Speaker
Description
We developed the Kenzan Method, a scaffold-free, 3D Biofabrication system that uses multicellular spheroids as building blocks. These spheroids are temporarily pierced on a needle array (“KenZan”), where they fuse, self-organize and secrete their own extracellular matrix, yielding purely cellular, functional tissue constructs without foreign materials.
We have demonstrated its versatility in three areas:
Vascular grafts: Made from patient-derived fibroblast into tube shape, these grafts remodel, endothelialize and self-repair in rat and minipig models. A clinical trial for hemodialysis shunts began in Japan in March 2020.
Peripheral nerve conduits: Bio 3D nerve constructs support significant regeneration and functional recovery in rodent and canine models; Kyoto University’s physician-led clinical trial in Japan was successfully completed, demonstrating safety and preliminary efficacy in patients with peripheral nerve injury.
Cartilage repair: iPSC-derived cartilage constructs achieve osteochondral regeneration in animal models; The constructs are expected to regenerate extensive articular cartilage surfaces and Kyoto University is preparing a physician-led clinical trial in accordance with Japan’s regenerative medicine legislation.
Key challenges remain reducing culture time (currently 1–2 months) and cost for broader access; navigating Japan’s rigorous, precedent-scarce regulatory pathway; and scaling production with long-term outcome data. The Kenzan Method paves the way toward patient-specific, immune-compatible organs and tissues fabricated entirely ex vivo.
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