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Taking Aim at Organ Preservation Constraints to Revolutionize Transplant Logistics


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Jedediah Lewis, JD
Organ Preservation Alliance
Moffett Field, CA, USA
Jedd@organpreservationalliance.org



Last June, the White House convened the first Organ Summit, bringing together many stakeholder organizations across transplantation to discuss ways to reduce the organ shortage [1]. The Organ Summit heavily emphasized the promise of research and development to provide solutions for patients on the transplant waitlist, unveiling new initiatives aimed at organ preservation, tissue engineering, donor management, bioartificial organs, and reconditioning of marginal organs, among other topics [2].

Among the initiatives announced by the White House was the upcoming Summit on Organ Banking through Converging Technologies, organized by the Organ Preservation Alliance [2]. The Summit is part of a growing research effort aimed at dramatically increasing preservation time and quality for transplant organs, combining advances in ex vivo perfusion, cryopreservation, hibernation and related areas that have occurred in recent years [3-5]. This effort has been spearheaded by an interdisciplinary coalition of transplant professionals, researchers and engineers; the consortium supporting it includes entities as varied as the American Society of Mechanical Engineers, Society for Cryobiology, and Association of Organ Procurement Organizations [2].

The technologies being pursued could have a profound impact on thoracic transplantation. Today utilization rates for donor hearts in the U.S. are roughly 30%, and roughly half these grafts have been rejected after 10 years [6,7]. Meanwhile lung offers are accepted only 20% of the time, and almost 3/4 of transplants have been rejected within a decade [6,7]. These numbers result from many factors, but they're fueled largely by logistical constraints that can be addressed by achieving new preservation capabilities.

Preservation advances could create new possibilities for organ assessment prior to transplantation, allowing utilization of more hearts and lungs without adding risk to patients. They could provide windows for gene therapy, immunomodulation and immune tolerance induction, as well as new approaches to reanimate and repair marginal organs. Extending preservation times would enable donor-recipient matching over longer distances and could allow new methods to screen for transmissible diseases and malignancies. And it would add more flexibility to transplant surgery, lowering costs and make the surgical team's lives easier.

Like with any platform technology, organ preservation is likely to lead to new approaches that would be unthinkable under today's circumstances. For instance, cryopreserving and banking organs has been suggested as a way to tap unused 'borderline' organs (studies have suggested that most hearts may fit into this category) as a backup supply in case of primary graft dysfunction. Preservation advances can also accelerate progress toward other technologies that are on the horizon. It could also make xenotransplantation research a much more attractive investment, by allowing access to the same manufacturing capabilities (maintaining an inventory, quality control, global distribution, etc.) that many other industries enjoy.

This reasoning - make commercialization of a technology that can address the organ shortage more feasible, and research investment will follow - was reflected at the White House Organ Summit, in the form of a $160 million solicitation for an Advanced Tissue Biomanufacturing institute. The institute will focus on developing technologies and make tissue engineering clinically and commercially more feasible; the announcement and solicitation emphasized tissue preservation as a major component [2,8].

Researchers and clinicians seeking to capture these benefits have put together a compelling vision for preservation capabilities of the 21st century and have begun to chart the research path to get to us there at recent events such as the first global Organ Banking Summit, [9] an NSF-funded roadmapping workshop, [10] and a White House Roundtable on Organ Banking and Bioengineering. By building on the last decade's revolution in ex vivo perfusion and combining it with cryopreservation methods that have worked well for cells, human embryos, simple tissues, and even whole organisms that can enter 'suspended animation' in nature, a focused research effort could achieve flexible infrastructure for transplantation in which an organ can preserved under conditions that vary according to need - allowing for unrestrained transport, new methods for assessment and repair (including at specialized facilities), and, when needed, even extended storage of organs.

Achieving these technologies will be no easy feat, and no small-scale effort either. On the contrary, organ preservation is an exceptionally interdisciplinary challenge: the quintessential "convergence technology" [11,12]. Which is why the upcoming Summit will bring together organ preservation researchers and other members of the transplant community with scientists and engineers from a diverse set of surrounding fields, such as nanotechnology, imaging, metabolomics, that were identified during the NSF roadmapping process [10].

Members of the ISHLT community from all backgrounds are welcome. Their expertise will be needed to push this effort forward, for the benefit of the transplant community and the hundreds of thousands of patients worldwide still waiting for a new organ.

To learn more about the Summit, visit obs2017.org. To learn more about the Organ Preservation Alliance, visit organpreservationalliance.org or contact jedd@organpreservationalliance.org

Disclosure Statement: The author has no conflcits of interest to disclose


References:

  1. Mesiwala, A., Erickson, J. & Barbero, R. Saving Lives and Improving Health Care through Innovation in Organ Donations and Transplants. (2016). Available at: https://www.whitehouse.gov/blog/2016/06/13/saving-lives-and-giving-hope-reducing-organ-waiting-list.
  2. White House. Fact Sheeet: Obama Administration Announces Key Actions to Reduce the Organ Waiting List. (2016).
  3. Palmer, J. Organ Preservation: Wait Not in Vain. The Economist (2016).
  4. Scudellari, M. U.S. Funds Efforts to Freeze Human Organs for Long-Term Storage. Scientific American (2015).
  5. Patel, N. V. Organ Banking: From Impossible to Slightly Less Impossible. WIRED1 (2015).
  6. Scientific Registry of Transplant & (SRTR). OPTN/SRTR 2013 Annual Data Report. American Journal of Transplantation 15, (2015).
  7. OPTN/SRTR. Unadjusted Graft and Patient Survival at 3 Months, 1, 3, 5, & 10Y. OPTN/SRTR Annual Report - 2011 ADR Data Tables Section 1.13 (2011).
  8. FOA: Advanced Tissue Biofabrication Manufacturing Innovation Institute (ATB-MII). U.S. Dept. of Defense, Dept. of the Army - Materiel Command (2016).
  9. Lewis, J. K. et al. The grand challenges of organ banking: proceedings from the first global summit on complex tissue cryopreservation. Cryobiology 72, 169-82 (2016).
  10. Organ Preservation Alliance. Organ Bioengineering and Banking Beta Roadmap. (Organ Preservation Alliance, 2015).
  11. Sharp, P., Jacks, T. & Hockfield, S. Convergence: The Future of Health. (2016).
  12. Sharp, P. Meeting global challenges: Discovery and innovation through convergence. Science (80-. ). 346, 1468-71 (2014).



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