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

NCT01394432.

Trial name or title Endocardial mesenchymal stem cells implantation in patients after acute myocardial infarction (ESTIMATION Study)
Methods Type of study: parallel RCT
 Source of funding: not reported
Country of origin: Russia
 Number of centres: not reported
Intended enrolment: 50
Participants Population: AMI with successful PCI
 Age, mean (SD) each arm: not reported (30 to 75 years)
 Sex, % male in each arm: not reported
Number of diseased vessels: 1
 Number of stunned hyperkinetic, etc segments: not reported
 Time from symptom onset to initial treatment: not reported
 Statistically significant baseline imbalances between the groups?: not reported
Interventions Intervention arm: BM‐MSC
 Type of stem cells: bone marrow‐derived mesenchymal stem cells
 Summary of how stem cells were isolated and type and route of delivery: not reported, except for delivery using NOGA mapping
 Dose of stem cells: not reported
 Timing of stem cell procedure: 7 to 10 days after PCI
Comparator arm: placebo
Outcomes Primary outcomes: reduction of LVESV by 15%
 Secondary outcomes: death, Thrombosis, hospitalisation for HF, 6 min‐walk, BNP levels
 Outcome assessment points: baseline, 12 months
 Method(s): MRI
Starting date July 2011
Contact information Principal Investigator: Professor Evgeny Pokushalov, MD; State Research Institute of Circulation Pathology, Novosibirsk, Russian Federation, 630055
Notes Estimated completion date: November 2012