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Clinical Trials/NCT00933621
NCT00933621
Completed
Phase 2

Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up

Assaf-Harofeh Medical Center1 site in 1 country8 target enrollmentApril 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Chronic Ischemic Symptomatic Heart Failure
Sponsor
Assaf-Harofeh Medical Center
Enrollment
8
Locations
1
Primary Endpoint
Procedure success
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2003
End Date
December 2003
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Procedure success

Time Frame: 9 months

Secondary Outcomes

  • Functional class improvement(9 months)

Study Sites (1)

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