Summary of published clinical trials treating myocardial infarction with cellular therapies
| Name of study or authors . | Cell type . | Delivery method . | Cell isolation/purification . | Diagnosis . | No. of patients (exp/control) . | Safety and adverse events . | Other observations . | Length of study . |
|---|---|---|---|---|---|---|---|---|
| Zohlnhofer et al14 | G-CSF to mobilize bone marrow | SC | NA | Acute MI | 56/58 | Safe | No significant effects | 4-6 mo |
| STEMMI; Ripa et al15 | G-CSF to mobilize bone marrow | SC | NA | Acute ST-elevation MI | 36/36 | Safe | No significant effects | 6 mo |
| Huttmann et al16 | G-CSF to mobilize bone marrow | SC | NA | Chronic heart disease | 9 ICM/8 ICM controls | ICM may risk increased angina and arrhythmia | 4 DCM and 5 ICM NYHA improvement and increased 6-min walking distance | 6 mo |
| Valgimigli et al17 | G-CSF to mobilize bone marrow | SC | NA | Acute MI | 7/7 | Safe | LVEF up, EDV down | 3, 6 mo and follow-up |
| REPAIR-AMI; Schachinger et al18 | BMCs or PBSCs | ICI | Ficoll density gradient sedimentation | Acute MI | 103/101 | Safe | LVEF up, ESV down, improved contractility at 4 mo; lower mortality, recurrence, and procedures at 1 y | 4 mo, 1 y |
| TOPCARE-AMI; Schachinger et al19 | BMCs or PBSCs | ICI | Ficoll density gradient sedimentation | Acute MI | 30 PBSC and 29 BMC | Safe | LVEF up, ESV down, reduced infarct size | 1 y |
| MAGIC; Kang et al20 | G-CSF mobilized PBSCs | ICI | COBE Spectra Apheresis System | Reperfused MI | 10 PBSC, 10 G-CSF only/7 control | G-CSF alone caused complications | LVEF up, better perfusion and exercise time | 6 mo |
| Archundia et al21 | G-CSF mobilized PBSCs | IMI in old infarct | Baxter closed circuit apheresis | Old MI | 5/10 | Safe | Improved contractility | 28-52 wk |
| Yaoita et al22 | BMCs or G-CSF mobilized PBSCs | IMI | BMCs: Not specified/PBSCs: apheresis | Ischemic heart disease | 10 | Safe | Increased perfusion | Up to 32 mo |
| Assmus et al23 | BMCs or PBSCs | ICI | Ficoll density gradient sedimentation | Healed MI | 24 PBSC, 28 BMC/23 control with crossover | Safe | With BMCs or crossover, LVEF up, improved contractility and NYHA; with PBSCs, no significant improvements | 3 mo, 3 mo crossover |
| Lunde et al24 | BMCs | ICI | Ficoll density gradient sedimentation | Acute MI | 47/50 | Safe | No significant effects on global left ventricular function | 3 wk, 6 mo |
| BOOST; Meyer et al25 | BMCs | ICI | Gelatin-polysuccinate density gradient sedimentation | Acute MI | 30/30 | LVEF normal at 18 mo | LVEF up at 6 months | 6-18 mo |
| Janssens et al26 | BMCs | ICI | Ficoll density gradient sedimentation | Acute ST-elevation MI | 33/34 | Safe | Smaller infarcts, improved recovery of systolic functions | 4 mo |
| Fernandez-Aviles et al27 | BMCs | ICI | Ficoll density gradient sedimentation | Reperfused MI | 20/13 | Safe | LVEF up, ESV down, wall thickening | 6 mo |
| IACT; Strauer et al28 | BMCs | ICI | Ficoll density gradient sedimentation | Chronic coronary artery disease | 18/18 | Safe | LVEF up, O2 consumption up, viability up, increased WMV, smaller infarct | 3 mo |
| Dohmann et al29 | BMCs | IMI | Ficoll density gradient sedimentation | Ischemic heart failure | 14/7 | Safe | LVEF up, ESV down, smaller infarct, NYHA score improvement | 6 mo |
| Ruan et al30 | BMCs | ICI | Not specified | Acute MI | 9/11 | Safe | LVEF up, EDV up, ESV down | 3 mo |
| Strauer et al31 | BMCs | ICI | Ficoll density gradient sedimentation | Acute MI | 10/10 | Safe | LVEF up, WMV up, ESV down increased perfusion | 3 mo |
| Perin et al32 | BMCs | IMI | Ficoll density gradient sedimentation | Ischemic cardiomyopathy | 11/9 | Safe | NYHA and CCS angina scores improved, exercise capacity up, perfusion up | 6, 12 mo |
| Hamano et al33 | BMCs | IMI | COBE Spectra Apheresis System | Ischemic heart disease | 5 | Safe | Perfusion up in 3/5 | 1 y |
| Silva et al34 | BMCs | IMI | Ficoll density gradient sedimentation | Patients listed for heart transplantation | 5 | Safe | O2 consumption up, perfusion up, exercise improved, 4/5 no longer needed heart transplant | 6 mo |
