Status:
COMPLETED
Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
Blood Transfusion Centre of Slovenia
Stanford University
Conditions:
Dilated Cardiomyopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Several studies have documented that transplantation of bone marrow-derived cells (BMC) following acute myocardial infarction is associated with a reduction in infarct scar size and improvements in le...
Detailed Description
Patients were randomly allocated in a 1:1 ratio to receive intracoronary transplantation of autologous CD34+ stem cells (SC group) or no intracoronary infusion (control group). At the time of enrollme...
Eligibility Criteria
Inclusion
- Normal coronary angiogram
- Left ventricular ejection fraction \< 40%
- NYHA III or IV heart failure symptoms
- Bone marrow reactivity (G-CSF test)
- Presence of viable myocardium
Exclusion
- Hematologic malignancy
- Multiorgan failure
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00629018
Start Date
May 1 2006
End Date
April 1 2013
Last Update
May 12 2015
Active Locations (1)
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1
Ljubljana University Medical Center
Ljubljana, Slovenia, 1000