Skip to main content
Clinical Trials/ISRCTN58194927
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.

Registry
who.int
Start Date
January 27, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
eiden University Medical Centre (LUMC) (The Netherlands)

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

Similar Trials