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Completed

NCT Number: NCT02248532

Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)

The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is (1) on repetitive administration of cell therapy that would allow for long-lasting improvements in heart function and outcome in this patient population. In parallel, the investigators aim to (2) develop a standardized patient-specific stem cell product that could be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for therapeutic application when clinically indicated. By using a unique multimodality imaging platform, the goal of this project is also to (3) define standardized clinical criteria that would serve as a guideline for evaluation of the effects of stem cell therapy in future clinical trials and everyday clinical settings. Finally, to improve the clinical implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery technique that could be used to treat both left and right and ventricular failure and could be implemented in a standardized fashion designed for a widespread clinical use.

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Failure Laminopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UMC Ljubljana

Ljubljana, Please Select, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-70 years old
  • Diagnosis of DCM according to European Society of Cardiology position statement
  • Left ventricular ejection fraction (LVEF) by echocardiography 20-40%,
  • New York Heart Association (NYHA) functional class heart failure II or III for at least 3 months before referral.

Exclusion criteria

  • Acute multi-organ failure
  • History of any malignant disease within 5 years
  • Diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity)
  • Pregnancy

Treatment and study plan

Stem cell therapy

Biological

Bone marrow cells will be mobilized into peripheral blood by daily subcutaneous injections of G-CSF (10 µg/kg daily) and collected by leukapheresis. Positive immunomagnetic selection of CD34+ cells will be performed. Electroanatomic mapping of the left ventricle will be performed using the Biosense NOGA system (Biosense-Webster®, Diamond Bar, CA). The target area for cell delivery will be defined as the myocardial segments with unipolar voltage potentials ≥8.3 mV, bipolar amplitudes >1.9 mV, and linear shortening <6%. Intramyocardial delivery of cell suspension will be performed with the MyoStar (BiosenseWebster®, Diamond Bar, CA) injection catheter. Each patient will receive 20 injections (0.3 mL each; total volume of 6 mL). All the procedures will be repeated 6 months after baseline.

Primary outcomes

  1. Change in left ventricular ejection fraction

    Time frame: baseline and 1 year

    The echocardiography data will be recorded and analyzed at the end of the study by an independent echocardiographer who will be blinded to the patient's treatment status and the timing of the recordings. Left ventricular end-systolic volume and end-diastolic volume and LVEF will be estimated using the Simpson's biplane method and left ventricular end-systolic dimension and end-diastolic dimension will be measured in the parasternal long axis view. All echocardiographic measurements will be averaged for 5 cycles.. The change in left ventricular ejection fraction (LVEF) between randomization and 1 year thereafter will be assessed by 2D echocardiography.

Secondary outcomes

  1. Changes in regional wall motion

    Time frame: baseline and 1 year

    Left ventricular segmental wall motion analysis (strain) will be evaluated with TomTec software (TomTec Imaging Systems GmbH, Unterschleissheim, Germany), using a 17-segment model of the left ventricle.

  2. Change in left ventricular dimension

    Time frame: 1 year

    The change in left ventricular dimensions between randomization and 1 year thereafter will be assessed by 2D echocardiography.

  3. Change in exercise capacity

    Time frame: baseline and 1 year

    Change in exercise capacity will be evaluated by 6-minute walk test was performed by a blinded observer according to the standard protocol.

  4. Change in NT-proBNP

    Time frame: baseline and 1 year

Other outcomes

  1. Incidence of ventricular arrhythmias

    Time frame: 1 year

  2. Cardiac mortality

    Time frame: 1 year

  3. Hospitalization for heart failure

    Time frame: 1 year

  4. Pump failure mortality

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy

Acronym: REMEDIUM

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2014
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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