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. 2015 Sep 30;2015(9):CD006536. doi: 10.1002/14651858.CD006536.pub4

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
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
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)
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
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 All outcomes Unclear risk 10 randomised participants were withdrawn or excluded from the analysis of all outcomes, 2/92 in the BMSC group (1 emigrated to another country and one could not follow up due to economic change) and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