Table 1 Completed and ongoing ASC-based clinical trials for cardiovascular diseases
From: Harnessing the secretome of adipose-derived stem cells in the treatment of ischemic heart diseases
Clinical trial ID | Phase | Pathologies | Enrolled number | Cell delivery route | Outcome measures | Status | Study designs | Cell quantity |
|---|---|---|---|---|---|---|---|---|
NCT00442806 [83] | 1 | STEMI | 14 | Intracoronary injection | Safety, MACCE, feasibility, cardiac function | Completed | Randomized, parallel assignment, double-blind | 20–40 × 106 cells |
NCT02673164 | 2 | Heart failure | 138 | Direct intra-myocardial injection | LVESV, safety | Recruiting | Randomized, parallel assignment, double-blind | 100 × 106 cells |
NCT01449032 [86] | 2 | Chronic ischemic heart disease | 60 | Direct intra-myocardial injection | Exercise test, clinical evaluation | Completed | Randomized, parallel assignment, double-blind | 72.0 ± 44.9 × 106 cells |
NCT02387723 | 1 | Heart failure | 10 | Direct intra-myocardial injection | Safety, LVESV, LVEF, LVEDV (ml), LV end-systolic mass (g) | Completed | Single group assignment, open-label | 100 × 106 cells |
NCT00426868 [84] | 1 | Ischemic heart disease | 27 | Direct intra-myocardial injection | Safety, MACCE, feasibility, cardiac function | Completed | Randomized, parallel assignment, double-blind | 0.4–1.2 × 106 cells/kg |
NCT03092284 | 2 | Heart failure | 81 | Direct intra-myocardial injection | LVESV, safety, LVEF, KCCQ, 6 min walking test, Seattle Angina Questionnaire | Recruiting | Randomized, parallel assignment, double-blind | 100 × 106 cells |
NCT02052427 [85] | 2 | Chronic myocardial Ischemia | 3 | Direct intra-myocardial injection | MLHFQ, mVO2, LVESV/LVEDV, EF, perfusion defect, NYHA classification, CCS classification | Completed | Randomized, parallel assignment, double-blind | 0.8 × 106 cells/kg |
NCT01216995 | 2 | STEMI | 23 | Intracoronary injection | Infarct size, MACCE rates | Completed | Randomized, parallel assignment, double-blind | Not yet open |
NCT01556022 [85] | 2 | Chronic ischemic heart disease | 28 | Direct intra-myocardial injection | Safety, SAEs, MACE, arrhythmia assessment, feasibility, cardiac function, LVESV/LVEDV, EF | Completed | Randomized, parallel assignment, double-blind | 0.4 × 106 cells/kg |
NCT01709279 | Not applicable | Ischemic heart failure | 6 | Intracoronary injection | All-cause harmful events | Enrolling by invitation | Single group assignment, open-label, | Not yet open |