Table 1.
Characteristics of Included Studies
Study; Country |
Study Design |
Center | Inclusion Criteria | Exclusion Criteria | Cell Type; Route of Delivery |
Outcome | Follow-up |
---|---|---|---|---|---|---|---|
Losordo;14 USA |
RCT: double- blind, placebo- controlled |
3 | Age >21 yr, CCS III/IV, refractory to medical therapy, 2 anti-anginals, ineligible for revascularization, documented ischemia on nuclear perfusion |
MI ≤ 30 days, revascularization ≤ 3 months, joint disease/COPD/PVD which may limit walking on treadmill severe AS/MS, CHF symptoms, life expectancy < 1 year, uncontrolled HTN |
CD34+ cells, Intramyocardial (EMM, NOGA guided) |
Angina frequency, NTG use, exercise tolerance, CCS class, SPECT imaging, QoL; Safety |
1,2,4 weeks; 2,3,6, 9 and 12 months |
Tse;15 Hong Kong, Australia |
RCT: blind, placebo- controlled |
2 | CCS III/IV, refractory to medical therapy, ineligible for revascularization, documented viable myocardium on SPECT, |
Unprotected L main, decompensated CHF, LVEF ≤ 30%, ACS or stroke within 3 months, significant renal, liver or hematological abnormalities; AF/AS/LV thrombus/PAD prevent electromechanical LV mapping |
BMMNC; Intramyocard ial (EMM, NOGA guided) |
Exercise treadmill, SPECT, cardiac MRI |
3,6 months |
Ramshorst;16 Netherlands |
RCT: double- blind, placebo- controlled |
1 | CCS III/IV despite medical therapy, documented ischemia in at least 1myocardial segment on SPECT, ineligible for revascularization |
LVEF < 35%, MI within 6 months, GFR < 30 ml/min, unexplained hematological abnormalities, malignancy |
BMMNC; Intramyocard ial (EMM, NOGA guided) |
CCS class, QoL, exercise capacity, myocardial perfusion, LV function and volumes, arrhythmia |
3,6 months |
Wang;17 China |
RCT; placebo- controlled |
1 | Age >30 yr, CCS III/IV, refractory to medical therapy, ineligible for revascularization, ischemia on nuclear perfusion, angina during baseline exercise |
MI within 30 days, revascularization within 6 months, TIA within 60 days, severe AS/MS, CHF symptoms, life expectancy < 1 year, uncontrolled HTN; joint disease/COPD/PVD which may limit walking on treadmill |
CD34+ cells; Intracoronary |
Angina frequency, NTG use, exercise tolerance, CCS class, SPECT imaging; Safety |
1,2,4 weeks; 3 and 6 months |
Losordo;18 USA |
RCT: double- blind, placebo- controlled |
26 | Age >21 yr, CCS III/IV, refractory to medical therapy, angina during baseline exercise, ischemia on nuclear perfusion, ineligible for revascularization |
MI within 60 days, revascularization within 3 months, LVEF < 25%, predominant CHF symptoms, severe AS, prosthetic aortic valve, COPD which may limit walking on treadmill, creatinine > 2.5 mg/dl |
CD34+ cells; Intramyocard ial (EMM, NOGA guided) |
Angina frequency, anti-anginal use, exercise tolerance, CCS class, SPECT imaging, MRI; Safety |
28 days; 3,6 and 12 months |
Quevedo;19 Spain |
RCT; single- blind, placebo- controlled |
3 | CCS II-IV, refractory to medical therapy, coronary anatomy not amenable to revascularization, documented ischemia on SPECT |
MI within 3 months, LV thrombus, aortic valve ds, hemorrhagic disorder, LV wall thickness < 8 mm, history of malignancy ≤5 years, pregnancy |
CD133+ cells; Intramyocard ial (EMM, NOGA guided) |
CCS class, treadmill test, SPECT, anti- anginal medication; QoL, MRI; Safety |
1 week; 1,3 and 6 months; 1 and 2 years |
Abbreviations: USA, United States; RCT, Randomized controlled trial; CCS, Canadian cardiovascular society functional angina class; MI, Myocardial Infarction; AS, Aortic stenosis; MS, Mitral stenosis; CHF, Congestive heart failure; HTN, Hypertension; COPD, Chronic obstructive pulmonary disease; PVD, Peripheral vascular disease; NTG, Nitroglycerine; SPECT, Single photon emission computed tomography; QoL, Quality of life; BMMNC, Bone marrow mononuclear cells, LV, Left ventricular.