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

Myocardial Infarction Clinical Trial

— Bmmsct  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421274
• Other study ID #: ScPHFPC-100306
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 2008
• Est. completion date: July 15, 2011

Study information

• Verified date: June 2020
• Source: Af?liated Hospital of North Sichuan Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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） .

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 15, 2011
• Est. primary completion date: July 10, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
China	The Third Hospital of Mianyang	Mianyang	Sichuan

Sponsors (4)

Lead Sponsor	Collaborator
Af?liated Hospital of North Sichuan Medical College	Beijing Tongren Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in myocardial metabolic activity	changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)	Baseline + after 6 months
Primary	Changes in left ventricular ejection fraction (LVEF)	Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.	Baseline + after 12 months
Secondary	incidence of cardiovascular events	incidence of cardiovascular events	in 12 months after transplantation of autologous BM-MSCs
Secondary	overall mortality	overall mortality	in 12 months after transplantation of autologous BM-MSCs
Secondary	adverse events at 12 months after transplantation of autologous BM-MSCs	adverse events at 12 months after transplantation of autologous BM-MSCs	in 12 months after transplantation of autologous BM-MSCs