Li Hanlai, Gu Tingting, Xu Jingjing, Gan Lin, Liu Chang, Wan Jixian, Mu Zhihao, Lyu Haiyan, Wang Zhibin, Liu Qianqian, Chen Jie, Tang Yaohui
School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.
Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Biomater Transl. 2025 Jun 25;6(2):165-180. doi: 10.12336/bmt.24.00020. eCollection 2025.
Due to the limited effects of current treatments on brain repair and regeneration, stroke continues to be the predominant cause of death and long-term disability on a global scale. In recent years, hydrogel-based biomaterials combined with stem cells and extracellular vesicles have emerged as promising new treatments to improve brain regeneration after stroke. However, the clinical translation of hydrogel-based biomaterials for the treatment of brain injury is still far from satisfactory. In this review, we first summarise the present status of stroke-related clinical treatments and the advantages provided by hydrogel-based materials in combination with stem cells and extracellular vesicles in preclinical studies. We then focus on the possible causes of the gap between preclinical studies and clinical translation of hydrogel-based biomaterials from the perspective of biocompatibility and safety, the choices of preclinical models, the lack of clinical noninvasive imaging methods, standardisation and quality control, manufacturing scalability, and regulatory compliance. With the progress in the abovementioned areas, we believe that the clinical translation of hydrogel-based biomaterials will greatly improve brain regeneration after stroke and that this improvement will be realised by the general public in the near future.
由于目前的治疗方法对脑修复和再生的效果有限，中风仍然是全球范围内死亡和长期残疾的主要原因。近年来，基于水凝胶的生物材料与干细胞和细胞外囊泡相结合，已成为改善中风后脑再生的有前景的新疗法。然而，基于水凝胶的生物材料用于治疗脑损伤的临床转化仍远不能令人满意。在本综述中，我们首先总结了中风相关临床治疗的现状以及基于水凝胶的材料与干细胞和细胞外囊泡在临床前研究中所提供的优势。然后，我们从生物相容性和安全性、临床前模型的选择、缺乏临床无创成像方法、标准化和质量控制、制造可扩展性以及法规遵从性等角度，关注基于水凝胶的生物材料临床前研究与临床转化之间差距的可能原因。随着上述领域的进展，我们相信基于水凝胶的生物材料的临床转化将极大地改善中风后脑再生，并且这种改善将在不久后由普通大众实现。
