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

Affiliated Hospital of North Sichuan Medical College

Status and phase: Completed; Phase 3; Phase 2

Conditions: Myocardial Infarction

Treatments: Drug: Best medical treatment; Biological: Bone marrow mesenchymal stem cells transfer; Procedure: Percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04421274

ScPHFPC-100306

Details and patient eligibility

About

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） .

Full 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).

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

43 participants in 2 patient groups

BM-MSCs group

Experimental group

Description:

Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery )

Treatment:

Biological: Bone marrow mesenchymal stem cells transfer

Drug: Best medical treatment

Procedure: Percutaneous coronary intervention

Control group

Sham Comparator group

Description:

Receive the best medication, percutaneous coronary intervention

Treatment:

Drug: Best medical treatment

Procedure: Percutaneous coronary intervention