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Trial record 38 of 157 for:    Idiopathic Dilated Cardiomyopathy

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

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ClinicalTrials.gov Identifier: NCT02248532
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bojan Vrtovec, University Medical Centre Ljubljana

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Heart Failure Biological: Stem cell therapy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy
Actual Study Start Date : January 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Active Comparator: Group A
Repetitive stem cell administration
Biological: Stem cell therapy
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.

Active Comparator: Group B
Single stem cell administration
Biological: Stem cell therapy
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248532


Locations
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Slovenia
UMC Ljubljana
Ljubljana, Please Select, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bojan Vrtovec, Medical Director, Advanced Heart Failure and Transplantation, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02248532     History of Changes
Other Study ID Numbers: REMEDIUM
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly