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Abstract：
BACKGROUND: Mesenchymal stromal/stem cells (MSCs) have been suggested for salivary gland (SG) restoration following radio-induced salivary gland damage. This study aimed to determine the safety and effectiveness of MSC therapy on radio-induced SG damage and hypofunction in preclinical in vivo studies.
METHODS: PubMed and EMBASE were systematically searched for preclinical in vivo interventional studies evaluating efficacy and safety of MSC treatment following radio-induced salivary gland damage published before 10th of January 2022. The primary endpoint was salivary flow rate (SFR) evaluated in a meta-analysis. The study protocol was published and registered on PROSPERO ( www.crd.ac.uk/prospero ), registration number CRD42021227336.
RESULTS: A total of 16 preclinical in vivo studies were included for qualitative analysis (858 experimental animals) and 13 in the meta-analysis (404 experimental animals). MSCs originated from bone marrow (four studies), adipose tissue (10 studies) and salivary gland tissue (two studies) and were administered intravenously (three studies), intra-glandularly (11 studies) or subcutaneously (one study). No serious adverse events were reported. The overall effect on SFR was significantly increased with a standardized mean difference (SMD) of 6.99 (95% CI: 2.55-11.42). Studies reported improvements in acinar tissue, vascular areas and paracrine factors.
CONCLUSIONS: In conclusion, this systematic review and meta-analysis showed a significant effect of MSC therapy for restoring SG functioning and regenerating SG tissue following radiotherapy in preclinical in vivo studies without serious adverse events. MSC therapy holds significant therapeutic potential in the treatment of radio-induced xerostomia, but comprehensive, randomized, clinical trials in humans are required to ascertain their efficacy in a clinical setting.
METHODS: PubMed and EMBASE were systematically searched for preclinical in vivo interventional studies evaluating efficacy and safety of MSC treatment following radio-induced salivary gland damage published before 10th of January 2022. The primary endpoint was salivary flow rate (SFR) evaluated in a meta-analysis. The study protocol was published and registered on PROSPERO ( www.crd.ac.uk/prospero ), registration number CRD42021227336.
RESULTS: A total of 16 preclinical in vivo studies were included for qualitative analysis (858 experimental animals) and 13 in the meta-analysis (404 experimental animals). MSCs originated from bone marrow (four studies), adipose tissue (10 studies) and salivary gland tissue (two studies) and were administered intravenously (three studies), intra-glandularly (11 studies) or subcutaneously (one study). No serious adverse events were reported. The overall effect on SFR was significantly increased with a standardized mean difference (SMD) of 6.99 (95% CI: 2.55-11.42). Studies reported improvements in acinar tissue, vascular areas and paracrine factors.
CONCLUSIONS: In conclusion, this systematic review and meta-analysis showed a significant effect of MSC therapy for restoring SG functioning and regenerating SG tissue following radiotherapy in preclinical in vivo studies without serious adverse events. MSC therapy holds significant therapeutic potential in the treatment of radio-induced xerostomia, but comprehensive, randomized, clinical trials in humans are required to ascertain their efficacy in a clinical setting.
摘要：
背景：间充质基质/干细胞（MSC）已被建议用于放射性诱导的唾液腺损伤后的唾液腺（SG）恢复。本研究旨在确定临床前体内研究中MSC治疗对放射性SG损伤和功能减退的安全性和有效性。
方法：PubMed和EMBASE在2022年1月10日前发表的评估放射性唾液腺损伤后MSC治疗有效性和安全性的临床前体内介入研究进行了系统搜索。主要终点是在荟萃分析中评估的唾液流速（SFR）。该研究方案已在PROSPERO上发布并注册（www。crd.AC.英国/普劳里)，注册号CRD42021227336。
结果：共有16项临床前体内研究用于定性分析（858只实验动物），13项纳入荟萃分析（404只实验动物）。骨髓间充质干细胞（四项研究），脂肪组织（10项研究）和唾液腺组织（两项研究），静脉给药（三项研究），腺内（11项研究）或皮下（一项研究）。未报告严重不良事件。对SFR的总体影响显着增加，标准化平均差（SMD）为6.99（95％CI：2.55-11.42）。研究报告腺泡组织有所改善，血管面积和旁分泌因子。
结论：结论：本系统综述和荟萃分析显示,在临床前体内研究中,MSC治疗对于放疗后恢复SG功能和再生SG组织具有显著效果,且无严重不良事件.MSC治疗在治疗放射性口干症方面具有重要的治疗潜力，但全面，随机化，需要在人体中进行临床试验以确定其在临床环境中的功效。
方法：PubMed和EMBASE在2022年1月10日前发表的评估放射性唾液腺损伤后MSC治疗有效性和安全性的临床前体内介入研究进行了系统搜索。主要终点是在荟萃分析中评估的唾液流速（SFR）。该研究方案已在PROSPERO上发布并注册（www。crd.AC.英国/普劳里)，注册号CRD42021227336。
结果：共有16项临床前体内研究用于定性分析（858只实验动物），13项纳入荟萃分析（404只实验动物）。骨髓间充质干细胞（四项研究），脂肪组织（10项研究）和唾液腺组织（两项研究），静脉给药（三项研究），腺内（11项研究）或皮下（一项研究）。未报告严重不良事件。对SFR的总体影响显着增加，标准化平均差（SMD）为6.99（95％CI：2.55-11.42）。研究报告腺泡组织有所改善，血管面积和旁分泌因子。
结论：结论：本系统综述和荟萃分析显示,在临床前体内研究中,MSC治疗对于放疗后恢复SG功能和再生SG组织具有显著效果,且无严重不良事件.MSC治疗在治疗放射性口干症方面具有重要的治疗潜力，但全面，随机化，需要在人体中进行临床试验以确定其在临床环境中的功效。
