Study Reference |
Study Design |
No of Patients |
Cell Dose |
Procedure Time |
Follow-Up |
Outcomes |
[106,119] (TOPCARE-AMI Trial) |
Randomized, controlled |
n=29 BMNC; n=30 CPC; n=11 Control |
7.35±7.31x106 CD34+/CD45+ Cells |
~4 days post-AMI |
4 months & 1 year |
Cell therapy significantly improved LVEF and WMS at border-zone. No significant difference between cell therapy groups. CFR normalized and viability in infarct-zone significantly increased with cell therapy. At 1 year LVEF and infarct size significantly improved with cell therapy. |
[105,109] (BOOST Trial) |
Randomised controlled |
n=30 BMNC; n=30 Control |
24.6x108 nucleated cells, 9.5x106 CD34+cells, 3.6x106 haemopoietic colony-forming cells |
~5 days post-AMI |
6 Months and 5 years |
LVEF and WMS at border-zone significantly improved in BMNC group vs. controls at 6 months. EDV, ESV, LV mass index and myocardial injury did not significantly differ from control. No significant difference in MACEs or restenosis at 5 years. No significant improvement in LVEF at 5 years. |
[103,104,110] (REPAIR-AMI Trial) |
Randomized, double-blind, placebo-controlled, multicentred |
n=101 BMNC; n=101 Control |
236±174x106 |
3-7 days post-PCI |
4 months & 1 year |
Significant improvement in LVEF and regional contractility in control and BMNC groups. Absolute change in LVEF significantly greater in BMNC vs. control. Inverse relationship between baseline and absolute change in LVEF in treatment group. Trend for increased contractile function in patients treated >4 days post-PCI. CFR normalized and vascular resistance decreased in treatment group. No MACEs at 1 year. |
[111] (REGENT Trial) |
Randomised controlled, Multicentered |
n=80 CD34+/CXCR4+ cells; n=80 BMNC; n=40 control |
1.90x106 CD34+/CXCR4+ cells; 1.78x108 BMNC |
7 days post-PCI |
6 Months |
Procedure is safe. No significant difference in absolute change in LVEF or EDV and ESV between groups. Inverse correlation between baseline LVEF and its change after cell therapy in patients treated with CD34+/CXCR4+ cells but not with BMNCs. Significant improvement in patients receiving any cell therapy when baseline LVEF was <median. No significant difference in MACEs or restenosis between groups. |