Mansour 2011.
Trial name or title | Comparison of intracoronary injection of CD133+ bone marrow stem cells to placebo in patients after acute myocardial infarction (COMPARE‐AMI) |
Methods |
Type of study: parallel RCT
Source of funding: fonds de la recherche en santé du Québec, Miltenyi Biotec, Inc., and Boston Scientific in Canada Country of origin: Canada Number of centres: 1 Intended enrolment: not reported |
Participants |
Population: AMI
Age, mean (SD) each arm: 52.2 (8.9) years
Sex, % male in each arm: 90% male Number of diseased vessels: not reported Number of stunned hyperkinetic, etc segments: not reported Time from symptom onset to initial treatment: not reported Statistically significant baseline imbalances between the groups?: not reported |
Interventions |
Intervention arm: BMSC
Type of stem cells: bone marrow‐derived CD133‐positive cells
Summary of how stem cells were isolated and type and route of delivery: BM aspiration and separation of mononuclear cells using gradient centrifugation. CD133‐positive cells were immunomagnetically separated using the Clinimacs (Miltenyi)
Dose of stem cells: not reported
Timing of stem cell procedure: < 12 hours Comparator arm: saline and 10% autologous plasma |
Outcomes | Primary outcomes: safety and efficacy and functional effect of the treatment Secondary outcomes: not reported Outcome assessment points: baseline, 4 months and 12 months Method(s): echocardiography, MRI, LV angiography |
Starting date | — |
Contact information | — |
Notes | — |