Invention: Sustaining transplant organs
Hundreds of thousands of people around the world are waiting for life-saving donor organs. Many organs fail to reach their recipients because technology limits preservation time outside the body. A major improvement, the Organ Care System (OCS) developed by US heart surgeon Waleed Hassanein, preserves organ function for longer periods and ensures higher transplant success rates.
Deployed in clinics since 2007, OCS replaces the decades-old technique known as "cold ischemia". Cold ischemia relies on flushing the freshly retrieved donor organ with a cool, sterilised solution to remove all blood before packing it in ice. The process forestalls the death of the organ by a few hours. Hassanein's system preserves the organ outside the human body by maintaining its vital functions.
Hassanein began working on his breakthrough as a resident physician at Georgetown University in the early 1990s. Frustrated by losing potentially life-saving donor organs during cold storage, he experimented with keeping them in a warm environment, surrounded by nutrient-rich blood. His findings became the foundation for OCS, which not only sustains the life of organs without loss of function, but also allows clinicians to inspect organs for damage during storage and even to treat infections outside the body. Originally developed for storing human hearts, OCS is now also available for lungs and livers and has already been used in over 800 successful transplants worldwide.
The invention holds the potential to improve outlooks significantly for patients in need of donor organs. According to the United Network for Organ Sharing, a person is added to the waiting list for donor organs every 10 minutes in the US alone, and 22 people die each day while waiting for a transplant. In EU countries - along with Iceland, Norway and Turkey - around 86 000 patients were on organ waiting lists in 2013. Given the limitations of cold storage, experts estimate that globally, 60% to 65% of donor hearts cannot be used for transplant operations.
OCS expands the pool of available organs in three ways. First, it prolonges the lifespan of an organ en route to a recipient. While the time limit for cold-stored hearts is four hours, hearts stored in OCS have been transplanted successfully after 11 hours. Second, OCS allows doctors to monitor and assess the health of the donor organ outside the body, which is impossible with cold ischemia. And third, OCS can obtain donor organs from non-beating heart patients, which expands the pool by 25% in the UK.
Widespread adoption of OCS could create an end-to-end live organ storage network between donors, clinics and recipients. Currently, the OCS technology platform - consisting of the OCS Lung, OCS Heart and OCS Liver systems - is CE-marked in the EU and approved in Australia and Canada, while FDA approval is pending in the US. As a first step, the UK's National Institute for Health and Care Excellence (NICE) officially endorsed the OCS Heart system for clinical use in 2016.
In order to market his patented inventions, Hassanein founded Massachusetts-based start-up company TransMedics in 1998. So far, the company has received some EUR 280 million in venture capital and private equity and employs 70 people.
Replacing the decades-old standard of cold storage, Hassanein's organ-preserving systems have the potential to reinvigorate the organ preservation solutions market. Currently valued at EUR 56.7 million by analysts Transparency Market Research, the market is expected to triple in size over the next years, exceeding EUR 189 million by 2019.
Waleed Hassanein with the Organ Care System (OCS)
How it works
About the size of a small household refrigerator, OCS can be wheeled into an ambulance. It replicates human functions and continuously supports the donor organ with warm, oxygenated blood through a "perfusion system". The organ is stored inside the system's perfusion module: a clear, sterile, temperature-controlled chamber shaped to accommodate hearts, lungs or livers. The chamber simulates the functions of the human body through a pump motor and ventilation system.
An array of non-invasive, ultrasound sensors monitor critical parameters, such as blood pressure, blood flow and blood cell counts, to sustain the organ's health while in transit. A "solution set" infuses the organ with essential nutrients and substrates.
Waleed Hassanein was born in 1968 in a suburb of Cairo. Growing up near the city's airport, he initially wanted to become a pilot. But family tradition - he was born into a family of physicians - steered him towards a medical career.
He moved to London for his pre-med education, then attended Cairo University for three years of medical training. After moving to the United States in 1990 - he is now a US citizen - the inventor earned his MD in medicine from the Georgetown University School of Medicine in Washington DC in 1993.
After completing two years of general surgery residency at Georgetown University Medical Center, he moved to Boston for a cardiothoracic surgery research fellowship at the Brigham and West Roxbury VA Medical Center from 1995 to 1998. In 1998, he founded TransMedics to pioneer the entirely new concept of "living organ transplants". Today, Hassanein serves as the CEO, president and director of TransMedics.
Did you know?
In Hassanein's long-term vision for his patented technology platform, keeping donor organs alive ex vivo (outside the body) is only the first step in a series of future applications. Looking ahead, the inventor believes that OCS technology holds the potential to unlock ex-vivo chemotherapy, genetic therapy and regenerative medicine on isolated organs. That means, doctors could work on repairing organs outside the body without any risk of the side effects caused by aggressive treatments such as chemotherapy.
It's not the only futuristic approach to organ repair nominated for this year's European Inventor Award. In the "Research" category, Hans Clevers and team at the University Medical Center (UMC) in Utrecht have pioneered "organoids". While these "mini versions" of actual organs currently serve for drug testing, future possibilities include growing full-sized "spare" organs from a patient's stem cells.