Efficacy assessment of REpeat intramyocardial INJECTion of autologous bone marrow cells in previously responding no-option patients with residual or recurrent refractory Angina Pectoris and documented ischemia.

Recruiting

Conditions: refractory angina pectorisbone marrow cell intramyocardial injection

Registration Number: NL-OMON20190

Lead Sponsor: eiden University Medical Center (LUMC), Department of Cardiology

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 23

Inclusion Criteria

1. Having received intramyocardial bone marrow cell injection in study P02.051 (Injection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Refractory Angina Pectoris and Ischemia, a two-phased study of safety, feasibility and efficacy) or P05.025 (Efficacy assessment of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia, a randomized, double blind, placebo controlled study);

2. Disabling refractory angina pectoris despite optimal medical therapy;

Exclusion Criteria

1. Evidence of cancer (except low grade and fully resolved non-melanoma skin malignancy) as bone marrow cell infusion might promote tumor growth through induction of angiogenesis in the tumor;

2. Concurrent participation in a study using an experimental drug or an experimental procedure within 2 months before the injection procedure;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in myocardial perfusion at 3 months follow-up relative to baseline.

Secondary Outcome Measures

Name	Time	Method
Clinical end points:<br /><br>1. Canadian cardiovascular society score;<br /><br>2. Quality of life (translated Seattle angina questionnaire);<br /><br>3. Exercise capacity.<br><br /><br /><br>Functional end points:<br /><br>1. Left ventricular ejection fraction at 3 monhts follow-up.<br><br /><br /><br>Safety:<br /><br>1. Occurence of ahrrythmias; <br /><br>2. Pericardial effusion > 5 mm (echo); <br /><br>3. Myocardial damage;<br /><br>4. Severe inflammation.