The Third Hospital of Mianyang
Mianyang, Sichuan, 0816, China
NCT Number: NCT04421274
To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction( STEMI) .
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Mianyang, Sichuan, 0816, China
To investigate the safety of intra-coronary injection of autologous bone marrow mesenchymal stem cells (BM-MSCs) in patients with ST-segment elevation myocardial infarction and its effect on cardiac function and viable myocardium. We plan to include approximately 40 patients with ST-segment elevation myocardial infarction as a research object, and conduct a randomized, single-blind, parallel-controlled multi-center clinical trial. The patients were randomly divided into a BM-MSCs group and a control group, and were given the best drug treatment and percutaneous coronary intervention (PCI). The primary study endpoint was the change in myocardial metabolic activity 6 months after autologous BM-MSCs transplantation and the change in left ventricular ejection fraction (LVEF) at 12 months; The incidence of adverse events. The above indexes were evaluated by cardiac color echocardiography and single photon emission computed tomography (SPECT).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inject the BM-MSCs into the infarct-related arterial hypertension through the central cavity of the guide wire balloon catheter under the complete blockage of the target blood vessel. Each time the balloon continues to fill for 2 minutes to block blood flow, then resume perfusion for 2 minutes. The above process is repeated 6 ~ 8 times
Refer to the latest medication guidelines and give the best medication to the patients
Percutaneous coronary intervention
Time frame: Baseline + after 6 months
changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
Time frame: Baseline + after 12 months
Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.
Time frame: in 12 months after transplantation of autologous BM-MSCs
incidence of cardiovascular events
Time frame: in 12 months after transplantation of autologous BM-MSCs
overall mortality
Time frame: in 12 months after transplantation of autologous BM-MSCs
adverse events at 12 months after transplantation of autologous BM-MSCs
Affiliated Hospital of North Sichuan Medical College
Other
Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial
Acronym: Bmmsct
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02425345
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT03161678
Cardiovascular Diseases, Embolism and Thrombosis
Lancaster, Pennsylvania, United States
View Trial DetailsNCT04123197
Cardiovascular Diseases, Heart Diseases
Atlanta, Georgia, United States
View Trial DetailsNCT05820295
Arrhythmias, Cardiac, Atrial Fibrillation
New York, United States
View Trial Details