Jazi 2012.

Methods	Type of study: parallel RCT Type of publication: full Source of funding: not reported Country of origin: Iran Number of centres: 1 Dates of trial enrolment: 06/02 to 01/04 Length of follow‐up: 6 months Number (N) of participants randomised to each arm: not reported Number (N) of participants analysed (primary outcome) in each arm: 16 in the treatment arm, 16 in the control arm
Participants	Population: AMI within 1 month with a history of anterior MI and LVEF < 35% Age, mean (SD) each arm: 48.0 (SEM 2.5) years in treatment arm, 45.2 (SEM 3.2) years in control arm Sex, % male in each arm: 66% in treatment arm, 90% in control arm Number of diseased vessels: 1 Number of stunned hyperkinetic, etc segments: not reported Time from symptom onset to initial treatment: up to 1 month 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: bone marrow aspirates were obtained under local anaesthesia with a standard Jamshidi needle with heparin (50 U/mL) from posterior iliac crests. Bone marrow‐derived mononuclear cells (BMCs) were isolated by layering on a Ficoll‐Paque gradient. Cell populations included hematopoietic progenitor cells. A haemocytometer was used to estimate the number of nucleated cells in the final preparation of bone marrow cells. Nucleated cell viability was assessed by trypan blue exclusion. Nucleated cells were cultured in an M199 medium, 10% human serum supplemented with 50 ng/mL vascular endothelial growth factor (VEGF), 1 ng/mL basic fibroblast growth factor (bFGF), and 2 ng/mL insulin‐like growth factor‐1 (IGF‐1). The cells were incubated overnight at 37 ºC in a fully humidified atmosphere with 5% CO2. Then, cells were washed twice and re‐suspended in 5 mL human serum Dose of stem cells: (24.6 ± SEM 8.4) × 108 cells Timing of stem cell procedure: within 1 month of AMI, at the time of PCI Comparator arm: no additional therapy (control)
Outcomes	Primary outcomes: not reported Secondary outcomes: perfusion defects, regional wall motion of LV and LVEF, adverse events Outcome assessment points: 6 months Method(s): SPECT, echocardiography
Notes	—
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	Allocation concealment was not reported
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. Blinding of outcome assessors was not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The number of participants randomised to each treatment arm was unclear; the study states that 20 participants met the inclusion criteria but the analysis includes 16 participants in each group. It is therefore unclear how many patients were randomised to each treatment group. No details of patient withdrawal were reported
Selective reporting (reporting bias)	Unclear risk	All outcomes mentioned in the methods were reported in the results, although echocardiography measurements taken at 1 month were not reported. It would be difficult to rule out other selective reporting
Other bias	Low risk	None reported or identified