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Background: Bone-marrow-derived mesenchymal stromal (stem) cells [also called MSC(M)] and their extracellular vesicles (EVs) are considered a potentially innovative form of therapy for traumatic brain injury (TBI). Nevertheless, their application to TBI particularly remains preclinical, and the effects of these cells remain unclear and controversial. Therefore, an updated meta-analysis of preclinical studies is necessary to assess the effectiveness of MSC(M) and MSC(M) derived EVs in clinical trials. Methods: The following databases were searched (to December 2022): PubMed, Web of Science, and Embase. In this study, we measured functional outcomes based on the modified neurological severity score (mNSS), cognitive outcomes based on the Morris water maze (MWM), and histopathological outcomes based on lesion volume. A random effects meta-analysis was conducted to evaluate the effect of mNSS, MWM, and lesion volume. Results: A total of 2163 unique records were identified from our search, with Fifty-five full-text articles satisfying inclusion criteria. A mean score of 5.75 was assigned to the studies’ quality scores, ranging from 4 to 7. MSC(M) and MSC(M) derived EVs had an overall positive effect on the mNSS score and MWM with SMDs −2.57 (95 % CI -3.26; −1.88; p |