Autologous Mesenchymal Stromal Cell Therapy in Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Biological: Mesenchymal stromal cell
* Biological: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>The number of mesenchymal stromal cells reached after two culture expansion passages. | Biological: Mesenchymal stromal cell<br>* Mesenchymal stromal cells 20 - 40 mill.<br>|
| Placebo Comparator: 2<br>Saline | Biological: Saline<br>* 12 injection with 0.2 ml saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in left ventricular function |  | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvements |  | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, stem cell, mesenchymal stromal cell, mesenchymal stem cell