| Tse et al35 | BMCs | IMI | Ficoll density gradient sedimentation | Ischemic myocardium | 8 | Safe | Improved perfusion, WMV, and function at infarct | 3 mo |
| Fuchs et al36 | BMCs | IMI | Ficoll density gradient sedimentation | Advanced coronary artery disease | 10 | Safe | CCS angina score improved, stress-induced ischemia improved | 3 mo |
| Bartunek et al37 | CD133+ BMCs | ICI | Ficoll and anti-CD133 MACs | Recent MI | 19/16 | Various coronary complications | LVEF up, ESP/ESV ratio up, perfusion up, viability up, LVEDV down | 4 mo |
| Stamm et al38 | CD133+ BMCs | IMI | Ficoll and anti-CD133 MACs | Patients undergoing LAVD | 6 | Safe | Improved LVEF in 4/6 and perfusion in 5/6 | 3-9 mo |
| Chen et al39 | MSCs | ICI | Percoll density gradient sedimentation | Acute MI | 34/35 | Safe | LVEF up, LVEDV and ESV down, WMV up, perfusion up, better electromechanics | 3 mo |
| Katritsis et al40 | MSCs + EPCs | ICI | Ficoll and plastic adherence | Infarcted myocardium | 11/11 | Safe | Improved contractility, lower wall motion score, increased viability | 4 mo |
| Menasche et al41 | Skeletal myoblasts | IMI | Biopsy dissociation and plastic culture | Postinfarct left ventricle dysfunction | 10 | Arrhythmia | LVEF up, scar thickening, NYHA score improvement | 10.9 mo |
| Pagani et al42 | Skeletal myoblasts | IMI | Biopsy dissociation and plastic culture | Ischemia-damaged myocardium | 5 | Arrhythmia | More blood vessels | 68, 91, 144, and 191 d |
| Herreros et al43 | Skeletal myoblasts | IMI | Biopsy dissociation and plastic culture | Nonacute MI | 12 | Safe | LVEF up, viability up, contractility improved | 3 mo |
| Name of study or authors . | Cell type . | Delivery method . | Cell isolation/purification . | Diagnosis . | No. of patients (exp/control) . | Safety and adverse events . | Other observations . | Length of study . |
|---|---|---|---|---|---|---|---|---|
| Zohlnhofer et al14 | G-CSF to mobilize bone marrow | SC | NA | Acute MI | 56/58 | Safe | No significant effects | 4-6 mo |
| STEMMI; Ripa et al15 | G-CSF to mobilize bone marrow | SC | NA | Acute ST-elevation MI | 36/36 | Safe | No significant effects | 6 mo |
| Huttmann et al16 | G-CSF to mobilize bone marrow | SC | NA | Chronic heart disease | 9 ICM/8 ICM controls | ICM may risk increased angina and arrhythmia | 4 DCM and 5 ICM NYHA improvement and increased 6-min walking distance | 6 mo |
| Valgimigli et al17 | G-CSF to mobilize bone marrow | SC | NA | Acute MI | 7/7 | Safe | LVEF up, EDV down | 3, 6 mo and follow-up |
| REPAIR-AMI; Schachinger et al18 | BMCs or PBSCs | ICI | Ficoll density gradient sedimentation | Acute MI | 103/101 | Safe | LVEF up, ESV down, improved contractility at 4 mo; lower mortality, recurrence, and procedures at 1 y | 4 mo, 1 y |
| TOPCARE-AMI; Schachinger et al19 | BMCs or PBSCs | ICI | Ficoll density gradient sedimentation | Acute MI | 30 PBSC and 29 BMC | Safe | LVEF up, ESV down, reduced infarct size | 1 y |
| MAGIC; Kang et al20 | G-CSF mobilized PBSCs | ICI | COBE Spectra Apheresis System | Reperfused MI | 10 PBSC, 10 G-CSF only/7 control | G-CSF alone caused complications | LVEF up, better perfusion and exercise time | 6 mo |
| Archundia et al21 | G-CSF mobilized PBSCs | IMI in old infarct | Baxter closed circuit apheresis | Old MI | 5/10 | Safe | Improved contractility | 28-52 wk |
| Yaoita et al22 | BMCs or G-CSF mobilized PBSCs | IMI | BMCs: Not specified/PBSCs: apheresis | Ischemic heart disease | 10 | Safe | Increased perfusion | Up to 32 mo |
| Assmus et al23 | BMCs or PBSCs | ICI | Ficoll density gradient sedimentation | Healed MI | 24 PBSC, 28 BMC/23 control with crossover | Safe | With BMCs or crossover, LVEF up, improved contractility and NYHA; with PBSCs, no significant improvements | 3 mo, 3 mo crossover |
| Lunde et al24 | BMCs | ICI | Ficoll density gradient sedimentation | Acute MI | 47/50 | Safe | No significant effects on global left ventricular function | 3 wk, 6 mo |
