Autologous Mesenchymal Stromal Cell Therapy in Heart Failure

Phase 1

Completed

• Conditions: Congestive Heart Failure
• Interventions: Biological: Mesenchymal stromal cell; Biological: Saline

• Registration Number: NCT00644410
• Lead Sponsor: Rigshospitalet, Denmark

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 Timeline

• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Study Start: 2008-09
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• EF < 45 %
• NYHA 2 - 3

Exclusion Criteria

• Acute coronary syndrome within last 6 weeks.
• Pregnancy
• FEV1 <1.0
• Cancer
• Any severe disease which could interfere with the treatment or the outcome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mesenchymal stromal cell	The number of mesenchymal stromal cells reached after two culture expansion passages.
2	Saline	Saline

Primary Outcome Measures

Name	Time	Method
Improvements in left ventricular function	6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Clinical improvements	6 and 12 months

Trial Locations

Locations (1)

The Heart Centre, Rigshospitalet University Hospital Copenhagen,; 🇩🇰 Copenhagen, Denmark