biostudies-literatureQayyum AAConsejo Superior de Investigaciones CientíficasAase and Ejnar Danielsens FoundationInnovationsfonden100254https://www.ebi.ac.uk/biostudies/studies/S-EPMC12005341biostudies-literatureUnknown8<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.JHLT openAllogeneic mesenchymal stromal cell therapy on primary graft dysfunction after lung transplantation.PMC120053410176-00012BJensen PBJohansen EMLund TKMathiasen ABHaack-Sorensen MKalhauge AMoller-Sorensen HPerch MQayyum AABruunsgaard HLitman TJensen KMoller CHHojgaard LDRorvig SBNorgaard MJKastrup JEkblond AfalseAllogeneic mesenchymal stromal cell therapy on primary graft dysfunction after lung transplantation.<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 NCT04714801.2025-01-01T00:00:00Z2025 May2026-06-01T14:49:15.181Z2026-04-08T13:31:39.834ZS-EPMC120053414024799710.1016/j.jhlto.2025.100254