Randomised, double blind, placebo controlled trial of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischaemia

Completed

• Conditions: Angina pectoris, myocardial ischaemia; Circulatory System; Angina pectoris

• Registration Number: ISRCTN58194927
• Lead Sponsor: eiden University Medical Centre (LUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Severe refractory angina despite optimal medical therapy
2. Reversible ischaemia on gated-single photon emission computed tomography (SPECT)
3. Not a candidate for (repeat) revascularisation (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI])
4. Male or female, greater than 18 years old
5. Patients must be stable (e.g. not be in a setting of life-threatening heart failure)
6. Written informed consent

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)
3. Unexplained haematological or biochemical abnormalities
4. Concurrent participation in a study using an experimental drug or an experimental procedure within 6 months before the injection procedure
5. Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal failure)
6. Bleeding diathesis or human immunodeficiency virus (HIV) infection
7. Inability to follow the protocol and comply with follow-up requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified