Bioprinting Technology May Ease Donor Organ Deficit

Each year, about 120,000 Americans need organ transplants, yet the demand for donor organs far outweighs the supply. The solution: Bioprinting. A 3-D printer is used to dispense different cells, creating layers of cells that form tissue. So far, artificial organs are successfully functioning in animals. Mice, for instance, were able to conceive and give birth by means of prosthetic ovaries.

However, as this new industry emerges, so does the opportunity to capitalize on it. A company in China estimates that the market in America for artificial livers is approximately $3 billion annually. With that sort of potential for profits, larger companies have taken an interest in the future of bioprinting. Well-known companies are making significant progress printing skin for burns and ulcers. A company in Pennsylvania has developed a method to print skin directly onto the patient by spraying stem cells onto the area in need of new skin. Such interest by major companies is advancing this new technology.

From The Economist, “Printed human body parts could soon be available for transplant”

Excerpt from article:

But a lack of suitable donors, particularly as cars get safer and first-aid becomes more effective, means the supply of such organs is limited. Many people therefore die waiting for a transplant. That has led researchers to study the question of how to build organs from scratch.

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First Uterus Transplant Planned in the U.S.

The Cleveland Clinic is one step closer to performing the first uterus transplantation in the United States.  Uterus transplantation is performed on a woman without a uterus who would like to become pregnant and give birth to a child. Sweden has performed nine uterine transplantations; four of the women gave birth and two transplants were unsuccessful. Saudi Arabia and Turkey have attempted uterine transplantations as well, but both were unsuccessful.

Strict protocols have been implemented regarding this transplantation. Unlike Sweden which allows transplantation from live donors, the transplantations in the United States are from deceased organ donors. Recipients of the transplantation must be in a stable relationship and have ovaries. They will be screened for psychological disorders and interviewed to make sure they are not being pressured into the transplantation. Since the uterus will not be connected to the recipient’s fallopian tubes, fertilization must be completed through in-vitro fertilization. Babies will only be delivered through caesarian section. Before, during and after pregnancy, the woman will have to take anti-rejection medication. The uterus will be removed from the recipient surgically after she has had one or two children so that she can discontinue anti-rejection drugs.

There are ethical concerns regarding the transplantation of reproductive tissue. Bioethicists and others have asked whether the deceased would want her organ used for reproductive purposes and how to prioritize the recipients of reproductive tissue since those receiving uteri for reproductive purposes are  not in life-threatening circumstances. Nevertheless, Cleveland Clinic’s fifteen-member ethics board approved the experimental uterus transplantation. Additionally, other medical ethicists have stated that they do not find anything ethically wrong with the procedure. The first candidate to undergo the procedure is aware of the transplantation and pregnancy risks and has begun hormone treatments as she prepares for the procedure.


A Potential End to the “Ice Age” of Transplant Organ Transportation

An innovative means for transporting organs may soon debut in the United States. It has the potential to bring organ transportation out of the “ice age.” TransMedics, a company headquartered in Andover, Massachusetts, has developed the Organ Care System, also known as the “heart in a box.” of the system can keep human organs “alive, beating, and breathing” during transport. Rather than transporting disconnected organs via ice cooler, the Organ Care System plugs hearts, lungs, livers, and other organs into a system that keeps blood, air, and other fluids circulating while the organ is maintained at body temperature. Organs – transported alive – have been successfully transplanted up to twenty-four hours after removal, which is roughly six times the current average life span for an organ outside the body. Waleed Hassanein, founder and president of TransMedics, has asserted that as long as an organ remains alive and “perfused in [the Organ Care System] . . . there really is no time limitation [for successful transplantation.]” Even more astonishing is the device’s ability to revive organs from recently deceased patients. Thus far, seventeen people have successfully received hearts from patients whose hearts had stopped beating for thirty minutes or more.

Although the Organ Care System has been in use for many years in Europe and Australia, the FDA has yet to approve its use in the United States. However, this may soon change: TransMedics is scheduled to introduce its system to the FDA on November 18, 2015. If FDA approves the system’s use, the “ice age” of transplant organ transportation may come to and end.


