Table 1.
Clinical Studies of Cellular Cardiomyoplasty for Chronic Congestive Heart Failure
| Indication + year of publication | Pts. (no.) | E.F, pre − post tx (%) | Follow-up | Death: arrhythmia | Cell type | Cell (no.) | Delivery method | Results | |
|---|---|---|---|---|---|---|---|---|---|
| MI >10 d to <3 mo before tx, ischemic CMP, 2003 NR |
6 | 36.2 ± 10.6 48.8 ± 5.6 |
3–10 mo | None | BMC | 1.5 × 106 | CABG + epicardial injection | Improved LVEF and improved perfusion by scintigraphy | (121) |
| Old MI + ischemic CMP, 2003 NR |
12 | 35.5 ± 2.3 53.5 ± 4.98 |
3 mo | None | Skeletal myoblasts | 1.75–3 × 108 | CABG + epicardial injection | Improved LVEF and improved viability by 18F-FDG-PET | (53) |
| Old MI, 2003 NR |
5 | 36 ± 11 41 ± 9 |
6 mo | 1 pt. requiring ICD for NSVT | Skeletal myoblasts | 2.96 × 108 | Catheter-based endomyocardial injection | Improved LVEF and regional thickening (MRI) in cell tx arm | (119) |
| Old MI + ischemic CMP, 2003 NR |
10 | 24 ± 1 32 ± 1 |
10.9 mo | 4 pts. VT requiring ICD | Skeletal myoblasts | 8.71 × 108 | CABG + epicardial injection | Improved LVEF and regional thickening (echo) in cell tx arm | (84) |
| CHF pre HT, 2003 NR |
5 | n.a. | 68–191 d | None | Skeletal myoblasts | 2.8 × 108 | LVAD + epicardial injection | Myoblasts identified at heart recovery | (96) |
| Old MI + ischemic CMP, 2003 NR |
14 | 20 ± 9 29 ± 13 |
4 mo | 1 pt. SCD | BMC | 3 ± 0.4 × 107 | Catheter-based endomyocardial injection | Improved LVEF and mechanical improvement by EMM | (98) |
| Old MI + ischemic CMP, 2004 NR |
10 | 35.2 (25–40) 42 (29–47) |
12 mo | 1 death, 2 pts. VT requiring amiodarone | Skeletal myoblasts | 2.45 ± 2.42 × 107 | CABG + epicardial injection | Improved LVEF | (116) |
| Old MI + ischemic CMP, 2005 NR |
30 | 28 ± 9 36 ± 11 at 24 mo |
33–45 mo | 4 deaths, 5 pts. VT 2 requiring ICD, 1 pt with VF on LVAD | Skeletal myoblasts | 1 × 107–3 × 108 | CABG (n = 24) or LAVD (n = 6) + epicardial injection | Improved LVEF and improved viability by 18F-FDG-PET | (29) |
| Old MI, 2006 R |
75 | BMC: 41 ± 11 → 43 ± 10 CPC: 39 ± 10 → 39 ± 10 No cells: 43 ± 13 → 42 ± 13 |
3 mo | 1 death | BMC (n = 28) CPC (n = 24) No cells (n = 23) |
BMC: 2.05 ± 1.1 × 108 CPC: 2.2 ± 1.1 × 107 |
IC infusion | Improved LVEF in BMC group | (6) |
| Old ant. MI, 2007 NR |
12 | 27.2 ± 6.8 29.7 ± 7.3 |
11.3 ± 3 mo | None | BMC | 2.79 ± 0.89 × 107 | IC infusion | Improved LVEF and improved perfusion by scintigraphy | (78) |
| Old MI, 2007 NR |
10 | 35.2 ± 4.6 42.3 ± 5.1 |
12 mo | 1 pt. VT requiring ICD | BMC | 8.6 ± 3 × 107 | Catheter-based endomyocardial injection | Improved LVEF | (25) |
| Old MI, 2007 NR |
15 | 23 ± 8 27 ± 9 |
3 mo | 1 death | BMC | 9.4 ± 1.4 × 107 | Catheter-based endomyocardial injection | Improved LVEF | (14) |
| Old MI + ischemic CMP, 2008 NR |
14 | 35 ± 10 37 ± 9 |
4 yr | 3 deaths | Skeletal myoblasts | 2.06 (1.5–2.94) × 107 | Catheter-based endomyocardial injection | No improvement in LVEF and tissue Doppler indices | (135) |
| Old MI + ischemic CMP, 2007 NR |
11 | 19 ± 1 19 ± 2 |
4 mo | 1 death, 1 pt VT requiring ICD | BMC | 2.5 × 107 | IC infusion | No improvement in LVEF and WMSI | (107) |
| Old MI + ischemic CMP, 2008 R |
97 | High dose: 29.6 → 35.1 Low dose: 25.2 → 32.3 Placebo: 28.7 → 32.5 |
6 mo | 5 deaths, VT all pts. prophylactic CD | Skeletal myoblasts: 30 high dose 33 low dose 34 placebo |
High dose: 8 × 108 Low dose: 4 × 108 |
CABG + epicardial injection | No difference in LVEF between groups, more arrhythmia in myoblast groups | (83) |
Ant, anterior; BMC, bone marrow–derived mononuclear cell; CABG, coronary artery bypass surgery; CPC, circulating progenitor cell; CMP, cardiomyopathy; d, day; Dec, decreased; DSE, dobutamine stress echocardiography; Echo, echocardiography; EF, ejection fraction; EMM, electromechanical mapping; FDG-PET, fluorodeoxyglucose positron emission tomography; HT, heart transplantation; IC, intracoronary; ICD, internal cardiac defibrillator; LV, left ventricular; LVEF, left ventricular ejection fraction; MI, myocardial infarction; MRI, magnetic resonance imaging; mo, month; n.a., not applicable; NR, nonrandomized; NSVT, nonsustained ventricular tachycardia; Pts, patients; R, randomized; SAE, serious adverse event; SCD, sudden cardiac death; tx, therapy; vs., versus; VT, ventricular tachycardia; WMSI, wall-motion score index; yr, year.