title: One-year clinical study of NeuroRegen scaffold implantation following scar resection in complete chronic spinal cord injury patients.
abstract: 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.
authors.affiliation: State Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, 100190, China.
authors.forename: Zhifeng
authors.initials: Z
authors.lastname: Xiao
authors.affiliation: Neurology and Neurosurgery Hospital, Affiliated Hospital of Logistics University of Chinese People's Armed Police Forces (CAPF), Tianjin, 300162, China.
authors.forename: Fengwu
authors.initials: F
authors.lastname: Tang
authors.affiliation: Department of Orthopaedics, First Affiliated Hospital of People's Liberation Army (PLA) General Hospital, Beijing, 100048, China.
authors.forename: Jiaguang
authors.initials: J
authors.lastname: Tang
authors.affiliation: Department of Orthopaedics, The First Affiliated Hospital of Soochow University, Suzhou, 215006, China.
authors.forename: Huilin
authors.initials: H
authors.lastname: Yang
authors.affiliation: State Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, 100190, China.
authors.forename: Yannan
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: State Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, 100190, China.
authors.forename: Bing
authors.initials: B
authors.lastname: Chen
authors.affiliation: State Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, 100190, China.
authors.forename: Sufang
authors.initials: S
authors.lastname: Han
authors.affiliation: State Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, 100190, China.
authors.forename: Nuo
authors.initials: N
authors.lastname: Wang
authors.affiliation: State Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, 100190, China.
authors.forename: Xing
authors.initials: X
authors.lastname: Li
authors.affiliation: Neurology and Neurosurgery Hospital, Affiliated Hospital of Logistics University of Chinese People's Armed Police Forces (CAPF), Tianjin, 300162, China.
authors.forename: Shixiang
authors.initials: S
authors.lastname: Cheng
authors.affiliation: Neurology and Neurosurgery Hospital, Affiliated Hospital of Logistics University of Chinese People's Armed Police Forces (CAPF), Tianjin, 300162, China.
authors.forename: Guang
authors.initials: G
authors.lastname: Han
authors.affiliation: Neurology and Neurosurgery Hospital, Affiliated Hospital of Logistics University of Chinese People's Armed Police Forces (CAPF), Tianjin, 300162, China.
authors.forename: Changyu
authors.initials: C
authors.lastname: Zhao
authors.affiliation: Department of Orthopaedics, First Affiliated Hospital of People's Liberation Army (PLA) General Hospital, Beijing, 100048, China.
authors.forename: Xiaoxiong
authors.initials: X
authors.lastname: Yang
authors.affiliation: Department of Nerve Electrophysiology, First Affiliated Hospital of People's Liberation Army (PLA) General Hospital, Beijing, 100190, China.
authors.forename: Yumei
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Orthopaedics, The First Affiliated Hospital of Soochow University, Suzhou, 215006, China.
authors.forename: Qin
authors.initials: Q
authors.lastname: Shi
authors.affiliation: Department of Orthopaedics, First Affiliated Hospital of People's Liberation Army (PLA) General Hospital, Beijing, 100048, China. hsxortho@hotmail.com.
authors.forename: Shuxun
authors.initials: S
authors.lastname: Hou
authors.affiliation: Neurology and Neurosurgery Hospital, Affiliated Hospital of Logistics University of Chinese People's Armed Police Forces (CAPF), Tianjin, 300162, China. zhangsai718@vip.126.com.
authors.forename: Sai
authors.initials: S
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, 100190, China. jwdai@genetics.ac.cn.
authors.forename: Jianwu
authors.initials: J
authors.lastname: Dai
mesh_terms: D000328:Adult; D002921:Cicatrix / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009416:Nerve Regeneration; D013119:Spinal Cord Injuries / Q000503:physiopathology / Q000601:surgery*; D054457:Tissue Scaffolds; D016896:Treatment Outcome
keywords: NeuroRegen scaffold; bone marrow mononuclear cells; chronic spinal cord injury; collagen scaffold transplantation; scar resection; tissue regeneration