Approximately 5,000 Americans die annually waiting for organ transplants. More than 100,000 patients remain on the kidney transplant waitlist, but only 25,000 receive transplants each year. The availability of viable organs continues to be an issue around the world, but research shows decellularized porcine organs can offer a scalable solution.
In June 2024, Intermountain Medical Center treated the first patient with a bioengineered external liver support system. United Therapeutics announced positive Phase 1 results in January 2025. The technology behind it: decellularized porcine organs recellularized with human cells.
How Decellularized Porcine Organs Work
Perfusion-based decellularization removes porcine cells while preserving native extracellular matrix architecture, including intact vascular networks and major ECM components such as collagen, elastin, and residual glycosaminoglycans. The scaffold is then recellularized with human endothelial and parenchymal cells. Porcine ECM demonstrates approximately 93% homology with human ECM, and decellularized porcine matrices have shown biocompatibility in some FDA-cleared products.
Unlike genetically modified organs that retain porcine cells with genetic edits, decellularized scaffolds remove xenogeneic cellular antigens. This eliminates primary triggers of hyperacute rejection, but requires recellularization to achieve full organ function.
For example, Miromatrix’s miroliverELAP completed the first FDA-cleared trial using bioengineered liver for acute liver failure treatment. This trial is a crucial step toward life-saving treatment for the 5,000 people who die annually waiting for a liver transplant.
Similarly, bioengineered kidneys have shown functional blood filtration and urine production when implanted in porcine models. These results demonstrate that decellularized scaffolds can support meaningful renal function in a non-porcine setting, with the hope of creating a pathway to better access to kidney grafts for the treatment of end-stage renal disease.
Critical Research Challenges
While decellularized porcine organs offer a promising foundation for bioengineered grafts, translating them into functional, implantable organs presents significant hurdles. Success depends not only on removing cellular material, but on preserving structure, controlling immune and clotting responses, and restoring complex organ function. The following challenges continue to shape progress in the field:
- ECM Preservation: Decellularization must remove cells without damaging structural integrity, and current methods are often time consuming and not standardized. However, one study shows that approximately 60% of collagen content can be preserved while achieving complete decellularization in 24 hours for full-sized porcine livers.
- Immune Response: Residual DNA must be reduced below 50 ng/mg tissue, and α-Gal epitopes must be effectively removed to mitigate rejection. Even properly decellularized tissue can trigger inflammatory responses requiring management strategies.
- Thrombosis: Decellularization removes protective endothelium, exposing ECM to blood. Without complete re-endothelialization, platelet activation causes thrombosis. Studies show this is the primary cause of graft failure in decellularized organs.
- Functional Integration: Achieving organ-specific function — filtration for kidneys, metabolism for liver — requires optimal cell seeding density, proper distribution, and sustained viability. Long-term graft survival remains an ongoing challenge.
Future Outlook
Based on positive Phase 1 results, United Therapeutics will initiate a Phase 2 study of miroliverELAP for external liver support. The company is also developing mirokidney, a fully transplantable bioengineered kidney using the same decellularization and recellularization technology. Long-term goals include manufacturing-scale production of functional organs and addressing the transplant shortage.
Decellularized porcine organs are advancing from laboratory to clinic. However, success depends on high-quality source tissue with proper documentation. Partnering with suppliers who understand decellularization requirements, from vascular preservation to regulatory documentation, is essential for clinical translation.
How Tissue Quality Shapes Scaffold Performance
Age, health status, and processing of tissue affects ECM composition and decellularization efficiency. Consistency is required for reproducible results and regulatory approval.
Critical tissue parameters:
- Animal specifications: Source animals are maintained under controlled conditions with documented end-to-end traceability from source animal through final tissue shipment.
- Harvest and processing: Rapid post-mortem harvest minimizes tissue degradation.
- Quality control: Tissue collection and processing performed by trained personnel in accordance with ISO 13485-registered Quality Management System.
Common failures are caused by unknown tissue provenance, inadequate documentation, and inconsistent animal characteristics. Avoiding these issues by sourcing quality tissue ensures a scientifically sound process from the start.
Where to Source Porcine Tissue for Organ Bioengineering Research
Tissue Source provides high-quality porcine organs for decellularization and organ engineering research:
- Custom organ specifications for your protocol
- Expedited delivery options available
- ISO-certified quality management
Contact us to discuss your organ bioengineering research needs.