Trial | NCT04421274  Report issue

Title

Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction
Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    43
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） .
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 Started
May 01
2008
Primary Completion
Jul 10
2010
Study Completion
Jul 15
2011
Last Update
Jun 09
2020

Biological Bone marrow mesenchymal stem cells transfer

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

Drug Best medical treatment

Refer to the latest medication guidelines and give the best medication to the patients

Procedure Percutaneous coronary intervention

Percutaneous coronary intervention

BM-MSCs group Experimental

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

Control group Sham Comparator

Receive the best medication, percutaneous coronary intervention

Criteria 

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
No Results Posted