Bench-to-bedside translation of Self-Healing colloidal hydrogels as 2 nd generation design of Flowable Hemostatic Matrix: From Preclinical evaluation to Human Clinical Trials

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Abstract The emergence of self-healing materials has brought a paradigm shift in the design of functional biomedical devices for applications such as drug delivery, tissue regeneration, and 3D bioprinting. However, their clinical translation remains limited due to challenges including insufficient mechanical strength, potentially cytotoxic chemical modifications, and complex healing activation conditions. Herein, we present the development of self-healing colloidal gelatin hydrogel as an innovative design of flowable hemostatic matrix, and successfully demonstrate its bench-to-bedside translation into a biomedical device (named as Colloidose ® ). Specifically, amphoteric gelatin submicron particles self-assemble into an integrated gel network exhibiting a high storage modulus (G’> 15 kPa) and a healing efficiency exceeding 95%, enabling rapid in situ solidification to accelerate blood clot formation. By comparing with more conventional design strategy flowable gelatin matrix based on dispersion of hundreds micrometer-sized gelatin granules, we demonstrate that Colloidose ® are more effective for hemostasis in anatomically challenging or pressure-intolerant sites such as hepatobiliary surgery, otorhinolaryngology, and gynecology based on comprehensive preclinical animal studies and over 300 clinical cases. Overall, Colloidose ® exemplifies the successful clinical translation of an advanced self-healing biomaterial, establishing its role as a 2 nd generation flowable hemostatic matrix and opening new avenues for the development of injectable and moldable biomedical devices.

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