helping patients who need organ transplants
This revolutionary organ bank initiative is funded for a second year by the Frankel Innovation Initiative, a $20 million fund made possible by a generous donation from the Maxine and Stuart Frankel Foundation that supports the research and development of life-saving therapies at Michigan Medicine. This project was renewed based on the successful completion of the Year 1 milestones and the Year 2 milestones proposed.
Typical organ transplant procedures, especially for heart, lungs, and composite tissue grafts, must be completed within six hours, making these life-saving procedures limited by geography and time. Preservation techniques of the organs may extend this timeframe. However, there are few reports of successful temperature-controlled, device-based organ perfusion outside of the body for 24 hours or more.
In an effort to extend the timeframe for organ transplant procedures, the University of Michigan’s Extracorporeal Life Support (ECLS) Laboratory, directed by Robert H. Bartlett, M.D., and led by Alvaro Rojas-Pena, M.D., has developed prolonged normothermic ex vivo heart perfusion (NEVP). NEVP is a system that prolongs heart function through a system that pumps oxygenated blood (perfusion). The blood passes through filters that provide nutrients and remove cellular waste. In NEVP, perfusion is done while the organ is outside the body, using normal body temperature conditions.
“Our goal is to routinely preserve hearts via ex vivo perfusion for at least three days,” explains Dr. Bartlett. “Three days, significantly longer than the current six-hour window without preservation techniques, will provide ample time to procure and perfuse hearts in a central facility, evaluate recovery after cold storage, rehabilitate hearts until normal function is demonstrated, match hearts to recipients, and transport hearts to recipient hospitals, making transplantation elective.”
This research also has the promise of developing the first-ever human organ banks, which would be safer and more cost-effective than the current transplant practices.
“NEVP is focused on the heart because the model is well established, heart function can be measured continuously, and heart failure is obvious and objective,” says Rojas-Pena. “Lessons from the research with hearts will apply to other organs, specifically liver and kidneys, and can ultimately lead to the development of organ banks.”
Current organ procurement practices require immediate action by surgeons, donors, and recipients. This procedure is a time-sensitive and delicate process that often requires cold preservative solutions, which only preserve the organ for a short time.
Normothermic perfusion is essentially extracorporeal membrane oxygenation (ECMO) applied to a single organ. ECMO was developed in the ECLS lab and clinic and is now routine clinical practice in cardiopulmonary failure. During the first of funding for the NEVP system, the ECLS Lab has demonstrated that continuous plasma exchange allowed successful heart perfusion for three days (72 hours), indicating that critical factors are being added or removed to prevent organ failure.
Few research groups focus on developing successful prolonged normothermic organ perfusion systems, and the opportunity to develop organ banks based on this research would be groundbreaking. Lack of donor hearts is an unmet need that could be addressed by prolonged heart perfusion, especially for pediatric patients. Hearts that are currently not procured (e.g., Donors after Circulatory Dead and borderline function hearts) could be salvaged, rehabilitated, and added to the donor pool. Lessons from the research with hearts will apply to other organs and can ultimately lead to the development of organ banks.
- Intellectual Property – The unique IP for this project is the perfusion device and the business model of organ banks.
- Commercialization Strategy – A user-friendly, fully integrated engineering prototype will be designed for use in ongoing studies and to form a vision for commercial device development.
- Regulatory Pathway – FDA will approve the initial IDEs, which will be based on laboratory prototypes. FDA will approve applications from companies for the final devices.
- Product Launch Strategy – Use current commercial organ perfusion facilities as a model for the ultimate development of organ banks.
- Routinely successful NEVP for three days with successful transplantation.
- Totally automated perfusion and data collection system.
- Extend cardiac NEVP apparatus to other organs (kidney perfusion)