He wake forest institute for regenerative medicine (wfirm) has over two decades of experience using a variety of 3D printing modalities to develop implantable human tissue constructs

Wake Forest University Health Sciences received a $13.43 million Cooperative Agreement from the Advanced Research Projects Agency for Health (ARPA-H, CFDA 93.384) awarded September 26, 2025, with completion targeted for September 25, 2028. The award funds development of bioprinted vascularized autologous renal tissue constructs designed to augment renal function in patients with kidney disease. The institute will leverage its two decades of experience in three-dimensional (3D) printing technology to engineer implantable kidney tissue by extracting autologous renal cells from patient biopsies, combining them with functionalized hydrogel bioink, and applying multiphysics modeling to replicate native renal tissue architecture at 50-micrometer resolution.

The deliverables include development of cost-effective clinical manufacturing protocols for autologous cell expansion, proprietary software to translate tissue blueprints into printable code for rapid production, and specialized perfusion bioreactors with integrated sensor suites to monitor construct maturation and function. Preclinical validation will be conducted using small and large animal models to demonstrate post-implantation remodeling and tissue integration. The program culminates in Investigational New Drug (IND) enabling preclinical studies and a commercialization strategy to address the nation's donor organ shortage through a scalable, cost-efficient tissue therapy solution.

Over time the cellular compositions and implant dimensions relevant to clinical applications have increased requiring an integrated vascular system that allows perfusion of the entire construct. These bioprinted vascularized tissue constructs open the possibility of supporting a functional microanatomy that can perform nuanced organ specific functions. The overall strategy will include a protocol for cost effective clinical manufacturing of a sufficient number of autologous renal cells from a small surgical sample or tissue biopsy. These cells will be combined with a functionalized hydrogel bioink that both supports the long term viability of the embedded cells and promotes the activation of endogenous developmental pathways that guide the formation of a functional cellular microanatomy. Cutting edge multiphysics modeling will be applied to native renal tissue to establish a blueprint that approximates renal tissue architecture at a resolution of 50 UM. Software will also be developed to translate this blueprint into a printable code that will guide the rapid production of rudimentary renal tissue. These constructs will be further enhanced through maturation in a specialized perfusion bioreactor with an integrated sensor suite that monitors tissue function. Strategies will also be developed using small and large preclinical animal models to promote further remodeling of bioprinted renal tissue following implantation. The overarching goal is the production of bioprinted vascularized autologous renal tissue to augment renal function in patients suffering from kidney disease. This tissue therapy will be qualified using IND enabling preclinical animals in parallel with a commercialization plan to make this a cost efficient solution to the nations growing donor organ shortage.