| BOOST; Meyer et al25 | BMCs | ICI | Gelatin-polysuccinate density gradient sedimentation | Acute MI | 30/30 | LVEF normal at 18 mo | LVEF up at 6 months | 6-18 mo |
| Janssens et al26 | BMCs | ICI | Ficoll density gradient sedimentation | Acute ST-elevation MI | 33/34 | Safe | Smaller infarcts, improved recovery of systolic functions | 4 mo |
| Fernandez-Aviles et al27 | BMCs | ICI | Ficoll density gradient sedimentation | Reperfused MI | 20/13 | Safe | LVEF up, ESV down, wall thickening | 6 mo |
| IACT; Strauer et al28 | BMCs | ICI | Ficoll density gradient sedimentation | Chronic coronary artery disease | 18/18 | Safe | LVEF up, O2 consumption up, viability up, increased WMV, smaller infarct | 3 mo |
| Dohmann et al29 | BMCs | IMI | Ficoll density gradient sedimentation | Ischemic heart failure | 14/7 | Safe | LVEF up, ESV down, smaller infarct, NYHA score improvement | 6 mo |
| Ruan et al30 | BMCs | ICI | Not specified | Acute MI | 9/11 | Safe | LVEF up, EDV up, ESV down | 3 mo |
| Strauer et al31 | BMCs | ICI | Ficoll density gradient sedimentation | Acute MI | 10/10 | Safe | LVEF up, WMV up, ESV down increased perfusion | 3 mo |
| Perin et al32 | BMCs | IMI | Ficoll density gradient sedimentation | Ischemic cardiomyopathy | 11/9 | Safe | NYHA and CCS angina scores improved, exercise capacity up, perfusion up | 6, 12 mo |
| Hamano et al33 | BMCs | IMI | COBE Spectra Apheresis System | Ischemic heart disease | 5 | Safe | Perfusion up in 3/5 | 1 y |
| Silva et al34 | BMCs | IMI | Ficoll density gradient sedimentation | Patients listed for heart transplantation | 5 | Safe | O2 consumption up, perfusion up, exercise improved, 4/5 no longer needed heart transplant | 6 mo |
| Tse et al35 | BMCs | IMI | Ficoll density gradient sedimentation | Ischemic myocardium | 8 | Safe | Improved perfusion, WMV, and function at infarct | 3 mo |
| Fuchs et al36 | BMCs | IMI | Ficoll density gradient sedimentation | Advanced coronary artery disease | 10 | Safe | CCS angina score improved, stress-induced ischemia improved | 3 mo |
| Bartunek et al37 | CD133+ BMCs | ICI | Ficoll and anti-CD133 MACs | Recent MI | 19/16 | Various coronary complications | LVEF up, ESP/ESV ratio up, perfusion up, viability up, LVEDV down | 4 mo |
| Stamm et al38 | CD133+ BMCs | IMI | Ficoll and anti-CD133 MACs | Patients undergoing LAVD | 6 | Safe | Improved LVEF in 4/6 and perfusion in 5/6 | 3-9 mo |
| Chen et al39 | MSCs | ICI | Percoll density gradient sedimentation | Acute MI | 34/35 | Safe | LVEF up, LVEDV and ESV down, WMV up, perfusion up, better electromechanics | 3 mo |
| Katritsis et al40 | MSCs + EPCs | ICI | Ficoll and plastic adherence | Infarcted myocardium | 11/11 | Safe | Improved contractility, lower wall motion score, increased viability | 4 mo |
| Menasche et al41 | Skeletal myoblasts | IMI | Biopsy dissociation and plastic culture | Postinfarct left ventricle dysfunction | 10 | Arrhythmia | LVEF up, scar thickening, NYHA score improvement | 10.9 mo |
| Pagani et al42 | Skeletal myoblasts | IMI | Biopsy dissociation and plastic culture | Ischemia-damaged myocardium | 5 | Arrhythmia | More blood vessels | 68, 91, 144, and 191 d |
| Herreros et al43 | Skeletal myoblasts | IMI | Biopsy dissociation and plastic culture | Nonacute MI | 12 | Safe | LVEF up, viability up, contractility improved | 3 mo |
G-CSF indicates granulocyte colony-stimulating factor; SC, subcutaneous; NA, not applicable; MI, myocardial infarcttion; ICM, ischemic cardiomyopathy; DCM, dilated cardiomyopathy; NYH, New York Heart Association; LVEF, left ventricular ejection fraction; EDV, end-diastolic volume; BMCs, bone marrow mononuclear cells; PBSCs, peripheral blood stem cells; ICI, intracoronary injection; ESV, end-systolic volume; IMI, intramyocardial injection; WMV, wall movement velocity; CCS, Canadian Cardiovascular Society; MACs, magnetic-assisted cell sorting; LAVD, left ventricular assist device; MSCs, mesenchymal stem cells or multipotent stromal cells; EPCs, endothelial progenitor cells.