Yao 2006.
Methods |
Type of study: parallel RCT
Type of publication: full
Source of funding: National Key Technologies R & D Program of China Country of origin: China Number of centres: 1 Dates of trial enrolment: 05/03 to 12/05 Length of follow‐up: 30 months Number (N) of participants randomised to each arm: 92 in treatment arm/92 in control arm Number (N) of participants analysed (primary outcome) in each arm: 90 in treatment arm/84 in control arm |
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Participants |
Population: AMI within 1 week, PCI within 1 week
Age, mean (SD) each arm: 58.3 (9.5) years in treatment arm, 58.1 (9.0) years in control arm
Sex, % male in each arm: 89.1% in treatment arm, 88% in control arm Number of diseased vessels: 1 Number of stunned hyperkinetic, etc segments: not reported Time from symptom onset to initial treatment: PCI within 1 week of AMI in both arms 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: low temperature density gradient centrifugation of heparinised bone marrow cell suspension in lymphocyte isolation medium. PCI
Dose of stem cells: single 2.1(3.7) x 108 cells
Timing of stem cell procedure: infusion performed 2 hours after revascularisation Comparator arm: no additional therapy (control) |
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Outcomes |
Primary outcomes: morbidity, mortality and adverse events Secondary outcomes: LVEF, LVEDD Outcome assessment points: baseline, 6 and 30 months Method(s): echocardiography, LV angiography |
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Notes | Translated from Chinese (Mandarin) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | This Chinese trial was described as randomised but the method of randomisation was not reported |
Allocation concealment (selection bias) | High risk | Treatment allocation was not concealed |
Blinding (performance bias and detection bias) All outcomes | High risk | Controls did not undergo bone marrow aspiration and no placebo was administered; neither participants nor patients were blinded. It was not reported whether outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 10 randomised participants were withdrawn or excluded from the analysis of all outcomes, 2/92 in the BMSC group (1 emigrated to another country and one could not follow up due to economic change) and 8/92 in the control group (3 had changed address at 12 months, another 3 had changed address at 24 months, and a further 2 non‐local participants refused follow‐up) |
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 |