Patients with severe stable coronary artery disease on medical therapy and no further revascularisation options with balloon angioplasty or coronary artery by-pass surgery and still severe angina pectoris MedDRA version: 12.1 Level: LLT Classification code 10008937 Term: Chronic ischemic heart disease, unspecified
Conditions
Interventions
Product Name: Mesenchymal stromal cells
Product Code: Mesenchymal stromal cells
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: I
Sponsors
Cardiovascular laboratory 2014, The Heart Centre, Rigshospitalet
Cardiovascular laboratory 2014, The Heart Centre, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stable coronary artery disease CCS class 2 - 4 A myocardial area with reduced perfusion due to an occluded vessel or a stenotic vessel bi-cycle exercise time between 2 - 10 min Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hematologic disease Acute coronary artery disease Reduced pulmonary function Heart failure Heart valve disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve myocardial perfusion and exercise capacity;Secondary Objective: Improve quality of life and angina symptoms;Primary end point(s): Bi-cycle exercise capacity Angina pectoris attacks Nitroglycerin consumption Quality of life Myocardila perfusion | — |
Countries
Denmark
Outcome results
None listed