Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)
- Conditions
- Heart FailureDilated Cardiomyopathy
- Interventions
- Biological: Stem cell therapy
- Registration Number
- NCT02248532
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Stem cell therapy Single stem cell administration Group A Stem cell therapy Repetitive stem cell administration
- Primary Outcome Measures
Name Time Method Change in left ventricular ejection fraction 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
Name Time Method Changes in regional wall motion 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.
Change in NT-proBNP baseline and 1 year Change in left ventricular dimension 1 year The change in left ventricular dimensions between randomization and 1 year thereafter will be assessed by 2D echocardiography.
Change in exercise capacity 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.
Trial Locations
- Locations (1)
UMC Ljubljana
🇸🇮Ljubljana, Please Select, Slovenia