Biocompatibility and wound-healing prospect of KAPs-depleted residual hair biomaterial

This work is an in-depth investigation of the <i>in vitro</i> and <i>in vivo</i> biocompatibility of processed and treated residual human hair samples with intact cuticle layers. The specimens included oxidized hair with minimal melanin (BLH) and hair with medium- (M-KAP) and low- (L-KAP) amounts of keratin associated proteins (KAPs), confirmed through gel electrophoresis, electron microscopy, trichrome histological staining, and tensile biomechanics, in comparison to the untreated regular hair (REG) control. All hair groups, high KAPs (H-KAPs: REG and BLH), M-KAP, and L-KAP, are non-cytotoxic in the adipose fibroblast's response to their extracts based on the ISO 10993-5 medical device biomaterial testing standard. <i>In vivo</i> mouse subcutaneous implantation (ISO 10993-6, local effects) at 2 weeks showed a foreign body response (FBR) with thin fibrous encapsulation at 28% relative skin dermis thickness; but the L-KAP implant mitigated a significant decrease in FBR area compared to H-KAPs and a lower number of immune cells of mostly macrophages and mast cells on the biomaterial's surface. In the bulk of the capsules, blood vessels and collagen extracellular matrix densities were similar among groups. These findings suggest that small globular KAPs diffuse out of the cortex to the host-biomaterial interface which induce a slightly-elevated FBR but limited to the implant's surface vicinity. For translatability, we evaluated the effectiveness of the residual hair with the most depleted KAPs (L-KAP) in a 10 mm-diameter, splinted, and full-thickness mouse skin excision wound. Treatment with the L-KAP mesh exhibited an 8% healing improvement per day compared to the untreated control: significantly reducing the projected complete healing time by 30%. On-going research focuses on purer keratin-based and macromolecularly organized residual hair biomaterials for drug-delivery as they are deemed the most biocompatible.