NCT03797092.
Study name | Stem cell therapy in non‐ischaemic non‐treatable dilated cardiomyopathies II: a pilot study |
Methods | Open (2:1) RCT Follow‐up: 6 months |
Participants | Adults aged 30–80 years with non‐ischaemic DCM |
Interventions |
SCT group: allogeneic adipose‐derived stromal cells (CSCC_ASC) Control: no treatment |
Outcomes | Left ventricle end‐systolic volume (echocardiography) Allogeneic antibodies Changes in LVEF Change in echocardiogram‐measured global myocardial mass NYHA Kansas City Cardiomyopathy Questionnaire EQ‐5D3L Questionnaire 6‐minute walking test |
Starting date | |
Contact information | Principal investigator: Jens Kastrup, MD, DMSc |
Notes | Study completion date: 1 September 2021 |
AE: adverse event; BNP: brain natriuretic peptide; DCM: dilated cardiomyopathy; EQ‐5D3L: EQ‐5D three level version; LVEF: left ventricular ejection fraction; MACE: major adverse cardiovascular event; MRI: magnetic resonance imaging; MSC: mesenchymal stem cell; NYHA: New York Heart Association; RCT: randomized controlled trial; SAE: serious adverse event; SCT: stem cell therapy; SPECT: single‐photon emission computed tomography; VO2: oxygen uptake.