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

Ge 2006.

Methods Type of study: parallel RCT
 Type of publication: full
 Source of funding: Shanghai Scientific Research Fund
Country of origin: China
 Number of centres: 1
Dates of trial enrolment: not reported
 Length of follow‐up: 6 months
 Number (N) of participants randomised to each arm: 10 in treatment arm/10 in control arm
 Number (N) of participants analysed (primary outcome) in each arm: 10 in treatment arm/10 in control arm
Participants Population: AMI, within 24 hours. PCI within 24 hours. Cell transplantation after successful PCI
 Age, mean (SD) each arm: 58 (11) years in treatment arm, 59 (8) years in control arm
 Sex, % male in each arm: 80% in treatment arm, 100% in control arm
Number of diseased vessels: 1:7, 2:2, 3:1 in treatment arm; 1:7, 2:3, 3:0 in control arm
 Number of stunned hyperkinetic, etc segments: not reported
 Time from symptom onset to initial treatment: 7.9 (3.8) hour in treatment arm/7.1(3.1) hour 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: bone marrow aspirate (40 mL). The method of cell separation was not reported. Cells were infused after successful PCI
 Dose of stem cells: a single dose of 4 x 107/mL mononuclear cells
 Timing of stem cell procedure: cells infused within 15 hours of onset of AMI
Comparator arm: 15 mL injection of bone marrow supernatant
Outcomes Primary outcomes: LVEF, LVEDD, myocardial perfusion defect
 Secondary outcomes: not listed
 Outcome assessment points: baseline, 1 week and 6 months
 Method(s): echocardiography
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised in a 1:1 ratio with the use of sequentially numbered, sealed envelopes
Allocation concealment (selection bias) Low risk Sequentially numbered, sealed envelopes were used
Blinding (performance bias and detection bias) 
 All outcomes Low risk Controls underwent bone marrow aspiration and received an injection of BM supernatant. The study states that clinical data were acquired and analysed in a 'blinded fashion' by clinicians who were blinded to the groups' identities
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised participants were included in the analysis of clinical outcomes 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