Research Methodology in Medicine and Health Sciences, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Regenerative Medicine Center, Basic and Translational Research Unit (BTRU) of Special Unit for Biomedical Research and Education (BRESU), Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, 54636, Greece.
Stem Cell Rev Rep. 2024 May;20(4):938-966. doi: 10.1007/s12015-024-10696-5. Epub 2024 Feb 26.
The aim of the study is to determine the effectiveness of stem cells in scaffolds in the treatment of bone deficits, in regard of bone regeneration, safety, rehabilitation and quality of life in humans. The systematic review was conducted in accordance with PRISMA 2020. A systematic search was conducted in three search engines and two registries lastly in 29-9-2022.for studies of the last 15 years. The risk of bias was assessed with RoB-2, ROBINS- I and NIH Quality of Before-After (Pre-Post) Studies with no Control group. The certainty of the results was assessed with the GRADE assessment tool. Due to heterogeneity, the results were reported in tables, graphs and narratively. The study protocol was published in PROSPERO with registration number CRD42022359049. Of the 10,091 studies retrieved, 14 were meeting the inclusion criteria, and were qualitatively analyzed. 138 patients were treated with mesenchymal stem cells in scaffolds, showing bone healing in all cases, and even with better results than the standard care. The adverse events were mild in most cases and in accordance with the surgery received. When assessed, there was a rehabilitation of the deficit and a gain in quality of life was detected. Although the heterogeneity between the studies and the small number of patients, the administration of mesenchymal stem cells in scaffolds seems safe and effective in the regeneration of bone defects. These results pave the way for the conduction of more clinical trials, with greater number of participants, with more standardized procedures.
本研究旨在确定支架中的干细胞在治疗人类骨缺损方面的疗效，包括骨再生、安全性、康复和生活质量。系统评价按照 PRISMA 2020 进行。最后在 2022 年 9 月 29 日，在三个搜索引擎和两个注册处进行了系统搜索，以寻找过去 15 年的研究。使用 RoB-2、ROBINS-I 和 NIH 无对照组的前后质量（术前-术后）研究评估偏倚风险。使用 GRADE 评估工具评估结果的确定性。由于存在异质性，结果以表格、图形和叙述形式报告。研究方案已在 PROSPERO 上发表，注册号为 CRD42022359049。在检索到的 10091 项研究中，有 14 项符合纳入标准，并进行了定性分析。138 名患者接受了支架中的间充质干细胞治疗，所有病例均显示骨愈合，甚至比标准治疗效果更好。大多数情况下，不良事件较轻，与所接受的手术相符。评估时，发现缺损得到了康复，生活质量得到了提高。尽管研究之间存在异质性和患者数量较少，但支架中间充质干细胞的给药似乎安全有效，可促进骨缺损的再生。这些结果为开展更多临床试验铺平了道路，这些试验将有更多的参与者和更标准化的程序。
