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

A

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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