Registered Trials on Stem Cell Therapy in Liver Diseases: a Cross-sectional Study on ClinicalTrials.gov

Abstract Background: Stem cells have the ability of self-renewal and differentiation into liver cells, suggesting as a promising therapy for liver diseases. However, the efficacy and safety for clinical application remain unknown for limited number of clinical trials. ClinicalTrials.gov contributes to the development of clinical practice. This study aimed to systematically analyze the registered trials on stem cell therapy in liver diseases based on ClinicalTrials.gov.Methods: We searched the registered trials on stem cell therapy in liver diseases on ClinicalTrials.gov up to 23 September 2021. We investigated the study type, source of stem cells, and kind of liver diseases of included trials and these characteristics were analyzed by SPSS18.0 software.Results: Five hundred and fifty-nine registered trials were initially identified on ClinicalTrials.gov and 92 trials were included ultimately. Among them, 84 trials were interventional trials and eight (8.70%) were observational trials. Twenty-four (28.57%) trails aimed to evaluate the efficacy, 16 (19.05%) to evaluate the safety, and 44 (52.38%) to evaluate both. For stem cell source, 73 trials (81.52%) used mesenchymal stem cells (MSCs), including 26 with bone marrow mesenchymal stem cells, 22 with umbilical cord mesenchymal stem cells, 20 with unclassified mesenchymal stem cells, and five with adipose tissue-derived stem cells. For liver disease classification, sixty trials focused on cirrhosis, 16 trials on liver failure, while eight trials on autoimmune liver disease. However, only 22 (23.91%) trials had been completed and four (4.35%) had available results on the website.Conclusions: Our study suggest that more stem cell therapy trials are needed in liver diseases and sponsors are encouraged to report the results.