Intracoronary Human Wharton's Jelly- Derived Mesenchymal Stem Cells (WJ-MSCs) Transfer in Patients With Acute Myocardial Infarction (AMI) (WJ-MSC-AMI)
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|ClinicalTrials.gov Identifier: NCT01291329|
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : February 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|ST-Elevation Myocardial Infarction||Genetic: intracoronary human umbilical WJ-MSC transfer||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 2 Study of Intracoronary Human Wharton's Jelly- Derived Mesenchymal Stem Cells (WJ-MSCs) Transfer in Patients With ST-segment Elevation Acute Myocardial Infarction (AMI)|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||July 2012|
Wharton's jelly- Derived Mesenchymal Stem Cells Transfer
Genetic: intracoronary human umbilical WJ-MSC transfer
intracoronary infusion of WJ-MSCs or placebo medium into the infarct artery 4-7 days after successful reperfusion therapy.
- Quantify myocardium metabolic and perfusion measured by F-18-fluorodeoxyglucose (F-18-FDG) postremission tomography (PET) and 99 mTctetrofosmine single-photon (SPET), as well as global left ventricular ejection fraction measured by echocardiography. [ Time Frame: 4 months- 1 year ]The primary endpoints were differences between the two treatments and from baseline to 4 months in quantitative myocardial metabolic and perfusion images, as measured by 18F-FDG positron emission tomography and 99 mTctetrofosmine single-photon imaging. Left ventricular ejection fraction is measured by 16-segment 2-D echocardiography.
- Secondary endpoints: safety will be determined by the assessment of major adverse coronary events (MACE). [ Time Frame: 4 months-1year ]Safety will be determined by the assessment of major adverse coronary events (MACE) defined as cardiac death, peri-procedural myocardial infarction, or any repeat coronary intervention at 4 months-1year. Furthermore, safety is also determined by the occurrence of stent thrombosis, arrhythmias events. immune system disorders. The trial will be monitored by a Data and Safety Monitoring Board (DSMB) and the trial will be discontinued in case of safety concerns.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291329
|Fu Cheng Lu 6|
|Beijing, China, 100048|
|Study Chair:||Lian Ru Gao, MD||Cardiology Division of Navy General Hospital|