now, candidacy for hand transplantation has been limited to adults. Why? There are vast complexities associated with hand transplantation. For example, the innovative surgical procedure comes in an attempt to improve quality of life while balancing the possible negative side effects that come from a life on immunosuppressant drugs. Remember that unlike solid organ transplantation, hand transplantation is not considered life-saving. Hand transplantation as a life-enhancing procedure is furthermore complicated by complex health policies that govern nation’s organ transplant system.

The University of Pennsylvania’s success with the first bilateral hand transplant on an adult in 2011 provided the technical foundation for adapting the delicate surgical techniques for a pediatric patient. Zion was ready, the doctors were ready. Now, with confidence in technical skill achieved, all they needed were the right donor hands. What kind of donor hands would be a “match?” While there is a degree of histocompatibility testing involved (HLA typing) like with solid organ transplants, size, skin color, and blood type are the three primary determinants making donor hands a good match for a transplant recipient. Another consideration: obtaining specific informed consent from a donor family for the unique gift of VCA donation goes beyond what is required for organs and other tissue.

Then, it happened one day out of the blue. The federally designated organ procurement organization serving the Philadelphia area, Gift of Life Donor Program, made the special call to Zion’s doctors. Gratitude to the donor and family is difficult to explain with simple words; donation is a remarkable gift of life. Couple the gift of life with 3D printing technology, and one can see the amazing potential. In order to see if the potential donor hands would in fact fit Zion, doctors created 3D printed version of Zion’s hands from detailed CT scans of his forearms and used them to evaluate potential donor candidates. The power of tissue donation coupled with that of technology has brought forth a revolutionary era in medicine. We need to prepare for the long-term implications of our revolution with ethical health policy development that is evidence-based and committed to improving the health of all Americans, including those who are affected by organ and tissue donation.

Ethical Transplant Policy Development in a Learning Healthcare System
As we are developing new transplantation policy, we must be cognizant of the Triple Aim goals for a learning healthcare system focused on reduction of cost while improving access and care quality. While questions of service utilization and resource allocation have been debated on medical, legal, and ethical merits for decades regarding solid organ transplantation, the new era of reconstructive transplantation will once again challenge us to remain vigilant in protecting the public perceptions of the health policy we develop and support.

Vascularized Composite Allograft (VCA) transplants are an emerging science in the United States. Federal oversight for these transplants (which include hand and face) was designated to the Organ Procurement and Transplantation Network (OPTN) in July of 2014. Current policy states that a VCA transplant program must have and maintain approval for a separate organ transplant program to be approved to perform VCA transplants. This means that the VCA transplant program cannot be the sole active and approved transplant program at the hospital. In fact, new healthcare workforce requirements will soon be added to current policy language mandating a certain level of experience for the primary physician and surgeon at a VCA transplant program.

If you take into consideration the progress in VCA transplantation to date, the reconstructive transplant community is anticipating the circumstance where a living donor could be considered.

What are the potential risks, needed safeguards, and impact of donation on a living VCA donor?

To improve the transparency of the process, OPTN/ United Network for Organ Sharing (UNOS) Committees, including the Living Donor and Ethics Committees created a guidance document which has the potential to lay the ground for future discussions and policy development. While it is important to remember that guidance documents aren’t policy, they can serve as the basis for future policy development.

The guidance document supports a consensus about VCA organ procurement from living donors that supports three basic protective objectives:

  1. A VCA transplant from a living donor must provide added benefit to the recipient over other options.
  2. The risk to the donor must be low in relationship to the benefits to be gained by the recipient.
  3. As with additional authorization required by deceased VCA transplant, the informed consent process for a potential living VCA donor must include all risk as well as likely recipient outcomes.

What should be the required elements in the informed consent process for a woman who wants to donate her uterus to her infertile sister? Similar to other living organ donors (such as kidney and liver donors) we will need to examine and likely standardize the medical and psychosocial evaluation of living VCA donors. This means there is still further policy development needed in order to widely implement safe, ethical, and transparent VCA donation and transplantation in America.

While we implement new federal oversight and develop policies to improve the new frontier of reconstructive transplantation, we are reminded of this exciting time ripe for medical and scientific innovation also requiring ethical oversight. Moving forward, we will need to revisit conversations about the allocation of VCA organs, how we gather data and information about how to improve conversion rates for VCA transplantation when authorization has been obtained from the donor or the donor family, financing and payer issues, and international collaboration with existing hand composite and tissue transplantation researchers and patient registries.

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