ISRCTN58194927
Completed
Not Applicable
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
eiden University Medical Centre (LUMC) (The Netherlands)0 sites40 target enrollmentJanuary 27, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eiden University Medical Centre (LUMC) (The Netherlands)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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