ixCELL-DCM, 2016 trial summary

A randomised clinical trial investigating the effect of ixmyelocel-T versus placebo in patients with New York Heart Association class III or IV symptomatic heart failure due to ischaemic dilated cardiomyopathy, who had left ventricular ejection fraction 35% or less, an automatic implantable cardioverter defibrillator, and who were ineligible for revascularisation procedures

NCT01670981    Lancet 2016;:  




Studied treatment ixmyelocel-T
expanded, multicellular therapy produced from a patient's own bone marrow by selectively expanding two key types of bone marrow mononuclear cells: CD90+ mesenchymal stem cells and CD45+ CD14+ auto-fluorescent+ activated macrophages
Control treatment placebo
cell type randomised



Patients patients with New York Heart Association class III or IV symptomatic heart failure due to ischaemic dilated cardiomyopathy, who had left ventricular ejection fraction 35% or less, an automatic implantable cardioverter defibrillator, and who were ineligible for revascularisation procedures
Group sizes 60 / 66



Blindness Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint Design



EndpointX1N1X0N0TE95% CI ventricular tachycardia - 60 - 66 no data NYHA deterioration - 60 - 66 no data cardiac event - 60 - 66 no data all-cause mortality - 60 - 66 no data acute heart failure - 60 - 66 no data0,22,01,0


Patel AN, Henry TD, Quyyumi AA, Schaer GL, Anderson RD, Toma C, East C, Remmers AE, Goodrich J, Desai AS, Recker D, DeMaria A Ixmyelocel-T for patients with ischaemic heart failure: a prospective randomised double-blind trial. Lancet 2016;:     [PMID: 27059887]   link to pdf  



Registering number NCT01670981 (see trial on clinicaltrials.gov)
Code Name

 




Appears in following systematic reviews: