First in-human trial protocol investigating a scaffold-free Bio 3D conduit developed from autologous dermal fibroblasts for peripheral nerve regeneration: a safety and feasibility study

Abstract Background Autologous nerve grafting is considered to be the gold standard treatment for severe and/or wide-ranging damage resulting in neurotmesis. However, the technique has several disadvantages including donor site morbidity and the limited supply of donor nerves. B3CON-01 is a scaffold-free three-dimensional conduit composed entirely of autologous dermal fibroblasts and is designed to overcome these disadvantages. Herein, the authors propose a protocol to evaluate the safety and utility of B3CON-01 in humans with peripheral nerve injury as the first step before randomized clinical trial test. Methods Individuals with a severed peripheral nerve cutting or defect, measuring ≤ 20 mm in length and diameter ≤ 2 mm, will be recruited. After participants provide informed consent, autologous dermal fibroblasts will be collected from each via skin biopsy. B3CON-01 is produced using the fibroblasts and transplanted into each subject. To avoid contamination among tissues, the protocol will be performed separately in each subject. Outcomes will be assessed at baseline and post-intervention at each time point. Participants will be assessed at 12 months’ follow-up. The primary outcome measure is the safety of the intervention. The safety endpoint will be the incidence of adverse events and defects. As a secondary assessment, efficacy will be assessed using nerve system and functional analyses. Conclusion The protocol of this study will be the first to assess the safety and efficacy of B3CON-01 in humans, and will contribute to not only the development of a treatment for peripheral nerve injury, but also to “made-to-order” personalized therapies in regenerative medicine.