Zhukova 2009.

Methods	Type of study: parallel RCT Type of publication: full Source of funding: not reported Country of origin: Russia Number of centres: 1 Dates of trial enrolment: not reported Length of follow‐up: 36 months Number (N) of participants randomised to each arm: 8 in treatment arm/3 in control arm Number (N) of participants analysed (primary outcome) in each arm: 8 at 1 year, 6 at 3 years in treatment arm/2 at 1 year, 1 at 3 years in control arm
Participants	Population: MI of the front wall and low EF (< 38%). Males with systolic dysfunction who had successful reperfusion therapy (thrombolysis and/or urgent angioplasty) Age, mean (SD) each arm: 48 (7) years in treatment arm, 50 (10) years in control arm Sex, % male in each arm: 100% in treatment arm/100% in control arm Number of diseased vessels: not reported Number of stunned hyperkinetic, etc segments: not reported Time from symptom onset to initial treatment: PCI within 6.5 (3) hours of AMI in treatment arm/PCI within 6.2 (2) hours of AMI in control arm 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: 50 to 80 mL bone marrow was aspirated and centrifuged to obtain the mononuclear cells. These were re‐suspended into autologous patient serum Dose of stem cells: 2 to 5 mL portions for a total of 20 mL; 5 x 106 BMMNC Timing of stem cell procedure: 14 to 19 days after AMI Comparator arm: no additional therapy (control)
Outcomes	Primary outcomes: none Secondary outcomes: mortality, morbidity, QOL, LVEF, LVEDV, LVESV, perfusion defect, myocardial viability Outcome assessment points: baseline, 3, 6, 12, 24 and 36 months Method(s): echocardiography, SPECT, gadolinium‐based MRI
Notes	Translated from Russian
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The trial was described as randomised but the method of randomisation was not reported
Allocation concealment (selection bias)	Unclear risk	The use of envelopes was mentioned, but insufficient detail was provided to establish whether appropriate allocation concealment was used
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 clinicians were blinded. Blinding of outcome assessors was not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	All randomised participants were included in the analysis of clinical outcomes and of scientific outcomes at 3 months. In MRI and echocardiographic analysis at 12 months follow‐up, 1 control patient had died, and at 3 years follow‐up 1 further control and 2 patients in the BMSC group had died
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

AE, adverse events; AMI, acute myocardial infarction; ASTAMI, Autologous Stem Cell Transplantation in Acute Myocardial Infarction; BM, bone marrow; BMMNC, bone marrow‐derived mononuclear cells; BMSC, bone marrow‐derived stem cells; CFU, colony forming units; CMR, cardiac magnetic resonance; DMEM, Dulbecco's modified Eagle's medium; DTI, Doppler tissue imaging; ECG, electrocardiogram; Echo, echocardiography; EDV, end diaslotic volume; EF, ejection fraction; ESV, end systolic volume; FACS, fluorescence‐activated cell sorting; FBS, fetal bovine serum; G‐CSF, granulocyte colony stimulating factor; GMP, good manufacturing procedures; HF, heart failure; ICD, internal cardia defibrillator; IQR, interquartile range; IRA, infarct‐related artery; IVUS, intravascular ultrasound; LAD, left anterior descending; LSM, lymphocyte separation medium; LV, left ventricle or ventricular; LVDV, left ventricular diastolic volume; LVEDD, left ventricular end diastolic diameter; LVEDV, left ventricular end‐diastolic volume; LVEDVI, left ventricular end diastolic volume index; LVEF, left ventricular ejection fraction; LVESV, left ventricular end‐systolic volume; LVESVI, left ventricular end systolic volume index; MBM, creatine kinase‐MB mass; MLHFQ, Minnesota Living with Heart Failure Questionnaire; MNC, mononuclear cells; MRI, magnetic resonance imaging; MSC, mesenchymal stromal cells; NNYHA, New York Heart Association; PBS, phosphate buffered saline; PCI, percutaneous coronary intervention; PET, positron emission tomography; PTCA, percutaneous transmural coronary angioplasty; QoL, quality of life; RCT, randomised controlled trial; RNV, radionuclide ventriculography; SD, standard deviation; SEM, standard error of the mean; SPECT, single photon emission computed tomography; STEMI, ST‐elevation myocardial infarction; VMC, vasomotor centre; WMSI, wall motion score index.