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Table 1 Inclusion and exclusion criteria

From: Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial): 3-years follow-up results

Inclusion criteria

 Age between 30 and 80 years

 Moderate to severe angina (CCS Angina Class II–III) or angina equivalent dyspnea (NYHA class II–III) despite optimal medical therapy

 Must have, within 12 months prior to entry, documented coronary angiographic evidence of significant vessel disease, and at least one remaining larger coronary vessel from which new collaterals/vessels could be supplied

 Must not be eligible for any other re-vascularization procedures

 Left ventricular ejection fraction > 40% measured by echocardiography, SPECT, CT-scan, or MRI

 Duration of bicycle ergometry exercise tolerance tests: 2 to 10 min

 CABG or PCI within 6 months of entry must have angiography performed at least 4 months after the previous intervention to rule out early restenosis and to document remaining significant vessel disease

 Ventricular wall thickness of the treatment zone > 7 mm measured by echocardiography, CT-scan, or MRI

Exclusion criteria

 Pregnant or lactating women

 Clinically significant anemia, leukopenia, leukocytosis, or thrombocytopenia

 Conditions other than angina that will limit exercise test (e.g. severe peripheral vascular disease, COPD; FEV1 < 1)

 Immunocompromised status or currently receiving immunosuppressive therapy

 Valvular heart disease requiring surgical intervention

 Less than 6 weeks prior to screening: ACS with increase in CK-MB or Troponins/PCI/CABG/Stroke or TIA

 History of malignancy < 5 years (except cured non-melanoma skin cancer) or suspicion of current malignancy

 Other experimental medications within the last 4 weeks prior to the baseline ETT

  1. CABG coronary artery bypass grafting, CCS Canadian Cardiovascular Society, CT computed tomography, MRI magnetic resonance imaging, NYHA New York Heart Association, PCI percutaneous coronary intervention, SPECT single-photon emission computed tomography, ACS acute coronary syndrome, COPD chronic obstructive pulmonary disease, ETT exercise tolerance test, FEV1 forced expiratory volume in 1 s, TIA transient ischemic attack