One-year clinical study of NeuroRegen scaffold implantation following scar resection in complete chronic spinal cord injury patients

Zhifeng Xiao, Fengwu Tang, Jiaguang Tang, Huilin Yang, Yannan Zhao, Bing Chen, Sufang Han, Nuo Wang, Xing Li, Shixiang Cheng, Guang Han, Changyu Zhao, Xiaoxiong Yang, Yumei Chen, Qin Shi, Shuxun Hou, Sai Zhang, Jianwu Dai

The objective of this clinical study was to assess the safety and feasibility of the collagen scaffold, NeuroRegen scaffold, one year after scar tissue resection and implantation. Scar tissue is a physical and chemical barrier that prevents neural regeneration. However, identification of scar tissue is still a major challenge. In this study, the nerve electrophysiology method was used to distinguish scar tissue from normal neural tissue, and then different lengths of scars ranging from 0.5-4.5 cm were surgically resected in five complete chronic spinal cord injury (SCI) patients. The NeuroRegen scaffold along with autologous bone marrow mononuclear cells (BMMCs), which have been proven to promote neural regeneration and SCI recovery in animal models, were transplanted into the gap in the spinal cord following scar tissue resection. No obvious adverse effects related to scar resection or NeuroRegen scaffold transplantation were observed immediately after surgery or at the 12-month follow-up. In addition, patients showed partially autonomic nervous function improvement, and the recovery of somatosensory evoked potentials (SSEP) from the lower limbs was also detected. The results indicate that scar resection and NeuroRegen scaffold transplantation could be a promising clinical approach to treating SCI.