Status:
COMPLETED
Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Dilated Cardiomyopathy
Heart Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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 repetitiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02248532
Start Date
January 1 2014
End Date
December 1 2017
Last Update
January 23 2018
Active Locations (1)
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1
UMC Ljubljana
Ljubljana, Please Select, Slovenia, 1000