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ORIGINAL RESEARCH
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Preclinical evaluation of aligned fibrin nanofibre hydrogels in a non-human primate model of spinal cord injury: A pilot study

Jia Yang1# ,  Weitao Man2# ,  Kaiyuan Yang2# ,  Zheng Cao1,3 ,  Chao Ma4 ,  Kunkoo Kim1 ,  Zhe Meng2 ,  Yaosai Liu2 ,  Yuzhe Ying2 ,  Jie Zhang2 ,  Zide Wang2 ,  Yang Lu2 ,  Xiaolei Zhang2 ,  Guihuai Wang2* ,  Xiumei Wang1*
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1 State Key Laboratory of New Ceramics and Fine Processing, Key Laboratory of Advanced Materials, School of Materials Science and Engineering, Tsinghua University, Beijing, China
2 Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine, Tsinghua University, Beijing, China
3 Centre for Biomaterials and Regenerative Medicine, Wuzhen Laboratory, Tongxiang, Zhejiang Province, China
4 Department of Neurosurgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
BMT 2025 , 6(3), 334–344; https://doi.org/10.12336/bmt.24.00079
Submitted: 28 October 2024 | Revised: 27 January 2025 | Accepted: 15 March 2025 | Published: 22 September 2025
Copyright © 2025 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution–NonCommercial–ShareAlike 4.0 License.
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Abstract

Spinal cord injury (SCI) often leads to partial or complete loss of motor, sensory, and autonomic functions. We have previously shown that the transplantation of hierarchically aligned fibrin nanofibre hydrogel scaffolds (AFGs) facilitates robust neuroregeneration and functional recovery in rat and dog SCI models. Given these positive results, we aimed to evaluate the biosafety and efficacy of AFGs in a non-human primate SCI model before exploring its potential in the clinic. In the present study, no significant adverse reactions were observed over 24 weeks following AFG implantation into 1-cm gaps in the hemisected thoracic spinal cords of monkeys (Macaca fascicularis). Scaffold implantation also reduced cystic cavity formation and encouraged axonal sprouting across the lesion site. Notably, detailed histological analysis demonstrated that AFG promoted high-density, sequential, and aligned nerve fibre regeneration, resulting in remyelination and vascularisation, ultimately leading to remarkable motor function recovery. These results indicate that AFG transplantation exhibits reliable biocompatibility and effectiveness in promoting spinal cord repair in a non-human primate SCI model. Owing to the similarities in genetics and physiology between non-human primates and humans, AFG transplantation therapy is likely suitable for use in human spinal cord repair. 

Keywords
Aligned fibrin hydrogel
Lateral hemisection model
Non-human primate
Spinal cord injury repair
Funding
This study was financially supported by the National Natural Science. Foundation of China (Nos. 32271414, 82201521, 82301560), the Tsinghua. Precision Medicine Foundation (No. 2022TS001), the Beijing Natural Science. Foundation (Nos. 7242187, 2254091), and State Key Laboratory of New Ceramic Materials Tsinghua University (No. KF202409).
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Conflict of interest
The authors declare that there are no conflicts of interest.
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