Autologous Mesenchymal Stromal Cell Therapy in Heart Failure

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644410
• Other study ID #: MSC heart failure
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 20, 2008
• Last updated: March 16, 2015
• Start date: September 2008
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Biological:
• Mesenchymal stromal cell
Mesenchymal stromal cells 20 - 40 mill.
• Saline
12 injection with 0.2 ml saline

Locations

Country	Name	City	State
Denmark	The Heart Centre, Rigshospitalet University Hospital Copenhagen,	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in left ventricular function		6 and 12 months	Yes
Secondary	Clinical improvements		6 and 12 months	Yes