Globally, millions of lives each year can be saved by increased availability of organs and tissues

 
 

Organs and tissues are among the most precious resources that exist, saving and improving millions of lives through transplantation, regenerative medicine, and medical research. Supplies are severely limited, and for lifesaving transplant organs and many tissues, currently the only source is a person’s selfless decision to become a donor. We must make every one of these gifts count. 

This makes the preservation of organs and tissues – the ability to keep them healthy outside of the body during transplantation, storage, transport, and other processes – a fundamental need in biomedicine. Advances in organ and tissue preservation can have a major impact on diverse areas of human health.

Building on recent advances in cryopreservation, organ perfusion, the study of animals that can enter ‘suspended animation’ in nature, and a variety of other platform technologies, the Organ Preservation Alliance is helping to bring about a world in which organs and tissues are as durable outside the body as they are inside it – with profound implications for science, medicine, and millions of patients around the globe.

 
 
 
 

Transplantation

“The ability to bank organs would be one of the most important breakthroughs – and perhaps the most important breakthrough – in the field of transplantation in the last 50 years. It could be as impactful for patients in need of a transplant as the introduction of Cyclosporine.”

— Dr. David Nelson Chief of Heart Transplantation, Baptist Integris Medical Center

The global organ shortage is one of the greatest public health crises today. Roughly 30,000 vital organs are transplanted each year in the U.S., whereas hundreds of thousands of U.S. patients could benefit from organ replacement. The problem is even more severe worldwide. For instance, the continent of Africa contains 16% of the world’s population but performs less than 0.5% of its organ transplants.

Yet each year, a substantial fraction of donor organs go unused because of logistical constraints that could be eased or overcome by organ preservation advances. At the same time, organ preservation can improve our ability to match organ donors and recipients and screen for transmissible diseases, while decreasing the cost of transplantation. This means transplant recipients can live longer, healthier lives.

Organ preservation technologies also promise to accelerate the development of game-changing technologies for transplantation, such as immune tolerance induction and xenotransplantation.

 
 

Research and Drug Discovery

Clinical trial success rates for new drugs are as low as 10%, driven by the unmet need for laboratory methods that can predict a treatment’s impact on real patients. For many diseases, our tools for pre-clinical drug discovery are even more limited. For instance, promising results in laboratory animals treatments have translated into clinical trial success for less than 1% of new drugs to treat Alzheimer’s Disease.

Meanwhile, taking an investigational new drug through clinical trials costs on average close to $1 billion. This makes developing new therapies an expensive, high-risk proposition, stifling the advancement of medicine. New laboratory models are needed that can capture the complexities of human tissues.

Advances in human tissue banking could allow donor tissues that currently must be discarded to instead be used for pre-clinical drug testing, making a powerful new experimental platform available to the biotechnology and pharmaceutical industries. Tissue banking could also make cutting-edge approaches such as organs-on-a-chip practical and inexpensive at scale.

This would translate into more lifesaving therapies reaching the clinic and could reduce the aggregate cost of developing new medicines by hundreds of millions of dollars each year.

The impact on basic medical research could be equally profound. For example, a National Cancer Institute official identified inadequate tissue preservation as the number one roadblock to cancer cures. Across many fields, banking of functional tissues can increase the quality and reliability of data while making new experimental approaches possible.

 
 

Tissue Engineering

Preservation constraints have been identified as a key bottleneck in tissue engineering progress by over a dozen science and healthcare agencies in the U.S., including 6 NIH institutes. The White House recently announced a $160 million “Manufacturing Innovation Institute” focused on advanced tissue biomanufacturing, once again recognizing tissue preservation as one of the major challenges to be tackled.

Many tissues currently take months to create but expire within days, forcing a “just in time” manufacturing model. This prevents some aspiring regenerative medicine companies from adjusting to changing demand, limits the distance that tissues can be shipped, and keeps many methods for quality control and assurance off limits. Living tissues need a shelf-life to make clinical use practical and routine.

Tissue preservation advances can greatly increase the commercial attractiveness of tissue engineering as an industry. This will drive investment in fundamental tissue engineering research, for the benefit of future generations. And it will directly benefit patients in need of regenerative medicine therapies today.

 
 

Cancer and Fertility Protection

More than 140,000 girls and young women become cancer survivors each year in the U.S., and many more worldwide. Chemotherapy and radiation are often the best treatment options, which can leave patients infertile and with impaired hormone balance. This can result in lifelong sexual and psychological side effects and leave patients at risk for heart disease and other life-threatening conditions.

Cutting edge research on organ cryopreservation has the potential to enable the banking whole ovaries (and already has in animal models), allowing them to be saved as a fertility-preserving treatment for cancer patients. Cryobanking of ovarian tissue has already become a promising experimental therapy, resulting in dozens of healthy live births. Cryopreservation research can also enable the banking of whole testes and testicular tissue, making these treatments available to young men and boys as well.

Reproductive organ and tissue banking could become a routine treatment for children and young adults worldwide, helping millions of patients ensure that they can enjoy a normal life after winning their battle with cancer.

 
 

Trauma and Emergencies

"Organ and tissue banking can bring regenerative medicine into completely new contexts, allowing lifesaving transplants for victims of accidents, wounded soldiers, and many others. And cryobanking heart, liver, and even brain tissue could be a game changer for bioterrorism preparedness."

— Lt. Col. Luis Alvarez, PhD Professor, U.S. Military Academy, West Point Former Deputy Director,
Armed Forces Institute of Regenerative Medicine

A vast array of existing treatments from transplantation and regenerative medicine can be be lifesaving or life-changing for victims of traumatic injury, but preservation advances are needed to make them widely available. Extending preservation times for complex tissues could have a transformative impact on:

  • Limb, hand and face transplantation, by addressing one of the key obstacles to widespread use, allowing for improved matching and making new strategies in immune tolerance induction available
  • Reconstructive surgery, by overcoming logistical barriers to the transplantation (and engineering) of cartilage, bone, facial tissues, and a great many other anatomical structures
  • Mass casualty preparedness, by making stockpiles of transplantable bone marrow, skin, blood vessels, and other tissues available as medical countermeasures
  • Limb and tissue recovery for victims of traumatic amputation, explosions, and other disfiguring injuries – buying time for reattachment, especially relevant for wounded service members who are often far from advanced trauma centers
  • Bio-agent testing, allowing rapid identification of chemical or biological threats using banked slices of liver, heart, kidney or brain tissue
  • Treatment of acute organ failure, for instance by making whole or partial liver transplants a lifesaving option for victims of poisoning or traumatic injury – currently the number one cause of death in children and adolescents

The beneficiaries of these advances would be as diverse as their applications. Battlefield medicine, preparedness for natural disasters, counterterrorism, and routine emergency medicine could all see important advances as a result of preservation breakthroughs. In the coming years, this could add up to millions of patients worldwide whose lives are saved or improved.