Intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia; a registry.
Recruiting
- Conditions
- bone marrow cells, stem cell therapy, refractory angina, intramyocardial injection
- Registration Number
- NL-OMON28156
- 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
- 150
Inclusion Criteria
1. Severe refractory angina despite optimal medical therapy;
2. Reversible ischemia on GATED-SPECT;
Exclusion Criteria
1. Acute myocardial infarction, PCI or CABG within 6 months of enrolment in the study;
2. History of malignancy (except low grade and fully resolved non-melanoma skin malignancy);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in myocardial perfusion (SPECT) at 3 monhts follow-up relative to baseline.
- Secondary Outcome Measures
Name Time Method EFFICACY:<br /><br>Clinical end points:<br /><br>1. Angina frequency;<br /><br>2. Canadian cardiovascular society score;<br /><br>3. Quality of life;<br /><br>4. Exercise capacity.<br><br /><br /><br>Functional end points:<br /><br>5. Change in LV ejection fraction at 3 monhts follow-up;<br /><br>6. Regional myocardial function on a segmental base at 3 monhts follow-up.<br><br /><br /><br>Safety:<br /><br>7. Occurence of ahrrythmias;<br /><br>8. Pericardial effusion > 5 mm (echo);<br /><br>9. Myocardial damage;<br /><br>10. Severe inflammation.