Autologous Mesenchymal Stromal Cell Therapy in Heart Failure
|ClinicalTrials.gov Identifier: NCT00644410|
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : March 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Biological: Mesenchymal stromal cell Biological: Saline||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||September 2008|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
Active Comparator: 1
The number of mesenchymal stromal cells reached after two culture expansion passages.
Biological: Mesenchymal stromal cell
Mesenchymal stromal cells 20 - 40 mill.
Placebo Comparator: 2
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644410
|The Heart Centre, Rigshospitalet University Hospital Copenhagen,|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Jens Kastrup, MD DMSc||Rigshospitalet, Denmark|