Autolog mesenkymal stromal cellebehandling af patienter med hjertesvigt.

Phase 1

Conditions: Congestive heart failure
MedDRA version: 9.1Level: LLTClassification code 10010684Term: Congestive heart failure

Registration Number: EUCTR2008-001850-42-DK

Lead Sponsor: The Heart Centre, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

EF < 40 %
NYHA 2-3
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Acute coronary syndrome within the last 6 weeks
Chronic atrial fibrillation
Pregnancy
Reduced lung function
Cancer
Any disease which potentially could interfere with the treatment or the outcome

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: It is a single centre, randomised controlled study of the effect of NOGA guided direct intramyocardial injection of mesenchymal stromal cells on the developement of new myocardium and blood vessels in patients with heart failure.<br><br>Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before injected into the myocardium.<br><br>The patients will be followed for safety, clinicalm MRI and CT for 12 months;Secondary Objective: ;Primary end point(s): Clinical and left ventricular function<br>Safety

Secondary Outcome Measures