{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Qayyum AA"],"funding":["Consejo Superior de Investigaciones Científicas","Aase and Ejnar Danielsens Foundation","Innovationsfonden"],"pagination":["100254"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12005341"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["8"],"pubmed_abstract":["<h4>Background</h4>Primary graft dysfunction (PGD) is common in lung transplantation affecting 15-30% of recipients. It represents a multifactorial injury to the transplanted lung within the first 72 hours after transplantation.We aimed to investigate clinical safety and efficacy of allogeneic adipose tissue-derived stromal cells (ASCs), as an add-on therapy in patients undergoing double lung transplantation.<h4>Methods</h4>Single center, double-blinded, investigator-initiated randomized phase I/II study with intravenous infusion of either ASCs or placebo within two hours after lung transplantation. A total of 31 patients were included and randomized 1:1:1 to either 200 million or 100 million ASCs, or placebo infusion.The primary endpoint was difference in PGD grade 72 hours after transplantation between groups.<h4>Results</h4>No significant differences in PGD were seen between the 3 groups 72 hours after lung transplantation (P=0.426). Combined ASC groups compared to placebo group did not show any difference in PGD 72 hours after transplantation (P=0.252). A reduced progression in PGD from day 1 to day 3 and day 2 to day 3 was observed between the ASC treated patients and patients in the placebo group (P=0.034 and P=0.034, respectively). There were no significant differences in number of serious adverse events or in secondary endpoints such as kidney function, lung function, or quality-of-life between groups.<h4>Conclusions</h4>Intravenous infusion of allogeneic ASCs in patients immediately after double lung transplantation was safe. The therapy did not show statistic difference in PGD between groups 72 hours after lung transplantation.<h4>Clinical trial registration information</h4>EudraCT number 2019-004848-30 and NCT04714801."],"journal":["JHLT open"],"pubmed_title":["Allogeneic mesenchymal stromal cell therapy on primary graft dysfunction after lung transplantation."],"pmcid":["PMC12005341"],"funding_grant_id":["0176-00012B"],"pubmed_authors":["Jensen PB","Johansen EM","Lund TK","Mathiasen AB","Haack-Sorensen M","Kalhauge A","Moller-Sorensen H","Perch M","Qayyum AA","Bruunsgaard H","Litman T","Jensen K","Moller CH","Hojgaard LD","Rorvig SB","Norgaard MJ","Kastrup J","Ekblond A"],"additional_accession":[]},"is_claimable":false,"name":"Allogeneic mesenchymal stromal cell therapy on primary graft dysfunction after lung transplantation.","description":"<h4>Background</h4>Primary graft dysfunction (PGD) is common in lung transplantation affecting 15-30% of recipients. It represents a multifactorial injury to the transplanted lung within the first 72 hours after transplantation.We aimed to investigate clinical safety and efficacy of allogeneic adipose tissue-derived stromal cells (ASCs), as an add-on therapy in patients undergoing double lung transplantation.<h4>Methods</h4>Single center, double-blinded, investigator-initiated randomized phase I/II study with intravenous infusion of either ASCs or placebo within two hours after lung transplantation. A total of 31 patients were included and randomized 1:1:1 to either 200 million or 100 million ASCs, or placebo infusion.The primary endpoint was difference in PGD grade 72 hours after transplantation between groups.<h4>Results</h4>No significant differences in PGD were seen between the 3 groups 72 hours after lung transplantation (P=0.426). Combined ASC groups compared to placebo group did not show any difference in PGD 72 hours after transplantation (P=0.252). A reduced progression in PGD from day 1 to day 3 and day 2 to day 3 was observed between the ASC treated patients and patients in the placebo group (P=0.034 and P=0.034, respectively). There were no significant differences in number of serious adverse events or in secondary endpoints such as kidney function, lung function, or quality-of-life between groups.<h4>Conclusions</h4>Intravenous infusion of allogeneic ASCs in patients immediately after double lung transplantation was safe. The therapy did not show statistic difference in PGD between groups 72 hours after lung transplantation.<h4>Clinical trial registration information</h4>EudraCT number 2019-004848-30 and NCT04714801.","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 May","modification":"2026-06-01T14:49:15.181Z","creation":"2026-04-08T13:31:39.834Z"},"accession":"S-EPMC12005341","cross_references":{"pubmed":["40247997"],"doi":["10.1016/j.jhlto.2025.100254"]}}