The quality of evidence is downgraded by study limitations (unclear allocation concealment), and by imprecise results (few outcome events).
A Cochrane review [Abstract] 1 included 38 studies with a total of 1 907 participants. The studies comparied autologous adult stem/progenitor cells with no cells in people with chronic ischaemic heart disease and congestive heart failure. Fourteen studies included participants with chronic ischaemic heart disease (IHD), 17studies included participants with congestive heart failure (CHF), and 7 studies were of people with intractable or refractory angina. Co-interventions, such as primary angioplasty, surgery, or administration of stem cell mobilising agents were included, when administered to treatment and control arms equally. All studies maintained participants with a standard set of drugs including aspirin, clopidogrel, heparin, blockers, statins, angiotensin converting enzyme (ACE) inhibitors, nitrates, and/or diuretics. Thirteen studies administered the treatment via a coronary artery (intracoronarily,IC), and 24 studies delivered the treatment intramyocardially (IM). Twenty-five studies compared cell therapy with administration of a placebo consisting of a cell-free solution, 2 studies used a simulated mock injection procedure for participants in the control arm without placebo solution, and 11 studies compared treatment to no treatment.
Cell therapy reduced the incidence of long-term mortality (≥ 12 months) (table T1). Periprocedural adverse events associated with the mapping or cell/placebo injection procedure were infrequent. Cell therapy was also associated with a long-term reduction in the incidence of non-fatal myocardial infarction and incidence of arrhythmias. Cell therapy did not affect the risk of rehospitalisation for heart failure or composite incidence of mortality, non-fatal myocardial infarction, and/or rehospitalisation for heart failure (MACE), or long-term left ventricular ejection fraction when measured by magnetic resonance imaging, although it was associated with an improvement in LVEF measured by MRI at short-term follow-up.
| Outcome | Relative effect (95% CI) | Assumed risk (Control) | Corresponding risk (Cell therapy) | Participants (studies) |
|---|---|---|---|---|
| Mortality - Long-term follow-up (≥ 12 months) | RR 0.42 (0.21 to 0.87) | 102 per 1000 | 43 per 1000(21 to 89) | 491 (9 studies) |
| Non-fatal myocardial infarction - Long-term follow-up (≥ 12 months) | RR 0.38 (0.15 to 0.97) | 83 per 1000 | 31 per 1000(12 to 80) | 345 (5 studies) |
| Rehospitalisation due to heart failure - Long-term follow-up (≥ 12 months) | RR 0.63 (0.36 to 1.09) | 155 per 1000 | 98 per 1000(56 to 169) | 375 (6 studies) |
| Arrhythmias- Long-term follow-up (≥ 12 months) | RR 0.42 (0.18 to 0.99) | 333 per 1000 | 140 per 1000(60 to 330) | 82 (1 study) |
| Composite MACE*- Long-term follow-up (≥ 12 months) | RR 0.64 (0.38 to 1.08) | 350 per 1000 | 224 per 1000(133 to 378) | 141 (3 studies) |
| LVEF** (%) measured by MRI- Long-term follow-up (≥ 12 months) | MD 1.6 lower (8.7 lower to 5.5 higher) | 25 (1 study) | ||
| * MACE = major adverse clinical events (composite incidence of mortality, non-fatal myocardial infarction, and/or rehospitalisation for heart failure); **LVEF = left ventricular ejection fraction | ||||
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