Ge 2006.
Methods |
Type of study: parallel RCT
Type of publication: full
Source of funding: Shanghai Scientific Research Fund Country of origin: China Number of centres: 1 Dates of trial enrolment: not reported Length of follow‐up: 6 months Number (N) of participants randomised to each arm: 10 in treatment arm/10 in control arm Number (N) of participants analysed (primary outcome) in each arm: 10 in treatment arm/10 in control arm |
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Participants |
Population: AMI, within 24 hours. PCI within 24 hours. Cell transplantation after successful PCI
Age, mean (SD) each arm: 58 (11) years in treatment arm, 59 (8) years in control arm
Sex, % male in each arm: 80% in treatment arm, 100% in control arm Number of diseased vessels: 1:7, 2:2, 3:1 in treatment arm; 1:7, 2:3, 3:0 in control arm Number of stunned hyperkinetic, etc segments: not reported Time from symptom onset to initial treatment: 7.9 (3.8) hour in treatment arm/7.1(3.1) hour in control arm Statistically significant baseline imbalances between the groups?: none |
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Interventions |
Intervention arm: BMMNC
Type of stem cells: bone marrow‐derived stem cells (mononuclear cells‐MNC)
Summary of how stem cells were isolated and type and route of delivery: bone marrow aspirate (40 mL). The method of cell separation was not reported. Cells were infused after successful PCI
Dose of stem cells: a single dose of 4 x 107/mL mononuclear cells
Timing of stem cell procedure: cells infused within 15 hours of onset of AMI Comparator arm: 15 mL injection of bone marrow supernatant |
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Outcomes | Primary outcomes: LVEF, LVEDD, myocardial perfusion defect Secondary outcomes: not listed Outcome assessment points: baseline, 1 week and 6 months Method(s): echocardiography | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised in a 1:1 ratio with the use of sequentially numbered, sealed envelopes |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, sealed envelopes were used |
Blinding (performance bias and detection bias) All outcomes | Low risk | Controls underwent bone marrow aspiration and received an injection of BM supernatant. The study states that clinical data were acquired and analysed in a 'blinded fashion' by clinicians who were blinded to the groups' identities |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants were included in the analysis of clinical outcomes and scientific outcomes |
Selective reporting (reporting bias) | Unclear risk | All outcomes mentioned in the methods were reported in the results, although it would be difficult to rule out selective reporting |
Other bias | Low risk | None reported or identified |