Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
Phase 2
Completed
- Conditions
- Chronic Ischemic Symptomatic Heart Failure
- Interventions
- Procedure: Autologous bone marrow intracoronary infusion
- Registration Number
- NCT00933621
- Lead Sponsor
- Assaf-Harofeh Medical Center
- Brief Summary
The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.
- Detailed Description
Several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. There are no data about the long term outcome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography
Exclusion Criteria
- Idiopathic or non-ischemic cardiomyopathy
- Other etiology for heart failure, history of past or current disease involving the bone marrow
- Patients on dialysis
- Positive serologic test for HIV, hepatitis B or C or any neoplastic or terminal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Autologous Bone Marrow infusion Autologous bone marrow intracoronary infusion Percutaneous intracoronary autologous bone marrow infusion
- Primary Outcome Measures
Name Time Method Procedure success 9 months
- Secondary Outcome Measures
Name Time Method Functional class improvement 9 months
Trial Locations
- Locations (1)
Assaf Harofeh
🇮🇱Zerifin, Israel