{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Sawitzki B"],"funding":["British Heart Foundation","Medical Research Council","National Institute for Health Research (NIHR)","Wellcome Trust"],"pagination":["1627-1639"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC7613154"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["395(10237)"],"pubmed_abstract":["Background
Use of cell-based medicinal products (CBMPs) represents a state-of-the-art approach for reducing general immunosuppression in organ transplantation. We tested multiple regulatory CBMPs in kidney transplant trials to establish the safety of regulatory CBMPs when combined with reduced immunosuppressive treatment.Methods
The ONE Study consisted of seven investigator-led, single-arm trials done internationally at eight hospitals in France, Germany, Italy, the UK, and the USA (60 week follow-up). Included patients were living-donor kidney transplant recipients aged 18 years and older. The reference group trial (RGT) was a standard-of-care group given basiliximab, tapered steroids, mycophenolate mofetil, and tacrolimus. Six non-randomised phase 1/2A cell therapy group "],"journal":["Lancet (London, England)"],"pubmed_title":["Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials."],"pmcid":["PMC7613154"],"funding_grant_id":["211122","RG/13/12/30395","MR/K025538/1","CL-2013-13-005","MR/N027930/1","211122/Z/18/Z"],"pubmed_authors":["Geissler EK","James B","Miloud T","Josien R","Otto NM","Guinan EC","Ahrens N","Ollinger R","Karitzky S","Moreau A","Dupas N","Turka LA","Friend PJ","Hilton R","Reinke P","van der Net JB","Issa F","Blancho G","Lechler RI","Scotta C","Braudeau C","Contreras-Ruiz L","Morris PJ","Hester JL","Kapinsky M","Cuturi MC","Roberts ISD","Bluestone JA","Burlingham WJ","Hernandez-Fuentes MP","Juerchott K","Edinger M","Battaglia M","Streitz M","Boger CA","Caldara R","Brent L","Hutchinson JA","Kunzendorf U","Schlickeiser S","Bushell A","Game DS","Bergler T","Harden PN","Tang Q","Meyenberg C","Grinyo J","Kang SM","Secchi A","Banas B","Volk HD","Wood KJ","Crisalli K","Petchey W","Mutzbauer I","Schlitt HJ","Knechtle SJ","Lombardi G","Scheffold A","Sawitzki B","Markmann JF"],"additional_accession":[]},"is_claimable":false,"name":"Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials.","description":"Background
Use of cell-based medicinal products (CBMPs) represents a state-of-the-art approach for reducing general immunosuppression in organ transplantation. We tested multiple regulatory CBMPs in kidney transplant trials to establish the safety of regulatory CBMPs when combined with reduced immunosuppressive treatment.Methods
The ONE Study consisted of seven investigator-led, single-arm trials done internationally at eight hospitals in France, Germany, Italy, the UK, and the USA (60 week follow-up). Included patients were living-donor kidney transplant recipients aged 18 years and older. The reference group trial (RGT) was a standard-of-care group given basiliximab, tapered steroids, mycophenolate mofetil, and tacrolimus. Six non-randomised phase 1/2A cell therapy group ","dates":{"release":"2020-01-01T00:00:00Z","publication":"2020 May","modification":"2026-05-27T21:37:57.033Z","creation":"2022-08-07T16:01:49.28Z"},"accession":"S-EPMC7613154","cross_references":{"pubmed":["32446407"],"doi":["10.1016/S0140-6736(20)30167-7","10.1016/s0140-6736(20)30167-7"]}}