Autologous Mesenchymal Stromal Cell Therapy in Heart Failure

Rigshospitalet

Status and phase: Completed; Phase 2; Phase 1

Conditions: Congestive Heart Failure

Treatments: Biological: Mesenchymal stromal cell; Biological: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00644410

MSC heart failure

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

The number of mesenchymal stromal cells reached after two culture expansion passages.

Treatment:

Biological: Mesenchymal stromal cell

2

Placebo Comparator group

Description:

Saline

Treatment:

Biological: Saline