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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Improvements in left ventricular function
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •EF < 45 %
- •NYHA 2 - 3
Exclusion Criteria
- •Acute coronary syndrome within last 6 weeks.
- •Pregnancy
- •FEV1 <1.0
- •Any severe disease which could interfere with the treatment or the outcome
Arms & Interventions
1
The number of mesenchymal stromal cells reached after two culture expansion passages.
Intervention: Mesenchymal stromal cell (Biological)
2
Saline
Intervention: Saline (Biological)
Outcomes
Primary Outcomes
Improvements in left ventricular function
Time Frame: 6 and 12 months
Secondary Outcomes
- Clinical improvements(6 and 12 months)
Investigators
JKastrup
Professor
Rigshospitalet, Denmark