Effect studied	Model	Result	Reference
Safety and efficacy	Phase I clinical trial in patients (n = 5) with NYHA class greater than 2 and previous anterior wall MI administered 16 ± 4 injections each containing 16.6 × 106 SkM cells by trans-catheter delivery.	LVEF increased from 36 to 41 (at 3 months) and 45% (at 6 months) with increased wall thickness. No serious adverse events were observed. One patient had non-sustained ventricular tachycardia.	853498
Efficacy	Phase I clinical trial in patients (n = 5) with NYHA class greater than 2, reduced LVEF and a previous anterior wall MI administered 15 endocardial MyoStar injections each containing approximately 10 × 106 cells.	The mean NYHA class was 2.4 ± 0.9, 1.8 ± 0.4 and 2.2 ± 0.4 at baseline, 6 and 12 months, respectively. Cardiac output increased from 4.6 ± 0.9 l/min at baseline to 5.6 to 1.6 ± 1.6 and 5.4 ± 1.5 l/min at 6 and 12 months, respectively. Ejection fraction was significantly increased at 6 months (from 33 ± 7 to 41 ± 11%) and dP/dtmax was significantly increased at 12 months (from 1025 ± 236 to 1281 ± 328 mmHg/s). The end-systolic pressure-volume relationship was significantly reduced at 6 and 12 months (from 190 ± 95 to 150 ± 107 and 157 ± 75 ml, respectively). No serious adverse events were observed apart from two patients experiencing single episodes of non-sustained ventricular tachycardia.	920357
Efficacy and safety	Phase I clinical trial (MYOHEART) in patients (n = 20) with MI administered 2 to 27 injections of 25, 75, 225 and 675 × 106 SkM cells.	There was general but insignificant improvement in LVEF, quality-of-life score and the 6-min walk test. One out of five patients at the highest dose died and six patients experienced arrhythmias of which four were thought to be related to the treatment. Arthralgia, dizziness and pleural effusion were observed in one patient each.	954669
Efficacy and safety	Phase II clinical trial in patients (n = 46) with congestive heart failure post MI administered 6 to 32 injections of 150 to 800 × 106 SkM cells using the MyoCath catheter.	Over a 6-month period of the trial, 50% of the treatment-arm patients obtained some improvement in LVEF, while 57% of patients in the control group had a worsening of LVEF. At 6 months, 50% of the treated patients had improvement in NYHA class score compared with 25% of the control group. Observed adverse events following treatment were ventricular tachycardia in six patients, one death by multiple organ failure, one worsening of heart failure, one hematoma and one herpes zoster.	954661