Study |
Study Design |
No of Patients |
Cell Dose |
Procedure Time |
Follow-Up |
Outcomes |
[120] (TOPCARE-CHD Trial) |
Randomized, controlled |
n=28 BMNC; n=24 CirPC; n=23 Control |
22x106 ± 11x106 CPCs; 205x106 ± 110x106 BMNCs |
≥3 months post-MI |
3 months |
No MACE from procedure. LVEF significantly improved in BMNC group only. No other functional benefit in either groups. Significant improvement in NYHA score in BMNC group only. |
[112] (STAR-heart Trial) |
Controlled |
n=191 BMNC; n=200 Control |
6.6±3.3x107 |
8.5±3.2 years post-MI |
5 years |
No MACE. Cell therapy significantly increased exercise capacity. Significant increase in LVEF & contractility with reduced infarct size in cell group. NYHA score significantly improved in cell group. Improvements maintained up to 5 years. Mortality rates significantly reduced in cell group at 5 years and significantly differed from controls. |
[113]
(FOCUS-HF Trial) |
Randomized, blinded, controlled |
n=20 BMNC; n=10 Control |
2 million |
Not Stated |
6 Months |
No MACE. Cell therapy had no significant effect on myocardial function. Downward trend in infarct size with cell therapy. QOL and CCS, but not NYHA scores significantly improved with cell therapy. BMNC dysfunction with presence of CHF and increased age (˃60 years). |