Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy

Brief Title

Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy

Official Title

Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy

Brief Summary

      BACKGROUND. In patients with non-ischemic dilated cardiomyopathy, intracoronary stem cell
      transplantation has been shown to improve exercise capacity, reduce ventricular remodelling
      and improve 1-year survival. Pre-clinical data demonstrate that stem cell effects on the
      diseased heart can be further enhanced by direct intramyocardial delivery route.

      AIMS.

        1. To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with
           non-ischemic dilated cardiomyopathy.

        2. To directly compare clinical effects of intracoronary and intramyocardial stem cell
           delivery.

      METHODS. Of 60 patients with dilated cardiomyopathy, 30 will be randomized to intramyocardial
      transplantation of CD34+ cells (Study Group), and 30 will receive intracoronary stem cell
      therapy (Control Group). In both groups peripheral blood stem cells will be mobilised by
      daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and
      labelled with technetium. In the Study Group electromechanical mapping will be used to
      identify viable myocardium and intramyocardial injections in the target areas will be
      performed with NOGA catheter. In the Control group patients will undergo myocardial perfusion
      scintigraphy and CD34+ cells will be injected intracoronary in the artery supplying segments
      of reduced viability. Patients will be followed for 1 year. Primary endpoints will include
      changes in left ventricular ejection fraction and left ventricular dimensions (measured by
      echocardiography). Secondary endpoints will include changes in exercise capacity and changes
      in NT-proBNP values.

      HYPOTHESES.

        1. At 1 year, intramyocardial stem cell therapy will be associated with improved left
           ventricular ejection fraction, reduced left ventricular dimensions, improved exercise
           capacity and reduced levels of NT-proBNP.

        2. Beneficial effects of intramyocardial stem cell therapy will be superior to those
           observed with intracoronary stem cell delivery.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Changes in left ventricular ejection fraction and dimensions

Secondary Outcome

 Changes in exercise capacity

Condition

Dilated Cardiomyopathy

Intervention

Intramyocardial injection

Study Arms / Comparison Groups

 Intramyocardial Injections

Description:  Peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labelled with technetium. Electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with NOGA catheter. Nuclear imaging for quantitation of myocardial retention rates of labeled cells will be performed at 2 and 18 hours after the procedure.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

110

Start Date

March 2011

Completion Date

December 2014

Primary Completion Date

August 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Established dg. of dilated CMP (defined according to ESC position statement - absence
             of any stenotic lesions on coronary angiography, no congenital heart disease, no
             primary valve disease on echocardiography, and no history of hypertension or alcohol
             abuse1)

          -  left ventricular ejection fraction < 30%

          -  NYHA functional class III or IV for at least 3 months before referral

          -  Optimal medical management for at least 6 months

        Exclusion Criteria:

          -  Left ventricular aneurysm or thrombus

          -  Hematologic disease

          -  Multiorgan failure

          -  Active malignancy
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Slovenia

Location Countries

Slovenia

NCT ID

NCT01350310

Organization ID

NOGA-DCM

Responsible Party

Principal Investigator

Study Sponsor

University Medical Centre Ljubljana

Collaborators

 The Methodist Hospital System

Study Sponsor

, , 

Verification Date

April 2015