Table 2.
Selected clinical trials of stem cell therapy for cardiac regeneration
| Trial name/References | Classification | Cell type | Delivery method | Patient number | Follow-up period | Outcome | Side effects |
|---|---|---|---|---|---|---|---|
| MAGIC (Menasche et al, 2008) | Phase I/II | SKMs | Intramyocardial injection during CABG | 97 | 6 m | Unchanged LVEF and regional wall motion/decreased LVEDV in patients receiving high dose | Ventricular arrhythmias in 9 of 63 patients, and 9 of 63 patients died |
| MARVEL (Povsic et al, 2011) | Phase I/II | SKMs | Transcatheter intramyocardial | 20 | 3, 6 m | Improved 6-minute walk distance | Ventricular tachycardia in 7 of 14 patients |
| Repair-AMI (Assmus et al, 2014) (Schachinger et al, 2009) | Phase III | BMMNCs | Intracoronary | 204 | 4, 12 m; 2,5 y | Reduced LV remodeling/Improved ventricular function | 5 of 101 patients hospitalized for heart failure, and 7 of 101 patients died |
| BAMI (NCT01569178) | Phase III | BMMNCs | Intracoronary | 3000 | 3 y | Currently recruiting | |
| RENEW (Povsic et al, 2013) | Phase III | BM-derived CD34+ stem cells | Intramyocardial | 444 | 12 m | Currently ongoing | |
| PERFECT (Donndorf et al, 2012) | Phase III | BM-derived CD133+ stem cells | Intramyocardial injection during CABG | 142 | 6 m | Currently recruiting | |
| POSEIDON (Hare et al, 2012) (Suncion et al, 2014) | Phase I/II | BM-derived MSCs | Intramyocardial (transendocardial) | 30 | 13 m | Unchanged LVEF/decreased LVEDV and scar mass/improved physical performance | 3 patients hospitalized for heart failure |
| PROMETHEUS (Karantalis et al, 2014) | Phase I/II | BM-derived MSCs | Intramyocardial injection during CABG | 6 | 3, 6, 18 m | Increased LVEF/reduced scar mass | No major complications reported |
| TAC-HFT (Heldman et al, 2014) | Phase I/II | BMMNCs vs. BM-derived MSCs | Intramyocardial (transendocardial) | 65 | 3, 6, 12 m | Unchanged LVEF and LV volumes/improved regional LV function and decreased infarct size (only with MSCs) | No major complications reported |
| ADVANCE (NCT01216995) | Phase II | Adipose-derived MSCs | Intracoronary | 216 | 6, 12 m; 3 y | Currently ongoing | |
| SCIPIO (Chugh et al, 2012) | Phase I | c-kit+ CPCs | Intracoronary | 33 | 4, 12 m | Increased LVEF/reduced infarct size/increased viable mass | No major complications reported |
| ALCADIA (NCT00981006) | Phase I | CPCs | Intramyocardial injection during CABG | 6 | 12 m | Currently ongoing | |
| CADUCEUS (Malliaras et al, 2014) | Phase I | Cardiosphere-derived CPCs | Intracoronary | 25 | 6, 12 m | Unchanged LVEF and LV volumes/reduced scar mass/increased viable mass | Serious adverse events in 6 of 17 patients, and 1 of 17 patients died |
| ALLSTAR (NCT01458405) | Phase I/II | Cardiosphere-derived CPCs | Intracoronary | 274 | 12 m | Currently recruiting | |
For ongoing trials with no published results, the ClinicalTrials.gov Identifier (NCT…) has been indicated.
BM, bone marrow; BMMNCs, bone marrow mononuclear cells; CPCs, cardiac progenitor cells; MSCs, mesenchymal stem cells; SKMs, skeletal myoblasts; CABG, coronary artery bypass graft; LV, left ventricular; LVEDV, left ventricular end-diastolic volume; LVEF, left ventricular ejection fraction; m, months; y, years.