Table 1.
Summary of trials assessing the effects of stem cell therapy in cardiomyopathy.
| Patient characteristics | Design | Delivery methods | Cell type/# | Results | Refs. |
|---|---|---|---|---|---|
| Ischemic cardiomyopathy, LVEF ≤ 30% |
Non-randomized, 8 patients | Direct injection via NOGA electro-mechanical mapping |
Autologous BMCs (n = 0.7 to 8.8 × 106 CD34+ cells) |
Improved symptoms, myocardial perfusion and function of ischemic regions by MRI |
[73] |
| Ischemic cardiomyopathy, LVEF ≤ 30% |
Non-randomized, 10 patients | Direct injections (n = 12) via biosense electro-mechanical mapping |
Autologous BMCs (n = 32.6 ± 27.5 × 106 cells/mL) |
Improved angina class, reduced stress-induced ischemia in injected territories |
[50] |
| Ischemic cardiomyopathy, LVEF ≤ 40%, reversibility on SPECT |
Non-randomized, 21 patients (first 14 treated, last 7 control) |
Direct injection via NOGA electro-mechanical mapping |
Autologous BMCs (n = 25.5 ± 6.3 × 106) |
Improvement in LVEF (5%), reduction in end systolic volume |
[51] |
| Ischemic cardiomyopathy, LVEF ≤ 40%, heart Tx candidates |
Non-randomized, 5 patients | Direct injection via NOGA electro-mechanical mapping |
Autologous BMCs (n = not listed) |
Increase in myocardial oxygen consumption (10.6 ± 3 to 16.3 ± 7 mL/kg/min) |
[52] |
| History of transumural anterior MI with LAD stenting |
Non-randomized, 5 consecutive patients |
Intracoronary with balloon occlusion in infarct related artery |
Autologous BMCs (n = 2.9 ± 0.9 × 107 cells) |
No improvement in myocardial function or physical performance |
[53] |
| History of transmural MI 2 7 ± 3.1 months prior treated by PCTA and/or stent |
Non-randomized, 18 consecutive patients with 18 patients in parallel as controls |
Intracoronary with balloon occlusion in infarct related artery |
Autologous BMCs (n = 2.9 ± 0.9 × 107 cells) |
Reduction in infarct size by 30%, increase in LVEF by 15% and infarct wall movement by 57% |
[54] |
| History of MI, nonviability, scheduled for elective CABG |
Randomized 1:1, open label, 20 patients |
Direct injection into infarct border zone at time of CABG |
Autologous BMCS (n = 60.1 ± 31.6 × 106 cells) |
Increase in global LVEF, improvement in systolic thickening |
[55] |
| History of MI 14 days prior, akinetic region, need for CABG |
15 consecutive patients (safety and feasibility) followed by 40 patients randomized, open label |
Direct injection at time of CABG into region of perfusion defect |
Autologous BMCs isolated for CD133 (median number = 5.8 × 106) |
Increase in LVEF compared to CABG group alone |
[56] |
| History of MI > 3 months prior, infarct region supplied by patent coronary artery |
Randomized, open label, peripheral EPCs (n = 75), BMCs (n = 24), no infusion (n = 23) |
Intracoronary with balloon occlusion in infarct related artery |
Autologous EPCs (n = 22 ± 11 × 10 6) or BMCs (n = 20.3 ± 11.0 × 106) |
Increase in ejection fraction (2.9%) in BMC cohort, no effect in CPC cohort |
[57] |
| History of MI > 3 months prior, regional LV dysfunction |
Non-randomized, 121 consecutive patients |
Intracoronary with balloon occlusion in infarct related artery |
Autologous BMCs (n = 214 ± 98 × 106 cells) |
Decrease in BNP levels from baseline |
[99] |
| Class III or class IV angina, not candidate for revasulcarization, reversiblity on perfusion scan |
Randomized, double-blinded to 3 doses of GCSF |
Direct injection via NOGA electro-mechanical mapping |
Leukapheresis after GCSF infusion with CD34+ Cells |
No adverse events, trend toward decrease in angina and nitroglycerin use |
[58] |
| History of MI > 4 weeks prior, 35% ≤ EF ≥ 15%, akinetic nonviable by DSE |
Randomized, double-blinded, placebo-controlled, 3 arms, 120 patients, 97 patients received cells (33,400 × 106 cells, 34,800 × 106 cells) and 30 placebo |
Direct injection (mean of 30 sites) around akinetic segment at time of CABG |
Cells expanded from muscle biopsy of approximately 10 g |
No improvement in LV function, high dose cohort did have a decrease in LV volume |
[59] |
| MI > 6 months prior, class III or class IV Angina, LVEF ≥ 35%, reversiblity by SPECT |
Randomized 1:1, double- blinded, placebo-controlled, 50 patients |
Direct injection via NOGA electro-mechanical mapping into ischemic region. |
Autologous BMCs (n = 98 × 106 cells) |
Significant but modest improvement perfusion by SPET, improvement in angina class |
[60] |
| Non-ischemic cardiomyopathy | Randomized, 44 patients (n = 24 treated) |
Intracoronary (2/3 into left Main, 1/3 into RCA) with balloon occlusion of coronary sinus for 3 min |
Autologous BMCs | Significant improvement in NYHA class and LVEF (5.4%), reduction in end-systolic volumes |
[100] |
BMCs: Bone marrow stem cells; CABG: Coronary artery bypass; LVEF: Left ventricular ejection fraction; MI: Myocardial infarction; MRI: Magnetic resonance imaging; NOGATM:; PCI: Percutaneous coronary intervention; PCTA: Percutaneous transluminal angioplasty; SPECT: Single-photon emission computed tomography.