Table 2.
Heart Failure (HF) Major Clinical Trials
| Study | Patients (treated/control) | Cell Type | Route | Time Post-MI | Imaging Technique | Follow-Up (months) | Outcomes in Treated Group |
|---|---|---|---|---|---|---|---|
| Tse66 | 8/0 | BMC | Transendocardial | Not reported | SPECT | 3 | Decreased angina, + safety outcomes, No change in EF |
| Fuchs67 | 10/0 | BMC | Transendocardial | Not reported | SPECT | 3 | Decreased angina, + safety outcomes, No change in EF |
| Perin68 | 14/7 | BMC | Transendocardial | Not reported | Echo, SPECT | 4 | Improved EF by 9 % & volumes, + safety outcomes |
| Stamm69 | 12/0 | BMC enriched for CD133+ | IM with CABG | 1–4 months | SPECT | 10 | Improved EF by 9 %, Improved perfusion, + safety outcomes |
| Erbs70 | 13/13 | G-CSF mobilized EPC | IC | >7 months | Cardiac MRI | 3 | Improved EF by 14 % & infarct size |
| Patel71 | 10/10 | BMC enriched for CD34+ | IM with CABG | Not reported | Echo, SPECT, LV angiogram | 6 | Improved EF by 16 % |
| IACT72 | 18/18 | BMC | IC | 5 months–8.5 years | LV angiogram | 3 | Improved EF by 15 % & infarct size |
| TOPCARE-CHD73 | 28 vs. 24/23 | BMC vs. EPC | IC | > 3 months | LV angiogram | 3 | Improved EF by 2.9 % in BMC group |
| Hendrikx74 | 10/10 | BMC | IM with CABG | 2–12 months | Cardiac MRI | 4 | Improved contractile function, No difference in EF |
| PROTECT-CAD75 | 19/9 | BMC | Transendocardial | Not reported | Cardiac MRI, SPECT | 6 | Improved EF by 5.4 %, Improved functional class, + safety outcomes |
| Ang76 | 21 vs. 21/20 | BMC | IM vs. IC | > 6 weeks | DSE, Cardiac MRI | 6 | No difference in EF or scar size |
| Yao77 | 24/23 | BMC | IC | > 4 months | Echo, Cardiac MRI, SPECT | 6 | Improved diastolic function, No change in EF |
| CAuSMIC78 | 12/11 | SMB | Transendocardial | > 1 month | Echo, Questionnaire | 12 | Improved viability & functional class, + safety outcomes (EF not studied) |
| STAR-Heart79 | 191/200 | BMC | IC | 5–11 years | LV angiogram | 5 years | Improved EF by 7.4 %, Decreased mortality |
| PRECISE80 | 21/6 | ASC | Transendocardial | Not reported | MRI, SPECT, Echo | 18 | Improved infarct size & functional capacity, + safety outcomes, No increase in EF |
| ACT-3481 | 167/0 | CD34+ | IM | Not reported | ETT, SPECT, Questionnaire | 12 | Improved angina frequency & exercise tolerance (EF not studied) |
| SCIPIO82,83 | 20/13 | CSC | IC | Not reported | Echo, Cardiac MRI, Questionnaire | Ongoing | Improved EF by 8.1 % at 1 year & 12.9 % at 2 years, Decreased scar size, Improved functional class, + safety outcomes |
| CADUCEUS84 | 17/8 | CDC | IC | 1.5–3 months | Cardiac MRI | 6 | Improved scar size and contractility, + safety outcomes, No difference in EF |
| FOCUS-CCTRN85 | 61/31 | BMC | Transendocardial | Not reported | SPECT | Ongoing | No difference in LVESV at 6 months (EF was not a pre-specified endpoint) |
| POSEIDON86 | 15 vs. 15 | MSC Allogeneic vs. Autologous | Transendocardial | 0.2–32 years | Cardiac CT | 13 | + safety outcomes, Improved functional class & ventricular remodeling, No change in EF |
HF heart failure; BMC bone marrow-derived cells; SPECT single photon emission computed tomography; + positive; EF ejection fraction; Echo echocardiogram; IM intramuscular; CABG coronary artery bypass graft; G-CSF granulocyte colony stimulating factor; EPC endothelial progenitor cells; IC intracoronary; MRI Magnetic Resonance Imaging; LV left ventricular; DSE dobutamine stress echocardiogram; SMB skeletal myoblasts; ASC adipose-derived stem cells; ETT exercise tolerance testing; CSC cardiac stem cells; CDC cardiosphere-derived cells; MSC mesenchymal stem cells; CT computed tomography