Liver Transplants Do Not Necessarily Go to the Sickest Patients

Liver transplants are usually available for patients who are deemed the sickest on the national transplant waiting list. Currently, the United Network for Organ Sharing (“UNOS”), divides the country into 10 regional transplant boundaries. This means that sometimes geography, and not the severity of illness, determines the recipient of a liver. The Midwestern and the Southern regions have more organ donors per capita but less demand for transplants than people living in coastal regions. As a result, patients with “means” often avoid the wait in high demand regions by traveling to low demand regions, but the poor are left to wait. This has prompted UNOS to consider new regional boundaries which incorporate parts of high demand transplant regions into lower demand regions. Some lawmakers oppose this reorganization plan fearing that their regions will become “organ farms” for other parts of the country. They blame high demand on a failure to run effective grassroots campaigning to increase rates of donation.

Read more here.

The House Approves the HOPE Act

The House placed its stamp of approval on the HIV Organ Policy Equity Act (HOPE), which passed the Senate in June of 2013. HOPE lifts the federal ban on the transplantation of HIV positive organs to HIV positive donees. The Department of Health and Human Services and the Organ Procurement Transplant Network are responsible for creating and implementing standards for research on the transplantation of HIV positive organs.

Read more here.

Welsh Government Presumes Consent for Organ Donation Starting 2015

The Welsh government passed the Human Transplantation Act of 2013 this July, and as of 2015 the government will presume that every citizen has consented to donate their organs upon their deaths, unless they opted out of the program. The current system in the UK is described as a “voluntary,” opt-in program. However, the shortage of human organs motivated the Welsh government to institute the new legislation. The government hopes the Act will increase transplant rates by as much as 25%, and drive down the statistics on “preventable” deaths. Over the next two years, the government will launch a public information campaign to inform citizens of their rights under the opt-out program.

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Sebelius Prompts OPTN Revision of Transplant Policy for Pediatric Patients in Response to Judicial Intervention and Media Blitz

The Organ Procurement and Transplantation Network (OPTN) issued changes to its transplant policy for lung candidates under the age of 12 on June 11, 2013, after a meeting of the Executive Committee. The Secretary of the Department of Health and Human Services (HHS), Kathleen Sebelius, prompted the meeting in response to the controversy surrounding the case of Sarah Murnaghan. Sarah Murnaghan suffered from end-stage cystic fibrosis at 10 years old and was on the waiting list for pediatric donor lungs. On June 12 Sarah received a transplant, with adult donor lungs, in contravention of the former OPTN policy for children, but in accordance with the temporary restraining order (TRO), issued by Federal Judge Michael Baylson from the Eastern District of Pennsylvania, that stopped Sebelius from enforcing the policy.

Sarah’s mother, understandably, launched a media blitz after her daughter was denied an exception to the policy. However the public-relations onslaught and subsequent judicial intervention troubles some bioethicists. Members of the Executive Committee voiced serious medical and ethical concerns at the meeting. To resolve the matter, the Committee incorporated a review process into the policy for children. The process allows for an exception application for anyone under 12 years old, to request that the person be classified as an adolescent in order to receive either adult or adolescent lungs. Dr. Arthur Caplan, a renowned bioethicist, stated that in implementing the review system the OPTN is addressing the concerns raised by Justice Baylor, while simultaneously issuing a warning. Dr. Caplan believes it is inappropriate for bureaucrats and politicians to decide how organs are allocated based on the medical complexity of a case.

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Case: Flynn v. Holder, 684 F.3d 852 (9th Cir. 2012)

In Flynn v. Holder, 684 F.3d 852 (9th Cir. 2012), the U.S. Court of Appeals for the Ninth Circuit held that the National Organ Transplant Act does not prohibit compensation for bone marrow donors when the donation is accomplished via peripheral blood stem cell apheresis.  The peripheral blood stem cell apheresis method of transplantation does not require any “soft, fatty marrow” to be donated and transplanted.  As a result, there is no transfer of a “human organ” as defined by the statute.

Read the full decision here.