Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction

Phase 2

Completed

• Conditions: Myocardial Infarction
• Interventions: Biological: Bone marrow mesenchymal stem cells transfer; Drug: Best medical treatment; Procedure: Percutaneous coronary intervention

• Registration Number: NCT04421274
• Lead Sponsor: Affiliated Hospital of North Sichuan Medical College

Brief Summary

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） .

Detailed Description

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).

Study Timeline

• Study Start: 2008-05-01
• Primary Completion: 2010-07-10
• Study Completion: 2011-07-15
• Study First Submitted: 2020-05-14
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-05
• Last Update Submitted: 2020-06-05
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Age> 18 years old;
• Diagnosed acute ST-elevation myocardial infarction (STEMI)
• STEMI onset <1 month
• Successful vascular remodeling, blood flow of infarct-related blood vessels recovered to TIMI level 3
• All patients included in the study signed an informed consent form and promised to complete all follow-up plans

Exclusion Criteria

• Refractory persistent ventricular tachycardia
• High cardiac block and no pacemaker control
• Liver or renal dysfunction (ALT>80U/ L, Cr> 440mmol / L)
• Bleeding disorders, malignant tumors
• Autoimmune disease or any serious fatal disease
• Contraindications for coronary intervention
• Combined with other heart disease: congenital heart Disease (ventricular deficiency, atrial deficient, patent ductus arteriosus and other congenital alformations),primary valvular disease, active myocarditis, pulmonary heart disease,hyperthyroidism, mucous edema heart disease and so on
• Mental illness, no self-awareness, and no precise expression and cooperation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BM-MSCs group	Bone marrow mesenchymal stem cells transfer	Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
BM-MSCs group	Best medical treatment	Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
BM-MSCs group	Percutaneous coronary intervention	Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )
Control group	Percutaneous coronary intervention	Receive the best medication, percutaneous coronary intervention
Control group	Best medical treatment	Receive the best medication, percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
changes in myocardial metabolic activity	Baseline + after 6 months	changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
Changes in left ventricular ejection fraction (LVEF)	Baseline + after 12 months	Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.

Secondary Outcome Measures

Name	Time	Method
incidence of cardiovascular events	in 12 months after transplantation of autologous BM-MSCs	incidence of cardiovascular events
overall mortality	in 12 months after transplantation of autologous BM-MSCs	overall mortality
adverse events at 12 months after transplantation of autologous BM-MSCs	in 12 months after transplantation of autologous BM-MSCs	adverse events at 12 months after transplantation of autologous BM-MSCs

Trial Locations

Locations (1)

The Third Hospital of Mianyang; 🇨🇳 Mianyang, Sichuan, China