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

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Completed; Phase 2

Conditions: Chronic Ischemic Symptomatic Heart Failure

Treatments: Procedure: Autologous bone marrow intracoronary infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00933621

19-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Autologous Bone Marrow infusion

Experimental group

Description:

Percutaneous intracoronary autologous bone marrow infusion

Treatment:

Procedure: Autologous bone marrow intracoronary infusion