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

Huang 2006.

Methods Type of study: parallel RCT
 Type of publication: full
 Source of funding: not reported
Country of origin: China
 Number of centres: 1 (assumed)
Dates of trial enrolment: 05/04 to 05/05
 Length of follow‐up: 6 months
 Number (N) of participants randomised to each arm: 20 in treatment arm/20 in control arm
 Number (N) of participants analysed (primary outcome) in each arm: 20 in treatment arm/20 in control arm
Participants Population: AMI, within 24 hours. PCI within 24 hours. Cell transplantation within 2 hours of successful PCI
 Age, mean (SD) each arm: 57.3 (10.1) years in treatment arm, 56.7 (9.2) years in control arm
 Sex, % male in each arm: 65% in treatment arm, 70% in control arm
Number of diseased vessels: not reported
 Number of stunned hyperkinetic, etc segments: not reported
 Time from symptom onset to initial treatment: 6.3 (4.2) hours in treatment arm/6.3 (3.9) hours in control arm
 Statistically significant baseline imbalances between the groups?: none
Interventions Intervention arm: BMSC
 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 (80 to 140 mL). Cells separated by gradient centrifugation. Cells re‐suspended in heparinised saline (with 0.9% NaCl) prior to transplantation. Intracoronary infusion using a microcatheter (Judkins method)
 Dose of stem cells: a single dose of 1.8 (4.2) x108/mL cells
 Timing of stem cell procedure: cells infused within 2 hours of successful PCI
Comparator arm: 15 mL of heparinised saline (with 0.9% NaCl)
Outcomes Primary outcomes: not reported
 Secondary outcomes: LVEF, LVEDV and infarct size measured by CMR imaging and LV arteriography
 Outcome assessment points: baseline, 1 week and 6 months
 Method(s): CMR imaging
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 Allocation concealment was not reported
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk The control group received a placebo but it was unclear whether they underwent bone marrow aspiration and therefore it was unclear whether they were appropriately blinded. Blinding of clinicians and outcome assessors was not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised participants were included in the analysis of clinical 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