The Business of Biofabrication

Addressing the Organ Shortage Crisis

The Advanced Research Projects Agency for Health (ARPA-H), a part of the U.S. Department of Health and Human Services (HHS), has announced the Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program. This ambitious initiative aims to help push forward organ transplantation by leveraging cutting-edge bioprinting technology and regenerative medicine to potentially 3D print personalized organs on demand. The program aims to ideally make therapies that will be immune-matched, eliminating the need for lifelong immunosuppressive drugs and drastically reducing the current transplant wait times.

The Dire Need for Innovation

In the United States alone, over 120,000 people are on organ transplant wait lists, with only 45,000 transplants performed each year. This significant gap leads to prolonged suffering and numerous deaths among patients awaiting a compatible organ. Transplanted organs generally last between 15 and 23 years, necessitating multiple transplants over a patient’s lifetime, each time accompanied by the risks and costs associated with immunosuppressive drugs.

“If we look at organ need, kidneys are the most transplanted with the longest wait lists, followed by the heart and liver,” notes ARPA-H PRINT Program Manager Ryan Spitler, Ph.D. “PRINT will work to address long-standing organ shortages and wait lists, first focusing on the kidney, liver, and heart. By starting from multiple different types of cells, we will be creating organs that will be individually matched. The body will not recognize it as a foreign entity, eliminating the need for immunosuppressive drugs, which has never been done in the history of organ transplantation.”

Revolutionizing Organ Transplantation

The PRINT program aims to overcome one of the most significant challenges in the field of regenerative medicine: creating functional, complex solid organs essential for sustaining life. The program plans to utilize a combination of 3D bioprinting, cell manufacturing, biomaterials, modeling, and tissue engineering to biofabricate kidneys, hearts, and livers. By using patient-derived cells or cells from a biobank, PRINT intends to produce immune-matched replacement organs that restore normal function and obviate the need for immunosuppressive therapy.

Comprehensive Approach and Technical Areas

PRINT will address its goals through three technical areas (TAs):

1. TA1: Generating Necessary Organ Cell Types – This involves creating all required cell types for organ bioprinting using sources such as blood draws, biopsies, or biobanks.
2. TA2: Large-Scale Manufacturing of Organ Cell Types – This area focuses on scaling up the production of organ-specific cells to meet the demands of biofabrication.
3. TA3: Organ Biofabrication and Testing – The final area concentrates on the actual bioprinting of organs and conducting in vivo tests to ensure their safety and efficacy.

Innovation and Future Prospects

ARPA-H Director Renee Wegrzyn, Ph.D., emphasizes the groundbreaking nature of the PRINT initiative: “PRINT’s approach has not been done before, and as difficult as it is, it does not come close to how arduous the current state of transplantations is for those in need. PRINT is pushing research beyond transplanting much-needed organs. If successful, this technology would decrease donor list wait times, reduce the need and cost for immunosuppressive drugs, and make organs and tissues more widely available for people across the country.”

What is ARPA-H?

The Advanced Research Projects Agency for Health (ARPA-H) is a specialized agency within the U.S. Department of Health and Human Services. ARPA-H is dedicated to funding and facilitating high-risk, high-reward research projects aimed at making significant advancements in health and medicine. By bringing together advanced technologies and expert knowledge, ARPA-H strives to overcome major challenges in healthcare and transform innovative ideas into practical solutions.

Through an upcoming Innovative Solutions Opening (ISO), ARPA-H will seek proposals that address these technical areas, with multiple awards anticipated based on the quality of submissions and available funding. Learn more about the PRINT program, including how to participate, on ARPA-H’s program page.

Conclusion

The PRINT program hopes to produce results from participants that discover significant leap forward in bioprinting and regenerative medicine. By addressing the critical shortage of transplantable organs and eliminating the need for immunosuppressive drugs, PRINT has the potential to save countless lives and transform the field of organ transplantation. It will be interesting to see first who gets awarded and then further see the results produced from this initiative.

Original announcement can be found on ARPA-H’s website and the specific challenge can be found here.