A Phase 1/2 interventional study of Mesenchymal stromal cell and Saline in Congestive Heart Failure, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Rigshospitalet, Denmark · Phase 1/2, Interventional, and Treatment
It is a single centre, randomised controlled study of the effect of NOGA-guided direct intramyocardial injection of mesenchymal stromal cells on the development of new myocardium and blood vessels in patients with heart failure.
Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before injected into the myocardium.
The patients will be followed with safety, clinical, MRI and CT endpoints for 1 year.
The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of mesenchymal stromal cells in patients with reduced left ventricular EF (≤45%) and heart failure NYHA 2-3.
A total of 60 patients with will be enrolled in the study and randomised 2: 1 to cells or placebo (saline).
The patients will be followed for 12 months. The primary endpoint is changes in left ventricle end-systolic volume (LVESV) at 6 months follow-up.
The secondary endpoints are changes in left ventricular ejection fraction (LVEF), end-diastolic volume and end-systolic mass at 6 months follow-up.
Other secondary endpoints are NYHA, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6 min walking test, and major adverse events endpoints: all-causes death, cardiovascular death, and hospitalization for worsening heart failure and MI at 12 months follow-up.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 59 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The number of mesenchymal stromal cells reached after two culture expansion passages.
Biological: Mesenchymal stromal cell
Saline
Biological: Saline
Mesenchymal stromal cells 20 - 40 mill.
12 injection with 0.2 ml saline
Improvements in left ventricular function
Time frame: 6 and 12 months
Clinical improvements
Time frame: 6 and 12 months
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark