Traverse 2012.

Methods	Type of study: parallel RCT Type of publication: full Source of funding: National Heart, Lung, and Blood Institute under co‐operative agreement 5 UO1 HL087318‐04. Support for cell processing (Sepax) was provided by Biosafe SA Inc. Angioplasty catheters were provided by Boston Scientific Corporation Country of origin: USA Number of centres: 5 Dates of trial enrolment: 07/08 to 01/11 Length of follow‐up: 12 months Number (N) of participants randomised to each arm: 79 (day 3/day 7: 43/36) in the treatment arm, 41 (day 3/day 7: 24/17) in the control arm Number (N) of participants analysed (primary outcome) in each arm: 75 (day 3/day 7: 41/34) in the treatment arm, 37 (day 3/day 7: 22/15) in the control arm
Participants	Population: STEMI within 7 days Age, mean (SD) each arm: 55.6 (10.8) years (day 3) and 58.2 (11.3) years in the treatment arm, 57.0 (12.4) years (day 3) and 57.0 (8.0) years (day 7) in the control arm Sex, % male in each arm: 88.4% (day 3) and 86.1% (day 7) in the treatment arm, 87.5% (day 3) and 88.3% (day 7) in the control arm Number of diseased vessels: 1 or 2 Number of stunned hyperkinetic, etc segments: not reported Time from symptom onset to initial treatment: PCI to infusion: median 3.3 (IQR 2.8 to 3.8) days or median 7.4 (IQR 7.0 to 7.9) days in BMSC arm, median 3.2 (IQR 2.5 to 4.1) days or median 7.6 (IQR 7.0 to 8.3) days in the control arm. Statistically significant baseline imbalances between the groups? Higher peak creatine kinase and troponin levels among patients randomised to day 7 treatment group and lack of diabetes among patients randomised to day 7 placebo
Interventions	Intervention arm: BMMNC Type of stem cells: bone marrow‐derived mononuclear cells (MNC) Summary of how stem cells were isolated and type and route of delivery: patients underwent bone marrow aspiration on the morning of their treatment day, and BMCs were isolated using a closed, automated Ficoll cell processing system (Sepax, Biosafe) to ensure a uniform cellular product across centres Dose of stem cells: 1.50 x 108 cells Timing of stem cell procedure: 3 or 7 days post AMI Comparator arm: placebo (0.9% saline and 5% human serum albumin)
Outcomes	Primary outcomes: change in global LVEF and regional LV function (infarct and border zone) (day 7) and whether these changes were dependent on day of cell administration (day 3 versus day 7) Secondary outcomes: major adverse cardiovascular events, LV volumes, infarct size Outcome assessment points: 6 and 12 months Method(s): cardiac MRI
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A computer‐generated scheme randomly allocated eligible patients to an intervention time group (3 or 7 days post‐PCI), with subsequent randomisation after BM aspiration to BMC or placebo group by a computer‐generated scheme
Allocation concealment (selection bias)	High risk	The computer‐generated randomisation scheme was not blinded
Blinding (performance bias and detection bias) All outcomes	Low risk	All patients underwent bone marrow aspiration and control group patients were given an intracoronary injection of 5% human serum albumin in an identical volume of saline with a 100 μL of blood matching the appearance of an active cell preparation and thereby blinding the identity of the infusate being delivered. Blinding of outcome assessors was not reported although the trial was described as "double‐blind"
Incomplete outcome data (attrition bias) All outcomes	Low risk	All randomised participants were included in the analysis of clinical outcomes. 8 patients (BMSC: 4/79 versus placebo: 4/41) were not included in MRI analysis at 6 months. 1 patient in the BMSC group died due to subarachnoid haemorrhage after randomisation but before cell delivery, MRI was contraindicated in 2 BMSC patients and 1 control patient, and MRI was not performed (reason not reported) in 1 BMSC patient and 3 control patients
Selective reporting (reporting bias)	Low risk	All outcomes described in the trial protocol (www.clinicaltrials.gov: NCT00684021) were reported
Other bias	Low risk	None reported or identified