The Business of Biofabrication

UT Southwestern Medical Center has been awarded up to $25 million from Advanced Research Projects Agency for Health (ARPA-H) to develop fully personalized, bioprinted human livers using patients’ own cells. The initiative, known as Vascularized Immunocompetent Tissue as an Alternative Liver (VITAL), is part of ARPA-H’s PRINT program and aims to address the persistent shortage of donor organs.

Led by Muhammad Rizwan, Assistant Professor of Biomedical Engineering and Ophthalmology, the project integrates advances in stem cell biology, biomaterials, and 3D bioprinting to fabricate transplant-ready liver tissue. The program is overseen within ARPA-H by Ryan Spitler, Ph.D.

Building Livers from Patient Biopsies

At the core of VITAL is a patient-specific manufacturing workflow. Researchers begin with a small liver biopsy, from which cells are reprogrammed into induced pluripotent stem cells (iPSCs). Under the direction of Jun Wu, these iPSCs are differentiated into the multiple specialized cell types required for liver function.

The resulting cells are combined with engineered hydrogel “bioinks” and printed into three-dimensional tissue constructs designed to replicate native liver architecture. Early work focuses on creating dense organoid building blocks that can be assembled into full-scale organs.

Solving the Vascular and Biliary Bottleneck

A major barrier to artificial organ development has been the inability to generate functional blood vessels and bile ducts, both essential for long-term survival and metabolic activity. Rizwan’s team reports a novel approach for growing integrated vascular and biliary networks within printed tissue, enabling sustained perfusion and waste removal.

This capability is critical for scaling organoids into clinically relevant grafts and represents one of the most technically ambitious components of the VITAL program.

Multidisciplinary and Multi-Institutional Collaboration

The initiative brings together clinicians, engineers, and manufacturing specialists across several institutions. Partners include Ibrahim T. Ozbolat at Pennsylvania State University and researchers from University of California, Davis, who are contributing expertise in advanced bioprinting systems and GMP-grade cell production.

Within UTSW, transplant surgeon Madhukar Patel is guiding clinical integration, while imaging and validation efforts are led by Samuel Achilefu, Chair of Biomedical Engineering.

From Bench to Bedside

According to the research team, a personalized bioprinted liver could be manufactured in approximately 10–13 weeks. Initial validation will occur in small and large animal models, with the goal of progressing toward human studies within five years.

Because the organs are derived from a patient’s own cells, they are expected to be immunocompatible—potentially eliminating the need for lifelong immunosuppressive therapy, one of the major burdens of current transplantation.

Beyond transplantation, the platform will enable high-fidelity liver models for:

• Drug toxicity and metabolism testing
• Disease modeling
• Precision medicine screening
• Mechanistic studies of liver regeneration

Addressing a Critical Clinical Gap

In the United States alone, tens of thousands of patients die annually from liver disease, and nearly 10,000 remain on transplant waiting lists at any given time. With average transplant costs approaching $1 million per patient, scalable biofabrication approaches could also reshape the economics of liver care.

By combining organoid biology, vascular engineering, and industrialized bioprinting, VITAL represents one of the most comprehensive efforts to date to close the supply-demand gap in organ transplantation.

Toward Industrial-Scale Organ Manufacturing

A key component of the program is the establishment of a scalable organoid manufacturing facility at UT Southwestern. This infrastructure is intended to support standardized, reproducible production—moving organ printing from bespoke laboratory experiments toward regulated biomedical manufacturing.

As Achilefu noted, the project exemplifies a new translational model in which engineers, clinicians, and scientists collaborate from inception to clinical deployment.

Strategic Significance for Biofabrication

The VITAL award reinforces ARPA-H’s growing investment in organ biofabrication as a national priority. Alongside parallel efforts in kidney, heart, and vascular tissue engineering, UT Southwestern’s program highlights a shift toward:

• Autologous, immune-compatible organs
• Integrated vascular systems
• GMP-ready bioprinting workflows
• Platform technologies for multiple organs

If successful, VITAL could establish a template for personalized organ manufacturing that extends well beyond liver disease—reshaping how regenerative medicine, transplantation, and pharmaceutical testing are conducted in the coming decades.